Advances in Pharmacoepidemiology and Drug Safety

Abstract

Safety and Tolerability of EPs 7630 in Clinical Trials

Heinrich Matthys, Stephan Köhler and Wolfgang Kamin

Herbal medicines play an increasingly important role in the perception of physicians and patients looking for equally effective, albeit safer approaches to conventional management of certain diseases. The controversy surrounding effective management regimes for respiratory tract infections (RTI) has made many healthcare providers reconsider current therapeutic strategies.

This review presenting the available evidence from clinical trials and non-interventional studies on the safety and tolerability profile of EPs 7630 is based on publications and study reports of 29 clinical trials and post-marketing surveillance studies completed by February 2010. It includes study data from 10,026 adults and children suffering from acute or chronic RTI such as acute tonsillopharyngitis, rhinopharyngitis, sinusitis, bronchitis, or COPD and from 31 healthy subjects.

In 19 double-blind, placebo-controlled trials, the type and incidence rate of adverse events under EPs 7630 were similar to those in patients treated with placebo. For gastrointestinal complaints and epistaxis, event rate differences of 2.9% and of 0.6% against EPs 7630 were determined; hypersensitivity reactions and all other system groups showed rate differences <0.5%. For liver associated events, rate differences of 0.0% for all events and of 0.1% for potentially related events were observed. Patients treated with EPs 7630 did not exhibit increased liver enzyme or bilirubin values – neither in terms of a shift in the mean, nor according to individual deviations from the reference ranges. These findings were fully supported by the data from the post-marketing surveillance studies reviewed.

EPs 7630 appears to be a well-tolerated herbal medicine in the management of RTI in adults and children alike. Evidence for hepatotoxic effects in humans during routine administration was neither provided in the literature, nor by our own analyses.