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1. In patients eligible for meniscal surgery who first receive physical therapy, multivariable prognostic models cannot predict who will eventually undergo surgery

Author: Noorduyn, J.C.A., Teuwen, M.M.H., Graaf, V.A. van de, Willigenburg, N.W., Schavemaker, M., Dijk, R. van, Scholten-Peeters, G.G.M., Heymans, M.W., Coppieters, M.W., Poolman, R.W., Scholtes, V.A.B., Mutsaerts, E.L.A.R., Wolkenfelt, J., Krijnen, M.R., Deurzen, D.F.P. van, Moojen, D.J.F., Bloembergen, C.H., Gast, A.G. de, Snijders, T., Halma, J.J., Saris, D.B.F., Wolterbeek, N., Neeter, C., Kerkhoffs, D.M.M.J., Peters, R.W., Brand, I.C.J.B. van den, Vos-Jakobs, S. de, Spoor, A.B., Gosens, T., Rezaie, W., Hofstee, D.J., Burger, B.J., Haverkamp, D., Vervest, A.M.J.S., Rheenen, T.A. van, Wijsbek, A.E., Arkel, E.R.A. van, Thomassen, B.J.W., Sprague, S., Mol, B.W.J., Tulder, M.W. van, Kraan, J. van der, Escape Res Grp, Surgery, Amsterdam Movement Sciences, Epidemiology and Data Science, APH - Methodology, APH - Personalized Medicine, Neuromechanics, AMS - Musculoskeletal Health, AMS - Rehabilitation & Development, Faculty of Behavioural and Movement Sciences, and APH - Societal Participation & Health
Subjects: medicine.medical_specialty, Knee Joint, Meniscal tears, Knee Injuries, Meniscus (anatomy), Logistic regression, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Knee, Meniscus, Orthopedics and Sports Medicine, In patient, 030212 general & internal medicine, Physical Therapy Modalities, Prognostic models, Aged, business.industry, 030229 sport sciences, Middle Aged, Prognosis, Explained variation, Tibial Meniscus Injuries, Surgery, medicine.anatomical_structure, Orthopedic surgery, Physical therapy, Prognostic model, business
Abstract: Purpose Although physical therapy is the recommended treatment in patients over 45 years old with a degenerative meniscal tear, 24% still opt for meniscal surgery. The aim was to identify those patients with a degenerative meniscal tear who will undergo surgery following physical therapy. Methods The data for this study were generated in the physical therapy arm of the ESCAPE trial, a randomized clinical trial investigating the effectiveness of surgery versus physical therapy in patients of 45–70 years old, with a degenerative meniscal tear. At 6 and 24 months patients were divided into two groups: those who did not undergo surgery, and those who did undergo surgery. Two multivariable prognostic models were developed using candidate predictors that were selected from the list of the patients’ baseline variables. A multivariable logistic regression analysis was performed with backward Wald selection and a cut-off of p Results At 6 months, 32/153 patients (20.9%) underwent meniscal surgery following physical therapy. Based on the multivariable regression analysis, patients were more likely to opt for meniscal surgery within 6 months when they had worse knee function, lower education level and a better general physical health status at baseline. At 24 months, 43/153 patients (28.1%) underwent meniscal surgery following physical therapy. Patients were more likely to opt for meniscal surgery within 24 months when they had worse knee function and a lower level of education at baseline at baseline. Both models had a low explained variance (16 and 11%, respectively) and an insufficient predictive accuracy. Conclusion Not all patients with degenerative meniscal tears experience beneficial results following physical therapy. The non-responders to physical therapy could not accurately be predicted by our prognostic models. Level of evidence III.
Published: 2021

2. A Machine Learning Algorithm to Identify Patients at Risk of Unplanned Subsequent Surgery After Intramedullary Nailing for Tibial Shaft Fractures

Author: Bhandari, M., Bulstra, A.E.J., Bzovsky, S., Doornberg, J.N., Goslings, J.C., Hendrickx, L.A.M., Jaarsma, R.L., Jeray, K.J., Kerkhoffs, G.M.M.J., Petrisor, B., Ring, D., Schemitsch, E.H., Swiontkowski, M., Sanders, D., Sprague, S., Tornetta, P., Walter, S.D., Heels-Ansdell, D., Buckingham, L., Leece, P., Viveiros, H., Mignott, T., Ansell, N., Sidorkewicz, N., Agel, J., Bombardier, C., Berlin, J.A., Bosse, M., Browner, B., Gillespie, B., Jones, A., O'Brien, P., Poolman, R., Macleod, M.D., Carey, T., Leitch, K., Bailey, S., Gurr, K., Konito, K., Bartha, C., Low, I., MacBean, L.V., Ramu, M., Reiber, S., Strapp, R., Tieszer, C., Kreder, H.J., Stephen, D.J.G., Axelrod, T.S., Yee, A.J.M., Richards, R.R., Finkelstein, J., Gofton, W., Murnaghan, J., Schatztker, J., Ford, M., Bulmer, B., Conlan, L., Laflamme, G.Y., Berry, G., Beaumont, P., Ranger, P., Laflamme, G.H., Gagnon, S., Malo, M., Fernandes, J., Poirier, M.F., McKee, M.D., Waddell, J.P., Bogoch, E.R., Daniels, T.R., McBroom, R.R., Vicente, M.R., Storey, W., Wild, L.M., McCormack, R., Perey, B., Goetz, T.J., Pate, G., Penner, M.J., Panagiotopoulos, K., Pirani, S., Dommisse, I.G., Loomer, R.L., Stone, T., Moon, K., Zomar, M., Webb, L.X., Teasdall, R.D., Birkedal, J.P., Martin, D.F., Ruch, D.S., Kilgus, D.J., Pollock, D.C., Harris, M.B., Wiesler, E.R., Ward, W.G., Shilt, J.S., Koman, A.L., Poehling, G.G., Kulp, B., Creevy, W.R., Stein, A.B., Bono, C.T., Einhorn, T.A., Brown, T.D., Pacicca, D., Sledge, J.B., Foster, T.E., Voloshin, I., Bolton, J., Carlisle, H., Shaughnessy, L., Obremskey, W.T., LeCroy, C.M., Meinberg, E.G., Messer, T.M., Craig, W.L., Dirschl, D.R., Caudle, R., Harris, T., Elhert, K., Hage, W., Jones, R., Piedrahita, L., Schricker, P.O., Driver, R., Godwin, J., Kregor, P.J., Tennent, G., Truchan, L.M., Sciadini, M., Shuler, F.D., Driver, R.E., Nading, M.A., Neiderstadt, J., Vap, A.R., Vallier, H., Patterson, B.M., Wilber, J.H., Wilber, R.G., Sontich, J.K., Moore, T.A., Brady, D., Cooperman, D.R., Davis, J.A., Cureton, B.A., Mandel, S., Orr, R.D., Sadler, J.T.S., Hussain, T., Rajaratnam, K., Drew, B., Bednar, D.A., Kwok, D.C.H., Pettit, S., Hancock, J., Cole, P.A., Smith, J.J., Brown, G.A., Lange, T.A., Stark, J.G., Levy, B.A., Garaghty, M.J., Salzman, J.G., Schutte, C.A., Tastad, L., Vang, S., Seligson, D., Roberts, C.S., Malkani, A.L., Sanders, L., Dyer, C., Heinsen, J., Smith, L., Madanagopal, S., Frantz-Bush, L., Coupe, K.J., Tucker, J.J., Criswell, A.R., Buckle, R., Rechter, A.J., Sheth, D.S., Urquart, B., Trotscher, T., Anders, M.J., Kowalski, J.M., Fineberg, M.S., Bone, L.B., Phillips, M.J., Rohrbacher, B., Stegemann, P., Mihalko, W.M., Buyea, C., Augustine, S.J., Jackson, W.T., Solis, G., Ero, S.U., Segina, D.N., Berrey, H.B., Agnew, S.G., Fitzpatrick, M., Campbell, L.C., Derting, L., McAdams, J., Ponsen, K.J., Luitse, J., Kloen, P., Joosse, P., Winkelhagen, J., Duivenvoorden, R., Teague, D.C., Davey, J., Sullivan, J.A., Ertl, W.J.J., Puckett, T.A., Pasque, C.B., Tompkins, J.F., Gruel, C.R., Kammerlocher, P., Lehman, T.P., Puffinbarger, W.R., Carl, K.L., Weber, D.W., Jomha, N.M., Goplen, G.R., Masson, E., Beaupre, L.A., Greaves, K.E., Schaump, L.N., Goetz, D.R., Westberry, D.E., Broderick, J.S., Moon, B.S., Tanner, S.L., Powell, J.N., Buckley, R.E., Elves, L., Connolly, S., Abraham, E.P., Steele, T., Ellis, T., Herzberg, A., Crawford, D.E., Hart, R., Hayden, J., Orfaly, R.M., Vigland, T., Vivekaraj, M., Bundy, G.L., Miclau, T., Matityahu, A., Coughlin, R.R., Kandemir, U., McClellan, R.T., Lin, C.H.H., Karges, D., Cramer, K., Watson, J.T., Moed, B., Scott, B., Beck, D.J., Orth, C., Puskas, D., Clark, R., Jones, J., Egol, K.A., Paksima, N., France, M., Wai, E.K., Johnson, G., Wilkinson, R., Gruszczynski, A.T., Vexler, L., Mallee, W.H., Schipper, I.B., and SPRINT Investigators
Subjects: prediction model, intramedullary nailing, machine learning, subsequent surgery, tibia shaft fracture, Orthopedics and Sports Medicine, Surgery, General Medicine
Abstract: Objectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is clinically relevant for surgeon and patient to anticipate unplanned secondary procedures, other than operations that can be readily expected such as reconstructive procedures for soft tissue defects. Therefore, the objective of this study was to develop a machine learning (ML) prediction model using the SPRINT data that can give individual patients and their care team an estimate of their particular probability of an unplanned second surgery. Methods: Patients from the SPRINT trial with unilateral TSFs were randomly divided into a training set (80%) and test set (20%). Five ML algorithms were trained in recognizing patterns associated with subsequent surgery in the training set based on a subset of variables identified by random forest algorithms. Performance of each ML algorithm was evaluated and compared based on (1) area under the ROC curve, (2) calibration slope and intercept, and (3) the Brier score. Results: Total data set comprised 1198 patients, of whom 214 patients (18%) underwent subsequent surgery. Seven variables were used to train ML algorithms: (1) Gustilo-Anderson classification, (2) Tscherne classification, (3) fracture location, (4) fracture gap, (5) polytrauma, (6) injury mechanism, and (7) OTA/AO classification. The best-performing ML algorithm had an area under the ROC curve, calibration slope, calibration intercept, and the Brier score of 0.766, 0.954, -0.002, and 0.120 in the training set and 0.773, 0.922, 0, and 0.119 in the test set, respectively. Conclusions: An ML algorithm was developed to predict the probability of subsequent surgery after IMN for TSFs. This ML algorithm may assist surgeons to inform patients about the probability of subsequent surgery and might help to identify patients who need a different perioperative plan or a more intensive approach.
Published: 2021

3. Heterotopic Ossification Following Arthroplasty for Femoral Neck Fracture

Author: Comeau-Gauthier, M., Zura, R.D., Bzovsky, S., Schemitsch, E.H., Axelrod, D., Avram, V., Manjoo, A., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Sprague, S., and HLTH Investigators
Subjects: Male, Reoperation, musculoskeletal diseases, medicine.medical_specialty, WOMAC, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Osteoarthritis, Severity of Illness Index, Article, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Risk Factors, Prevalence, Medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Prospective Studies, Femoral neck, Randomized Controlled Trials as Topic, Hip surgery, 030222 orthopedics, Hip fracture, business.industry, Proportional hazards model, Ossification, Heterotopic, General Medicine, Middle Aged, medicine.disease, Arthroplasty, Surgery, Femoral Neck Fractures, medicine.anatomical_structure, Treatment Outcome, Quality of Life, Heterotopic ossification, Female, business, Follow-Up Studies
Abstract: Background: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. Methods: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. Results: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. Conclusions: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021

4. What factors increase revision surgery risk when treating displaced femoral neck fractures with arthroplasty

Author: Blankstein, M., Schemitsch, E.H., Bzovsky, S., Poolman, R.W., Frihagen, F., Axelrod, D., Heels-Ansdell, D., Bhandari, M., Sprague, S., Schottel, P.C., and HEALTH Investigators
Subjects: Reoperation, medicine.medical_specialty, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Population, Femoral Neck Fractures, law.invention, 03 medical and health sciences, Femoral head, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Orthopedics and Sports Medicine, education, Aged, Femoral neck, 030222 orthopedics, education.field_of_study, Hip fracture, femoral neck fracture, business.industry, Bone Cements, revision surgery, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Surgery, Treatment Outcome, medicine.anatomical_structure, Female, Hemiarthroplasty, business, Body mass index
Abstract: Objectives HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture. Methods We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable. Results Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05). Conclusion Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Published: 2020

5. Clockwise torque of sliding hip screws: is there a right side?

Author: Wurdemann, F.S., Poolman, R.W., Krijnen, P., Bzovsky, S., Sprague, S., Kaptein, B.L., Hegeman, J.H., Schemitsch, E.H., Bhandari, M., Swiontkowski, M., Schipper, I.B., Dutch Hip Fracture Audit Grp, FAITH Investigators, and Public Health
Subjects: Bone Screws, sliding hip screw, Dentistry, Logistic regression, biomechanics, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, left, right, medicine, Humans, Orthopedics and Sports Medicine, Clinical significance, Femoral neck, 030222 orthopedics, Hip fracture, femoral neck fracture, Hip Fractures, business.industry, Biomechanics, side, Implant failure, 030208 emergency & critical care medicine, General Medicine, Odds ratio, medicine.disease, Confidence interval, Femoral Neck Fractures, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], medicine.anatomical_structure, Torque, implant failure, clockwise torque, Female, Surgery, business, rotational stability
Abstract: Contains fulltext : 228691.pdf (Publisher’s version ) (Closed access) OBJECTIVES: This study evaluated whether patients with a left-sided femoral neck fracture (FNF) treated with a sliding hip screw (SHS) had a higher implant failure rate than patients treated for a right-sided FNF. This was performed to determine the clinical relevance of the clockwise rotational torque of the femoral neck lag screw in a SHS, in relation to the rotational stability of left and right-sided FNFs after fixation. METHODS: Data were derived from the FAITH trial and Dutch Hip Fracture Audit (DHFA). Patients with a FNF, aged ≥50, treated with a SHS, with at least 3-month follow-up data available, were included. Implant failure was analyzed in a multivariable logistic regression model adjusted for age, sex, fracture displacement, prefracture living setting and functional mobility, and American Society for Anesthesiologists Class. RESULTS: One thousand seven hundred fifty patients were included, of which 944 (53.9%) had a left-sided and 806 (46.1%) a right-sided FNF. Implant failure occurred in 60 cases (3.4%), of which 31 were left-sided and 29 right-sided. No association between fracture side and implant failure was found [odds ratio (OR) for left vs. right 0.89, 95% confidence interval (CI) 0.52-1.52]. Female sex (OR 3.02, CI: 1.62-6.10), using a mobility aid (OR 2.02, CI 1.01-3.96) and a displaced fracture (OR 2.51, CI: 1.44-4.42), were associated with implant failure. CONCLUSIONS: This study could not substantiate the hypothesis that the biomechanics of the clockwise screw rotation of the SHS contributes to an increased risk of implant failure in left-sided FNFs compared with right-sided fractures. LEVEL OF EVIDENCE: Therapeutic Level II.See Instructions for Authors for a complete description of levels of evidence.
Published: 2020

6. Predictors of long-term pain after hip arthroplasty in patients with femoral neck fractures

Author: Noori, A., Sprague, S., Bzovsky, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Axelrod, D., Heels-Ansdell, D., Bhandari, M., Busse, J.W., and HEALTH Investigators
Subjects: medicine.medical_specialty, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Osteoarthritis, Femoral Neck Fractures, law.invention, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Humans, Orthopedics and Sports Medicine, pain, hip arthroplasty, hemiarthroplasty, Aged, Ontario, 030222 orthopedics, Hip fracture, femoral neck fracture, business.industry, Absolute risk reduction, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Confidence interval, Treatment Outcome, predictors, Female, Surgery, business, Cohort study
Abstract: Objectives To identify factors associated with the development of prolonged pain after hip fracture surgery. Design Secondary analysis of a randomized controlled trial. Setting Eighty hospitals in 10 countries. Patients/participants One thousand four hundred forty-one hip fracture patients in the HEALTH trial. Interventions Total hip arthroplasty or hemiarthroplasty. Main outcome measures Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty. Results Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%). Conclusions Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Published: 2020

7. What predicts health-related quality of life for patients with displaced femoral neck fractures managed with arthroplasty?

Author: Axelrod, D., Comeau-Gauthier, M., Bzovsky, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Guerra-Farfan, E., Heels-Ansdell, D., Bhandari, M., Sprague, S., and HEALTH Investigators
Subjects: medicine.medical_specialty, WOMAC, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Population, Osteoarthritis, Femoral Neck Fractures, femoral neck fractures, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, medicine, Humans, Orthopedics and Sports Medicine, education, Femoral neck, 030222 orthopedics, education.field_of_study, function, business.industry, Repeated measures design, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, health-related quality of life, Treatment Outcome, medicine.anatomical_structure, Quality of Life, Surgery, Hemiarthroplasty, business
Abstract: BACKGROUND: Total hip arthroplasty (THA) has been argued to improve health-related quality of life (HRQoL) and function in femoral neck fracture patients compared with hemiarthroplasty (HA). The HEALTH trial showed no clinically important functional advantages of THA over HA. The current analysis explores factors associated with HRQoL and function in this population. METHODS: Using repeated measures regression, we estimated the association between HRQoL and function [Short Form-12 (SF-12) physical component score (PCS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score] and 23 variables. RESULTS: THA as compared to monopolar HA, but not bipolar HA, was more likely to improve PCS scores (adjusted mean difference [AMD] 1.88 points, P = 0.02), whereas higher American Society of Anesthesiologists score (AMD -2.64, P < 0.01), preoperative use of an aid (AMD -2.66, P < 0.01), and partial weight-bearing status postoperatively (AMD -1.38, P = 0.04) demonstrated less improvement of PCS scores over time. THA improved WOMAC function scores over time compared with monopolar HA (but not bipolar HA) (AMD -2.40, P < 0.01), whereas higher American Society of Anesthesiologists classification (AMD 1.99, P = 0.01) and preoperative use of an aid (AMD 5.39, P < 0.01) were associated with lower WOMAC function scores. Preoperative treatment for depression was associated with lower functional scores (AMD 7.73, P < 0.01). CONCLUSION: Patients receiving THA are likely to receive small and clinically unimportant improvements in health utility and function compared with those receiving monopolar HA and little improvement compared with those receiving bipolar HA. Patient-specific characteristics seem to play a larger role in predicting functional improvement among femoral neck fracture patients. LEVEL OF EVIDENCE: Prognostic Level II.
Published: 2020

8. Arthroplasty versus internal fixation for the treatment of undisplaced femoral neck fractures

Author: Afaq, S., OʼHara, N.N., Schemitsch, E.H., Bzovsky, S., Sprague, S., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frolke, J.P.M., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Schreurs, B.W., Swiontkowski, M., and Slobogean, G.P.
Subjects: Male, Reoperation, medicine.medical_specialty, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Femoral Neck Fractures, law.invention, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Randomized controlled trial, law, medicine, Risk of mortality, internal fixation, Internal fixation, Humans, Orthopedics and Sports Medicine, undisplaced femoral neck fracture, Aged, Retrospective Studies, Aged, 80 and over, 030222 orthopedics, business.industry, Mortality rate, 030208 emergency & critical care medicine, Retrospective cohort study, General Medicine, Odds ratio, Middle Aged, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, Quality of Life, arthroplasty, Female, Hemiarthroplasty, business
Abstract: Contains fulltext : 228684.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). DESIGN: Retrospective cohort study. SETTING: Secondary data analysis of 2 multinational randomized controlled trials. PARTICIPANTS: Patients aged 50 years or older with a FNF. INTERVENTION: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. MAIN OUTCOME MEASUREMENT: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. RESULTS: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). CONCLUSIONS: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2020

9. Factors Associated With Mortality After Surgical Management of Femoral Neck Fractures

Author: Bzovsky, S., Comeau-Gauthier, M., Schemitsch, E.H., Swiontkowski, M., Heels-Ansdell, D., Frihagen, F., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frölke, J.P., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Bhandari, M., and Sprague, S.
Subjects: medicine.medical_specialty, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Femoral Neck Fractures, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Risk Factors, Risk of mortality, Medicine, Internal fixation, Humans, Orthopedics and Sports Medicine, Femoral neck, Aged, Retrospective Studies, 030222 orthopedics, Hip fracture, business.industry, Hip Fractures, Mortality rate, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], medicine.anatomical_structure, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], business, Kidney disease
Abstract: Contains fulltext : 228698.pdf (Publisher’s version ) (Closed access) BACKGROUND: Hip fractures are recognized as one of the most devastating injuries impacting older adults because of the complications that follow. Mortality rates postsurgery can range from 14% to 58% within one year of fracture. We aimed to identify factors associated with increased risk of mortality within 24 months of a femoral neck fracture in patients aged ≥50 years enrolled in the FAITH and HEALTH trials. METHODS: Two multivariable Cox proportional hazards regressions were used to investigate potential prognostic factors that may be associated with mortality within 90 days and 24 months of hip fracture. RESULTS: Ninety-one (4.1%) and 304 (13.5%) of 2247 participants died within 90 days and 24 months of suffering a femoral neck fracture, respectively. Older age (P < 0.001), lower body mass index (P = 0.002), American Society of Anesthesiologists (ASA) class III/IV/V (P = 0.004), use of an ambulatory aid before femoral neck fracture (P < 0.001), and kidney disease (P < 0.001) were associated with a higher risk of mortality within 24 months of femoral neck fracture. Older age (P = 0.03), lower body mass index (P = 0.02), use of an ambulatory aid before femoral neck fracture (P < 0.001), and having a comorbidity (P = 0.04) were associated with a higher risk of mortality within 90 days of femoral neck fracture. CONCLUSIONS: Our analysis found that factors that are indicative of a poorer health status were associated with a higher risk of mortality within 24 months of femoral neck fracture. We did not find a difference in treatment methods (internal fixation vs. joint arthroplasty) on the risk of mortality. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Published: 2020

10. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study

Author: Pouramin P, Li C, Busse J, Sprague S, Devereaux P, Jagnoor J, Ivers R, Bhandari M, and INORMUS Investigators
Abstract: Background The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. Methods In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing. Findings Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63.8%) were men, and 14 524 (46.5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71.9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27 .5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [ 88.7%] of 195 patients with open fractures; 426 [44.7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47.7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50.5%]), while Second Delays (delays in reaching care) were the least common (423 [5.4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0.66, 99% CI 0.46-0.93). Compared with patients with closed lower limb fractures, patients with closed spine (adjusted RR 2.47, 99% CI 2.17-2.81) and pelvic (1.35, 1.10-1.66) fractures were most likely to have delays of more than 24 h before admission to hospital. Interpretation In low-income and middle-income countries, timely hospital admission remains largely inaccessible, especially among patients with open fractures. Reducing hospital-based delays in receiving care, and, in particular, improving interfacility referral systems are the most substantial tools for reducing delays in admissions to hospital. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.
Published: 2020

11. The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial

Author: Ghert, M., Bhandari, M., Bozzo, A., Dijkstra, P.D.S., Griffin, A., Grimer, R., Hayden, J., Manherz, A., Masrouha, K., McKay, P., Miller, B., Parasu, N., Puri, A., Randall, R.L., Schneider, P., Sprague, S., Szpakowski, N., Thabane, L., Turcotte, R., Velez, R., Wilson, D., Zbuk, K., Guyatt, G., and SAFETY Investigators
Subjects: medicine.medical_specialty, Lung Neoplasms, Aftercare, Pilot Projects, Disease-Free Survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Health care, medicine, Protocol, Humans, 030212 general & internal medicine, Research ethics, medicine.diagnostic_test, business.industry, Soft tissue sarcoma, General surgery, pilot study, Extremities, Sarcoma, General Medicine, Health Care Costs, medicine.disease, Patient recruitment, Oncology, 030220 oncology & carcinogenesis, soft tissue sarcoma, surveillance, Feasibility Studies, Radiography, Thoracic, Neoplasm Recurrence, Local, business, Chest radiograph, Tomography, X-Ray Computed, randomised controlled trial, Biomedical sciences, study protocol
Abstract: IntroductionFollowing the treatment of patients with soft tissue sarcomas (STS) that are not metastatic at presentation, the high risk for local and systemic disease recurrence necessitates post-treatment surveillance. Systemic recurrence is most often detected in the lungs. The most appropriate surveillance frequency and modality remain unknown and, as such, clinical practice is highly varied. We plan to assess the feasibility of conducting a multi-centre randomised controlled trial (RCT) that will evaluate the effect on overall 5-year survival of two different surveillance frequencies and imaging modalities in patients with STS who undergo surgical excision with curative intent.Methods and analysisThe Surveillance After Extremity Tumor Surgery trial will be a multi-centre 2×2 factorial RCT. Patients with non-metastatic primary Grade II or III STS treated with excision will be allocated to one of four treatment arms1: chest radiograph (CXR) every 3 months for 2 years2; CXR every 6 months for 2 years3; chest CT every 3 months for 2 years or4 chest CT every 6 months for 2 years. The primary outcome of the pilot study is the feasibility of a definitive RCT based on a combination of feasibility endpoints. Secondary outcomes for the pilot study include the primary outcome of the definitive trial (overall survival), patient-reported outcomes on anxiety, satisfaction and quality of life, local recurrence-free survival, metastasis-free survival, treatment-related complications and net healthcare costs related to surveillance.Ethics and disseminationThis trial received provisional ethics approval from the McMaster/Hamilton Health Sciences Research Ethics Board on 7 August 2019 (Project number 7562). Final ethics approval will be obtained prior to commencing patient recruitment. Once feasibility has been established and the definitive protocol is finalised, the study will transition to the definitive study.Trial registrationNCT03944798; Pre-results.
Published: 2019

12. Not All Garden-I and II Femoral Neck Fractures in the Elderly Should Be Fixed

Author: Okike, K, Udogwu, UN, Isaac, M, Sprague, S, Swiontkowski, MF, Bhandari, M, Heetveld, MJ, van Lieshout, Esther, Zielinski, Stephanie, Patka, Petr, Eversdijk, MG, Peters, RW, den Hartog, Dennis, van Waes, O.J.F., Oprel, Pim, Herriott, C, Dobb, C, and Surgery
Published: 2019

13. Development of feeds for juvenile Atlantic bluefin tuna (Thunnus thynnus, L): effect of lipid level and source

Author: Betancor, M.B., Ortega-García, A. (Aurelio), de-la-Gándara, F. (Fernando), Sprague, S., Tocher, D.R., and Mourente, G.
Subjects: fish, krill oil, weaning, growth, omega, survival, juvenile nutrition, lipid sources, biochemical composition, bluefin tuna, larval rearing, Thunnus thynnus, artificial diets, Gene expression, biosynthesis, transcription, fish farming, atún rojo
Abstract: In conclusion, the present study suggests that ABT juveniles can be grown on inert extruded dry feeds that result in good fish growth and accumulation of the health-promoting fatty acid DHA. Furthermore, a blend of VO and KO could be used as the dietary lipid source up to a dietary lipid level of 15 % without affecting fish performance. The expression of lipid metabolism genes in ABT liver showed a different response to dietary lipid level/fatty acid profile, consistent with previous data indicating limited n-3 LC-PUFA biosynthetic capability in ABT. However, gene expression showed some differences between the two trials, which highlight how the genetic background of different batches of ABT juveniles could affect the regulation of metabolic gene expression and thus be a factor in weaning success. The expression of antioxidant enzymes was also altered by diet, related to dietary contents of antioxidant nutrients. Thus, further studies are required in order to fully elucidate the lipid and fatty acid requirements of this iconic species in relation to dietary sources and production costs
Published: 2019

14. Are large clinical trials in orthopaedic trauma justified?

Author: Sprague, S, Tornetta, P, Slobogean, GP, O'Hara, NN, McKay, P, Petrisor, B, Jeray, KJ, Schemitsch, EH, Sanders, D, Bhandari, M, Guyatt, GH, Walter, S, Anglen, J, Bosse, M, Liew, S, Sancheti, P, Tai, K, Heels-Ansdell, D, Buckingham, L, Duraikannan, A, Tanner, SL, Snider, RG, Altman, D, Gandhi, R, Bischoff, M, Della Rocca, GJ, Ristevski, B, Rajaratnam, K, Williams, D, Denkers, M, Bednar, D, Sadler, J, Kwok, D, Drew, B, Wong, I, Madden, K, Hall, JA, McKee, MD, Ahn, H, Whelan, D, Waddell, J, Daniels, T, Bogoch, E, Nauth, A, Vicente, MR, Hidy, JT, Lawendy, AR, Gurr, K, Carey, T, Bailey, C, MacLeod, M, Bartley, D, Tieszer, C, Coles, C, Leighton, R, Richardson, CG, Biddulph, M, Gross, M, Dunbar, M, Amirault, JD, Alexander, D, Coady, C, Glazebrook, M, Johnston, D, Oxner, W, Trenholm, JA, Reardon, G, Trask, K, MacDonald, S, Papp, S, Gofton, W, Liew, A, Kingwell, S, O'Neill, J, Johnson, G, Wai, E, Foxall, J, Broekhuyse, HM, O'Brien, PJ, Blachut, PA, Lefaivre, KA, Johal, R, Leduc, S, Laflamme, GY, Beaumont, P, Malo, M, Benoit, B, Rouleau, D, Ranger, P, Fournier, J, Tardif, K, and Reindl, R
Subjects: Reoperation, medicine.medical_specialty, lcsh:Diseases of the musculoskeletal system, Sports medicine, medicine.medical_treatment, Pilot Projects, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Internal medicine, Epidemiology, Medicine and Health Sciences, Medicine, Humans, Multicenter Studies as Topic, Orthopedics and Sports Medicine, Orthopedic Procedures, 030212 general & internal medicine, Therapeutic Irrigation, Saline, Orthopaedic trial, Randomized Controlled Trials as Topic, FLOW trial, business.industry, Sample size, Confidence interval, 3. Good health, Clinical trial, Sample size determination, Relative risk, Orthopedic surgery, Large trials, lcsh:RC925-935, business, 030217 neurology & neurosurgery, Research Article
Abstract: The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.
Published: 2018

15. Factors associated with health-related quality of life, hip function, and health utility after operative management of femoral neck fractures

Author: Sprague, S., Bhandari, M., Heetveld, M.J., Liew, S., Scott, T., Bzovsky, S., Heels-Ansdell, D., Zhou, Q., Kampen, A. van, Biert, J., Vugt, A.B. van, Edwards, M.J.R., Blokhuis, T.J., Frolke, J.P.M., Geeraedts, L.M.G., Gardeniers, J.W.M., Tan, E.C.T.H., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Schreurs, B.W., Swiontkowski, M., and Schemitsch, E.H.
Subjects: Male, medicine.medical_specialty, Health utility, Femoral Neck Fractures, Disability Evaluation, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Medicine and Health Sciences, medicine, Humans, Orthopedics and Sports Medicine, In patient, 030212 general & internal medicine, Aged, Pain Measurement, Femoral neck, Aged, 80 and over, Health related quality of life, 030222 orthopedics, Hip fracture, business.industry, Middle Aged, Prognosis, medicine.disease, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Treatment Outcome, medicine.anatomical_structure, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Quality of Life, Physical therapy, Female, Surgery, business
Abstract: Aims The primary aim of this prognostic study was to identify baseline factors associated with physical health-related quality of life (HRQL) in patients after a femoral neck fracture. The secondary aims were to identify baseline factors associated with mental HRQL, hip function, and health utility. Patients and Methods Patients who were enrolled in the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial completed the 12-item Short Form Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index, and EuroQol 5-Dimension at regular intervals for 24 months. We conducted multilevel mixed models to identify factors potentially associated with HRQL. Results The following were associated with lower physical HRQL: older age (-1.42 for every ten-year increase, 95% confidence interval (CI) -2.17 to -0.67, p Conclusion We identified several baseline factors associated with lower HRQL, hip function, and utility after a femoral neck fracture. These findings may be used by clinicians to inform treatment and outcomes. Cite this article: Bone Joint J 2018;100-B:361–9.
Published: 2018

16. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author: Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, 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Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, 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D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.
Subjects: Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract: Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).
Published: 2012

17. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author: Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., Hannedouche T., Vela C., Lionet A., Ryckelynck P., Zaoui P., Choukroun G., Fessi H., Lang P., Stroumza P., Joly D., Mousson C., Laville M., Dellanna F., Erley C., Braun J., Rambausek M., Riegel W., Klingberg M., Schwertfeger E., Wizemann V., Eckardt K., Reichel H., Passauer J., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., Kulcsar I., Mezei I., Csiky B., Rikker C., Arkossy O., Berta K., Szegedi J., Major L., Ferenczi S., Fekete A., Szabo T., Zakar G., Wagner G., Kazup Erdelyine S., Borbas B., Eustace J., Reddan D., Capasso G., Locatelli F., Villa G., Cozzolino M., Brancaccio D., Messa P., Bolasco P., Ricciardi B., Malberti F., Moriero E., Cannella G., Ortalda V., Stefoni S., Frasca G., Cappelli G., Albertazzi A., Zoccali C., Farina M., Elli A., Avella F., Ondei P., Mingardi G., Errico R., Losito A., Di Giulio S., Pertosa G., Schena F., Grandaliano G., Gesualdo L., Auricchio M., Bochicchio-Ricardelli T., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak Gregoor P., Hagen E., Van Der Sande F., Klinger M., Nowicki M., Muszytowski M., Bidas K., Bentkowski W., Wiecek A., Ksiazek A., Marczewski K., Ostrowski M., Switalski M., Sulowicz W., Matuszkiewicz-Rowinska J., Mysliwiec M., Durlik M., Rutkowski B., Macario F., Carvalho B., Frazao J., Machado D., Weigert A., Andrusev A., Khrustalev O., Zemtchenkov A., Gurevich K., Staroselsky K., Khadikova N., Rozhinskaya L., Timokhovskaya G., Strokov A., Balkarova O., Ermolenko V., Kolmakova E., Komandenko M., Timofeev M., Shilo V., Shostka G., Smirnov A., Anashkin V., Volgina G., Domashenko O., Gurevich A., Perlin D., Martinez Garcia J., Andres Ribes E., Coll Piera E., Fernandez Lucas M., Galicia M., Prados M., Gonzalez M., Romero R., Martin de Francisco A., Montenegro J., Santiago C., Garcia F., Alcazar De La Ossa J., Arrieta J., Pons J., Martin-Malo A., Soler Amigo J., Cases A., Sterner G., Jensen G., Wikstrom B., Jacobson S., Lund U., Weiss L., Stahl A., Von Albertini B., Burnier M., Meier P., Martin P., Uehlinger D., Dickenmann M., Yaqoob M., Zehnder D., Kalra P., Padmanabhan N., Roe S., Eadington D., Pritchard N., Hutchison A., Davies S., Wilkie M., Davies M., Pai P., Swift P., Kwan J., Goldsmith D., Tomson C., Stratton J., Dasgupta I., Sarkar S., Moustafa M., Gandhi K., Jamal A., Galindo-Ramos E., Tuazon J., Batlle D., Tucker K., Schiller-Moran B., Assefi A., Martinez C., Samuels L., Goldman J., Cangiano-Rivera J., Darwish R., Lee M., Topf J., Kapatkin K., Baer H., Kopelman R., Acharya M., Tharpe D., Bernardo M., Nader P., Guzman-Rivera J., Pergola P., Sekkarie M., Alas E., Zager P., Liss K., Navarro J., Roppolo M., Denu-Ciocca C., Kshirsagar A., El Khatib M., Kant K., Scott D., Murthyr B., Finkelstein F., Keightley G., McCrary R., Pitone J., Cavalieri T., Tsang A., Pellegrino B., Schmidt R., Ahmad S., Brown C., Friedman E., Mittman N., Fadem S., Shapiro W., Reddy M., Goldberger S., Woredekal Y., Agarwal A., Anger M., Haque M., Chidester P., Kohli R., Rubinstein S., Newman G., Gladish R., Ayodeji O., Soman S., Sprague S., Hunt N., Gehr T., Rizk D., Warnock D., Polack D., Pahl M., Fischer D., Dreyer P., James G., Husserl F., Rogers T., Raff A., Sedor J., Silver M., Smith M., Steinberg S., DelGiorno T., Jones E., Cunha P. D., Cheng J., Pogue V., Blumenthal S., Brown E., Charytan C., Buerkert J., Cook M., Felsenfeld A., Tareen N., Gupta A., Herman T., Diamond S., Hura C., Laski M., MacLaurin J., Plumb T., Brosnahan G., Kumar J., Henriquez M., Poole C., Osanloo E., Matalon A., Sholer C., Arfeen S., Azer M., Belledonne M., Gross M., Dunnigan E., McConnell K., Becker B., Skinner F., Rigolosi R., Spiegel D., Stegman M., Patak R., Streja D., Ranjit U., Youell T., Wooldridge T., Stafford C., Cottiero R., Weinberg M., Schonefeld M., Shahmir E., Hazzan A., Ashfaq A., Bhandari K., Cleveland W., Culpepper M., Golden J., Lai L., Lien Y., Lorica V., Robertson J., Malireddi K., Morse S., Thakur V., Israelit A., Raguram P., Alfred H., Weise W., Al-Saghir F., El Shahawy M., Rastogi A., Nissenson A., Kopyt N., Lynn R., Lea J., McClellan W., Teredesai P., Ong S., Tolkan S., Sugihara J., Minga T., Mehrotra R., Minasian R., Bhatia D., Specter R., Capelli J., Sidhu P., Dalal S., Dykes P., Khan M., Rahim F., Saklayen M., Thomas A., Michael B., Torres M., Al-Bander H., Murray B., Abukurah A., Gupta B., Nosrati S., Raja R., Zeig S., Braun M., Amatya A., Endsley J., Sharon Z., Dolson G., Dumler F., Ntoso K., Rosansky S., Kumar N., Gura V., Thompson N., Goldfarb D., Halligan R., Middleton J., Widerhorn A., Arbeit L., Arruda J., Crouch T., Friedman L., Khokhar S., Mittleman J., Light P., Taparia B., West C., Cotton J., Dhingra R., Kleinman L., Arif F., Lew S., Nammour T., Sterrett J., Williams M., Ramirez J., Rubin J., McCarthy J., Noble S., Chaffin M., Rekhi A., Moe, S. M., Chertow, G. M., Parfrey, P. S., Kubo, Y., Block, G. A., Correa-Rotter, R., Drueke, T. B., Herzog, C. A., London, G. M., Mahaffey, K. W., Wheeler, D. C., Stolina, M., Dehmel, B., Goodman, W. G., Floege, J., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., 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Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences
Subjects: Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract: Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.
Published: 2015

18. Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease

Author: De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., McMurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., McCullough, P., Ivanovich, P., Ketteler, M., Lachin, J., McGill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., McMahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, DS., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., LeBeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), De Zeeuw, Dick, Akizawa, Tadao, Audhya, Paul, Bakris, George L., Chin, Melanie, Christ-Schmidt, Heidi, Goldsberry, Angie, Houser, Mark, Krauth, Melissa, Lambers Heerspink, Hiddo J., Mcmurray, John J., Meyer, Colin J., Parving, Hans-Henrik, Remuzzi, Giuseppe, Toto, Robert D., Vaziri, Nosratola D., Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, Chertow, Glenn M., Toto, B., Mccullough, P., Ivanovich, P., Ketteler, M., Lachin, J., Mcgill, J., Agarwal, R., Anker, S., Arenillas, J. F., Januzzi, J., Jardine, A., Kasner, S., Kissela, B., Kolansky, D., Mann, J., Thadhani, R., Champion de Crespigny, P., Chan, D. T., D'Almeida, E., Fraser, I., Gray, N., Holt, S., Irish, A., Isbel, N., Kerr, P., Packham, D., Phoon, R., Pollock, C., Roger, S., Suranyi, M., Walker, R., Wittert, G., Yue, D., Balcke, P., Prager, R., Schernthaner, G., Sunder-Plassmann, G., Jadoul, M., Krzesinski, J. M., Peeters, P., Van der Niepen, P., Van Gaal, L., Van Vlem, B., Warling, X., Chow, S., Cournoyer, S., Dumas, R., Jolly, S., Levin, A., Mcmahon, A., Mehta, H., Ooi, T. C., Perkins, D., Roy, L., Sapir, D., Tam, P., Bartaskova, D., Hemzsky, L., Kubina, D., Szabo, M., Tesar, V., Combe, C., Faller, B., Fauvel, J. P., Halimi, J. M., Hourmant, M., Le Meur, Y., Urena-Torres, P., Zaoui, P., Al-Sarraf, S., Burst, V., Degenhardt, S., Kempe, H. P., Kleophas, W., Kosch, C., Krumme, B., Kuhlmann, M., Pistrosch, F., Rambausek, M., Schmidt-Guertler, H., Segiet, T., Sommerer, C., Vielhauer, V., Wanner, C., Beberashvili, I., Benchetrit, S., Herskovits, T., Karnieli, E., Levin-Iaina, N., Mosenzon, O., Tsur, A., van Dijk, D. J., Wainstein, J., Yagil, Y., Yerushalmi, Y., Colussi, G., Conte, G., Di Luca, M., Giovambatista, C., Messa, P., Pani, A., Pisani, A., Rapana, M. R., Ruggenenti, P., Villa, G., Zoccali, C., Correa-Rotter, R., Diaz-Escobedo, S. L., Garcia, P., Gonzalez Galvez, G., Obrador Vera, G. T., Rico, R., Calero, F., Cigarran, S., de Alvaro, F., de Francisco, A. L., Egido, J., Fernandez, E., Fernandez Vega, F., Fort, J., Galan Serrano, A., Gorriz Teruel, J. L., Martinez, I., Martinez Castelao, A., Munar, M. A., Navarro, J., Nieto, J., Osuna, A., Pascual, J., Portoles, J., Praga, M., Vallés, M., Fellstrom, B., Frisenette-Fich, C., Hadimeri, H., Stenvinkel, P., Svensson, M., Weiss, L., Adamson, K., Dornhorst, A., El Kossi, M., Gnudi, L., Hendry, B., Johnson, A., Joseph, F., Kalra, P., Marshall, S., Mikhail, A., Myint, K. S., Soran, H., Taal, M., Zehnder, D., Abbott, L., Acharya, A., Ahmed, Z., Aiello, J., Akom, M., Ali, S., Alzohaili, O., Anderson, L., Anderson, S., Anger, M., Appel, G., Arakaki, R. F., Arif, A., Assefi, A. R., Atray, N., Awad, A., Barranco, E., Belledonne, M. O., Belo, D., Bernardo, M., Bernstein, R., Bhalla, V., Bhatia, D., Black, R. M., Block, G., Blondin, J., Blumenthal, S. S., Bononi, P., Brantley, R. R., Bresssler, P., Broumand, V., Brusco, O., Buerkert, J., Burgos-Calderon, R., Campbell, R., Canas, G., Cangiano, J., Cherlin, R., Chilakapati, V., Comunale, R., Coyne, D., Crawford, P. W., Darwish, R., Deeb, W., Denker, P. S., Desai, S., Desouza, C., Diamond, S., Dixon, B. S., Durham, J. H., Eisner, G., Elder, J. G., El-Shahawy, M., Fadda, G., Fitz-Patrick, D., Fonseca, V., Fraser, N. J., Frei, G., Fried, L., Galindo-Ramos, E., Germain, M., Ghantous, W., Gilbert, J. M., Gillum, D., Godwin, J., Goel, A., Goldfarb, Ds., Graf, R. J., Greenwood, T., Guasch, A., Hanna, A., Harper, K., Herman, T., Hilton, T., Hines, T., Hoggard, J., Hootkins, R., Huseman, R., Israelit, A., Jamal, A., Kant, K., Kaptein, E., Kathresal, A., Kaupke, J., Kaveh, K., Kaye, W., Keightley, G. E., Keith, K., Khairullah, Q., Kondle, V., Kopyt, N., Krishna, G., Lawrence, M. K., Lebeau, M., Leehey, D. J., Levine, M. M., Levinson, D., Lew, S. Q., Lewis, D., Linfert, D., Liss, K., Lund, R., Madeleine, P., Mahmood, K., Martin, E. R., Martinez, C., Mayeda, S. O., Mendez, R., Middleton, J., Molitch, M. E., Moncrief, J., Moustafa, M., Muoneke, R., Murray, A. V., Murugan, T. S., Nammour, T. M., Nassar, G., Navaneethan, S., Newman, J., Nossuli, A., Nwakoby, I., Osama, S., Ouseph, R., Parker, J., Parnes, E., Patel, N., Pergola, P., Perlman, A., Perry, R. G., Petrillo, R., Prabhakar, S., Purighalla, R. S., Quesada-Suarez, L., Rabiei, A., Raskin, P., Rastogi, A., Reisin, E., Rekhi, A., Rivera-Colon, L., Rizk, D., Rodelas, R., Roer, D., Rosas, S., Ross, D. L., Rovner, S., Sackel, H., Sader, S., Santos, P., Schmidt, R., Shafik, S., Shakeel, M., Sharon, Z., Silva, A. L., Silva, A., Singh, B., Smith, M., Solomon, R., Soman, S., Spinowitz, B., Sprague, S. M., Spry, L., Stonesifer, L., Streja, D., Suchinda, P., Sun, C., Thakar, C. V., Trespalacios, F., Tumlin, J. A., Van Buren, P., Vernace, M., Vicks, S., Warren, M., Weiss, D., Welker, J., Winston, J. A., Wombolt, D. G., Wood, M., Wu, M., Wynne, A., Yu, H., Zabaneh, R. I., de Zeeuw, D, Akizawa, T, Audhya, P, Bakris, Gl, Chin, M, Christ Schmidt, H, Goldsberry, A, Houser, M, Krauth, M, Lambers Heerspink, Hj, Mcmurray, Jj, Meyer, Cj, Parving, Hh, Remuzzi, G, Toto, Rd, Vaziri, Nd, Wanner, C, Wittes, J, Wrolstad, D, Chertow, Gm, Pisani, Antonio, De Zeeuw, D, Bakris, G, Lambers Heerspink, H, Mcmurray, J, Meyer, C, Parving, H, Toto, R, Vaziri, N, and Chertow, G.
Subjects: Male, medicine.medical_specialty, Intention to Treat Analysi, NF-E2-Related Factor 2, NEPHROPATHY, Urology, Renal function, Kaplan-Meier Estimate, Type 2 diabetes, Placebo, Article, Nephropathy, NRF2, Double-Blind Method, Cardiovascular Disease, Diabetes mellitus, Internal medicine, medicine, CKD, Treatment Failure, Bardoxolone methyl, Oleanolic Acid, Renal Insufficiency, Chronic, Aged, OUTCOMES, IRBESARTAN, ANALOGS, business.industry, Medicine (all), Hazard ratio, General Medicine, Middle Aged, medicine.disease, Weight Lo, Endocrinology, Diabetes Mellitus, Type 2, Diabetic Nephropathie, Kidney Failure, Chronic, Female, TRIAL, Stage 4 chronic kidney disease, business, Glomerular Filtration Rate, Human, RENAL EVENTS BEACON
Abstract: Background: Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)–related factor 2 activators further reduce this risk is unknown. Methods: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to < 30 ml per minute per 1.73 m2 of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. Results: The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P < 0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. Conclusions: Among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease, bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. A higher rate of cardiovascular events with bardoxolone methyl than with placebo prompted termination of the trial. (Funded by Reata Pharmaceuticals; BEACON ClinicalTrials.gov number, NCT01351675.)
Published: 2013

19. Corrigendum to 'Manganese(III)-mediated oxidative free-radical cyclisations of allenyl malonates' [Tetrahedron 65 (2009) 10882-10892] (DOI:10.1016/j.tet.2009.09.112)

Author: Curry, L, Hallside, MS, Powell, L, Sprague, S, and Burton, J
Published: 2010

20. Manganese(III)-mediated oxidative free-radical cyclisations of allenyl malonates (vol 65, pg 10882, 2009)

Author: Curry, L, Hallside, MS, Powell, L, Sprague, S, and Burton, J
Published: 2010

21. (Mis) Perceptions about intimate partner violence among orthopaedics surgeons

Author: Bhandari, M, Sprague, S, Dáurora, V, Shearer, H, Brink, Ole, Mathews, D, and Dosanjh, S
Published: 2008

22. Extracts from the Records of the Boston Society for Medical Observation

Author: Sprague, S. P.
Subjects: Selected Articles
Published: 1855

23. International orthopaedic Multicentre study (INORMUS) in fracture care: Protocol for a large prospective observational study INORMUS investigators

Author: Bhandari, M., PJ Devereaux, Ivers, R. Q., Miclau, T., Moroz, P., Thabane, L., Sprague, S., Mckay, P., Li, C. S., Jagnoor, J., Slobogean, G., Boniface, R., Browner, B., La Huerta, F., Pollak, A., Petrisor, B., Sancheti, P., Schemitsch, E., Zhou, J., Guyatt, G., Devereaux, P. J., Mundi, R., O Hara, N., Heels-Ansdell, D., Buckingham, L., Simunovic, N., Norton, R., Zhang, J., Tian, M., Yadav, L., Caldwell, A., Liu, Y., Wang, Q., Li, J., Zhang, Z., Zhang, W., Tian, S., Jia, Z., Guo, T., Ma, Y., Wu, G., Ma, X., Ma, J., Jia, H., Hu, S., Wang, Y., Sun, M., Qin, Y., Wang, J., Zhou, S., Qi, B., Wu, B., Zhi, C., Xing, B., Zhu, Y., Zhang, X., Yang, J., Dai, W., Lu, D., He, S., Cai, X., Liu, G., Rui, G., Hu, B., Chen, H., Hu, Y., Wang, T., Shyam, A., Borate, M., Gawande, N., Jadhav, N., Patil, S. D., Karkamakar, S., Patil, S., Ranaware, A., Tamboli, S., Gandhalikar, M., Tupe, R., Choudhary, V., Patil, P. V., Shetty, V., Shetty, N., Hegde, C., Shrivastava, S., Singh, P., Dhillon, M. S., Dhatt, S. S., Agrawal, G., Mittal, R., Sharma, V., John, B., Mahajan, A., Afzal, P. A., Prakash, J. S., Cherian, V. M., Jepegnanam, T. S., Titus, V. T. K., Nithyananth, M., Boopalan, P. R., Varghese, V. D., George, V. M., Rajagopalan, N., Nair, N., Amaravathy, R., Santhanagopal, S., Pilar, A., Chhabra, H. S., D Souza, A., Chawla, P., Raina, D., Vaksha, V., Subramanian, P., Moabelo, R. S., Segbefia, M., Baidoo, P. K., Ocloo, C. A., Baddoo, D. T., Ativor, V., Yeboah, D. K., Konadu, P., Kumah-Ametepey, R., Awariyah, D., Quartey, R., Saani, O., Quansah, R. E., Trafton, P., Anyitey-Kokor, D., Leat, M., Sobotey, J., Opuni, G., Agbenorwu, F., Gis, B. B. W. G., Ayana, B., Otsyeno, F. M. T., Jani, P., Mutiso, V. M., Atinga, J. E. O., Kilonzo, P. K., Muoki, J., Mbogori, M., Wambugu, J. W., Torutt, D., Odok, C., Kipkemoi, E., Otsyeno, D., Desmondnzioka, J. W., Owende, D., Lucinde, R., Kariuki, B., Kinyua, D., Kamau, M., Mwancha, M., Murgor, M., Nyabuti, M., Njoki, R., Lutomia, M., Nancy, N., Ndeleva, B. M., Johnson, M., Kimani, M., Gichui, K., Mara, M., Mwangi, G. C., Maina, A. M., Wamae, D., Mwangi, C., Kingori, I., Watson, P., Kiptoo, E. M., Temiloluwa, O. O., Ikechukwu, A. A., Bamidele, O. I., Akanbi, O. O., Olugbenga, I. O., Firth, G., Biscardi, A. G., Machuene, A. P., Moolman, J., Miller, B., Ramokgopa, M., Deventer, S., Pikor, T., Bhaga, R., Marealle, P., Wanini, A., Elisha, M., Zumbulu, D., Boniface, R. L., Temu, R., Mutanda, T., Ntuulo, J., Lubega, F., Tracy, G. T., Zaitun, K., Godfrey, P. B., Mandizvidza, V., Gova, M. F., Sabur, M. A., Qavi, M. I., Khundkar, T., Wangdi, K., Wangmo, N., Dorji, S., Baker, S., Thapa, J., Lodrel, K., Dorji, U., Saadat, S., Zafarghandi, M., Golbakhsh, M., Byanjankar, S., Joshi, R. R., Dwivedi, R., Sharma, J. R., Qadir, R. I., Bukhari, S. I., Baz, K. A., Wahid, I., Quang, L. N., Cuong Pham, V., Chinh, N. D., Amanquez, C., Vincenti, S. I., Bobarin, A. P., Sanchez, D. S., Elias, N., Ribeiro, J. E. G., Belangero, W. D., Mariolani, J. R. L., Livani, B., Lugnani, A., Rossi, F., Katayama, A., Kfuri, M., Fogagnolo, F., Baldy, F., Moraes, V. Y., Kojima, K. E., Dos Santos Silva, J., Demange, M. K., Andrade E Silva, F. B., Dan Silva, A. C. G., Quintero, J. E., Contreras, F., Merchan, G., Beauvoir, G., Mercado, E., Medina, F., Aguilar, G., Rubio-Avila, J., Ochoa, H. C., Cano, H. C., González, A. V., Gutierrez, N. I. G., Orozco, C. F., Jesús Martínez Ruíz, J., Martinez, D. A., Garuz, M., Altieri, J. S., Cutipa, I. J. S., Lurita, C. L., Manrique, D. T., Fernandez, J. H., Barquet, A., Rienzi, D., Elguezabal, I. A. E., Rizzo, E. A., Hovsepian, J. M., and Rodriguez, V.

24. Wind-tunnel investigations of blunt-body drag reduction using forebody surface roughness

Author: STEPHEN WHITMORE, Sprague, S., and Naughton, J. W.

25. Treatment of acute Achilles tendon ruptures: a systematic overview and metaanalysis

Author: Bhandari, M., Guyatt, G. H., Siddiqui, F., Morrow, F., Jason Busse, Leighton, R. K., Sprague, S., and Schemitsch, E. H.

26. Cancrum Oris

Author: Sprague, S. L.
Subjects: Fuel Technology, Energy Engineering and Power Technology, General Medicine
Abstract: n/a
Published: 1863

27. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author: P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. Chew Wong, Michael Roppolo, U. Neyer, S. Ahmad, J. Mackie, R. Minasian, M. Verrelli, A. Abukurah, M. Laski, P. Brunet, Madeleine V. Pahl, Daniel Zehnder, E. Alas, Muralidhar Acharya, G. Rudolf, G. Zakar, M. Reddy, R. Specter, G. Grandaliano, I. Kulcsar, A. Amatya, Eugenie Pedagogos, O. Ayodeji, G. Jensen, S. Diamond, Xavier Warling, P. Teredesai, M. Mathew, M. Haque, M. Solis, E. Andrés Ribes, M.A. van den Dorpel, Akhtar Ashfaq, Christian Rabbat, David G. Warnock, M. Sebastian Diaz, C. Mousson, R. Darwish, M. Sperto Baptista, N. Salgado, E. Alvarez Sandoval, M. Vasilevsky, P. Chidester, D. Polack, Simon J. Davies, G. Brosnahan, A. Agarwal, Chaim Charytan, T. Hannedouche, M. Gross, I. Arias, G. James, Jürgen Floege, Tom Dejagere, Patrick S. Parfrey, S. Cournoyer, T. Cavalieri, Gérard M. London, K. Gandhi, A. Kshirsagar, O. Khrustalev, J. Zacharias, Michel Dhaene, Jennifer Tuazon, W. Weise, J. Guzman-Rivera, HS Brink, Alastair J. Hutchison, P. D. Cunha, Robyn G Langham, S. Soman, J. Goldman, S. Kazup Erdelyine, A. Widerhorn, M. Henriquez, N. Hunt, W. Hoerl, O. Arkossy, J. Szegedi, R. Dhingra, M. Fernandez Lucas, Jesus Navarro, A. Kark, Andrey Gurevich, Cynthia J. Brown, Rajnish Mehrotra, L. Kleinman, S. Ferenczi, Loreto Gesualdo, V. Schwenger, M. Ramirez, N. Mittman, Ana María Cusumano, K. Marczewski, Moustafa Moustafa, Sônia M. H. A. Araújo, E. Ladanyi, M. Auricchio, Maurice Laville, P. Urena Torres, C. Gallart, A. Israelit, V. Altobelli, E. Hagen, S. Nosrati, John P. Middleton, Kant Ks, F. Al-Saghir, S. Steinberg, S. Neiva Coelho, Botond Csiky, Philip G Zager, M. Sekkarie, Vanda Jorgetti, Domingos O. d'Avila, Carol A. Pollock, L. Lai, B. von Albertini, Beckie Michael, U. Kunzendorf, N. Frischmuth, A. Durrbach, L. Vasconcellos, Raymond Vanholder, M. Dickenmann, B. Schiller-Moran, Steven D. Soroka, J. Rubin, O. Balkarova, S. Morse, M. Teixeira Araújo, D. Perlin, M. Khan, C. Hura, Dagmar-C. Fischer, D. Machado, Seamas C. Donnelly, D. Sapir, V. Lorica, L. Deboni, M. Jose, M. Galicia, K. Bidas, David Spiegel, David Goldsmith, Peter F Mount, A. Strokov, L. Yu, J. Pitone, Biagio Ricciardi, Alastair Gillies, M. Moyses Neto, Piergiorgio Bolasco, V. Anashkin, John R. Sedor, M. Lee, E.M. Jones, M. Culpepper, G. London, D. Joly, N. Khadikova, Charles A. Herzog, P. Meier, M. Farina, Dana V. Rizk, William M. McClellan, M. Cook, Bastian Dehmel, Patrizia Ferrari, F. Almeida, V. Pogue, R. McCrary, F. Macario, J. Golden, E. Wijeyesinghe, Tilman B. Drüeke, E. Osanloo, M. Muszytowski, F. Arif, Giuseppe Villa, M. Torres Zamora, Steven Zeig, N. Thompson, A. Jamal, C. Sholer, P. Stroumza, D. Reddan, Arun Gupta, J. Montenegro, T. DelGiorno, D. Eadington, G. Shostka, Michel Jadoul, A. Weigert, Sergio Stefoni, P. Dreyer, Carmel M. Hawley, J. Cardeal da Costa, M. Switalski, G. Talaulikar, A. Felsenfeld, J. MacLaurin, T. Herman, N. Pritchard, M. Michaud, K.-U. Eckardt, R. Romero, G. Volgina, Fred E. Husserl, J. Soler Amigó, David S. Goldfarb, A. Matalon, M. D. Torres, P. Sampaio Lacativa, L. Major, U. Lund, A. Lafalla, S. Sarkar, Jennifer M. MacRae, J. Lobo, Liudmila Rozhinskaya, Johann Braun, H. Daugaard, S. Khokhar, S. Rubinstein, D. Bhatia, G. Timokhovskaya, T. Wooldridge, A. Voßkühler, Nelson Kopyt, Pablo E. Pergola, Michel Burnier, L. Samuels, J. Alcázar de La Ossa, J. Billiouw, R. Liebl, P. Sidhu, S. Menahem, P. Montambault, E. Schwertfeger, K. Staroselsky, J. Kovarik, S. Horn, N. Tareen, Simon D. Roger, Francesco Locatelli, Kenneth W. Mahaffey, J Vanwalleghem, Robert I. Lynn, M. Prados, K. Kapatkin, N. Peñalba, Kailash Jindal, M. Stegman, R. Stahl, Joseph A. Eustace, S. Desmeules, A. Hazzan, D. Scott, B. Taparia, G. Keightley, P. Jensen, V. Ortalda, K. McConnell, Alejandro Martin-Malo, Margaret M. Williams, Stuart M. Sprague, S. Chow, Diego Brancaccio, Yumi Kubo, P. Dykes, E. de Francesco Daher, C. Erley, Joanna Matuszkiewicz-Rowińska, T. Minga, I. Dasgupta, Galen S. Wagner, N. Marchetta, R. Rigolosi, P. Raguram, P. Lang, P. Cambier-Dwelschauwers, A. Tsang, M. Schonefeld, W. Bentkowski, Z. Sharon, Daniel Batlle, James T. McCarthy, M. Vital Flores, M. Rambausek, A. Zemtchenkov, Fabio Malberti, V. Thakur, O. Domashenko, D. Wheeler, J. Capelli, Bernard Jones, D. Uehlinger, K. Olgaard, K. Lhotta, M. Bernardo, S. Goldberger, Alison Thomas, E. Dunnigan, A. Ksiazek, A. Assefi, C. Poole, G. Rosa Diez, G. Newman, J. Cotton, C. Combe, B. Murthyr, Sharon M. Moe, H. Neumayer, J. Mittleman, Robert G. Fassett, W. Cleveland, F. van der Sande, C. Vela, H. Fessi, J. Robertson, Giuseppe Cannella, Bryan N. Becker, João M. Frazão, V. Shilo, M. Rano, J. De Meester, R. Fiedler, J. Floege, B. Murray, Giovambattista Capasso, F. Dellanna, J. Luiz Gross, K. Tucker, C. Santiago, Paul J. Martin, M. Nowicki, L. Friedman, William G. Goodman, G. Diez, Markus Ketteler, S. Arfeen, I. Mezei, J. Ortiz, Elizabeth E. Brown, Deborah Zimmerman, Aleix Cases, M. El Khatib, Martine Leblanc, R. Daelemans, K. Malireddi, C. Rikker, R. Gladish, F. Aranda Verástegui, R. Kopelman, B. Borbas, J. Buerkert, K. Ntoso, J. Peña, V. Garcia, C. West, M. Azer, J. Kwan, J. Sterrett, P. Swift, A. Raff, R. Kohli, S. Lew, Steven J. Rosansky, H. Graf, K. Bouman, F. Skinner, C. Tielemans, S. Ferreira Filho, Jocemir Ronaldo Lugon, M. Weinberg, Parfrey, P. S., Drueke, T. B., Block, G. A., Correa-Rotter, R., Floege, J., Herzog, C. A., London, G. M., Mahaffey, K. W., Moe, S. M., Wheeler, D. C., Kubo, Y., Dehmel, B., Goodman, W. G., Chertow, G. M., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo de Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., de Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., de Almeida Romao, E., Cardeal da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., London, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., van den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., van der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar de La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, 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D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., and Rekhi, A.
Subjects: Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract: Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814
Published: 2015

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27 results on '"Sprague S"'

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27. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

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