Open Access吡格列酮对非酒精性脂肪性肝炎患者骨密度的影响:一项为期36个月的临床试验
Author(s) -
PortilloSanchez Paola,
Bril Fernando,
Lomonaco Romina,
Barb Diana,
Orsak Beverly,
Bruder Jan Marie,
Cusi Kenneth
Publication year - 2019
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12833
Subject(s) - pioglitazone , medicine , nonalcoholic steatohepatitis , bone mineral , diabetes mellitus , clinical trial , gastroenterology , nonalcoholic fatty liver disease , endocrinology , type 2 diabetes , fatty liver , osteoporosis , disease
Background The effects of pioglitazone on bone metabolism are unclear. This study evaluated the long‐term effects of pioglitazone on bone mineral density (BMD) and bone metabolism in patients with prediabetes or type 2 diabetes mellitus (T2DM) and non‐alcoholic steatohepatitis (NASH). Methods Ninety‐two patients with prediabetes or T2DM and biopsy‐proven NASH with BMD and baseline biochemical bone measurements were included. Patients (mean [±SEM] age 51 ± 1 years, 71% male, mean body mass index 34.5 ± 0.5 kg/m 2 ) were randomly assigned to pioglitazone (45 mg/day) or placebo for 18 months, followed by an 18‐month open‐label pioglitazone treatment phase. Baseline, 18‐ and 36‐month evaluations included plasma vitamin D and bone turnover biomarker levels, and BMD measurements at the spine, femoral neck, total hip, and one‐third radius. Results After 18 months of pioglitazone treatment, there were no differences in BMD versus placebo at either the femoral neck ( P =0.87), total hip ( P =0.78), or one‐third radius ( P =0.44); however, bone density decreased at the level of the spine with pioglitazone (−3.5%; P =0.002). During the extension phase (18–36 months), patients had no further decreases in BMD or plasma biomarkers of bone turnover during pioglitazone treatment. No patient experienced a low‐energy bone fracture. Conclusions Treatment of patients with prediabetes or T2DM with pioglitazone for up to 3 years was associated with decreased BMD at the level of the lumbar spine. This reduction in BMD at the lumbar spine at 18 months versus placebo suggests an early deleterious effect of pioglitazone on bone metabolism.