The MERCURY I open-label extension study — subgroup analysis in patients with diabetes

Abstract

Background The MERCURY I open-label extension study provides safety and efficacy data on hypercholesterolaemic patients with type 2 diabetes treated with rosuvastatin for up to three years.

Methods A total of 2,492 hypercholesterolaemic patients, including 665 (26.7%) with type 2 diabetes, on rosuvastatin 10 mg or 20 mg were followed for a mean of 672 days in an open-label extension study during which the dose could be increased to 20 or 40 mg to reach the 1998 European low-density lipoprotein-cholesterol (LDL-C) target of < 3.0 mmol/L (< 115 mg/dL)

Results Most diabetic and non-diabetic patients started (85.4 % and 88.7%) and finished (78.3% and 77.6%) on rosuvastatin 10 mg. Adverse event (9.8% and 12.3%) and treatment discontinuation (2.2% and 3.5%) rates were similar in diabetic and non-diabetic patients. No myopathy or rhabdomyolysis was observed. Mean serum creatinine decreased in both subgroups. Proteinuria was reported as an adverse event in five (0.7%) diabetic patients and eight (0.4%) non-diabetic patients. Fasting plasma glucose did not change markedly in either subgroup. LDL-C decreased by 51.1% and 47.4% in diabetic and non-diabetic patients, respectively, with 92.4% and 90.3% reaching target LDL-C.

Conclusion Long-term rosuvastatin treatment is effective and well tolerated in diabetic patients.