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3. Cross-Sectional Analysis of Baseline Visual Parameters in Subjects Recruited Into the RESCUE and REVERSE ND4-LHON Gene Therapy Studies.

Author

Moster, Mark, Sergott, Robert, Newman, Nancy, Yu-Wai-Man, Patrick, Carelli, Valerio, Bryan, Molly, Smits, Gerard, Biousse, Valérie, Vignal-Clermont, Catherine, Klopstock, Thomas, Sadun, Alfredo, DeBusk, Adam, Carbonelli, Michele, Hage, Rabih, Priglinger, Siegfried, Karanjia, Rustum, Blouin, Laure, Taiel, Magali, Katz, Barrett, and Sahel, José

Subjects
Adolescent, Adult, Aged, Cross-Sectional Studies, DNA, Mitochondrial, Double-Blind Method, Female, Genetic Therapy, Humans, Male, Middle Aged, Optic Atrophy, Hereditary, Leber, Retinal Ganglion Cells, Tomography, Optical Coherence, Visual Acuity, Visual Fields, Young Adult
Abstract

OBJECTIVE: This report presents a cross-sectional analysis of the baseline characteristics of subjects with Leber hereditary optic neuropathy enrolled in the gene therapy trials RESCUE and REVERSE, to illustrate the evolution of visual parameters over the first year after vision loss. METHODS: RESCUE and REVERSE were 2 phase III clinical trials designed to assess the efficacy of rAAV2/2-ND4 gene therapy in ND4-LHON subjects. At enrollment, subjects had vision loss for ≤6 months in RESCUE, and between 6 and 12 months in REVERSE. Functional visual parameters (best-corrected visual acuity [BCVA], contrast sensitivity [CS], and Humphrey Visual Field [HVF]) and structural parameters assessed by spectral-domain optical coherence tomography were analyzed in both cohorts before treatment. The cross-sectional analysis of functional and anatomic parameters included the baseline values collected in all eyes at 2 different visits (Screening and Inclusion). RESULTS: Seventy-six subjects were included in total, 39 in RESCUE and 37 in REVERSE. Mean BCVA was significantly worse in RESCUE subjects compared with REVERSE subjects (1.29 and 1.61 LogMAR respectively, P = 0.0029). Similarly, mean CS and HVF were significantly more impaired in REVERSE vs RESCUE subjects (P < 0.005). The cross-sectional analysis showed that the monthly decrease in BCVA, ganglion cell layer macular volume, and retinal nerve fiber layer thickness was much more pronounced in the first 6 months after onset (+0.24 LogMAR, -0.06 mm3, and -6.00 μm respectively) than between 6 and 12 months after onset (+0.02 LogMAR, -0.01 mm3, and -0.43 μm respectively). CONCLUSION: LHON progresses rapidly in the first months following onset during the subacute phase, followed by relative stabilization during the dynamic phase.

Published
2021

4. Variation in Sodium Intake and Intra-individual Change in Blood Pressure in Chronic Kidney Disease.

Author

Pathak, Chetna, Ix, Joachim, Anderson, Cheryl, Woodell, Tyler, Smits, Gerard, Persky, Martha, Block, Geoffrey, and Rifkin, Dena

Subjects
Aged, Blood Pressure, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Phosphates, Renal Insufficiency, Chronic, Sodium, Sodium, Dietary
Abstract

OBJECTIVE: In the kidney disease clinic setting, higher-than-usual blood pressure is often ascribed to recent dietary sodium indiscretion. While clinical trials demonstrate a clear relationship between salt intake and blood pressure on the population level, it is uncertain whether real-world variation in sodium intake within individual chronic kidney disease (CKD) patients is associated with fluctuations in blood pressure. METHODS: We analyzed data from the Phosphorus Normalization Trial, in which participants with CKD eating their usual diets completed at least three 24-hour urine collections over 9 months, from which we measured sodium. Blood pressure was measured at the time of 24-hour urine collections. For each individual participant, we assessed the slope of the relationship between sodium intake and mean arterial blood pressure (MAP). RESULTS: Among 119 participants (mean age 67 years and mean estimated glomerular filtration rate 31 mL/minute/1.73 m2), there was substantial variation in sodium intake as measured by 24-hour urine collections (mean intake 3,903 mg/day, standard deviation 1037 mg/day). Individual participants had highly variable associations between their sodium intake and their MAP; 47% (n = 56) had inverse associations between sodium and MAP, whereas the remainder had positive (salt-sensitive) associations. CONCLUSIONS: Among CKD patients, there is substantial variation in sodium intake but no predictable relationship between dietary sodium and blood pressure in individuals. The frequent dismissal of elevated blood pressure readings as related to recent sodium intake in clinic may be a misapplication of large-scale population data to explain individual variability and may contribute to clinical inertia regarding high blood pressure treatment.

Published
2018

5. Spot urine sodium measurements do not accurately estimate dietary sodium intake in chronic kidney disease.

Author

Dougher, Carly E, Rifkin, Dena E, Anderson, Cheryl Am, Smits, Gerard, Persky, Martha S, Block, Geoffrey A, and Ix, Joachim H

Subjects
Aged, Aged, 80 and over, Biomarkers: urine, Blood Pressure, Diet, Feeding Behavior, Female, Glomerular Filtration Rate, Humans, Kidney: physiopathology, Male, Mathematical Concepts, Middle Aged, Renal Insufficiency, Chronic: urine, Reproducibility of Results, Sodium: administration & dosage, urine, Sodium Chloride, Dietary: administration & dosage, urine, Sodium, Dietary: administration & dosage, urine, Urinalysis
Abstract

Sodium intake influences blood pressure and proteinuria, yet the impact on long-term outcomes is uncertain in chronic kidney disease (CKD). Accurate assessment is essential for clinical and public policy recommendations, but few large-scale studies use 24-h urine collections. Recent studies that used spot urine sodium and associated estimating equations suggest that they may provide a suitable alternative, but their accuracy in patients with CKD is unknown.We compared the accuracy of 4 equations [the Nerbass, INTERSALT (International Cooperative Study on Salt, Other Factors, and Blood Pressure), Tanaka, and Kawasaki equations] that use spot urine sodium to estimate 24-h sodium excretion in patients with moderate to advanced CKD.We evaluated the accuracy of spot urine sodium to predict mean 24-h urine sodium excretion over 9 mo in 129 participants with stage 3-4 CKD. Spot morning urine sodium was used in 4 estimating equations. Bias, precision, and accuracy were assessed and compared across each equation.The mean age of the participants was 67 y, 52% were female, and the mean estimated glomerular filtration rate was 31 ± 9 mL · min(-1) · 1.73 m(-2) The mean ± SD number of 24-h urine collections was 3.5 ± 0.8/participant, and the mean 24-h sodium excretion was 168.2 ± 67.5 mmol/d. Although the Tanaka equation demonstrated the least bias (mean: -8.2 mmol/d), all 4 equations had poor precision and accuracy. The INTERSALT equation demonstrated the highest accuracy but derived an estimate only within 30% of mean measured sodium excretion in only 57% of observations. Bland-Altman plots revealed systematic bias with the Nerbass, INTERSALT, and Tanaka equations, underestimating sodium excretion when intake was high.These findings do not support the use of spot urine specimens to estimate dietary sodium intake in patients with CKD and research studies enriched with patients with CKD. The parent data for this study come from a clinical trial that was registered at clinicaltrials.gov as NCT00785629.

Published
2016

7. Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

Author

Multack,Sam, Plummer,Nellie, Smits,Gerard, Hall,Brad, Multack,Sam, Plummer,Nellie, Smits,Gerard, and Hall,Brad

Abstract

Sam Multack,1 Nellie Plummer,1 Gerard Smits,2 Brad Hall3 1Multack Eye Care, Frankfort, IL, USA; 2CSC, Inc., Santa Barbara, CA, USA; 3Sengi, Penniac, NB, CanadaCorrespondence: Sam Multack, Multack Eye Care, 22200 Wolf Road, Frankfort, IL, 60423, USA, Tel +1 815-889-3333, Email smultack@mecvision.comPurpose: To compare the prediction accuracy of the Argos biometer using standard keratometry to the prediction accuracy of the IOLMaster 700 biometer using Total Keratometry.Methods: This was a randomized, prospective, single surgeon study of 80 right eyes of 80 patients that had preoperative biometry with both the Argos and IOLMaster 700 devices, followed by cataract surgery and intraocular lens (IOL) implantation. Prediction errors (directional and absolute) for each device were determined from the 1 month postoperative manifest refraction.Results: The directional prediction error was 0.07 ± 0.32 D for the Argos and 0.08 ± 0.34 D for the IOLMaster 700. The mean of the difference in prediction error (directional) was 0.02 D, which was not statistically significant (p > 0.05). The absolute prediction error was 0.21 ± 0.25 D for the Argos and 0.25 ± 0.24 D for the IOLMaster 700. The mean of the difference in absolute prediction error was 0.04 D, which was statistically significant (p < 0.004) but not clinically significant. The percentage of eyes with absolute prediction error ≤ 0.5 D was 91% (73 eyes) for the Argos and 88% (70 eyes) for the IOLMaster 700. This difference was not statistically significant.Conclusion: The prediction accuracies were similar between the Argos and IOLMaster 700 in eyes with normal axial length. There was a significant difference in mean absolute prediction error between devices; however, this was not clinically meaningful.Keywords: Argos, IOLMaster 700, swept source optical coherence tomography, SS-OCT, cataract surgery, biometry

Published
2023

9. Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial

Author

Tierney, Braden T., primary, Versalovic, James, additional, Fasano, Alessio, additional, Petrosino, Joseph F., additional, Chumpitazi, Bruno P., additional, Mayer, Emeran A., additional, Boetes, Jared, additional, Smits, Gerard, additional, Parkar, Shanthi G., additional, Voreades, Noah, additional, Kartal, Ece, additional, Al-Ghalith, Gabriel A., additional, Pane, Marco, additional, Bron, Peter A., additional, Reid, Gregor, additional, Dhir, Raja, additional, and Mason, Christopher E., additional

Published
2022
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14. Comparison of Astigmatism Prediction Accuracy for Toric Lens Implantation from Two Swept-Source Optical Coherence Tomography Devices

Author

Melendez,Robert F, Smits,Gerard, Nguyen,Thao, Ruffaner-Hanson,Chaselyn D, Ortiz,Danielle, Hall,Brad, Melendez,Robert F, Smits,Gerard, Nguyen,Thao, Ruffaner-Hanson,Chaselyn D, Ortiz,Danielle, and Hall,Brad

Abstract

Robert F Melendez,1,2 Gerard Smits,3 Thao Nguyen,1 Chaselyn D Ruffaner-Hanson,1 Danielle Ortiz,2 Brad Hall4 1Juliette Eye Institute, Albuquerque, NM, USA; 2University of New Mexico School of Medicine, Department of Ophthalmology, Albuquerque, NM, USA; 3CSC, Inc., Santa Barbara, CA, USA; 4Sengi, Penniac, NB, CanadaCorrespondence: Robert F Melendez, Juliette Eye Institute, 6401 Holly Ave., NE, Albuquerque, NM, 87113, USA, Tel +1 505-355-2020 ; +1 505-235-4781, Email robertmelendez@mac.comPurpose: To compare the astigmatism prediction accuracy for toric intraocular lens (IOL) implantation between two swept-source optical coherence tomography (SS-OCT) devices: Argos (Movu, a Santec Company) and the IOLMaster 700 (Carl Zeiss Meditec).Methods: This was a retrospective chart review of 59 eyes (44 patients) with corneal astigmatism and cataract that underwent cataract surgery or refractive lens exchange surgery with a toric IOL. Biometry was performed on all patients prior to cataract surgery and the Barrett toric IOL calculator was used. Visual acuity was measured postoperatively. Manifest refraction was measured at 1 month and compared to the predicted postoperative residual refraction. Preoperative K measurements between devices were also compared.Results: Mean cylinder prediction error was − 0.17 ± 0.43 for Argos and 0.12 ± 0.56 for IOLMaster 700. The cylinder prediction error 0.5 D or less was not significantly different between the devices, with 83.1% (49 eyes) for Argos and 76.3% (45 eyes) for IOLMaster 700 (p = 0.206). Spherical equivalent prediction error was 0.13 ± 0.39 for Argos and 0.25 ± 0.50 for IOLMaster 700. The mean spherical equivalent prediction error 0.5 D or less was significantly different between the devices, with 79.7% (47 eyes) for Argos and 61.0% (36 eyes) for IOLMaster 700 (p = 0.016).Conclusion: The prediction accuracies were similar between the devices, except for spherical equivalent, where a higher percentage of eyes were 0.5 D or less o

Published
2022

15. Comparison of Barrett and Emmetropia Verifying Optical Toric Calculators

Author

Pantanelli,Seth M, Sun,Ashley, Kansara,Neal, Smits,Gerard, Pantanelli,Seth M, Sun,Ashley, Kansara,Neal, and Smits,Gerard

Abstract

Seth M Pantanelli,1 Ashley Sun,1 Neal Kansara,2 Gerard Smits3 1Department of Ophthalmology, Penn State College of Medicine, Hershey, PA, USA; 2Department of Ophthalmology, Baylor College of Medicine, Houston, TX, USA; 3Computer and Statistical Consultants Incorporated, Santa Barbara, CA, USACorrespondence: Seth M Pantanelli, Department of Ophthalmology, Penn State College of Medicine, 500 University Drive, HU19, Hershey, PA, 17033-0850, USA, Tel +1 717-531-5690, Fax +1 717-531-5009, Email spantanelli@pennstatehealth.psu.eduPurpose: The purpose of this study was to compare the Barrett (BTC) and Emmetropia Verifying Optical (EVO) Toric Calculators’ performance with regards to prediction of residual post-operative astigmatism after cataract surgery.Methods: This was a secondary analysis of de-identified data that was collected as part of a prospective multicenter clinical trial in which 109 eyes from 109 patients were implanted with a monofocal toric intraocular lens (IOL). Post-operative biometry was used to calculate the predicted post-operative residual astigmatism for each eye using the two different calculators. The vector difference between the actual and predicted residual astigmatism was calculated.Results: The mean absolute astigmatism prediction errors were 0.59 ± 0.38 D and 0.59 ± 0.36 D for the BTC and EVO calculators, respectively (p = 0.98). The centroid of the prediction errors were 0.18 D @ 89° ± 0.68 D and 0.20 D @ 89° ± 0.66 D, respectively (p = 0.21). The proportion of eyes in which the astigmatism prediction error was ≤ 0.5 D was 50% for BTC and 46% for EVO (p = 0.28). The proportion of eyes in which the post-operative astigmatism orientation was correctly predicted as being against-the-rule, with-the-rule, or oblique was 81% for BTC and 77% for EVO (p = 0.15).Conclusion: The Barrett and Emmetropia Verifying Optical Toric Calculators had similar performance with re

Published
2022

17. Functional response to a microbial synbiotic in the gastrointestinal system of constipated children

Author

Tierney, Braden T, primary, Versalovic, James, additional, Fasano, Alessio, additional, Petrosino, Joseph F, additional, Chumpitazi, Bruno, additional, Mayer, Emeran A, additional, Boetes, Jared, additional, Smits, Gerard, additional, Parkar, Shanthi G, additional, Voreades, Noah, additional, Kartal, Ece, additional, Bron, Peter A, additional, Reid, Gregor, additional, Dhir, Raja, additional, and Mason, Christopher E, additional

Published
2022
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18. Predictability of Residual Postoperative Astigmatism After Implantation of a Toric Intraocular Lens Using Two Different Calculators

Author

Pantanelli, Seth M, Kansara, Neal, and Smits, Gerard

Subjects
EVO, astigmatism, cataract, intraocular lens power, calculators, Clinical Ophthalmology, toric, Original Research
Abstract

Seth M Pantanelli,1 Neal Kansara,1 Gerard Smits2 1Department of Ophthalmology, Penn State College of Medicine, Hershey, PA, USA; 2Computer and Statistical Consultants Incorporated, Santa Barbara, CA, USACorrespondence: Seth M PantanelliDepartment of Ophthalmology, Penn State College of Medicine, 500 University Drive; HU19, Hershey, PA 17033-0850, USATel +1 717-531-5690Fax +1 717-531-5009Email spantanelli@pennstatehealth.psu.eduPurpose: To compare predictability of postoperative refractive astigmatism (RA) using the Emmetropic Verifying Optical (EVO) Toric Formula v2.0 to one that accounts only for anterior corneal astigmatism.Methods: This is a secondary analysis of de-identified data from a clinical trial including 9 sites across the United States. Preoperative biometry was used to predict postoperative RA with the implanted toric IOL using legacy enVista and EVO online calculators. The RA prediction error was computed between back-calculated postoperative RA and predicted residual RA. Outcome measures included vector (centroid) and arithmetic mean RA prediction error.Results: Comparison of calculators was based on 109 eyes, 97 (89%) of which were implanted with a toric IOL with an effective astigmatism power of 1.4 D or less. Centroid of the RA prediction errors was 0.37 D @ 178 and 0.17 D @ 090 for the legacy and EVO calculators, respectively (p < 0.0001). The proportion of eyes with an absolute RA prediction error ≤ 0.5 was 47.3% and 49.1% (p = 0.78), while the proportion of eyes ≤ 1.0 D was 82.7% and 89.1% (p = 0.03). Differences in the proportions ≤ 0.5 D existed for WTR (p = 0.015) but not ATR (p = 0.75) eyes. The proportion in which orientation of the predicted RA (ATR, WTR, or oblique) matched the actual RA was 62% and 78% for legacy and EVO calculators, respectively (p = 0.0029).Conclusion: The EVO Toric Formula v2.0 out-performed the legacy calculator with regards to predictions in eyes with low astigmatism.Keywords: cataract, toric, intraocular lens power, astigmatism, calculators, EVO

Published
2020

23. Efficacy and Safety of Intravitreal Gene Therapy for Leber Hereditary Optic Neuropathy Treated within 6 Months of Disease Onset

Author

Newman, Nancy J., primary, Yu-Wai-Man, Patrick, additional, Carelli, Valerio, additional, Moster, Mark L., additional, Biousse, Valerie, additional, Vignal-Clermont, Catherine, additional, Sergott, Robert C., additional, Klopstock, Thomas, additional, Sadun, Alfredo A., additional, Barboni, Piero, additional, DeBusk, Adam A., additional, Girmens, Jean François, additional, Rudolph, Günther, additional, Karanjia, Rustum, additional, Taiel, Magali, additional, Blouin, Laure, additional, Smits, Gerard, additional, Katz, Barrett, additional, Sahel, José-Alain, additional, Vignal, Catherine, additional, Hage, Rabih, additional, Catarino, Claudia B., additional, Priglinger, Claudia, additional, Priglinger, Siegfried, additional, Thurau, Stephan, additional, von Livonius, Bettina, additional, Muth, Daniel, additional, Wolf, Armin, additional, Al-Tamami, Jasmina, additional, Pressler, Angelika, additional, Schertler, Cosima, additional, Hildebrandt, Martin, additional, Neuenhahn, Michael, additional, Heilweil, Gad, additional, Tsui, Irena, additional, Hubbard, G. Baker, additional, Hendrick, Andrew, additional, Dattilo, Michael, additional, Peragallo, Jason, additional, Hawy, Eman, additional, DuBois, Med, Lindreth, additional, Gibbs, Deborah, additional, Filho, Alcides Fernandes, additional, Dobbs, Jannah, additional, Carbonelli, Michele, additional, Di Vito, Lidia, additional, Contin, Manuela, additional, Mohamed, Susan, additional, La Morgia, Chiara, additional, Silvestri, Sara, additional, Acheson, James, additional, Eleftheriadou, Maria, additional, Esposti, Simona, additional, Gemenetzi, Maria, additional, Leitch-Devlin, Lauren, additional, Tucker, William R., additional, Jurkute, Neringa, additional, SantaMaria, Melissa, additional, Tollis, Heather, additional, Haller, Julie A., additional, and Massini, Maria, additional

Published
2021
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25. Predictability of Residual Postoperative Astigmatism After Implantation of a Toric Intraocular Lens Using Two Different Calculators

Author

Pantanelli,Seth M, Kansara,Neal, Smits,Gerard, Pantanelli,Seth M, Kansara,Neal, and Smits,Gerard

Abstract

Seth M Pantanelli,1 Neal Kansara,1 Gerard Smits2 1Department of Ophthalmology, Penn State College of Medicine, Hershey, PA, USA; 2Computer and Statistical Consultants Incorporated, Santa Barbara, CA, USACorrespondence: Seth M PantanelliDepartment of Ophthalmology, Penn State College of Medicine, 500 University Drive; HU19, Hershey, PA 17033-0850, USATel +1 717-531-5690Fax +1 717-531-5009Email spantanelli@pennstatehealth.psu.eduPurpose: To compare predictability of postoperative refractive astigmatism (RA) using the Emmetropic Verifying Optical (EVO) Toric Formula v2.0 to one that accounts only for anterior corneal astigmatism.Methods: This is a secondary analysis of de-identified data from a clinical trial including 9 sites across the United States. Preoperative biometry was used to predict postoperative RA with the implanted toric IOL using legacy enVista and EVO online calculators. The RA prediction error was computed between back-calculated postoperative RA and predicted residual RA. Outcome measures included vector (centroid) and arithmetic mean RA prediction error.Results: Comparison of calculators was based on 109 eyes, 97 (89%) of which were implanted with a toric IOL with an effective astigmatism power of 1.4 D or less. Centroid of the RA prediction errors was 0.37 D @ 178 and 0.17 D @ 090 for the legacy and EVO calculators, respectively (p < 0.0001). The proportion of eyes with an absolute RA prediction error ≤ 0.5 was 47.3% and 49.1% (p = 0.78), while the proportion of eyes ≤ 1.0 D was 82.7% and 89.1% (p = 0.03). Differences in the proportions ≤ 0.5 D existed for WTR (p = 0.015) but not ATR (p = 0.75) eyes. The proportion in which orientation of the predicted RA (ATR, WTR, or oblique) matched the actual RA was 62% and 78% for legacy and EVO calculators, respectively (p = 0.0029).Conclusion: The EVO Toric Formula v2.0 out-performed the legacy calculator with regards to predictions in eyes with low astigmatism.Keywords: cataract

Published
2020

27. Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy

Author

Yu-Wai-Man, Patrick, primary, Newman, Nancy J., additional, Carelli, Valerio, additional, Moster, Mark L., additional, Biousse, Valerie, additional, Sadun, Alfredo A., additional, Klopstock, Thomas, additional, Vignal-Clermont, Catherine, additional, Sergott, Robert C., additional, Rudolph, Günther, additional, La Morgia, Chiara, additional, Karanjia, Rustum, additional, Taiel, Magali, additional, Blouin, Laure, additional, Burguière, Pierre, additional, Smits, Gerard, additional, Chevalier, Caroline, additional, Masonson, Harvey, additional, Salermo, Yordak, additional, Katz, Barrett, additional, Picaud, Serge, additional, Calkins, David J., additional, and Sahel, José-Alain, additional

Published
2020
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30. Vitamin D, parathyroid hormone, and cardiovascular mortality in older adults: the Rancho Bernardo study

Author

Jassal, Simerjot K., Chonchol, Michel, Von Muhlen, Denise, Smits, Gerard, and Barrett-Connor, Elizabeth

Subjects
Alfacalcidol -- Health aspects, Alfacalcidol -- Research, Calcifediol -- Health aspects, Calcifediol -- Research, Vitamin D -- Health aspects, Vitamin D -- Research, Cardiovascular diseases -- Patient outcomes, Cardiovascular diseases -- Research, Parathyroid hormone -- Health aspects, Parathyroid hormone -- Research, Health, Health care industry
Abstract

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.amjmed.2010.07.013 Byline: Simerjot K. Jassal (a), Michel Chonchol (b), Denise von Muhlen (c), Gerard Smits (d), Elizabeth Barrett-Connor (c) Keywords: Aging; Cardiovascular mortality; Chronic kidney disease; Parathyroid hormone; Vitamin D Abstract: Recent systematic reviews have cast doubt on the association between vitamin D and cardiovascular disease. No prior studies have investigated the association between 25-hydroxyvitamin D (25[OH]D), 1,25-dihydroxyvitamin D (1,25[OH].sub.2D), or intact parathyroid hormone and cardiovascular mortality in a temperate climate. Author Affiliation: (a) Division of General Internal Medicine and Geriatrics, Department of Medicine, University of California, San Diego, and VA San Diego Healthcare System, La Jolla, Calif (b) Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Denver Health Sciences Center, Aurora, Colo (c) Division of Epidemiology, Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, Calif (d) CSC, Inc, Santa Barbara, Calif Article Note: (footnote) Funding: This work was supported by Grant DK31801 from the National Institute of Diabetes and Digestive and Kidney Diseases, Grant AG07181 from the National Institute on Aging, and Grant R01AG028507 from the National Institutes of Health and the National Institute on Aging., Conflict of Interest: None of the authors have any conflicts of interest associated with the work presented in this manuscript., Authorship: All authors had access to the data and played a role in writing this manuscript.

Published
2010

40. Different Risk for Hypertension, Diabetes, Dyslipidemia, and Hyperuricemia According to Level of Body Mass Index in Japanese and American Subjects

Author

Kuwabara, Masanari, primary, Kuwabara, Remi, additional, Niwa, Koichiro, additional, Hisatome, Ichiro, additional, Smits, Gerard, additional, Roncal-Jimenez, Carlos, additional, MacLean, Paul, additional, Yracheta, Joseph, additional, Ohno, Minoru, additional, Lanaspa, Miguel, additional, Johnson, Richard, additional, and Jalal, Diana, additional

Published
2018
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44. IL-1 Inhibition and Vascular Function in CKD

Author

Nowak, Kristen L., primary, Chonchol, Michel, additional, Ikizler, Talat Alp, additional, Farmer-Bailey, Heather, additional, Salas, Natjalie, additional, Chaudhry, Rafia, additional, Wang, Wei, additional, Smits, Gerard, additional, Tengesdal, Isak, additional, Dinarello, Charles A., additional, and Hung, Adriana M., additional

Published
2016
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45. Vascular Function and Uric Acid-Lowering in Stage 3 CKD

Author

Jalal, Diana I., primary, Decker, Emily, additional, Perrenoud, Loni, additional, Nowak, Kristen L., additional, Bispham, Nina, additional, Mehta, Tapan, additional, Smits, Gerard, additional, You, Zhiying, additional, Seals, Douglas, additional, Chonchol, Michel, additional, and Johnson, Richard J., additional

Published
2016
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46. MANAGEMENT PRACTICES IN PATIENTS WITH CHRONIC RENAL INSUFFICIENCY (CRI)

Author

Hartigan, Marguerite, Im, Hyonelle, Ratican, Michael, and Smits, Gerard

Subjects
Health
Abstract

An analysis was performed of patient characteristics and anemia management practices using data from 1,145 CRI patients treated during a 6-week period in 1999 at over 200 nephrologists' offices. Overall results are displayed in the table. 41.2% of patients had Hct levels below 30%, while 63.7% had levels below 33%. Overall, recombinant human erythropoietin was prescribed for 39% of patients. About 86% of patients with SCr [is greater than or equal to] 5 g/dL were anemic (Hct [is less than] 33%), yet only 53% of them received recombinant human erythropoietin therapy. Over half of the patients with SCr [is less than] 5 g/dL were anemic, however, about only 25% of them received recombinant human erythropoietin therapy. The results of this analysis illustrate anemia may develop early in the course of CRI, but the anemia of CRI is often underrecognized and undertreated. Current clinical practice and methods for improving these results will be discussed. Marguerite Hartigan, MSN, RN, CNN; Hyonelle Im, PharmD; Michael Ratican, MS; Amgen Inc., Thousand Oaks, CA; Gerard Smits, PhD, Statistical Consultant., Marguerite Hartigan, MSN, RN, CNN; Hyonelle Im, PharmD; Michael Ratican, MS; Amgen Inc., Thousand Oaks, CA; Gerard Smits, PhD, Statistical [...]

Published
2001

50. Mineral Metabolites, Angiotensin II Inhibition and Outcomes in Advanced Chronic Kidney Disease.

Author

Jovanovich, anna J., Chonchol, Michel B., Sobhi, atousa, Kendrick, Jessica B., Cheung, alfred K., Kaufman, James S., Smits, Gerard, and Jablonski, Kristen L.

Subjects
ACE inhibitors, ANGIOTENSIN receptors, COMBINATION drug therapy, CHRONIC kidney failure, LONGITUDINAL method, MINERALS, TREATMENT effectiveness, RETROSPECTIVE studies, THERAPEUTICS
Abstract

Background: Evidence suggests that the renin-angiotensin-aldosterone system (RAAS) interacts with the vitamin D-fibroblast growth factor 23-Klotho axis. We investigated whether circulating mineral metabolism markers modify outcomes in response to RAAS inhibition in subjects with advanced chronic kidney disease (CKD).Methods: In this retrospective cohort study, we analyzed the association of angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) use with all-cause mortality and dialysis initiation among 1,753 subjects (1,099 CKD, estimated glomerular filtration rate 18 ± 6 ml/min/1.73 m(2) and 654 end-stage renal disease [ESRD]) from the Homocysteine in Kidney and End Stage Renal Disease (HOST) study. A propensity score analysis accounted for indication bias and Cox regression models adjusted for mineral metabolism markers.Results: Mean follow-up was 3.2 years; 714 (41%) subjects died and 615 (56%) initiated dialysis. In adjusted analyses, all subjects treated with ACEI/ARB had a significantly lower hazard of death (hazards ratio (HR) 0.81, 95% CI 0.70-0.95, p = 0.007). Those with CKD not on dialysis and treated with ACEI/ARB trended toward a lower hazard of dialysis initiation (HR 0.86, 95% CI 0.73-1.01, p = 0.06). The association with mortality did not differ by level of mineral metabolism marker (p for interaction >0.16); however, the relationship with dialysis initiation differed according to the median serum phosphorus level (p for interaction <0.001).Conclusions: RAAS inhibition was associated with decreased all-cause mortality independent of disordered mineral metabolism among mostly male HOST subjects with advanced CKD and ESRD. However, among those with CKD not requiring dialysis, the renoprotection associated with RAAS inhibition was attenuated by higher serum phosphorus levels. Further studies are needed to confirm this association. [ABSTRACT FROM AUTHOR]

Published
2016
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