Canada - Rosiglitazone (Avandia®) is a member of the thiazolidinedione family of oral hypoglycaemic agents used to improve glycaemic control by increasing insulin sensitivity in muscle and adipose tissue and inhibiting hepatic gluconeogenesis (1). It has been marketed in Canada since March 2000.

Clinical trials using rosiglitazone as monotherapy detected increases in levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) and decreases in levels of free fatty acids (1). Decreased HDL-C levels were not seen in over 1400 patients treated with rosiglitazone in clinical trials (2). It is noteworthy that fibrates generally have a beneficial effect on HDL-C and triglyceride levels but occasionally have been associated with decreases in HDL-C and apolipoprotein A-I concentrations (2).

From 2000, to 2004, Health Canada received one report of a decreased HDL-C level suspected of being associated with rosiglitazone. The abnormal lipid values resolved 2 months after stopping rosiglitazone therapy. Subsequently, the patient developed symptoms of angina and underwent angioplasty. The medical literature describes 3 cases of profound decreases in HDL-C and apolipoprotein A-I concentrations during treatment with rosiglitazone (2). Triglyceride levels also increased during treatment. In all 3 cases, the HDL-C level increased after withdrawal of the rosiglitazone. Two patients were taking a fibrate but did not have a decreased HDL-C level until rosiglitazone was introduced.

Given the findings of the 3 cases from the medical literature and the Canadian case, it would be advisable to measure baseline HDL-C and triglyceride levels in patients prescribed rosiglita-zone and check them again shortly after the start of therapy.

Extracted from Canadian Adverse Reaction Newsletter, Volume 15 (3), July 2005.

References

1. Avandia (rosiglitazone) [product monograph]. Mississauga (ON): GlaxoSmithKline Inc.; 2004.

2. Sarker A, O'Rahilly S, Semple R, Martin S, Dinneen S. Severe hypo-lipoproteinemia during treatment with rosiglitazone. Diabetes Care 2004;27(11):2577-80.