[The safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus in China].

Objective: To assess the clinical safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus.

Methods: A multi-center, open-label and 12-week duration study comprising of three cohorts, rosiglitazone maleate mono-therapy, rosiglitazone maleate plus metformin (Met) or sulphonylurea (SU) was carried out.

Results: A total of 2 308 patients enrolled in the study; but 2 134 completed and 174 withdrew from it. The percentages of patients reporting on-therapy adverse events were similar in the three cohorts. The most frequent adverse experiences were hyperlipidaemia (9.77%), upper respiratory tract infection (6.11%) and oedema (5.32%). There were totally 11 patients with serious, on-therapy adverse experiences. All serious adverse events (SAE) were considered by the investigator being not related to study medication except one case of SAE which was considered to be possibly related to the study medication. The mean levels of ALT in the three treatment cohorts were all reduced from baseline (25.5 IU/L) after treatment of 12 weeks (22.8 IU/L). Minor decreases in haemoglobin and haematocrit were observed in all treatment cohorts. Slight increases in total cholesterol, low density lipoprotein cholesterol and triglyceride were observed following 12 weeks of treatment, whereas high density lipoprotein cholesterol remained stable. In the efficacy evaluable population, the fasting plasma glucose reduction following 12 weeks of treatment was 1.70 mmol/L in the rosiglitazone maleate mono-therapy cohort, 1.47 mmol/L in the rosiglitazone maleate plus SU cohort and 1.36 mmol/L in the rosiglitazone maleate plus Met cohort, respectively.

Conclusions: In this 12-week phase IV study, rosiglitazone maleate was found to be safe and well tolerated in all the three cohorts receiving rosiglitazone maleate as monotherapy or in combination with SU or MET for a large sample of population of patients with type 2 diabetes. Statistically significant reduction in fasting plasma glucose was observed in all the treated cohorts.