Statins Show Little Evidence of Benefit in Non-CVD Conditions

Megan Brooks

October 10, 2018

There is no convincing evidence that statins improve noncardiovascular disease (non-CVD) outcomes, and the current recommendations on statin use should not be changed, say the authors of an umbrella review of meta-analyses.

The researchers evaluated the validity and credibility of evidence on the effect of statins on 278 unique non-CVD outcomes.

"Overall, the vast majority of associations and effects that we observed in the statin meta-analyses we reviewed suggested favorable effects for these drugs," Evropi Theodoratou, PhD, Centre for Global Health Research, University of Edinburgh, United Kingdom, told theheart.org | Medscape Cardiology. "Yet, almost none of these positive effects seemed to have high credibility in our assessments."

The study was published online October 8 in Annals of Internal Medicine.

Evropi Theodoratou

Statins have been widely used to reduce cardiac morbidity and mortality in both primary and secondary prevention of CVD, and interest has grown considerably regarding the potential effect of these drugs on non-CVD outcomes, said Theodoratou.

"Recently, many meta-analyses have claimed that statins are also associated with outcomes of several other diseases," she noted, including cancer and diabetes.

"Therefore, we performed an umbrella review to summarize the literature and to evaluate the validity and credibility of the evidence regarding non-CVD outcomes of statin intake," she noted.

The study team reviewed 112 meta-analyses of observational studies and 144 meta-analyses of randomized controlled trials.

Among their findings, for the outcomes of decreased cancer mortality and decreased exacerbation of chronic obstructive pulmonary disease (COPD) with statins, no class I (convincing) evidence and only two class II (highly suggestive) associations were found in observational studies.

There were 21 class III (suggestive) associations and 42 class IV (weak) associations for these outcomes.

In randomized controlled trials, there was a "sufficient amount of evidence with no hints of bias" to show that statins decrease all-cause mortality in patients with chronic kidney disease (CKD), a finding already recognized in clinical guidelines, the authors note in their article.

However, there was no evidence that statins can help improve kidney function, and the effect on all-cause mortality might be attributed largely to protection from CVD events, they point out.

Reassuring Safety Data

Statins had no statistically significant effects on myopathy, myalgia, or rhabdomyolysis in randomized controlled trials. Observational studies show suggestive evidence that statins increase the risk for diabetes and myopathy; however, the evidence had a relatively low level of credibility.

"Despite the muscle problems commonly reported by statin users (10% to 25%), our study failed to identify strong evidence for adverse muscular events with statin use," the authors report.

Reached for comment, Gregg Fonarow, MD, University of California, Los Angeles, said, "This is a really comprehensive review that takes a sky-level view of all of the meta-analyses that have been done of statin trials."

One take-home, he said, is that this "phenomenally well-studied" class of medications, looks to be "remarkably safe, with no compelling signal of harm and two or three signals of potential benefit."

Fonarow noted that there are still patients with or at risk for CVD who should be on statin therapy but have been "scared off due to side effects that have nothing to do with the statin but have been attributed to the statin. So this type of rigorous analysis should be very reassuring to those who were concerned that there may have been some previously undetected non-CVD effect that could have emerged like damage to the liver or kidney or lead to cancer risk. None of that emerges in this analysis," said Fonarow.

Jack Ende, MD, University of Pennsylvania Perelman School of Medicine, Philadelphia, and past president of the American College of Physicians (ACP), also remarked on the safety data.

"This is not a game changer article for internists, as I suspect few, if any, internists prescribe statins for purposes unrelated to secondary and primary prevention of cardiovascular outcomes," he told theheart.org | Medscape Cardiology.

"Still, it is reassuring to know that concerns regarding negative associations between statin use and outcomes, such as diabetes and symptomatic myopathy, are less than convincing. Internists can use the information conveyed in this article to assure patients that the benefit of statins outweigh the harms," said Ende.

The study had no funding. The authors and Ende have disclosed no conflicts of interest. Fonarow has consulted for Amgen, Bayer, Janssen, Medtronic, Novartis, and St. Jude Medical.

Ann Intern Med. Published online October 8, 2018. Abstract

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