Avandia rosiglitazone: Additional Phase III data

A post hoc analysis of the open-label, international Phase III BARI 2D trial in 2,368 patients with Type II diabetes and stable coronary artery disease (CAD) showed that Avandia produced a significantly lower rate, as measured by events per 100 patients years of death, MI and stroke vs. no TZD therapy (3.79 vs. 5.81, RR=0.76, p=0.002). Avandia also led to a significantly lower rate of stroke (0.28 vs. 0.77, RR=0.36, p=0.008), but non-significantly reduced rates of MI (2.16 vs. 3.16, RR=0.76, p=0.06) and death (1.88 vs. 2.56, RR=0.77, p=0.08) vs. no TZD therapy. Additionally, Avandia produced a significantly higher rate of fracture vs. no TZD therapy (1.97 vs. 1.36, RR=1.45, p=0.03), with similar rates of congestive heart failure (CHF) (3.56 vs. 3.11, RR=1.14, p=0.31).

After adjusting for baseline characteristics and other anti-diabetes agents, Avandia still produced a significantly lower composite rate of death, MI and stroke vs. no TZD therapy (RR=0.72, p=0.01), as well as a significantly lower rate of stroke (RR=0.36, p=0.02). The rate of fracture was still significantly higher for Avandia vs. no TZD therapy (RR=1.62, p=0.03), and there was no significant difference between treatment groups on the rates of MI, CHF or death (RR=0.77, p=0.15; RR=1.17, p=0.35; and RR=0.83, p=0.29, respectively). Data were presented at the American Diabetes Association meeting in Orlando. ...