Ariela R Orkaby1,2, Michael W Rich3, Ryan Sun4, Eliah Lux5, Lee-Jen Wei4, Dae Hyun Kim5,6. 1. Geriatric Research, Education, and Clinical Center, Veterans Affairs Boston Healthcare System, Boston, Massachusetts. 2. Division of Aging, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. 3. Division of Cardiology, Department of Medicine, School of Medicine, Washington University, St Louis, Missouri. 4. Department of Biostatistics, T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts. 5. Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 6. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: To use restricted mean survival time, which summarizes treatment effects in terms of event-free time over a fixed time period, to evaluate the benefit of pravastatin therapy for primary prevention of cardiovascular disease in older adults. DESIGN: Secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial-Lipid-Lowering Trial (ALLHAT-LLT). SETTING: Ambulatory setting. PARTICIPANTS: Individuals aged 65 and older (mean aged 71, 49% female) free of cardiovascular disease (N=2,867). INTERVENTION: Pravastatin 40 mg/d (n=1,467) versus usual care (n=1,400). MEASUREMENTS: We estimated the difference in RMST for total and coronary heart disease (CHD)-free survival between the pravastatin and usual care groups over the 6-year trial period and used parametric survival models to estimate RMST differences projected over 10 years. RESULTS: Over 6 years, individuals treated with pravastatin lived (RMST 2,008.1 days), on average, 33.7 fewer days than those receiving usual care (RMST 2,041.8 days) (difference -33.7 days, 95% confidence interval (CI)=-67.0 to -0.5 days, p=.047). Pravastatin-treated individuals lived RMST 2,088.1 days), on average, 18.7 more days free of CHD over 6 years than those receiving usual care (RMST 2,069.4 days), but this difference was not statistically significant (difference 18.7 days, 95% CI=-10.4-47.8 days, p=.21). The 10-year projection showed that pravastatin-treated individuals would live 108.1 fewer days (95% CI=-204.5 to -14.1, p=.03) than those receiving usual care, although treated individuals would gain 77.9 days (95% CI=3.8-159.6, p=.046) of CHD-free survival. CONCLUSION:RMST provides an intuitive and explicit way to express the effect of pravastatin therapy on CHD-free and overall survival in older adults free of cardiovascular disease. This measure allows a more personalized interpretation than hazard ratios of the benefits and risks of a medical intervention for decision-making.
RCT Entities:
OBJECTIVES: To use restricted mean survival time, which summarizes treatment effects in terms of event-free time over a fixed time period, to evaluate the benefit of pravastatin therapy for primary prevention of cardiovascular disease in older adults. DESIGN: Secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial-Lipid-Lowering Trial (ALLHAT-LLT). SETTING: Ambulatory setting. PARTICIPANTS: Individuals aged 65 and older (mean aged 71, 49% female) free of cardiovascular disease (N=2,867). INTERVENTION: Pravastatin 40 mg/d (n=1,467) versus usual care (n=1,400). MEASUREMENTS: We estimated the difference in RMST for total and coronary heart disease (CHD)-free survival between the pravastatin and usual care groups over the 6-year trial period and used parametric survival models to estimate RMST differences projected over 10 years. RESULTS: Over 6 years, individuals treated with pravastatin lived (RMST 2,008.1 days), on average, 33.7 fewer days than those receiving usual care (RMST 2,041.8 days) (difference -33.7 days, 95% confidence interval (CI)=-67.0 to -0.5 days, p=.047). Pravastatin-treated individuals lived RMST 2,088.1 days), on average, 18.7 more days free of CHD over 6 years than those receiving usual care (RMST 2,069.4 days), but this difference was not statistically significant (difference 18.7 days, 95% CI=-10.4-47.8 days, p=.21). The 10-year projection showed that pravastatin-treated individuals would live 108.1 fewer days (95% CI=-204.5 to -14.1, p=.03) than those receiving usual care, although treated individuals would gain 77.9 days (95% CI=3.8-159.6, p=.046) of CHD-free survival. CONCLUSION:RMST provides an intuitive and explicit way to express the effect of pravastatin therapy on CHD-free and overall survival in older adults free of cardiovascular disease. This measure allows a more personalized interpretation than hazard ratios of the benefits and risks of a medical intervention for decision-making.
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