Polypill helps heart attack survivors take their meds potentially saving lives

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Lead investigator Dr. Valentin Fuster, director of Mount Sinai Heart Hospital, New York, NY, presented the findings of the FOCUS study at the European Society of Cardiology (ESC) 2014 Congress in Barcelona, Spain, on Tuesday.

He notes that despite medical advances in tackling cardiovascular disease, rates in the population have steadily increased, to the point where it is the number one killer worldwide.

Life after a heart attack can be dominated by a complicated schedule of pills. Some patients may have 10 different drugs, including beta-blockers to slow the heart, ACE inhibitors to improve blood flow, statins for cholesterol control, plus aspirin and other drugs to thin the blood and reduce risk of clots.

It is not surprising, therefore, that Dr. Fuster says there is evidence heart attack survivors contribute to the cardiovascular disease epidemic by not sticking to their medication schedule, and:

"The most important factors responsible for a lack of adherence to treatment are the complexity of treatment and the daily number of prescribed pills."

Polypill offers many potential benefits to patients and elsewhere

The idea of using a polypill that combines several drugs in one tablet to prevent cardiovascular disease is gaining ground because it could overcome these factors.

"A polypill could simplify health care delivery, improve cost-effectiveness, support the comprehensive prescription of evidence-based cardioprotective drugs, and reach underdeveloped regions of the world," says Dr. Fuster.

FOCUS - the Fixed-dose Combination Drug for Secondary Cardiovascular Prevention study - was carried out in two phases: FOCUS 1 and FOCUS 2.

FOCUS 1 revealed many factors affecting why heart attack survivors do not stick to their medication regime - such as age, illiteracy, other illnesses, smoking, exercise, social support and insurance. FOCUS 2 showed that a polypill significantly increases the chances that they will.

Dr. Fuster says FOCUS 2, which is a clinical trial, is still running and will assess whether there are any differences in the polypill versus the three-drug group in blood pressure, cholesterol, safety and costs.

However, he points out that while the two studies suggest the "polypill has the potential to prevent more patients having a second heart attack," only a randomized trial can show whether using the polypill actually results in fewer heart attack survivors having another heart attack.

FOCUS 1 - Factors affecting drug adherence after heart attack

FOCUS 1 measured how well 118 heart attack survivors living in five different countries (Spain, Italy, Argentina, Brazil and Paraguay) stuck to their medication regime. It also looked at social and economic background, other illnesses and other factors that might affect adherence.

The study found, on average, 45.5% of patients were taking their drugs correctly.

An analysis of the results showed that the under 50s, those taking more than 10 pills a day, those who also had other types of medication (i.e. non-oral), smokers, and those with sedentary lifestyles were the ones most likely not to stick to their drug regime.

Adherence was also significantly lower among people who had poor reading and writing skills, less social support, and less or no insurance cover.

Patients also appeared less likely to take their drugs correctly if they were depressed or treated by a GP as opposed to a specialist, or treated in a private clinic as opposed to a public health center.

FOCUS 2 - clinical trial comparing polypill against drug cocktail

FOCUS 2 was a randomized controlled clinical trial of 695 patients from four countries and tested the effectiveness of a polypill on drug adherence and cardiovascular risk factors in heart attack survivors.

The trial ran for 9 months and compared a fixed-dose combination (FDC) polypill combining three heart drugs against taking them as three separate medications: acetylsalicylic acid (ASA) 100 mg, simvastatin 40 mg and ramipril (in doses of 2.5, 5 or 10 mg).

The trial showed that patients were more likely to take their heart attack prevention medication as a polypill than as three separate pills.

Dr. Fuster explains they carried out two types of analysis to show this. One was based on self-reported questionnaires, and the other on a pill count. The questionnaire results showed 68% of patients in the polypill group took their pills, compared with only 59% in the three-drug group.

The pill count analysis showed 92% of patients in the polypill group were taking their pills, compared with only 84% in the three-drug group.

Meanwhile, a recently reported study suggests a new experimental drug called LCZ696 is 20% more effective than ACE inhibitors at treating heart failure. One of the investigators said he was confident the drug will eventually replace ACE inhibitors for the treatment of heart failure.

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