Rys P, Wilk R, Landa K, Witek A, Pankiewicz O; Health Technology Assessment International. Meeting (1st : 2004 : Krakow, Poland).
Proc One HTA Health Technol Assess Int Meet 1st 2004 Krakow Pol. 2004; 1: 252.
HTA Consulting, Krakow, Malopolska, Poland.
OBJECTIVES: To compare efficacy and safety of rosiglitazone versus placebo as adjunct therapy to metformin or sulphonylurea in type 2 diabetes mellitus. METHODS: The analysis was based on reliable primary studies found in systematic reviews. Randomized, double blind trials were included in the analysis. The outcome measure was the number of patients achieving desired reduction of HbA1c (bY0,7%) or level of FPG (<7,7mmol/l) after at least 6 months of therapy. Relative risk and number needed to treat were calculated with confidence intervals of 95%. RESULTS: Rosiglitazone (4 mg/day) added to metformin increases more than 3 times the probability of achieving a desired level of FPG and HbA1c. PetoOR is 3,57 [CI95% (2,29; 5,57)] and 3,07 [CI95% (1,61; 5,82) for FPG and HbA1c, respectively. Rosiglitazone (8 mg/day) added to metformin increases almost 5 times the probability of achieving desired level of FPG and more than 3 times the HbA1c reduction. PetoOR is 4,95 [CI95% (3,16; 7,76)] and 3,15 [CI95% (2,35; 4,22)] for FPG and HbA1c, respectively. Rosiglitazone (4 mg/day) added to sulfonylurea increases more than 5 times the probability of achieving desired level of FPG and almost 4 times the probability of HbA1c reduction. PetoOR is 5,14 [CI95% (3,32; 7,94)] and 3,56 [CI95% (2,72; 4,66) for FPG and HbA1c, respectively. There were no differences in safety profile between rosiglitazone and placebo. DISCUSSION: This analysis indicates that rosiglitazone added to metformin or sulphonylurea substantially increases probability of achievement of desired HbA1c and FPG levels. Higher doses of rosiglitazone are more effective.
Publication Types:
Keywords:
- Diabetes Mellitus, Type 2
- Double-Blind Method
- Humans
- Metformin
- Safety
- Sulfonylurea Compounds
- Thiazolidinediones
- rosiglitazone
- therapy
- hsrmtgs
UI: 103140881
From Meeting Abstracts