Long-term Use of Glycemic Control Medication Rosiglitazone Associated with Increased Risk of Heart Attack and Heart Failure
CHICAGO, Sept. 11, 2007-Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical
implications. These data suggest a reversal of the benefit-to-harm
balance for rosiglitazone present at the time of approval. Thus,
currently there appear to be much safer treatment alternatives.
Regulatory agencies ought to reevaluate whether rosiglitazone
should be allowed to remain on the market. Health plans and
physicians should not wait for regulatory actions. They should
avoid using rosiglitazone in patients with diabetes who are at risk
of cardiovascular events, especially since safer treatment
alternatives are available,” the authors conclude.
(JAMA.
2007;298(10):1189-1195. Available pre-embargo to the
media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: CARDIOVASCULAR RISK AND THE THIAZOLIDINEDIONES — DÉJÀ VU ALL OVER AGAIN?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. ...Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.”
“Third, after several drugs are available for a given
indication, new drug approval should be based on improvement in
clinical outcomes, not surrogate measures. ...Fourth, the decisions
for initial approval of a drug and subsequent continued marketing
should by symmetric. ...Finally, and perhaps most difficult, safety
and efficacy must be explicitly balanced when drugs are being
considered for approval or for continued marketing.”
(JAMA.
2007;298(10):1216-1218. Available pre-embargo to the
media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations@jama-archives.org .
Posted: September 2007
