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Study shows polypill to be safe and accepted by physicians and patients in developing countries
Date:3/21/2011

try, Soliman said. Among them, would the country have investigators capable and willing to participate in a study and the necessary follow-up? Would patients sign up to participate? And if the pill was proven to work, would doctors even feel comfortable prescribing it?

So Soliman and colleagues brought the study to Sri Lanka, where they enrolled 216 participants without diagnosed CVD, in the hope of answering some of these questions. Half of the participants received "standard' treatment for CVD risk prevention, and the other half received the polypill. Patients were recruited as planned. Two hundred three patients (94.0%) completed the treatment program and returned for their follow-up visits. No safety concerns were reported.

These findings suggest a high rate of patient acceptability, a finding that is bolstered by the fact that the majority of patients who completed the trial 90 percent indicated that they would take the polypill "for life" if proven to be effective in reducing CVD risk. Approximately 86 percent of the physicians surveyed agreed with and supported use of the polypill for primary prevention and 93 percent for secondary prevention of CVD. In terms of reduction in CVD risk, both the polypill and "standard treatment" resulted in marked reductions in systolic blood pressure, total cholesterol and 10-year estimated risk of CVD.

"Our trial has fulfilled its purposes," Soliman said. "We wanted to check the feasibility of doing a large-scale clinical trial with a polypill in a developing country and to examine the acceptability of the polypill by patients and physicians, and we now know that it's feasible and acceptable."

He added that the "standard" treatment in this trial was administered by highly specialized physicians in tertiary-care centers, making it a tough competitor, yet the simple polypill held its own.

Although feasibility has been demonstrated, Soliman explained that there are other importa
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Contact: Jessica Guenzel
jguenzel@wakehealth.edu
336-716-3487
Wake Forest University Baptist Medical Center
Source:Eurekalert

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