Rosiglitazone in diabetes control in hemodialysis patients with and without viral hepatitis infection: effectiveness and side effects

Abstract

Objective: Thiazolidinedione (TZD) may provide an additional benefit of cardiovascular protection in diabetic patients through targeting of insulin resistance. However, use of a TZD is hampered by possible effects of fluid retention and hepatotoxicity. In this study we aimed to determine whether the risk of TZD-induced fluid retention or hepatic injury is higher in hemodialysis patients with persistent viral hepatitis infection.

Research design and methods: This was a prospective, cohort study on hemodialysis patients. Type 2 diabetic patients with A1C levels of >8% were followed for at least 12 months. Rosiglitazone was initiated at 2-4 mg/day. The primary outcome was the target A1C (<7%) achieved and dosages of rosiglitazone. Secondary outcomes included changes in lipid profile and inflammatory biomarkers. Safety evaluations were number of hypoglycemic episodes, changes in liver transaminase levels, cardiothoracic ratio (CTR), fluid status control during dialysis, and events of symptomatic heart failure.

Results: A total of 78 patients, including 15.4% (n = 12) hepatitis B surface antigen-positive and 16.7% (n = 13) anti-hepatis C virus (HCV)-positive patients, were enrolled. The mean follow-up period was 15.4 +/- 3.8 months. The diabetic response rate (A1C <7%) to rosiglitazone was 86.1%. The serum triglyceride level was reduced (194 +/- 112.5 to 168 +/- 88 mg/dl, P = 0.037) more significantly than the total cholesterol level (178 +/- 42.1 to 174 +/- 46.5 mg/dl, P = 0.13). High-dose rosiglitazone (8 mg/day) reduced the serum level of C-reactive protein and increased the serum adiponectin level significantly. After rosiglitazone, interdialysis weight gain (2.07 +/- 1.6 to 3.2 +/- 1.2 kg, P < 0.01) and mean CTR (48.2 +/- 5.6 to 50.4 +/- 6.2%, P = 0.0213) of individuals increased significantly. Nevertheless, liver aminotransferase (aspartate aminotransferase and alanine aminotransferase) levels did not show a tendency to increase in patients (n = 25) with viral hepatitis B or C infections.

Conclusions: Among regular hemodialysis patients with chronic viral hepatitis infections, rosiglitazone may be safely used for diabetes control. However, one must be aware that a possible effect of its use is a deterioration in cardiovascular reserve.