PMID- 26253777 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20151215 LR - 20200929 IS - 2193-8261 (Print) IS - 2193-6544 (Electronic) IS - 2193-6544 (Linking) VI - 4 IP - 2 DP - 2015 Dec TI - Treatment of Hypertensive Patients with a Fixed-Dose Combination of Bisoprolol and Amlodipine: Results of a Cohort study with More Than 10,000 Patients. PG - 179-90 LID - 10.1007/s40119-015-0045-z [doi] AB - INTRODUCTION: Many patients need more than one antihypertensive agent for effective blood pressure (BP) control. Prescription of a fixed-dose combination (FDC) of bisoprolol and amlodipine in one tablet has been shown to significantly improve patient adherence. This non-interventional study investigated the effects on adherence and BP control of switching from a free-dose combination of the two antihypertensive substances to a FDC in a larger patient population. METHODS: Patients aged >/=18 years with essential hypertension were switched at least 4 weeks prior to study initiation from a free-dose combination of bisoprolol and amlodipine to the FDC. Dosage adjustment was implemented only if medically indicated. Adherence was assessed on the basis of the ratio of pills used to pills dispensed (%) at each visit (pill count). BP and key laboratory values were determined at baseline, 3 and 6 months. RESULTS: 10,532 patients (average age 59 years; 48% female) were recruited between 2013 and 2014; 22% of patients had type 2 diabetes and 38% had cardiovascular disease. The mean doses of the freely combined drugs prior to switching were 5.5 mg bisoprolol and 6.1 mg amlodipine once daily. The mean daily doses prescribed in the FDC were 5.8 and 6.4 mg, respectively. Pill counts at 6 months revealed a good to excellent adherence in >95% of the patients. Comparison of BP at baseline and at 6 months showed substantial changes (mean systolic BP: 147.3 vs. 130.9 mmHg; mean diastolic BP: 87.9 vs. 79.1 mmHg). Clinically relevant improvement in systolic BP was established for 82% of patients. In patients with comorbidities, switching to FDC produced a substantial improvement in BP. A total of 89 (0.7%) adverse events (AEs) were reported, including edema, headache, dizziness, bradycardia, nausea, and skin reactions. Only three AEs were classified as serious. CONCLUSION: These data from a non-interventional study in a large patient population demonstrate the benefits of prescribing a FDC of bisoprolol-amlodipine in terms of an excellent adherence and an associated improvement in control of previously elevated BP, which may be relevant in real-life practice. FUNDING: Merck KGaA. FAU - Hostalek, Ulrike AU - Hostalek U AUID- ORCID: 0000-0002-0770-4743 AD - Merck KGaA, Darmstadt, Germany. ulrike.gottwald-hostalek@merckgroup.com. FAU - Czarnecka, Danuta AU - Czarnecka D AD - Jagiellonion University Medical College, Krakow, Poland. FAU - Koch, Ernst M W AU - Koch EM AD - Clinical Research, Alsbach, Germany. LA - eng PT - Journal Article DEP - 20150808 PL - England TA - Cardiol Ther JT - Cardiology and therapy JID - 101634495 PMC - PMC4675749 OTO - NOTNLM OT - Adherence OT - Amlodipine OT - Bisoprolol OT - Blood pressure control OT - Fixed-dose combination COIS- D. Czarnecka was the Principal Investigator and has given lectures for Merck KGaA. U. Hostalek is an employee of Merck KGaA, and E. M. W. Koch is a consultant to the company. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. EDAT- 2015/08/09 06:00 MHDA- 2015/08/09 06:01 PMCR- 2015/08/08 CRDT- 2015/08/09 06:00 PHST- 2015/07/10 00:00 [received] PHST- 2015/08/09 06:00 [entrez] PHST- 2015/08/09 06:00 [pubmed] PHST- 2015/08/09 06:01 [medline] PHST- 2015/08/08 00:00 [pmc-release] AID - 10.1007/s40119-015-0045-z [pii] AID - 45 [pii] AID - 10.1007/s40119-015-0045-z [doi] PST - ppublish SO - Cardiol Ther. 2015 Dec;4(2):179-90. doi: 10.1007/s40119-015-0045-z. Epub 2015 Aug 8.