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Published ahead of print on November 8, 2006
J Am Soc Nephrol 17: 3482-3490, 2006
© 2006 American Society of Nephrology
doi: 10.1681/ASN.2006060606
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Clinical Nephrology

Effect of Various Diuretic Treatments on Rosiglitazone-Induced Fluid Retention

Janaka Karalliedde*, Robin Buckingham*, Margaret Starkie{dagger}, Daniel Lorand{ddagger}, Murray Stewart{dagger}, Giancarlo Viberti* for the Rosiglitazone Fluid Retention Study Group

* Unit for Metabolic Medicine, Department of Diabetes and Endocrinology, Cardiovascular Division, King’s College London School of Medicine, Guy’s Hospital, King’s College London, London, and {dagger} Clinical Development and Medical Affairs and {ddagger} Biomedical Data Sciences–Statistics & Programming, GlaxoSmithKline Pharmaceuticals, Harlow and Greenford, Essex, United Kingdom

Address correspondence to: Prof. Giancarlo Viberti, Unit for Metabolic Medicine, 5th Floor, Thomas Guy House, Guy’s Hospital, St. Thomas Street, London SE1 9RT, UK. Phone: +44-2071881910; Fax: +44-2071880146; E-mail: giancarlo.viberti{at}kcl.ac.uk

Received for publication June 13, 2006. Accepted for publication September 26, 2006.

The efficacy of diuretics in the management of rosiglitazone (RSG)-induced fluid retention was evaluated in a multicenter, randomized, open-label, parallel-group, proof-of-concept study. Of 381 patients who had type 2 diabetes and were on treatment with sulfonylurea or sulfonylurea plus metformin, 260 (63% male, 37% female) showed evidence of volume expansion as defined by an absolute reduction in hematocrit (Hct) of ≥0.5% after 12 wk of rosiglitazone 4 mg twice daily. They were randomly assigned to five treatments for 7 d: (1) Continuation of RSG (RSG-C), (2) RSG + furosemide (RSG+FRUS), (3) RSG + hydrochlorothiazide (RSG+HCTZ), (4) RSG + spironolactone (RSG+SPIRO), and (5) discontinuation of RSG. The primary end point was change in Hct at day 7 of diuretic treatment phase, powered to compare each diuretic group and the RSG discontinuation with the control group of RSG-C, with adjustments for multiple testing. After 12 wk on RSG, Hct fell by mean of 2.92% (95% confidence interval [CI] –3.10 to –2.63%; P < 0.001) and extracellular fluid volume increased by 0.62 L/1.73 m2 (95% CI 0.26 to 0.90 L/1.73 m2; P < 0.001). After treatment, the RSG+SPIRO group only showed a mean increase in Hct of 0.24%. The estimated mean difference in Hct reduction was significant: 1.14% (95% CI 0.29 to 1.98%) for RSG+SPIRO (P = 0.004) and 0.87% (95% CI 0.03 to 1.71%) for RSG+HCTZ (P = 0.041) only. In additional analyses of between-diuretic treatment effects SPIRO induced a greater Hct rescue at 0.88% (95% CI –0.12 to 1.87%; P = 0.095) and extracellular fluid volume reduction of –0.75 L/1.73 m2 (95% CI –1.52 to 0.03 L/1.73 m2; P = 0.06) compared with FRUS, suggesting superiority in the management of RSG-associated fluid retention. There were no significant differences between SPIRO and HCTZ. These findings are consistent with peroxisome proliferator–activated receptor-{gamma} agonist activation of the epithelial sodium channel in the distal collecting duct, a site of action of SPIRO and a potential target for thiazide diuretics.




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