6 results on '"Fleg, Jerome L."'
Search Results
2. Digoxin Reduces 30-day All-cause Hospital Admission in Older Patients with Chronic Systolic Heart Failure.
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Bourge, Robert C., Fleg, Jerome L., Fonarow, Gregg C., Cleland, John G.F., McMurray, John J.V., van Veldhuisen, Dirk J., Gheorghiade, Mihai, Patel, Kanan, Aban, Inmaculada B., Allman, Richard M., White-Williams, Connie, White, Michel, Filippatos, Gerasimos S., Anker, Stefan D., and Ahmed, Ali
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HEART failure treatment , *DIGOXIN , *ETIOLOGY of diseases , *HOSPITAL admission & discharge , *OLDER patients , *MEDICAL care - Abstract
Abstract: Background: Heart failure is a leading cause of hospital admission and readmission in older adults. The new United States healthcare reform law has created provisions for financial penalties for hospitals with higher than expected 30-day all-cause readmission rates for hospitalized Medicare beneficiaries aged ≥65 years with heart failure. We examined the effect of digoxin on 30-day all-cause hospital admission in older patients with heart failure and reduced ejection fraction. Methods: In the main Digitalis Investigation Group trial, 6800 ambulatory patients with chronic heart failure (ejection fraction ≤45%) were randomly assigned to digoxin or placebo. Of these, 3405 were aged ≥65 years (mean age, 72 years; 25% were women; 11% were nonwhite). The main outcome in the current analysis was 30-day all-cause hospital admission. Results: In the first 30 days after randomization, all-cause hospitalization occurred in 5.4% (92/1693) and 8.1% (139/1712) of patients in the digoxin and placebo groups, respectively, (hazard ratio {HR} when digoxin was compared with placebo, 0.66; 95% confidence interval {CI}, 0.51-0.86; P=.002). Digoxin also reduced both 30-day cardiovascular (3.5% vs 6.5%; HR, 0.53; 95% CI, 0.38-0.72; P<.001) and heart failure (1.7 vs 4.2%; HR, 0.40; 95% CI, 0.26-0.62; P<.001) hospitalizations, with similar trends for 30-day all-cause mortality (0.7% vs 1.3%; HR, 0.55; 95% CI, 0.27-1.11; P=.096). Younger patients were at lower risk of events but obtained similar benefits from digoxin. Conclusions: Digoxin reduces 30-day all-cause hospital admission in ambulatory older patients with chronic systolic heart failure. Future studies need to examine its effect on 30-day all-cause hospital readmission in hospitalized patients with acute heart failure. [Copyright &y& Elsevier]
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- 2013
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3. Body Mass Index and Clinical and Health Status Outcomes in Chronic Coronary Disease and Advanced Kidney Disease in the ISCHEMIA-CKD Trial.
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Mathew, Roy O., Kretov, Evgeny I., Huang, Zhen, Jones, Philip G., Sidhu, Mandeep S., O'Brien, Sean M., Prokhorikhin, Aleksei A., Rangaswami, Janani, Newman, Jonathan, Stone, Gregg W., Fleg, Jerome L., Spertus, John A., Maron, David J., Hochman, Judith S., and Bangalore, Sripal
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HEALTH status indicators , *CORONARY disease , *BODY mass index , *KIDNEY diseases , *OBESITY paradox - Abstract
• An obesity paradox was not seen in the ISCHEMIA-CKD cohort. • Obesity may increase death and myocardial infarction risk in advanced chronic kidney disease and chronic coronary disease. • Obesity is associated with greater dyspnea in advanced chronic kidney disease and chronic coronary disease. • There was no body mass index by treatment assignment interaction for the primary outcome in the ISCHEMIA-CKD trial. This study aimed to assess whether an obesity paradox (lower event rates with higher body mass index [BMI]) exists in participants with advanced chronic kidney disease (CKD) and chronic coronary disease in the International Study of Comparative Health Effectiveness of Medical and Invasive Approaches (ISCHEMIA)-CKD, and whether BMI modified the effect of initial treatment strategy. Baseline BMI was analyzed as both a continuous and categorical variable (< 25, ≥ 25 to < 30, ≥ 30 kg/m2). Associations between BMI and the primary outcome of all-cause death or myocardial infarction (D/MI), and all-cause death, cardiovascular death, and MI individually were estimated. Associations with health status were also evaluated using the Seattle Angina Questionnaire-7, the Rose Dyspnea Scale, and the EuroQol-5D Visual Analog Scale. Body mass index ≥ 30 kg/m2 vs < 25 kg/m2 demonstrated increased risk for MI (hazard ratio [HR] [95% confidence interval] = 1.81 [1.12-2.92]) and for D/MI (HR 1.45 [1.06-1.96]) with a HR for MI of 1.22 (1.05-1.40) per 5 kg/m2 increase in BMI in unadjusted analysis. In multivariate analyses, a BMI ≥ 30 kg/m2 was marginally associated with D/MI (HR 1.43 [1.00-2.04]) and greater dyspnea throughout follow-up (P <.05 at all time points). Heterogeneity of treatment effect between baseline BMI was not evident for any outcome. In the ISCHEMIA-CKD trial, an obesity paradox was not detected. Higher BMI was associated with worse dyspnea, and a trend toward increased D/MI and MI risk. Larger studies to validate these findings are warranted. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Digoxin and 30-day All-cause Hospital Admission in Older Patients with Chronic Diastolic Heart Failure.
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Hashim, Taimoor, Elbaz, Shereen, Patel, Kanan, Morgan, Charity J., Fonarow, Gregg C., Fleg, Jerome L., McGwin, Gerald, Cutter, Gary R., Allman, Richard M., Prabhu, Sumanth D., Zile, Michael R., Bourge, Robert C., and Ahmed, Ali
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DIGOXIN , *OLDER patients , *HEART failure patients , *HOSPITAL admission & discharge , *HOSPITAL care , *CONFIDENCE intervals , *PLACEBOS - Abstract
Abstract: Background: In the main Digitalis Investigation Group (DIG) trial, digoxin reduced the risk of 30-day all-cause hospitalization in older systolic heart failure patients. However, this effect has not been studied in older diastolic heart failure patients. Methods: In the ancillary DIG trial, of the 988 patients with chronic heart failure and preserved (> 45%) ejection fraction, 631 were age ≥ 65 years (mean age 73 years, 45% women, 12% non-whites), of whom 311 received digoxin. Results: All-cause hospitalization 30-day post randomization occurred in 4% of patients in the placebo group and 9% each among those in the digoxin group receiving 0.125 mg and ≥ 0.25 mg a day dosage (P = .026). Hazard ratios (HR) and 95% confidence intervals (CI) for digoxin use overall for 30-day, 3-month, and 12-month all-cause hospitalizations were 2.46 (1.25-4.83), 1.45 (0.96-2.20) and 1.14 (0.89-1.46), respectively. There was one 30-day death in the placebo group. Digoxin-associated HRs (95% CIs) for 30-day hospitalizations due to cardiovascular, heart failure, and unstable angina causes were 2.82 (1.18-6.69), 0.51 (0.09-2.79), and 6.21 (0.75-51.62), respectively. Digoxin had no significant association with 30-day all-cause hospitalization among younger patients (6% vs 7% for placebo; HR 0.80; 95% CI, 0.36-1.79). Conclusions: In older patients with chronic diastolic heart failure, digoxin increased the risk of 30-day all-cause hospital admission, but not during longer follow-up. Although chance finding due to small sample size is possible, these data suggest that unlike in systolic heart failure, digoxin may not reduce 30-day all-cause hospitalization in older diastolic heart failure patients. [Copyright &y& Elsevier]
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- 2014
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5. Digoxin Use and Lower 30-day All-cause Readmission for Medicare Beneficiaries Hospitalized for Heart Failure.
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Ahmed, Ali, Bourge, Robert C., Fonarow, Gregg C., Patel, Kanan, Morgan, Charity J., Fleg, Jerome L., Aban, Inmaculada B., Love, Thomas E., Yancy, Clyde W., Deedwania, Prakash, van Veldhuisen, Dirk J., Filippatos, Gerasimos S., Anker, Stefan D., and Allman, Richard M.
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DIGOXIN , *DRUG utilization , *MEDICARE , *HEART failure , *PATIENT readmissions , *MORTALITY - Abstract
Abstract: Background: Heart failure is the leading cause for hospital readmission, the reduction of which is a priority under the Affordable Care Act. Digoxin reduces 30-day all-cause hospital admission in chronic systolic heart failure. Whether digoxin is effective in reducing readmission after hospitalization for acute decompensation remains unknown. Methods: Of the 5153 Medicare beneficiaries hospitalized for acute heart failure and not receiving digoxin, 1054 (20%) received new discharge prescriptions for digoxin. Propensity scores for digoxin use, estimated for each of the 5153 patients, were used to assemble a matched cohort of 1842 (921 pairs) patients (mean age, 76 years; 56% women; 25% African American) receiving and not receiving digoxin, who were balanced on 55 baseline characteristics. Results: Thirty-day all-cause readmission occurred in 17% and 22% of matched patients receiving and not receiving digoxin, respectively (hazard ratio [HR] for digoxin, 0.77; 95% confidence interval [CI], 0.63-0.95). This beneficial association was observed only in those with ejection fraction <45% (HR 0.63; 95% CI, 0.47-0.83), but not in those with ejection fraction ≥45% (HR 0.91; 95% CI, 0.60-1.37; P for interaction, .145), a difference that persisted throughout the first 12 months postdischarge (P for interaction, .019). HRs (95% CIs) for 12-month heart failure readmission and all-cause mortality were 0.72 (0.61-0.86) and 0.83 (0.70-0.98), respectively. Conclusions: In Medicare beneficiaries with systolic heart failure, a discharge prescription of digoxin was associated with lower 30-day all-cause hospital readmission, which was maintained at 12 months, and was not at the expense of higher mortality. Future randomized controlled trials are needed to confirm these findings. [Copyright &y& Elsevier]
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- 2014
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6. Effects of Extended-Release Niacin Added to Simvastatin/Ezetimibe on Glucose and Insulin Values in AIM-HIGH.
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Goldberg, Ronald B., Bittner, Vera A., Dunbar, Richard L., Fleg, Jerome L., Grunberger, George, Guyton, John R., Leiter, Lawrence A., McBride, Ruth, Robinson, Jennifer G., Simmons, Debra L., Wysham, Carol, Xu, Ping, and Boden, William E.
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NIACIN , *SIMVASTATIN , *TREATMENT of diabetes , *DRUG efficacy , *CONTROLLED release drugs , *THERAPEUTICS - Abstract
Background: Niacin is an antidyslipidemic agent that may cause blood sugar elevation in patients with diabetes, but its effects on glucose and insulin values in nondiabetic statin-treated subjects with cardiovascular disease and at high risk for diabetes are less well known.Methods: This was a prespecified, intent-to-treat analysis of the Atherothrombosis Intervention in Metabolic syndrome with low high-density lipoprotein/high triglycerides: Impact on Global Health outcomes trial which randomized 3,414 participants at 92 centers in the US and Canada to extended-release niacin (ERN) plus simvastatin/ezetimibe (ERN) or simvastatin/ezetimibe plus placebo (Placebo). Baseline and annual fasting glucose and insulin values were measured. Those experiencing an adverse event indicative of diabetes or starting medications for diabetes were considered to have confirmed diabetes. In addition, nondiabetic subjects with 2 annual follow-up glucose measurements were categorized into normal, impaired fasting glucose or newly diagnosed diabetes (presumed or confirmed) states.Results: Compared with placebo, ERN increased annual fasting glucose from baseline to 1 year in both those with normal (7.9 ± 15.8 vs 4.3 ± 10.3 mg/dL; P < .001) and impaired fasting glucose (4.1 ± 18.7 vs 1.4 ± 14.9; P < .02) and increased insulin levels. Both effects waned over the next 2 years. There were less consistent effects in those with baseline diabetes. There was an increased risk of progressing from normal to presumed or confirmed impaired fasting glucose (ERN 197/336) cases (58.6%) vs placebo 135/325 cases (41.5%; P < .001) over time, but no difference in diabetes development in the 2 treatment groups except in those with normal fasting glucose at baseline.Conclusions: The addition of ERN to simvastatin/ezetimibe had marginal effects on glycemia in those with diabetes at baseline, and there was a trend toward increased development of new-onset diabetes. In addition, ERN increased the risk of developing impaired fasting glucose, which may have deleterious consequences over time and warrants further study. [ABSTRACT FROM AUTHOR]- Published
- 2016
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