The Guidelines Adherence with the Polypill Study - GAP
Will a simpler drug regime improve health outcomes for people at high risk of heart attack and stroke?
Background
People with previous heart attack, stroke or other vascular diseases are among those at highest risk of having a future cardiovascular event. Despite the availability of a number of simple, safe and effective drugs that reduce this risk, a substantial number of patients do not receive ‘indicated’ treatments, and particularly, appropriate combinations of these drugs that would maximise their beneficial effects.
This may be due to the complexity, inconvenience and costs associated with doctors prescribing, and patients then taking, multiple drugs.
A ‘polypill’ may help improve this scenario by offering patients a simpler drug regime in the form of a single pill containing fixed-dose combinations of treatments.
Aims
The GAP Study aims to assess whether patients prescribed a polypill-based drug regime have improved adherence and clinical outcomes compared with those given usual cardiovascular medications. The polypill used in the trial contains low dose aspirin, a cholesterol lowering drug and two blood pressure lowering drugs.
The study also aims to measure the prescription of combination therapy, barriers to adherence, quality of life, safety, cardiovascular events, prescriber acceptability and healthcare resource consumption to help build a complete picture with which to evaluate the polypill.
Methods
The study is a prospective, open, randomised controlled clinical trial of a polypill-based strategy compared to usual care among approximately 1000 individuals at high risk of cardiovascular events, augmented by a cost-effectiveness analysis and a formal process evaluation. The study will be conducted within general medical practices in Austalia, where participants will be followed up for an average of 18 months.
Institute Investigators
- Anushka Patel (Chief Investigator)
- Patrick Groenestein
- Stephen Jan
- Bruce Neal
Collaboration
- Clinical Trials Research Unit, School of Population Health, University of Auckland
- Department of Epidemiology and Preventative Medicine, Monash University, Victoria
Funding Agencies
This study is funded by a National Health and Medical Research Council (NHMRC) Project Grant , with additional funding provided through a Program Grant awarded by the NHMRC to researchers at The George Institute For International Health.