Generics Beat Brand-Name Statins for Patient Adherence and Improving Outcomes

September 15, 2014

BOSTON, MA — Patients are more likely to adhere to treatment if prescribed a generic over a brand-name statin, which results in significantly lower rates of hospitalizations for acute coronary syndrome (ACS) and stroke and all-cause mortality, according to a new study[1].

Overall, there was an 8% lower risk of hospitalizations for ACS and stroke and deaths from any cause among those treated with generic statins compared with those who received a branded medication. Investigators say this reduction in the composite end point is "commensurate with the expected effect based on the observed difference in adherence."

The study, led by Dr Joshua Gagne (Brigham and Women's Hospital, Boston, MA) and published September 15 in the Annals of Internal Medicine, included 83 731 patients 65 years of age or older who started a generic statin between 2006 and 2008. During this same period, 6380 patients started therapy with branded lovastatin, pravastatin, or simvastatin, the only statins that had generic counterparts available at the time.

Over one year, patients prescribed a generic statin took their medication 77% of the time, and adherence among those taking a brand-name statin was 71%. The difference in adherence rates between groups was significant. (Adherence was measured as the proportion of days covered.)

"Among patients in our study, the mean copayment for the index statin prescription was $10 for generic-drug recipients and $48 for brand-name-drug recipients," write Gagne and colleagues. "Our finding that adherence is greater with generic statins than brand-name statins is therefore not surprising and is consistent with other studies that have shown a direct relation between higher copayments and lower adherence."

In the article, the researchers say that statin doses used in clinical trials typically produce LDL-cholesterol reductions of approximately 70 mg/dL, which translates to a 38% expected reduction in major vascular events. Given the difference in adherence rates in their analysis—77% for generic vs 71% for brand-name statins—the expected reduction in major vascular events would be 32.3% and 29.8%, respectively. This is a 7.7% relative reduction in risk, which is in line with the 8% reduction observed in their analysis.

In an editorial[2], Drs Walter Cullen and Patrick Murray (University College, Dublin, Ireland) agree that the clinical benefits observed in the study are likely explained by increased adherence and that increased adherence among generic drug users is likely the result of low out-of-pocket expenses. They note that patient adherence is a complex topic, especially for patients with chronic diseases, but this study highlights a simple means to improve adherence among eligible patients. "Ample evidence supports the benefit of statins for secondary prevention, and maximizing this benefit while managing drug costs is a priority," they write.

"Gagne and colleagues make the distinction between generic and brand-name drugs, but the operating factor for patients is affordability," conclude the editorialists. "Although these findings require confirmation in other populations, they add to our understanding of the comparative effectiveness of generic medications and the importance of economic factors in medication adherence."

This study was supported by an unrestricted research grant from Teva Pharmaceuticals. Gagne reports grants from Teva Pharmaceuticals. Disclosures for the coauthors and editorialists are available on the journal website.

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