毒理性
alogliptin导致肝损伤是罕见的。在大规模临床试验中，血清酶升高不常见（1%至3%），并不比对照臂或安慰剂更高。在这些研究中，没有报告出现黄疸的临床明显肝损伤的实例。自从获得许可以来，已经向FDA和赞助商报告了alogliptin引起的血清酶升高和急性肝炎的病例，包括急性肝衰竭。这些病例在文献中没有报道，临床特征也尚未确定。其他DPP-4抑制剂（如sitagliptin和saxagliptin）也报告了临床明显的急性肝损伤病例。发病潜伏期通常在开始用药后2至12周内，肝酶升高的模式通常是肝细胞型。免疫过敏特征常常存在。大多数病例在停药后过程自我限制，并且迅速逆转。
Liver injury due to alogliptin is rare. In large clinical trials, serum enzyme elevations were uncommon (1% to 3%) and no greater than with comparator arms or placebo. In these studies, no instances of clinically apparent liver injury with jaundice were reported. Since licensure, instances of serum enzyme elevations and acute hepatitis including acute liver failure attributed to alogliptin have been reported to the FDA and the sponsor. These cases have not been reported in the literature and the clinical features have not been defined. Cases of clinically apparent acute liver injury have been reported with other DPP-4 inhibitors such as sitagliptin and saxagliptin. The latency to onset was typically within 2 to 12 weeks of starting and the pattern of liver enzyme elevations was usually hepatocellular. Immunoallergic features were often present. Most cases were self-limited in course and rapidly reversed once the medication was stopped.
来源:LiverTox
