Anti-inflammatory drugs associated with greater risk of hospitalization for heart failure

A new study from the Institute for Clinical Evaluative Sciences (ICES) has found increased risk of hospitalization for congestive heart failure (CHF) patients taking the COX-2 inhibitor rofecoxib, relative to those taking celecoxib and traditional NSAIDs.

COX-2 inhibitors are a new group of drugs that are part of a larger drug class called non-steroidal anti-inflammatory drugs (NSAIDs). Since their recent introduction, COX-2 inhibitors have rapidly gained acceptance in clinical practice because of a lower risk of gastrointestinal bleeding than traditional NSAIDs. About 1 in 5 elderly Ontarians currently use either a COX-2 inhibitor or traditional NSAIDs. However, recent research has begun to challenge their cardiovascular safety.

To further examine this issue, ICES researchers assessed the risk of hospitalization for heart failure for over 45,000 elderly Ontarians who were newly prescribed COX-2 inhibitors or traditional NSAIDs, as well as a randomly selected control group of 100,000 elderly patients who did not use these drugs. The study period was between April 2000 and March 2001.

Compared with the non-NSAID users control group, the results showed that patients on rofecoxib had an 80% increase in hospital admission for heart failure, and people using traditional NSAIDS had a 40% increased admission risk. However, users of celecoxib had the same rate of hospital admission for heart failure as people not using NSAIDs.

All of these drugs were associated with a significantly increased risk of requiring medications to treat hypertension or CHF.

“Given the large numbers of patients treated with these drugs, these results are clinically important and suggest a need for careful monitoring of the cardiovascular effects on patients receiving them,” said lead author and ICES scientist Dr. Muhammad Mamdani. “As well, there’s an urgent need for large head-to-head trials of these medications to better understand the outcomes shown in our study, such as the differences between the COX-2 inhibitors rofecoxib and celecoxib.”

The study, “COX-2 inhibitors vs. non-selective NSAIDS and congestive heart failure outcomes in elderly patients: a population-based cohort study”, is in the May 29, 2004 issue of The Lancet. This research was independently conducted by ICES and not sponsored by any drug company.

Author affiliations: All authors – ICES; Drs. Juurlink, Lee, Stukel, Rochon, Naglie, Austin, and Laupacis – University of Toronto Faculties of Pharmacy (Dr. Mamdani) and Medicine (Drs. Juurlink, Lee, Stukel, Rochon, Naglie, Austin, and Laupacis); Drs. Juurlink and Laupacis – Sunnybrook and Women’s College Health Sciences Centre; Dr. Naglie – University Health Network and Toronto Rehabilitation Institute; Dr. Rochon – Baycrest Centre for Geriatric Care).

ICES is an independent, non-profit organization that uses population-based health information to produce knowledge on a broad range of healthcare issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting healthcare 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 FURTHER INFORMATION, PLEASE CONTACT:

• Julie Argles
• Media Relations Officer, ICES
• (416) 480-4055 ext. 3602 or cell (416) 432-8143