Statins Questionable for Elderly Men Without Heart Disease

Kathleen Louden

May 28, 2015

NATIONAL HARBOR, Maryland — In older men, statins might not prevent major cardiovascular events, a large retrospective study suggests.

In fact, in men older than 70 years with no previous cardiovascular disease who used the cholesterol-lowering drugs, the 10% reduction in myocardial infarction, stroke, and revascularization was not significant.

"The jury is still out on whether to prescribe statins in this older male population for primary prevention," Ariela Orkaby, MD, from Brigham and Women's Hospital and the Boston Veterans Affairs Healthcare System.

"There is a signal in our study that statins may be beneficial for primary prevention, especially from ages 80 to 84, but we need more research on people older than 75," she told Medscape Medical News.

Dr Orkaby presented the research, which was named best poster in the epidemiology section, here at the American Geriatrics Society 2015 Annual Scientific Meeting.

The researchers analyzed 7142 men participating in the Physicians' Health Study who completed yearly questionnaires from 1999 to 2012. Statin use was self-reported and defined as use at least 180 days per year. The primary outcome was a composite of myocardial infarction, stroke, and revascularization. Median age in the cohort was 76 years.

An initial analysis showed that statin use had no primary prevention benefit for cardiovascular events.

The jury is still out on whether to prescribe statins in this older male population for primary prevention.

The researchers then conducted an analysis of 1168 statin users and 1168 nonusers who were matched for 30 predictors of statin initiation at baseline — from common cardiovascular risk factors to general health and specific physical functions, such as the ability to walk blocks without limitation.

In that analysis, there were 327 major cardiovascular events.

PROSPER Results Replicated

On propensity score matching, using pooled logistic regression, there was a 10% reduction in the rate of major cardiovascular events with statin use, although this was not significant (odds ratio [OR], 0.90; confidence interval [CI], 0.71 - 1.13).

This finding is similar to that seen in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER) in the subgroup of patients with no history of cardiovascular disease (Lancet. 2002;360:1623-1630), Dr Orkaby reported. In their study, however, her team did not evaluate mortality, which was part of the primary end point in PROSPER.

After stratifying the data by age, the cardiovascular risk reduction was greatest in patients 80 to 84 years, but was still not significant (OR, 0.58; CI, 0.3 - 1.1).

These data are "not definitive but provocative," said Lewis Lipsitz, MD, from the Beth Israel Deaconess Medical Center in Boston.

The current guidelines on statin use were not designed for elderly people with multiple comorbidities, Dr Lipsitz explained. These new findings will help guide clinical practice for geriatricians, who often must stop the prescription of medications for their patients.

"This study says statins may not be beneficial once you reach 70 years," he told Medscape Medical News.

"Statins are costly, have adverse effects, and can interact with other medicines," he added. "Why are we giving statins to 85-year-olds without knowing if they are effective?"

Study Limitations

Dr Lipsitz pointed out that the study data do not reveal whether, during the follow-up period, statin users stopped therapy or nonusers started therapy.

Most patients who received statin therapy reported that they stayed on this regimen, Dr Orkaby reported, but she acknowledged that misclassification of statin use was possible.

Other study limitations include the lack of information on statin type and dose and the lack of annual updating of the covariates, she said. It is also possible that the protective effects of statins were not evident because the study participants, all physicians, were fairly healthy, she explained. In each group, 77% reported being in good general health.

These data should not be extrapolated to older women, said Shelly Gray, PharmD, from the University of Washington School of Pharmacy in Seattle.

"You may see differences in drug benefits by gender," she told Medscape Medical News. "In older males, practitioners should weigh the risks and the benefits of statins for primary prevention and should inform these patients that the benefits are unclear."

This research was supported by the National Institutes of Health, the John A. Hartford Foundation, and Veterans Affairs. Dr Orkaby, Dr Lipsitz, and Dr Gray have disclosed no relevant financial relationships.

American Geriatrics Society (AGS) 2015 Annual Scientific Meeting: Poster abstract B36. Presented May 15, 2015.


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