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Review: Benefits of statins outweigh harms
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Despite strong evidence of benefit from randomized controlled trials, statins may be underused because of “exaggerated claims about side-effect rates,” according to a review published in The Lancet.
“Our review shows that the number of people who avoid [MIs] and strokes by taking statin therapy are very much larger than the numbers who have side effects with it,” Rory Collins, FMedSci, FRCP, from the Clinical Trial Services Unit and Epidemiological Studies Unit and the Nuffield Department of Population Health at the University of Oxford, said in a press release. “In addition, whereas most of the side effects can be reversed with no residual effects by stopping the statin, the effects of a [MI] or stroke not being prevented are irreversible and can be devastating. “Consequently, there is a serious cost to public health from making misleading claims about high side-effect rates that inappropriately dissuade people from taking statin therapy despite the proven benefits,” Collins said.
Risk reduced
When Collins and colleagues analyzed large-scale evidence from randomized controlled trials of statins, they determined that statin therapy reduced the risk for major vascular events — defined as coronary death, MI, stroke or coronary revascularization — by approximately one-fourth per 1 mmol/L reduction in LDL during each year that the therapy is taken (RR = 0.79; 95% CI, 0.77-0.81).
The proportional reductions in major vascular events associated with statin therapy were similar across pretreatment LDL levels, age groups, sex, history of vascular disease, diabetes status, hypertension status, smoking status and 5-year risk for major vascular events, according to the authors.
Collins and colleagues wrote that lowering LDL by 2 mmol/L with atorvastatin 40 mg per day for 5 years in 10,000 patients is likely to prevent major vascular events in 1,000 patients (10% absolute benefit) with previous occlusive vascular disease and in 500 patients (5% absolute benefit) at elevated risk who have not yet had an event. “Larger absolute benefits would accrue with more prolonged therapy, and these benefits persist long term,” they wrote.
The authors wrote that the only serious adverse events caused as a result of long-term statin therapy are myopathy, new-onset diabetes and, perhaps, hemorrhagic stroke. They determined that treatment of 10,000 patients for 5 years with atorvastatin 40 mg per day or a similar regimen would cause approximately five cases of myopathy (one of which might progress to rhabdomyolysis if statin therapy continued), 50 to 100 cases of new-onset diabetes and five to 10 hemorrhagic strokes, all of which were accounted for in the absolute-benefit calculations.
Possible misattribution
Collins and colleagues determined that symptomatic adverse events such as muscle pain or weakness occur in 50 to 100 patients per 10,000 treated with statin therapy for 5 years (absolute harm, 0.5%-1%). However, they wrote, in randomized, placebo-controlled statin trials, almost all adverse events attributed to statin therapy were misattributed.
“The large-scale evidence available from randomized trials also indicates that it is unlikely that large absolute excesses in other serious adverse events still await discovery,” the authors wrote, noting this means that the benefit–harm balance is unlikely to be changed.
Collins and colleagues concluded that publicity about adverse events associated with statins “may be responsible for underuse among individuals at increased risk [for CV] events. For, whereas the rare cases of myopathy and muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the [MIs] or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.” – by Erik Swain
Disclosure: Collins reports receiving institutional research grants from Abbott, AstraZeneca, Bayer, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche, Schering and Solvay but not receiving personal compensation with the exception of reimbursement for travel costs; and being co-inventor of but receiving no income from a genetic test for risk for statin-related myopathy. Please see the full review for a list of the other authors’ relevant financial disclosures.
Perspective
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Joseph S. Alpert, MD
I completely agree with the conclusions in the Lancet article and impart similar information to many of my patients who are not convinced that they should be taking a statin.
Unfortunately, statins are underused. Fifty percent of patients who have suffered an acute MI stop their statins for no good reason within 1 year of their MI. The reasons for stopping are usually uninformed prejudice about not wanting to take chemicals into their body, or similar reasoning.
The conclusions are in agreement with U.S. guidelines, although the Europeans still treat to an LDL goal, which the U.S. guidelines do not recommend.
Further research is ongoing with the PCSK9 inhibitors, which lower cholesterol dramatically. Long-term trials with these new agents will tell us if substantial lowering of lipids in the blood is more beneficial compared with more moderate lowering.
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