Effects of rosiglitazone maleate when added to a sulfonylurea regimen in patients with type 2 diabetes mellitus and mild to moderate renal impairment: a post hoc analysis.
BACKGROUND
Patients with type 2 diabetes mellitus (DM) and renal impairment whose disease is inadequately controlled on a sulfonylurea (SU) have limited oral combination treatment options.


OBJECTIVE
This post hoc analysis assesses the efficacy and tolerability of the insulin sensitizer rosiglitazone maleate (RSG) when added to an SU treatment regimen in patients with type 2 DM with mild to moderate renal impairment that is inadequately controlled by SU monotherapy.


METHODS
Data were pooled from 3 randomized, double-blind, placebo-controlled, parallel-group studies in which RSG or placebo was added to an SU (glibenclamide, gliclazide, or glipizide) treatment regimen for a period of 6 months. Patients were subcategorized as having mild to moderate renal impairment or normal renal function based on a baseline creatinine clearance rate of 30 to 80 mL/min or >80 mL/min, respectively, as estimated by the Cockcroft-Gault equation.


RESULTS
The population studied comprised 824 patients, 62% men and 38% women, aged 32 to 81 years, of whom 301 had mild to moderate renal impairment and 523 had normal renal function. In patients with and without renal impairment, glycemia was improved in the SU + RSG-treated group compared with the SU + placebo-treated group. The observed treatment differences between the groups were -2.6 mmol/L for fasting plasma glucose and -1.1% for glycosylated hemoglobin (for both renally impaired and nonimpaired patients). For patients receiving SU + RSG, little difference in the safety profile was found between patients with and without renal impairment.


CONCLUSIONS
RSG was effective and well tolerated when added to SU therapy in this population of patients with mild to moderate renal impairment.
Agrawal
Arvind
A
Clinical Development and Medical Affairs--Cardiovascular, Urology, and Metabolism, GlaxoSmithKline, Harlow, Essex, United Kingdom.
Sautter
Maureen C
MC
Jones
Nigel P
NP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D051437:Renal Insufficiency / Q000209:etiology*; D000077154:Rosiglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; D000077154:Rosiglitazone