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Lancet Study Highlights "Nocebo" Effect of Statins

Mary Caffrey
The findings will likely reopen discussion of what to do when patients report muscle-related symptoms from statins.
Statins are well-studied and have both benefits and some limited risks; for every 10,000 people at high risk of a stroke or heart attack, lowering LDL cholesterol by 2 mmol/L by taking 40 mg of atorvastatin for 5 years could prevent 1000 incidents of heart attack, stroke, or the need for a coronary bypass. There is a smaller risk of developing type 2 diabetes (T2D); this occurs in 50 to 100 people out of 1000. Myopathy can occur at very high doses, but this is even less common.
 
The issue of whether muscle-related effects of statins has become a major issue for payers with the arrival of PCSK9 inhibitors, because they not only lower LDL cholesterol up to 60%, but they do so without reports of the side effects. But this comes at a cost—PCSK9 inhibitors list for $14,000 a year, and even with their limited US indication, reports show nearly three-fourths of all initial claims are denied.
 
Advocates for the use of these new drugs say they could bring relief to those patients who cannot tolerate statins, and some leading physicians say there are patients for whom statin-intolerance is real. FDA has not approved PCSK9 inhibitors in the United States for this indication, but the drugs have received this indication in Europe, where they are considerably cheaper.
 
The problem created by patients who perceive side effects from statins are real, according to an accompanying editorial. The phenomenon “can lead to poor treatment adherence or even statin discontinuation, which is associated with increases cardiovascular risk leading to higher rates of heart attacks, strokes, and cardiovascular mortality,” the editorial states.2
 
Sever said the Lancet results show that for the vast majority of patients who need to lower LDL cholesterol, statins are a viable, cost-effective option.

“Widespread claims of high rates of statin intolerance still prevent too many people from taking an affordable, safe and potentially life-saving medication,” he said.
 
References
1. Gupta A, Thompson D, Whitehouse A, et al. on behalf of the ASCOT investigators. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase [published online May 2, 2017]. Lancet. 2017; http://dx.doi.org/10.1016/ S0140-6736(17)31075-9.
2. Statin-associated muscle symptoms: beware of the nocebo effect [published online May 2, 2017]. Lancet. 2017; http://dx.doi.org/10.1016/ S0140-6736(17)31163-7.


 
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