Abstract 14276: 30-Year Survival in the Active and Placebo Groups of the Systolic Hypertension in the Elderly Program
Introduction: There are scant data on differences in survival between clinical trial participants compared to individuals who do not volunteer to participate in such studies. In addition, quantitative studies of the benefits of antihypertensive therapy on extending survival have not been reported. The 30-year follow-up data from the Systolic Hypertension in the Elderly Program (SHEP) were used to address these questions.
Methods: SHEP was a randomized, placebo controlled clinical trial of chlorthalidone-based antihypertensive therapy in patients with isolated systolic hypertension (systolic blood pressure >160 and diastolic blood pressure <90). At 4.5 years there was a significant decrease in the rates of stroke, heart failure and coronary heart disease, but no effect on mortality. We used the National Death Index to study survival of SHEP participants for up to 30 years from randomization compared to actuarial controls i.e. persons of the same gender and race who were alive when each SHEP participant was randomized and were born on the same day.
Results: SHEP participants had markedly longer survival than actuarial controls, p<0.000001. The difference may be related to exclusion of sick patients by the protocol, self selection of persons with better lifestyles and interest in their health who volunteer for research studies and possibly to better control of conditions other than hypertension. Randomization to active therapy was associated with somewhat longer life expectancy (91 days, 95% CI -122 to 283, p=0.158 for all-cause death and 172 days, 95% CI -26 to 371, p=0.060 for cardiovascular death). The survival of SHEP participants exceeded our previously published projections based on the preceding trajectories of the survival curves.
Conclusions: This unique 30 year follow-up study indicates that SHEP participants had markedly higher survival than actuarial controls and better survival than prior projections.
Author Disclosures: W.J. Kostis: None. J.Q. Cheng: None. J.B. Kostis: Research Grant; Modest; Bayer, Boehringer Ingelheim. Research Grant; Significant; Novartis, Pfizer, Sanofi, AstraZeneca. Expert Witness; Modest; Vasios, Kelly & Strollo, PA, La Follette, Johnson De Haas, Fesler & Ames. Consultant/Advisory Board; Modest; ACI Clinical, Merck. Consultant/Advisory Board; Significant; Palatin, St. Jude Medical. J. Cabrera: None. D. Sargsyan: None. N.M. Cosgrove: None. S.L. Pressel: None. B.R. Davis: None.
- © 2016 by American Heart Association, Inc.