An international study of the effects of rosiglitazone plus sulphonylurea in patients with type 2 diabetes.
This was an open-label, randomised 26-week study to determine the effects of adding 4 mg rosiglitazone (Avandia) daily to existing sulphonylurea (SU) therapy in patients with type 2 diabetes from India, Brazil, The Philippines, Thailand, Argentina and Tunisia. Of the 348 patients, 175 received 2 mg rosiglitazone twice daily plus SU (RSG+SU) and 173 received SU alone (at their normal dose). The RSG+SU group showed a significant reduction in HbA1c (mean HbA1c 9.05% at baseline, 7.92% at 26 weeks, mean change -1.13 (95% Cl -1.37, -0.89)). Mean HbA1c essentially remained unchanged in the control group (8.9 to 9.0%). The RSG+SU group showed a significant decrease in fasting plasma glucose concentration (FPG) (mean FPG 198.7 mg/dl at baseline, 160.3 mg/dl at 26 weeks, mean change -38.4 (95% Cl -47.1, -29.7)) while the controls showed a non-significant increase from 194 to 200 mg/dl. Significantly more patients in the RSG+SU group achieved FPG < 140 mg/dl, > or = 0.7% decrease in HbA1c, and > or = 30 mg/dl decrease in FPG between baseline and week 26 than the controls (p = 0.0001 in each case). Adverse events were similar in both groups; more patients in the RSG+SU group reported hypoglycaemia, but most cases were mild. This study shows that adding rosiglitazone to existing SU treatment improves glycaemic control and is well-tolerated in patients with type 2 diabetes from a wide range of non-Western countries.
Vongthavaravat
Varaphon
V
Chulalongkom Hospital, Rama IV Road, Bangkok, Thailand.
Wajchenberg
Bernardo L
BL
Waitman
Jorge N
JN
Quimpo
Joselynna A
JA
Menon
Padmavathy S
PS
Ben Khalifa
Fethi
F
Chow
Weng-Ho
WH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003906:Developing Countries; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000077154:Rosiglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D013844:Thiazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D045162:Thiazolidinediones; D016896:Treatment Outcome
D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D013844:Thiazoles; D045162:Thiazolidinediones; D000077154:Rosiglitazone