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

Clinical Therapeutics

Volumn 25, Issue 11, 2003, Pages 2754-2764

  Agrawal, Arvind ^a   Sautter, Maureen C ^b   Jones, Nigel P ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

Author keywords

Glycemic control; Renal impairment; Rosiglitazone maleate; Sulfonylurea

Indexed keywords

GLIBENCLAMIDE; GLICLAZIDE; GLIPIZIDE; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR AGONIST; ROSIGLITAZONE; SULFONYLUREA DERIVATIVE;

ADD ON THERAPY; ANALYSIS; ANEMIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG MEGADOSE; DRUG TOLERABILITY; EDEMA; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPOGLYCEMIA; INJURY; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; UPPER RESPIRATORY TRACT INFECTION;

EID: 0344233280     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(03)80331-4     Document Type: Article

References (18)

1. Hasslacher C, Ritz E, Wahl P, Michael C. Similar risks of nephropathy in patients with type I or type II diabetes mellitus. Nephrol Dial Transplant. 1989;4:859-863.
2. Viberti GC, Bilous RW, Mackintosh D, et al. Long term correction of hyperglycaemia and progression of renal failure in insulin dependent diabetes. BMJ. 1983;286:598-602.
3. Bending JJ, Viberti GC, Watkins PJ, Keen H. Intermittent clinical proteinuria and renal function in diabetes: Evolution and the effect of glycaemic control. BMJ. 1986;292: 83-86.
4. Nyberg G, Blohme G, Norden G. Impact of metabolic control in progression of clinical diabetic nephropathy. Diabetologia. 1987;30:82-86.
5. Hasslacher C, Bostedt-Kiesel A, Kempe HP, Wahl P. Effect of metabolic factors and blood pressure on kidney function in proteinuric type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1993;36:1051-1056.
6. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38). BMJ. 1998;317:703-713.
7. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.
8. Howlett HCS, Bailey C. A risk-benefit assessment of metformin in type 2 diabetes mellitus. Drug Saf. 1999;20:498-503.
9. European Agency for the Evaluation of Medicinal Products. Summary of Product Characteristics, Metformin. Issued by European Commission 6 Feb 2001. Document CPMP/4082/00. Available at: http://www.emea.eu.int/pdfs/human/referral/ Glucophage/ 408201en.pdf. Accessed October 10, 2003.
10. DeFronzo RA, Goodman AM, for the Multicenter Metformin Study Group. Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. N Engl J Med. 1995;333:541-549.
11. Whitcomb R, Saltiel AR, Lockwood DH. New therapies for non-insulin-dependent diabetes mellitus: Thiazolidinediones. In: LeRoith D, Taylor SI, Olefsky JM, eds. Diabetes Mellitus: A Fundamental and Clinical Text. Philadelphia, Pa: Lippincott Raven; 1996:661-668.
12. Elbrecht A, Chen Y, Cullinan CA, et al. Molecular cloning, expression and characterization of human peroxisome proliferator activated receptors gamma 1 and gamma 2. Biochem Biophys Res Commun. 1996;224:431-437.
13. Patel J, Anderson RJ, Rappaport EB. Rosiglitazone monotherapy improves glycaemic control in patients with type 2 diabetes: A twelve-week, randomised, placebo-controlled study. Diabetes Obes Metab. 1999;1:165-172.
14. Wolffenbuttel BH, Gomis R, Squatrito S, et al. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in type 2 diabetic patients. Diabetic Med. 2000;17:40-47.
15. Thompson-Culkin K, Zussman B, Miller AK, Freed MI. Pharmacokinetics of rosiglitazone in patients with end-stage renal disease. J Int Med Res. 2002;30:391-399.
16. Chapelsky MC, Thompson-Culkin K, Miller AK, et al. Effect of renal impairment on the pharmacokinetics of rosiglitazone in patients with varying degrees of renal insufficiency. J Clin Pharmacol. 2003;43:252-259.
17. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
18. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.