Martin Schulz1,2,3, Nina Griese-Mammen1, Stefan D Anker4, Friedrich Koehler5, Peter Ihle6, Christian Ruckes7, Pia M Schumacher1, Dietmar Trenk8, Michael Böhm9, Ulrich Laufs10. 1. Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany. 2. Drug Commission of German Pharmacists (AMK), Berlin, Germany. 3. Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany. 4. Division of Cardiology and Metabolism; Department of Cardiology (CVK), Berlin-Brandenburg Centre for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany. 5. Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Charité - Universitätsmedizin Berlin, Berlin, Germany. 6. PMV Research Group, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. 7. Interdisciplinary Centre for Clinical Trials (IZKS), University Medical Centre Mainz, Mainz, Germany. 8. Department of Clinical Pharmacology, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany. 9. Department of Internal Medicine III - Cardiology, Angiology and Intensive Care Medicine, University Hospital of Saarland, Saarland University, Homburg, Germany. 10. Department of Cardiology, University Hospital, Leipzig University, Leipzig, Germany.
Abstract
AIMS: Medication non-adherence is frequent and is associated with high morbidity and mortality in patients with chronic heart failure (CHF). We investigated whether an interdisciplinary intervention improves adherence in elderly CHF patients. METHODS AND RESULTS:The study population (mean age 74 years, 62% male, mean left ventricular ejection fraction 47%, 52% in New York Heart Association class III) consisted of 110 patients randomized into the pharmacy care and 127 into the usual care group. The median follow-up was 2.0 years (interquartile range 1.2-2.7). The pharmacy care group received a medication review followed by regular dose dispensing and counselling. Control patients received usual care. The primary endpoint was medication adherence as proportion of days covered (PDC) within 365 days for three classes of heart failure medications (beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and mineralocorticoid receptor antagonists). The main secondary outcome was the proportion of adherent patients (PDC ≥ 80%). The primary safety endpoint was days lost due to unplanned cardiovascular hospitalizations (blindly adjudicated) or death. Pharmacy care compared with usual care resulted in an absolute increase in mean adherence to three heart failure medications for 365 days [adjusted difference 5.7%, 95% confidence interval (CI) 1.6-9.8, P = 0.007]. The proportion of patients classified as adherent increased (odds ratio 2.9, 95% CI 1.4-5.9, P = 0.005). Pharmacy care improved quality of life after 2 years (adjusted difference in Minnesota Living with Heart Failure Questionnaire scores -7.8 points (-14.5 to -1.1; P = 0.02), compared to usual care. Pharmacy care did not affect the safety endpoints of hospitalizations or deaths. CONCLUSION: Pharmacy care safely improved adherence to heart failure medications and quality of life.
RCT Entities:
AIMS: Medication non-adherence is frequent and is associated with high morbidity and mortality in patients with chronic heart failure (CHF). We investigated whether an interdisciplinary intervention improves adherence in elderly CHFpatients. METHODS AND RESULTS: The study population (mean age 74 years, 62% male, mean left ventricular ejection fraction 47%, 52% in New York Heart Association class III) consisted of 110 patients randomized into the pharmacy care and 127 into the usual care group. The median follow-up was 2.0 years (interquartile range 1.2-2.7). The pharmacy care group received a medication review followed by regular dose dispensing and counselling. Control patients received usual care. The primary endpoint was medication adherence as proportion of days covered (PDC) within 365 days for three classes of heart failure medications (beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and mineralocorticoid receptor antagonists). The main secondary outcome was the proportion of adherent patients (PDC ≥ 80%). The primary safety endpoint was days lost due to unplanned cardiovascular hospitalizations (blindly adjudicated) or death. Pharmacy care compared with usual care resulted in an absolute increase in mean adherence to three heart failure medications for 365 days [adjusted difference 5.7%, 95% confidence interval (CI) 1.6-9.8, P = 0.007]. The proportion of patients classified as adherent increased (odds ratio 2.9, 95% CI 1.4-5.9, P = 0.005). Pharmacy care improved quality of life after 2 years (adjusted difference in Minnesota Living with Heart Failure Questionnaire scores -7.8 points (-14.5 to -1.1; P = 0.02), compared to usual care. Pharmacy care did not affect the safety endpoints of hospitalizations or deaths. CONCLUSION: Pharmacy care safely improved adherence to heart failure medications and quality of life.
Authors: Robin Brünn; Dorothea Lemke; Jale Basten; Petra Kellermann-Mühlhoff; Juliane Köberlein-Neu; Christiane Muth; Marjan van den Akker Journal: Pharmaceuticals (Basel) Date: 2022-06-17
Authors: Martin Schulz; Nina Griese-Mammen; Pia M Schumacher; Stefan D Anker; Friedrich Koehler; Christian Ruckes; Volker Rettig-Ewen; Rolf Wachter; Dietmar Trenk; Michael Böhm; Ulrich Laufs Journal: ESC Heart Fail Date: 2020-07-23