Efficacy of Long-Term Pioglitazone Assessed in Patients with NASH, T2DM
(HealthDay News) — For patients with prediabetes or type 2 diabetes mellitus (T2DM) and nonalcoholic steatohepatitis (NASH), long-term pioglitazone is safe and effective, according to a study published online June 21 in the Annals of Internal Medicine.
Kenneth Cusi, M.D., from the University of Florida and Malcom Randall Veterans Affairs Medical Center in Gainesville, and colleagues conducted a randomized trial involving 101 patients with prediabetes or T2DM and biopsy-proven NASH. Participants were prescribed a hypocaloric diet and randomized to pioglitazone or placebo for 18 months, followed by an 18-month open-label pioglitazone treatment phase.
The researchers found that 58 percent of patients randomized to pioglitazone achieved the primary outcome of a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score, without worsening of fibrosis, and 51 percent had NASH resolution (both P < 0.001). Pioglitazone treatment correlated with improved histologic scores; reduced hepatic triglyceride content; and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 versus placebo). Over 36 months of therapy, all 18-month metabolic and histologic improvements persisted.
"These results suggest that NASH progression may be halted and the natural history of the disease may be modified with the use of pioglitazone in patients with prediabetes or T2DM," the authors write.
One author disclosed financial ties to pharmaceutical companies, including Takeda, which provided the pioglitazone and placebo tablets for the study.