Improving Adherence using Combination Therapy

Category Primary study
Registry of TrialsANZCTR
Year 2006
INTERVENTION: Polypill‐based care for 12 months until the last participant has been randomised. In the polypill arm, one polypill (a capsule) is to be taken orally, once a day. 2 versions of polypill (choice of which at the discretion of the General Practitioner): Version 1: One capsule contains aspirin 75mg, simvastatin 40mg, lisinopril 10mg and atenolol 50mg; Version 2: One capsule contains aspirin 75mg, simvastatin 40mg, lisinopril 10mg and hydrochlorothiazide 12.5mg CONDITION: High risk of cardiovascular disease PRIMARY OUTCOME: 1. Adherence (self‐reported current use of antiplatelet, statin and combination (2+) blood pressure lowering therapy) 2. Blood pressure change 3. LDL‐cholesterol change SECONDARY OUTCOME: 2. Barriers to adherence 3. Serious adverse events 4. Cardiovascular events 6. Prescriber acceptabitility 7. Change in other lipid fractions (HDL‐cholesterol, total cholesterol, triglycerides) 8. Healthcare resource consumption and cost‐effectiveness 9. Symptoms causing withdrawal of cardivoascular medications Adherence (self‐reported current use of antiplatelet, statin and combination (2+) blood pressure lowering therapy) Blood pressure change (if able to be assessed beyond 1 year; will be assessed by automatic sphygmomanometer) Change in other lipid fractions (High density lipoprotein [HDL]‐cholesterol, total cholesterol, triglycerides) (if able to be assessed beyond 1 year; will be assessed by blood analysis) Dispensing of statin and 2+ blood pressure lowering agents Dispensing of statin and 2+ blood pressure lowering agents (to be assessed via data linkage to national database) Low density lipoprotein (LDL)‐cholesterol change (if able to be assessed beyond 1 year; will be assessed by blood analysis) Quality of life (EQ5D) INCLUSION CRITERIA: 1. Adults with 5‐year cardiovascular risk of at least 15%2. The General Practitioner has the opinion that all the medications in at least one of the polypills are indicated3. The General Practitioner has uncertainty whether therapy is best provided as a polypill or with usual care4. The participant is able to give informed consent.
Epistemonikos ID: 83e87f96f068410c04e6bd8bdfb7cf9c26a5c7e0
First added on: Aug 25, 2024