In the hardest-hitting assessment of diabetes meds this year, two Wake Forest University researchers say regulators should restrict use of the glitazone class of drugs--which includes the long-suffering Avandia. In an editorial in the journal Heart, the researchers Drs. Sonal Singh and Curt Furberg say that the justification for using these drugs is "very weak to non-existent" given recent studies that highlighted the risks of heart failure and heart attack among patients using GlaxoSmithKline's Avanda. They also cite data from those studies--ACCORD, ADVANCE, and a VA diabetes study--that showed intensive control of blood sugar offered no benefit to cardiovascular health.
In fact, the researchers "question the rationale for leaving rosiglitazlone (Avandia) on the market." Singh said that "safer, cheaper and more effective treatment alternatives are available that do not carry these negative cardiovascular risks in patients with diabetes."
As you all know, the safety of Avandia--and to a lesser extent, its cousin Actos, marketed by Takeda--has been debated for more than a year now, ever since the infamous meta-analysis by Dr. Steve Nissen that linked the GSK med to cardiac risks. The FDA has sifted the data, and it plastered both Avandia and Actos with a "black box" warning of heart failure risks, and cautioned diabetics that these meds aren't proven to cut cardiac problems. Meanwhile, a study in the Journal of the American Medical Association called both Avandia and Actos risky for patients 65 and older, and Canadian regulators restricted its use. Will this editorial spawn a new round of FDA soul-searching? We'll have to wait and see.