- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Trial supports safety and efficacy profile of Pfizer’s varenicline
22 April 2016 • Author: Victoria White, Digital Content Producer
Pfizer has announced data from the largest ever randomised clinical trial of approved smoking cessation medicines, called EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study).
EAGLES is the largest placebo-controlled trial to compare the neuropsychiatric safety and efficacy of Champix (varenicline) and bupropion to placebo and nicotine patch to help people quit smoking.
The results demonstrated the use of varenicline or buproprion in patients with or without a history of psychiatric disorder is not associated with an increased risk of serious neuropsychiatric adverse events. In addition, patients taking varenicline in EAGLES showed statistically superior continuous abstinence rates at weeks 9-12 and 9-24 than patients treated with placebo, bupropion or nicotine patch during both time periods. Patients treated with each of the medications had higher abstinence rates than those treated with placebo.
Commenting on the results, Robert West, Professor of Health Psychology, University College London and co-author of the EAGLES study, said: “This study should reassure regulatory authorities, doctors and patients about the safety and effectiveness of medicines to help smokers to stop, whether or not those smokers have a history of a psychiatric disorder. Every smoker should receive the offer of evidence-based support to stop at least once a year – currently most do not.”
Patients taking varenicline had higher continuouse abstinence rates
The EAGLES study was designed to compare the neuropsychiatric safety of varenicline and bupropion with placebo and nicotine patch in adult smokers with and without a history of psychiatric disorders. Half of the trial participants had a history of psychiatric disorders, either past and in remission, or present and clinically stable. The trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with varenicline or bupropion compared to placebo and nicotine patch.
EAGLES also included an efficacy objective to determine smoking abstinence rates in patients treated with varenicline or bupropion, relative to placebo, during the last four weeks of the 12-week treatment period. Continuous abstinence was also evaluated relative to the nicotine patch. In addition, long-term abstinence through a 12-week non-treatment follow-up period (weeks 9-24) was evaluated for all treatments. The results showed that patients with and without a history of psychiatric disorders taking varenicline had significantly higher continuous abstinence rates than patients treated with bupropion or nicotine patch. Patients treated with each of the medications had higher abstinence rates than those treated with placebo during both time periods.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics