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New BARI 2D analysis shows no increased risk for death, stroke, MI with rosiglitazone
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ADA 70th Scientific Sessions
ORLANDO — Rosiglitazone poses no significant increased risk for death, stroke or myocardial infarction, and was even associated with a lower risk of such events for patients with type 2 diabetes and confirmed coronary artery disease, although it increases the risk for fractures, according to results of a post hoc analysis of the BARI 2D trial.
Researchers analyzed 4.5 years of follow-up data for patients treated with rosiglitazone (Avandia, GlaxoSmithKline) vs. those not taking any thiazolidinedione in the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) trial. In their analysis, the rate of death, stroke and MI was about 28% lower with rosiglitazone compared with no TZD.
However, as mirrored in previously published data, the rate of fractures was increased by 62% in patients taking rosiglitazone compared with no TZD. The drug was also linked to a higher, albeit not statistically significant, rate of congestive heart failure.
Of the 2,368 patients included in BARI 2D, 992 patients were treated with rosiglitazone at some point during the trial, allowing researchers to analyze up to 3,025 patient-years of rosiglitazone treatment. For the comparator non-TZD group, there were more than 7,100 patient-years and treatment data on 1,199 patients available for analysis.
Evaluating risk
Richard Bach, MD, who presented the data at a press conference, said it is difficult to reconcile the currently available data on rosiglitazone from observational studies and meta-analyses because there are inconsistencies in previous data as well.
“For patients who may be like the BARI 2D population with type 2 diabetes and stable CAD, our data appear reassuring that if they are well controlled and treated in a similar context our data suggest there may be a lower event rate with rosiglitazone than not being treated,” Bach, associate professor of medicine, Washington University School of Medicine, said at the press conference.
The safety of rosiglitazone has been a controversial topic since a 2007 meta-analysis published in The New England Journal of Medicine concluded that rosiglitazone was associated with a significantly increased risk for MI and death from CV causes. This, in addition with other studies, led to an FDA review in November 2007 of the drug’s safety, and a new warning label added to the drug regarding potential MIs.
“The controversy goes beyond what any single trial can address,” Bach said.
The landmark multicenter trial evaluated a CV treatment approach and diabetes control approach in 2,368 patients with type 2 diabetes and stable coronary artery disease. The first component compared intensive medical treatment with prompt coronary revascularization by either bypass surgery or angioplasty to intensive medical treatment alone. The second component compared whether controlling diabetes with insulin sensitization (TZDs) had an advantage for CV health or survival compared with a strategy emphasizing insulin provision.
“It is still up to the individual physician treating his or her patients whether rosiglitazone is the appropriate drug to prescribe — we cannot dictate that to physicians,” Saul Genuth, MD, professor of medicine at Case Western Reserve University, said at the press conference.
More news
New results published in the Journal of the American Medical Association are in stark contrast to the BARI 2D post hoc analysis data. Researchers found that, compared with pioglitazone (Actos, Takeda), rosiglitazone use was associated with an increased risk for stroke, heart failure and all-cause mortality in patients aged 65 years and older.
Also related, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will hold a two-day meeting on July 13 and 14 to weight the CV safety of rosiglitazone.
The data were presented at a press conference at the American Diabetes Association 70th Scientific Sessions.
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