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

RESEARCH 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 Pedro Amariles, PhD, PharmD; Daniel Sabater-Hernández, PhD, PharmD; Emilio García-Jiménez, PhD, PharmD; Miguel Ángel Rodríguez-Chamorro, PhD, PharmD; Rosa Prats-Más, PhD, PharmD; Francisco Marín-Magán, BSc, MSc; José Antonio Galán-Ceballos, BSc, MSc; José Jiménez-Martín, PhD, PharmD; and María José Faus, PhD, PharmD ABSTRACT BACKGROUND: Although some studies have demonstrated that pharmacist intervention can improve drug therapy among patients with cardiovascular disease (CVD), more evidence derived from randomized controlled trials (RCTs) is needed, including assessment of the effect of community pharmacist interventions in patients with CVD. OBJECTIVE: To assess the effectiveness of the Dader Method for pharmaceutical care on achieving therapeutic goals for blood pressure (BP), total cholesterol (TC), and both BP and TC (BP/TC) in patients with CVD and/or high or intermediate cardiovascular (CV) risk attending community pharmacies in Spain. METHODS: Patients aged 25 to 74 years attending community pharmacies with a prescription for at least 1 drug indicated for CVD or CV risk factors were randomized to 2 groups: an intervention group that received pharmaceutical care, which was provided by specially trained pharmacists working in collaboration with physicians, and a control group that received usual care (routine dispensing counseling) and verbal and written counseling regarding CVD prevention. Patients were recruited from December 2005 to September 2006, and both groups were followed for 8 months. Study outcomes were assessed at baseline and at 16 and 32 weeks after randomization. The primary outcome measures were the proportions of patients achieving BP, TC, and BP/TC therapeutic goals (BP lower than 140/90 mm Hg for patients with uncomplicated hypertension and lower than 130/80 mm Hg for patients with diabetes, chronic kidney disease, or history of myocardial infarction or stroke; TC lower than 200 mg per dL for patients without CVD and lower than 175 mg per dL for patients with CVD). Secondary outcomes were mean BP and TC values. BP was assessed manually by the pharmacist after a 10-minute rest in the supine position. This measurement was performed twice for every participant, and the average of the 2 measurements was calculated. TC was measured by the pharmacist during the study visit using the enzymatic dry method. Statistical analyses were performed using 2-tailed McNemar tests, Pearson chi-square tests, and Student’s t-tests; P < 0.05 was considered statistically significant. RESULTS: 714 patients were included in the study (356 intervention, 358 control), and the mean [SD] age was 62.8 [8.1] years. The 2 groups were similar at baseline in clinical and demographic characteristics, including the proportion of patients at therapeutic goals for BP, TC, and BP/TC. After 8 months of follow-up, there were statistically significant differences in favor of pharmaceutical care in the proportions of patients who achieved therapeutic 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). www.amcp.org CONCLUSION: Compared with usual care plus written education, pharmaceutical care focused on patient evaluation and follow-up in collaboration with physicians improved the achievement of BP, TC, and BP/TC treatment goals in patients with CVD and/or high or intermediate CV risk attending community pharmacies in Spain. J Manag Care Pharm. 2012;18(4):311-23 Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved. What is already known about this subject • Despite the availability of evidence-based guidelines for treatment and prevention of cardiovascular disease (CVD), many patients do not achieve therapeutic goals. In studies by Banegas et al. (1998) and Rodríguez-Roca et al. (2005), only 15.5%-33.5% of patients receiving drug therapy for hypertension achieved their blood pressure (BP) treatment goals. Similarly, Olson et al. (2001) reported that only 21% (range 18%-35%) of patients receiving lipid-lowering therapy achieved their cholesterol targets. • Community pharmacists working in cooperation with patients and other health care professionals could contribute to achieving desired outcomes in patients with chronic diseases. A prospective randomized controlled trial (RCT) by Morgado et al. (2011), conducted in a secondary care hypertension/dyslipidemia outpatient clinic, found BP control rates of 63.3% (62/98) in patients receiving pharmaceutical care, compared with 43.4% (40/99) in the usual care group. An RCT of patients at high cardiovascular (CV) risk by Tsuyuki et al. (2002) found the primary endpoint (performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication) was reached in 196 patients (57%) in a community pharmacy intervention group, compared with 102 (31%) in usual care. However, in a recent systematic review of studies evaluating community pharmacist interventions for preventing or managing diabetes, CVD, and/or major CV risk factors, Evans et al. (2011) concluded that there is a need for more high-quality studies of these interventions. Vol. 18, No. 4 May 2012 JMCP Journal of Managed Care Pharmacy 311 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 What is already known about this subject (continued) • The Dader Method for pharmaceutical care includes patient education about CV drugs, completion of a drug therapy profile and/ or drug history, assessment of drug compliance, patient counseling about lifestyle modifications, pharmacist-performed interventions not related to changes in drug therapy, and pharmacistdelivered treatment recommendations to physicians. • To our knowledge, there is a lack of large RCTs designed to evaluate the effect of community pharmacist interventions on achieving therapeutic goals for BP, total cholesterol (TC), and both BP and TC (BP/TC) in patients with CVD or CV risk factors. What this study adds • The EMDADER-CV (Efecto del Método Dáder de Seguimiento Farmacoterapéutico en el riesgo cardiovascular de pacientes con factores de riesgo o enfermedad cardiovascular [Effectiveness of Dader Method for Pharmaceutical Care on Control of Blood Pressure and Total Cholesterol in Outpatients with Cardiovascular Disease or Cardiovascular Risk]) study was a large RCT designed to assess the effect of the Dader Method for pharmaceutical care on the achievement of therapeutic goals for BP, TC, and BP/TC in community pharmacy patients (n = 714) with CVD or CV risk factors. • After 8 months follow-up, there were statistica (...truncated)