Effect of Statin Treatment Among Older Adults
Is statin therapy associated with lower all-cause mortality among older adults?
Data from the lipid-lowering component of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) study, ALLHAT-LLT, were used for the present analysis. Participants 65 years or older with no clinical evidence of atherosclerotic cardiovascular disease at baseline but with hypertension, were included in this post hoc secondary analysis. ALLHAT-LLT was conducted from February 1994 to March 2002 at 513 clinical sites. Participants in the lipid-lowering component were randomized to pravastatin 40 mg/day or usual care. The primary outcome of interest was all-cause mortality. Secondary outcomes included cause-specific mortality, nonfatal myocardial infarction (MI), or fatal coronary heart disease (CHD).
A total of 2,867 participants were included in the present analysis, of which 1,467 participants (mean age, 71.3 years; 48% female) were randomized to pravastatin and 1,400 participants (mean age, 71.2 years, 50.8% female) were randomized to usual care. The baseline mean (standard deviation [SD]) low-density lipoprotein cholesterol levels were 147.7 (19.8) mg/dl in the pravastatin group and 147.6 (19.4) mg/dl in the usual care group. By year 6, the mean (SD) low-density lipoprotein cholesterol levels were 109.1 (35.4) mg/dl in the pravastatin group and 128.8 (27.5) mg/dl in the usual care group. At year 6, of the participants assigned to pravastatin, 42 of 253 (16.6%) were not taking any statin; 71.0% in the usual care group were not taking any statin. The hazard ratios for all-cause mortality in the pravastatin group versus the usual care group were 1.18 (95% confidence interval [CI], 0.97-1.42; p = 0.09) for all adults 65 years and older, 1.08 (95% CI, 0.85-1.37; p = 0.55) for adults aged 65-74 years, and 1.34 (95% CI, 0.98-1.84; p = 0.07) for adults 75 years and older. CHD event rates were not significantly different among the groups. In multivariable regression, the results remained nonsignificant, and there was no significant interaction between treatment group and age.
The authors concluded that no benefit was found when pravastatin was given for primary prevention to older adults with moderate hyperlipidemia and hypertension, and a nonsignificant direction toward increased all-cause mortality with pravastatin was observed among adults 75 years and older.
Although caution should be used when interpreting a post hoc analysis, these data from a well run trial suggest a lack of benefit from statin therapy in older adults.
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