Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD , of the division of geriatric medicine and palliative care, New York University, and his associates.

To clarify the issue, they performed a secondary analysis of data from the randomized, open-label ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack) trial. The investigators focused on several important outcomes among 2,867 older participants who had hypertension and moderate hypercholesterolemia but no atherosclerotic cardiovascular disease at baseline. A total of 1,467 were randomly assigned to receive pravastatin and 1,400 to usual care (no statin therapy), and they were followed for 6 years.

The primary outcome, all-cause mortality, was slightly higher in the statin group. For patients aged 65-74 years, there were 141 deaths with pravastatin vs. 130 with usual care, for a hazard ratio of 1.08, and for those aged 75 and older, there were 92 deaths with pravastatin vs. 65 with usual care, for an HR of 1.34. This represents a nonsignificant trend toward increased mortality with statin therapy. The results were similar, with pravastatin providing no significant benefit, regarding coronary heart disease, stroke, heart failure, and cancer events.

These findings indicate that “statins may be producing untoward effects in the function or health of older adults that could offset any possible cardiovascular benefit,” Dr. Han and his associates said (JAMA Intern Med. 2017 May 22. doi: 10.1001/jamainternmed.2017.1442 ).

One important limitation of this secondary analysis is that patients were allowed to cross over to the other study group during follow-up, at their own or their physicians’ discretion. By the end of the study, 29% of the control group were taking lipid-lowering drugs while 22% of the active-treatment group had discontinued pravastatin. “This level of crossover should be considered when interpreting our findings,” the investigators noted.


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