Biased safety reporting in blinded randomized clinical trials: meta-analysis of angiotensin receptor blocker trials.

ABSTRACT:

Background

Cough is listed as an adverse drug reaction (ADR) on the labels of angiotensin receptor blockers (ARB). However, a causal association with cough has also been reported for angiotensin converting enzyme inhibitors (ACEI), which have frequently been used as comparator drugs in the registration clinical trials of ARBs. This prompted us to examine the possible influence of using comparator drugs with well-known ADRs on the safety reporting of investigational drugs in blinded randomized clinical trials.

Methods and findings

The double-blinded, randomized clinical trials with comparator drugs were identified in the Japanese dossiers for the new drug applications of ARBs. The risk ratios (RR) of reporting cough and headache in ARB arms were calculated for each ARB by com

SUBMITTER: Takabayashi N 

PROVIDER: S-EPMC3781030 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature