Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

GlaxoSmithKline1 enrolled

Overview

Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. The motivation is a cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following spontaneous reports of liver toxicity in people taking Xenical or Alli.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity

Interventions

Orlistat 120DRUG

Orlistat 120mg tid

Orlistat 60DRUG

Orlistat 60mg tid

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. The trial must be randomized and placebo-controlled 2. The orlistat dose must be 60mg or 120mg 3. Data on ALT or BIL must be available 4. The nominal treatment period must be 16 weeks or longer Exclusion Criteria: 1\. If cross-over trials are found, data from other than the first period will be excluded.

Outcomes

Primary Outcomes

Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)