Long-term effect of glimepiride and rosiglitazone on non-conventional cardiovascular risk factors in metformin-treated patients affected by metabolic syndrome: a randomized, double-blind clinical trial.
We evaluated the effect of glimepiride plus metformin and rosiglitazone plus metformin on glucose, and on cardiovascular risk parameters such as lipoprotein(a) (Lp[a]) and homocysteine (HCT) in patients with type 2 diabetes and metabolic syndrome. Ninety-nine patients in the multicentre, randomized, double-blind study took metformin (1500 mg/day) plus glimepiride (2 mg/day) or rosiglitazone (4 mg/day) for 12 months. Changes in body mass index, glycosylated haemoglobin (HbA1c), Lp(a) and HCT were primary efficacy variables. Fasting plasma glucose (FPG), post-prandial plasma glucose (PPG) and homeostasis model assessment index were also used to assess efficacy. On average, HbA1c decreased by 9.1% and 8.1%, FPG decreased by 7.3% and 10.9%, and PPG decreased by 7.6% and 10.5%, respectively, in the glimepiride and rosiglitazone groups after 12 months. Patients receiving rosiglitazone experienced more rapid improvement in glycaemic control than those on glimepiride, and showed a significant improvement in insulin resistance-related parameters. There was a statistically significant decrease in basal homocysteinaemia in glimepiride-treated patients (-27.3%), but not in rosiglitazone-treated patients. Rosiglitazone plus metformin significantly improved long-term control of insulin resistance-related parameters compared with glimepiride plus metformin, although glimepiride treatment was associated with a slight improvement in cholesterolaemia, not observed in the rosiglitazone-treated patients, and with significant improvements in non-traditional risk factors for cardiovascular disease, such as basal homocysteinaemia and plasma Lp(a) levels.
Derosa
G
G
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy. giuderosa@tin.it
Gaddi
A V
AV
Ciccarelli
L
L
Fogari
E
E
Ghelfi
M
M
Ferrari
I
I
Cicero
A F G
AF
D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002318:Cardiovascular Diseases; D002319:Cardiovascular System / Q000187:drug effects*; D002784:Cholesterol / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006710:Homocysteine / Q000737:chemistry; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology; D007333:Insulin Resistance; D017270:Lipoprotein(a) / Q000737:chemistry; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy; D008687:Metformin / Q000494:pharmacology*; D008875:Middle Aged; D012307:Risk Factors; D000077154:Rosiglitazone; D013453:Sulfonylurea Compounds / Q000494:pharmacology*; D045162:Thiazolidinediones / Q000494:pharmacology*; D013997:Time Factors
D001786:Blood Glucose; D002784:Cholesterol; D006442:Glycated Hemoglobin; D006710:Homocysteine; D007004:Hypoglycemic Agents; D017270:Lipoprotein(a); D008687:Metformin; D000077154:Rosiglitazone; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C057619:glimepiride