Effectiveness of dader method for pharmaceutical care on control of blood pressure and total cholesterol in outpatients with cardiovascular disease or cardiovascular risk: EMDADER-CV randomized controlled trial

Publication Type:
Journal Article
Citation:
Journal of Managed Care Pharmacy, 2012, 18 (4), pp. 311 - 323
Issue Date:
2012-01-01
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Background: Although some studies have demonstrated that pharmacistintervention can improve drug therapy among patients with cardiovasculardisease (CVD), more evidence derived from randomized controlled trials(RCTs) is needed, including assessment of the effect of community pharmacistinterventions in patients with CVD. Objective: To assess the effectiveness of the Dader Method for pharmaceuticalcare on achieving therapeutic goals for blood pressure (BP), totalcholesterol (TC), and both BP and TC (BP/TC) in patients with CVD and/orhigh or intermediate cardiovascular (CV) risk attending community pharmaciesin Spain. Methods: Patients aged 25 to 74 years attending community pharmacieswith a prescription for at least 1 drug indicated for CVD or CV riskfactors were randomized to 2 groups: an intervention group that receivedpharmaceutical care, which was provided by specially trained pharmacistsworking in collaboration with physicians, and a control group that receivedusual care (routine dispensing counseling) and verbal and written counselingregarding CVD prevention. Patients were recruited from December2005 to September 2006, and both groups were followed for 8 months.Study outcomes were assessed at baseline and at 16 and 32 weeks afterrandomization. The primary outcome measures were the proportions ofpatients achieving BP, TC, and BP/TC therapeutic goals (BP lower than140/90 mm Hg for patients with uncomplicated hypertension and lowerthan 130/80 mm Hg for patients with diabetes, chronic kidney disease,or history of myocardial infarction or stroke; TC lower than 200 mg perdL for patients without CVD and lower than 175 mg per dL for patientswith CVD). Secondary outcomes were mean BP and TC values. BP wasassessed manually by the pharmacist after a 10-minute rest in the supineposition. This measurement was performed twice for every participant,and the average of the 2 measurements was calculated. TC was measuredby the pharmacist during the study visit using the enzymatic dry method.Statistical analyses were performed using 2-tailed McNemar tests, Pearsonchi-square tests, and Student's t-tests; P < 0.05 was considered statisticallysignificant. Results: 714 patients were included in the study (356 intervention, 358control), and the mean [SD] age was 62.8 [8.1] years. The 2 groups weresimilar at baseline in clinical and demographic characteristics, includingthe proportion of patients at therapeutic goals for BP, TC, and BP/TC. After8 months of follow-up, there were statistically significant differences infavor of pharmaceutical care in the proportions of patients who achievedtherapeutic goals for BP (52.5% vs. 43.0%, P = 0.017), TC (56.5% vs.44.1%, P = 0.001), and BP/TC (37.1% vs. 21.8%, P <0.001). Researchconclusion: Compared with usual care plus written education, pharmaceuticalcare focused on patient evaluation and follow-up in collaborationwith physicians improved the achievement of BP, TC, and BP/TC treatmentgoals in patients with CVD and/or high or intermediate CV risk attendingcommunity pharmacies in Spain. © 2012, Academy of Managed Care Pharmacy.
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