In order to bring you the best possible user experience, this site uses Javascript. If you are seeing this message, it is likely that the Javascript option in your browser is disabled. For optimal viewing of this site, please ensure that Javascript is enabled for your browser.
Did you know that your browser is out of date? To get the best experience using our website we recommend that you upgrade to a newer version. Learn more.

We use cookies to optimise the design of this website and make continuous improvement. By continuing your visit, you consent to the use of cookies. Learn more

FOCUS: Fixed-dose combination drug for secondary cardiovascular prevention

ESC Congress 2014 - Hot Line report

Prevention


 

Presentation

By Valentin Fuster, FESC (New York, United States of America)
View Discussant report

Open the Presentation
Watch the Webcast
Resources are published as they become available during the congress

List of Authors:
VF. Fuster 1, JM. Castellano 1, G. Sanz 1
(1) National Centre for Cardiovascular Research (CNIC), Madrid, Spain

Abstract

RATIONALE
Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (AMI) is low after the first six months. The use of fixed-dose combinations (FDC) have been shown to improve treatment adherence and risk factor control in previous trials with various CV risk profiles. However, no randomized clinical trial has analyzed the impact of a FDC strategy on adherence in post-MI patients including factors affecting patients’ adherence to treatment.
METHODS
FOCUS (Fixed Dose Combination Drug for Secondary Cardiovascular Prevention) consisted of cross-sectional study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an AMI. A 5-country cohort (Argentina, Brazil, Italy, Paraguay, and Spain) of 2118 patients was analyzed. In addition, 695 patients from phase 1 were randomized into a controlled clinical trial (Phase 2) to test the effect of a FDC polypill containing aspirin 100 mg, simvastatin 40mg and ramipril 2.5, 5 or 10 mg on adherence, blood pressure and low density lipoprotein cholesterol (LDL-C), as well as safety and tolerability over a period of 9 months of follow-up. Patients were randomized to either the polypill or the three drugs separately. Primary end-point was adherence to treatment measured the self-report Morisky-Green questionnaire (MAQ) and pill count.
RESULTS
In phase 1, overall CV medication adherence defined as a MAQ score ≥16 was 89% and as MAQ score 20 was 45.5%. In a multivariable regression model, the risk of being non-adherent (MAQ<20) was associated with younger age, depression rating scale, being on a complex medication treatment, poorer health insurance coverage, a lower level of social support, with consistent findings across countries.
In Phase 2, the FDC group showed improved adherence compared to the group receiving separate medications after 9 months follow up: 63% vs 52% (p=0,006) when using MAQ plus pill count to assess adherence. Adherence was also higher in FDC group when measured by MAQ alone (68% vs. 59%, p=0.049) or pill count alone (92% vs. 82%, p=0.002). No treatment difference was found at follow-up in mean SBP (129.6 vs 128.6 mmHg) nor in mean LDL-C levels (89.9 vs 91.7 mg/dL) nor in serious adverse events (23 [6.6%] vs. 21 [6%]) or death (1, 0.2% in each group).
CONCLUSIONS AND RELEVANCE
In secondary prevention following an AMI, younger age, being depressed and following a complex drug treatment are associated with a lower medication adherence, while adherence is increased in patients with higher levels of insurance coverage and social support. Compared with the three drugs given separately, the use of a polypill strategy increased self-reported and direct measured medication adherence for secondary prevention following an AMI.

Discussion

By Salim Yusuf, FESC (Hamilton, Canada)
See Presenter abstract

Open the presentation
Watch the Webcast

 

References


712

SessionTitle:

Clinical Trial Update Hot Line: Infarction, interventions and outcome

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.