Improving Adherence using Combination Therapy

Conditions

None listed

Brief summary

Cardiovascular disease (CVD) is the leading cause of hospitalisation and premature death in New Zealand and the main reason for shorter life expectancy among Maori. The latest New Zealand guidelines recommend people at high risk of CVD receive long-term aspirin and medications to lower blood pressure and cholesterol, which together would cut CVD risk by around two-thirds. However most people do not receive all these medications, often because of cost, complexity and a reluctance to take (or to prescribe) multiple pills. This primary care-based trial aims to assess whether a single combination capsule (the Red Heart Pill) improves adherence to these effective medications and reduces costs compared to standard practice. Individuals will be allocated at random to receive the Red Heart Pill or to usual care. Most cardiovascular deaths occur among the group targeted in this trial, and so this new preventive approach could reduce the overall impact of CVD in New Zealand.

Vanessa Selak, C. Raina Elley, Chris Bullen, Sue Crengle, Angela Wadham et al. (15 authors)

BMJ2014-05-27195 citations

10.1136/bmj.g3318

Recruiting equal numbers of indigenous and non-indigenous participants to a 'polypill' randomized trial.

Selak V, Crengle S, Elley CR, Wadham A, Harwood M, Rafter N, Bullen C, Pillai A, Arroll B, Rodgers A.

2013-06-2210 citations

10.1186/1475-9276-12-44

IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care.

Selak V, Elley CR, Crengle S, Harwood M, Doughty R, Arroll B, Bryant L, Rafter N, Hoorn SV, Wadham A, Wells S, Milne R, Jackson R, Bramley D, Rodgers A.

2011-07-1830 citations

10.1016/j.cct.2011.07.006

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

No

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.

Exclusion criteria

1. Contraindication to any of the components of the relevant combination capsule 2. Confirmed clinical diagnosis of congestive heart failure (CHF) or currently treated CHF 3. Documented haemorrhagic stroke 4. Active stomach or duodenal ulcer 5. On warfarin 6. The General Practitioner has the opinion that changing a patient's cardiovascular medications would put the patient at risk 7. Known situation where medication regimen might be altered for a significant length of time 8. Unlikely to complete the trial or the trial procedures.

Outcome results