Study: Patients Do as Well on Generic Antiplatelet Drugs as Costly Brand

Researchers say this real-world study in Canada should also apply to the U.S.

Generic antiplatelet drugs seem to work as well as a brand-name drug for heart patients, according to research published in Circulation: Cardiovascular Quality and Outcomes.

When a Canadian health system switched from prescribing brand-name Plavix (clopidogrel bisulfate, Bristol-Myers Squibb/Sanofi) to a far-cheaper generic version, heart attack and chest pain patients were no more likely to die from any cause or be rehospitalized for a heart attack or unstable angina within a year than those prescribed Plavix (17.9% versus 17.6%). In addition, there were no significant differences between the drug groups in the percent of patients who died or were hospitalized for any reason; had a stroke or transient ischemic attack; or who developed bleeding as a side effect of treatment.

“People can safely use generic clopidogrel. This large and real-world study should be reassuring to physicians and health care organizations who have been concerned about changing what is prescribed,” Dennis T. Ko, MD, MSc, lead study author and senior scientist at the Institute for Clinical Evaluative Sciences (ICES) in Toronto, said in a press release.

In Canada and the United States, generic drugs are approved based on small studies in healthy people showing that the active ingredient is released at equivalent levels and over the same timeframe. That suggests, but doesn’t prove, that the generic product will also have the same safety and medical benefit.

Clopidogrel is used to treat patients with acute coronary syndrome, percutaneous coronary intervention, stroke, or peripheral vascular disease.

Researchers compared outcomes in patients (average age, 77 years; 57% male) who were prescribed clopidogrel after hospitalization for a heart attack or heart-related chest pain (unstable angina) in Ontario, Canada, where the Ministry of Health began to automatically substitute generic clopidogrel for Plavix once the brand-name drug’s patent expired in 2012. Between 2009 and 2014, 12,643 patients were prescribed Plavix and 11,887 generic clopidogrel.

Plavix cost about $2.58 Canadian dollars per pill in 2010 and was projected to cost the Ontario Drug Benefit Program $72.8 million by 2012. But by switching to a generic, which costs $0.39 per pill in 2018, the expense was only $19 million Canadian dollars.

“Plavix was one of the most commonly used drugs in cardiology, so switching to generics can reduce a lot of cost for individuals and health systems,” said Ko, who is also a cardiologist at the Schulich Heart Centre of the Sunnybrook Health Sciences Centre at the University of Toronto.

While the study was conducted in Canada, the results should apply to the United States, even if the generic drug offerings are slightly different, according to the researchers.

“There are quite a few different generic brands. In this study, we considered them as a group, but later found no differences in outcome when we compared between different generics,” said co-principal investigator Cynthia Jackevicius, PharmD, MSc, professor of pharmacy at Western University of Health Sciences and senior adjunct scientist at ICES.

The American Heart Association recommends clopidogrel—sometimes in combination with other drugs—for patients who have had acute coronary syndrome (unstable angina or heart attack) or stroke.

The Heart and Stroke Foundation of Canada funded the study.

Source: American Heart Association; March 13, 2018.