Archief Roodbont

From Heartwire — a professional news service of WebMD

December 3, 2008 — Generic cardiovascular drugs are just as good as brand-name drugs, a new analysis suggests [1]. Authors of the study say they hope their findings will help convince physicians and patients that generics are no different than brand-name agents, even if anecdotes in the media or drug manufacturers have suggested otherwise.

"There have been generic drugs on the market for decades and decades, and the fact that we haven't seen any systematic problems with generic drugs in cardiovascular disease — or in any field, for that matter — should give patients and physicians more confidence using them," lead author on the study, Dr Aaron S Kesselheim (Brigham and Women's Hospital, Boston, MA), told heartwire. "There's a perception, fueled in part, I think, by the brand-name industry and by physicians and patients who don't understand the US Food and Drug Administration (FDA) approval process, that brand-name drugs are superior. People tend to equate generic drugs with generic products that they might buy at a supermarket, that they feel are of lower quality than brand-name products. But in the field of drugs, generic products are just as safe and effective as brand-name drugs."

Kesselheim and colleagues reviewed peer-reviewed publications and International Pharmaceutical Abstracts from 1984 to 2008, identifying 38 randomized controlled trials (RCTs) comparing nine subclasses of generic and brand-name cardiovascular drugs. They found that clinical equivalence was demonstrated in the vast majority of trials for all the major cardiovascular disease drug classes, including the so-called "narrow-therapeutic-index drugs," such as antiarrhythmics and warfarin.

Number of trials showing clinical equivalence

Strikingly, however, more than half of all editorials, perspectives, commentaries, and letters to the editor published during the study period discussing brand-name vs generic drugs expressed a "negative view" of substituting a generic for a brand-name drug. Why editorials would take this view remains a mystery, the authors write, although one possibility is that editorials and commentaries rely less on data and more on anecdotal stories or nonclinical trial settings. Another possibility is that editorialists had undisclosed financial relationships with brand-name pharmaceutical companies — just half of the trials studied disclosed sources of funding, whereas "nearly all" of the editorials and commentaries made no mention of financial conflicts of interest, the authors note.

Distrust of generics

Speaking with heartwire, Kesselheim explained that distrust of generics also stems from misconceptions that generic drugs are not as rigorously vetted by the FDA. "The FDA, when it approves generic drugs, approves them on the basis of biochemical bioequivalence. Unfortunately, there is this perception out there that bioequivalence might not necessarily translate into clinical equivalence. And there isn't a lot of incentive out there for either brand-name or generic companies to conduct the kind of head-to-head tests to look at that question more substantively."

Kesselheim believes their analysis proves that bioequivalence, at least for the agents studied, means clinical equivalence. "The message to the cardiovascular community is that the data that are out there do not point to any clinical superiority of brand-name drugs when a generic equivalent is available."

Physicians need to understand that using generics can have a real impact on patient's survival and quality of life. "Lower-cost generic drugs, which are available for nearly every therapeutic drug class, can be a part of a medication regimen that leads to better patient adherence to important cardiovascular drugs. If patients aren't taking their drugs because they are expensive, and the economy is in difficult times, and they don't have full drug insurance, and they're doing that because they think they need a brand-name drug, that is a suboptimal outcome," Kesselheim stressed to heartwire. "To improve the clinical care of patients, we think that generic drugs should be a part of a physician's prescribing patterns. This study should give some reassurance to physicians that in the cardiovascular arena. There's no evidence that brand-name drugs are superior."

# posted by roodbont @ 1:27 AM