1. A fixed-dose combination (FDC) combination is a single pill containing doses of multiple individual medications indicated for treatment of a condition.
2. FDC therapy for patients with cardiovascular disease increased adherence and slightly improved LDL and systolic blood pressures in the experimental population.
Evidence Rating Level: 1 (Excellent)
Study Rundown: This study, based on data from the UMPIRE trial, reported the effect of fixed-dose combination (FDC), also known as “polypill”, therapy on adherence and risk factor levels in patients with or at risk of cardiovascular disease (CVD). The FDC formulations included aspirin, simvastatin, lisinopril and either atenolol or hydrochlorothiazide. It was found that compared to the control group, which was treated based on physician recommendations, patients taking one of two different formulations of the FDC achieved greater adherence and lower systolic blood pressures (SBP) and LDL cholesterol levels after a follow-up period of 12-15 months. The reductions in SBP and LDL were relatively small but still significant.
This study is not necessarily generalizable as the study population had a higher overall level of adherence relative to the overall population. Furthermore, other studies have demonstrated greater increases in adherence. While this trial is strengthened by its large number of participants and high reporting rates, the number of fatal CVD events and duration of follow-up are insufficient to draw firm conclusions on the overall effects of using the FDC. A point of concern and debate is whether the designated FDC regimens allow for enough control in the treatment of CVD patients. While pre-specified drugs dosages may be adequate for many patients, there may also be significant populations of patients who require a finer control of individual drug dosages.
In-Depth: [prospective, randomized clinical trial]: This prospective randomized study analyzed the effects of FDC regimens on adherence and outcome measures in patients with established and increased risk of CVD. The patient population included men and women aged 18 years or over with established coronary heart disease, cerebrovascular disease, or peripheral vascular disease, or an estimated 5-year CVD risk of 15% or greater. A total of 2,004 patients were enrolled into the trial. The participants were randomized into a control group or one of two FDC groups. Treatment of the control group was based on the patients’ physicians’ recommendations. The experimental groups received a polypill with aspirin 75mg, simvastatin 40 mg, lisinopril 10mg, and either atenolol 50mg or hydrochlorothiazide 12.5mg depending on physician preference.
The FDC group had improved adherence (RR1.33, CI95%[1.26 to 1.41]), systolic blood pressure (-2.6mmHg, CI95%[-4.0 to -1.1]) , and LDL measures (-4.2mg/dL, CI95%[-6.6 to -1.9]) when compared to the control group. HDL, triglyceride, and total cholesterol levels were not significantly different between the groups.
By Ravi Shah and Rif Rahman
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