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Statins shown to be safe in generic form for high-risk coronary patients

April 20, 2016 Toronto

First large-scale population health study of generic statin efficacy in high-risk population provides reassuring evidence for Ontario cost-saving move

Ontario patients prescribed generic statins after a diagnosis of acute coronary syndrome experienced no difference in major heart-related events or serious side effects after one year of taking the medication, compared to patients using the brand-name statin Lipitor®. This is among the findings of a new study from the Institute for Clinical Evaluative Sciences (ICES) that was published today in the Journal of the American Heart Association.

Statins shown to be safe and effective in generic form for acute coronary syndrome patientsClick image to enlarge

Originally marketed under the brand name Lipitor®, atorvastatin is a cholesterol-lowering drug that continues to be the most prescribed medication for Canadian adults, with over 17 million Canadian prescriptions filled annually, at nearly half a billion dollars in sales. Generic atorvastatin was approved in Canada in June 2010. In 2011 Ontario’s public prescription benefit program required substitution of generic atorvastatin for all Lipitor® prescriptions, which sharply reduced costs for the drug by 74 per cent (from $316 million in 2009-10 to $83 million in 2012-13).

The researchers say this is the first large-scale population health study in the world to look at differences in clinical outcomes between generic atorvastatin preparations and Lipitor® for patients with acute coronary syndrome (ACS), an umbrella term used for any condition brought on by sudden reduced blood flow to the heart such as heart attack or unstable angina.

“While most clinicians and patients welcome decreased generic drug costs, they often worry about whether it is safe to change from a brand to a generic medication,” says the study’s lead author Dr. Cynthia Jackevicius, who is a senior adjunct scientist at ICES and a professor in the College of Pharmacy at Western University of Health Sciences in Pomona, California. “The change in Ontario policy gave us a unique opportunity to look at large scale clinical outcomes of generic atorvastatin versus Lipitor® for patients at high risk of heart events. Our findings support the continued use of generic atorvastatin for these patients, which should be reassuring for all patients taking generic atorvastatin, along with their families and care providers.”

The researchers looked at anonymized data for all patients aged 65 and older between 2008 and 2012 who received either a generic atorvastatin or Lipitor® prescription within seven days of hospital discharge after a diagnosis of acute coronary syndrome. They divided the cohort into 7,863 matched pairs (15,726 patients), divided by receipt of either generic or Lipitor® prescriptions.  The mean age of the full cohort was 77 years old, 56 per cent were male, and nearly all had a diagnosis of myocardial infarction. Following the patient records for one year, they compared rates of negative health outcomes including death, recurrent ACS, heart failure, stroke, new-onset diabetes, rhabdomyolysis (severe breakdown of muscle tissue), or renal failure.

Among the study’s findings:

  • After one year, the rates of death or recurrent ACS were identical between matched patients receiving generic atorvastatin versus Lipitor®, at 18 per cent.
  • There were no significant differences in the rates of secondary outcomes including heart failure, stroke, new-onset diabetes, rhabdomyolysis (severe breakdown of muscle tissue), or renal failure.
  • There were no differences in rates of death or recurrent ACS for any of the nine different generic atorvastatin products.

The researchers note that until now, clinicians and policy-makers could only rely on bioequivalence studies to examine the safety of generic atorvastatin, which do not provide evidence of clinical outcomes or effectiveness. They say that clinical outcomes studies such as this one will be essential to implementing safe guidelines for the use of generic drugs.

“The substitution of safe and effective generic drugs when possible is essential to ensuring the sustainability of health systems in the United States and Canada, particularly for heavily prescribed medications such as statins,” comments Jackevicius. “Our study is an important step forward in reassuring patients and clinicians that these commonly used generic products are safe and effective. This will help to improve patient access and adherence, and provide health system policy-makers with the evidence they need to guide evidence-informed substitution policies.”

“Comparative effectiveness of generic atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome” was published today in the Journal of the American Heart Association.

Author block: Cynthia A. Jackevicius, Jack V. Tu, Harlan M. Krumholz, Peter C. Austin, Joseph S. Ross, Therese A. Stukel, Maria Koh, Alice Chong, Dennis T. Ko.

The Institute for Clinical Evaluative Sciences (ICES) is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of health care issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting health care needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy. For the latest ICES news, follow us on Twitter: @ICESOntario

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