Management of Hypertension With a Fixed-Dose (Single-Pill) Combination of Bisoprolol and Amlodipine.

Hypertension is currently one of the greatest global health care challenges. Although many effective drugs are available, combinations of 2 or more medications are often required to meet clinical targets. Combination therapy has several advantages over monotherapy: lower doses of each drug can be used to achieve therapeutic goals; lower doses may lead to fewer adverse events, facilitating patient adherence; and using multiple drugs with different modes of action may be more effective in treating multifactorial diseases, including hypertension. Adherence is an important consideration when requiring patients to self-administer multiple medications; as the number of concurrent medications increases, patient adherence tends to decrease. Recent evidence suggests that fixed-dose combinations (FDCs) may be more effective than free-dose combinations, as they provide all necessary medications in a single convenient tablet/single-pill combination. Among combinations of hypertension medications, a ß-blocker such as bisoprolol with a calcium channel blocker such as amlodipine is an effective combination therapy for hypertension, with distinct and complimentary modes of action. With advantages over free-dose combinations, the FDC of bisoprolol/amlodipine is thus an effective and convenient treatment for hypertension, allowing more patients to achieve their therapeutic goals, while potentially reducing the burden of hypertension on health care systems.

Sustained effects in hypercholesterolaemic patients on combined simvastatin/ezetimibe treatment: observational cohort study in clinical practice.

BACKGROUND: In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combination of simvastatin (SIM 10, 20, 40 or 80 mg) plus ezetimibe (EZ 10 mg). METHODS: A prospective, observational study in 512 general practices throughout Germany. From a sample of patients at moderate or high cardiovascular risk who had previously taken part in a half-year study of an SIM/EZ combination, 5485 patients were documented after 1 year of treatment (mean 58 +/- 16 weeks) with regard to lipid parameters, adverse drug reactions (ADRs) and adverse events. RESULTS: At the start of follow-up, 78.6% of patients were still on the SIM/EZ combination. At the end of follow-up, mean low density lipoprotein cholesterol (LDL-C) in patients on the combination versus those on other lipid-lowering therapy was reduced by 29.3 vs. 17.6% compared with baseline, total cholesterol by 23.1 vs. 14.5%, mean high density lipoprotein cholesterol (HDL-C) was increased by 15.9 vs. 13.4%, and mean triglycerides were reduced by 16.1 vs. 7.9%. Individual LDL-C targets were achieved by 56.6% on the SIM/EZ combination versus 35.9% on other therapy. In the long term (but not the short term), low acceptance of nutrition counselling as rated by the physician was associated with poor lipid levels. ADRs during follow-up occurred in 18 patients (0.3%; all cases non-serious), with seven cases of myalgia, and three cases each of nausea or arthralgia. CONCLUSIONS: This observational study showed that long-term therapy with the SIM/EZ combination resulted in sustained beneficial effects on serum lipids and was well-tolerated. Compared to patients with therapy discontinuations or switches, those remaining on the combination had better outcomes regarding lipid status.

Predictors of uncontrolled hyperlipidaemia in high-risk ambulatory patients in primary care.

OBJECTIVE: To determine (a) the proportion of patients at high risk of cardiovascular events who achieve low-density lipoprotein cholesterol (LDL-C) goals as recommended by the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and (b) the predictors of poor LDL-C control. METHODS: Two open-label, prospective, non-randomised, observational studies (study 1 with n=19 194 patients, predominantly with coronary artery disease (CHD); study 2 with n=19 484 patients, pre-dominantly with diabetes mellitus (DM)). Patients received, usually after statin pretreatment, ezetimibe 10 mg plus simvastatin as fixed-dose combinations over 3 months. Bivariate and multivariate regression analysis was performed to identify factors associated with poor LDL-C control. RESULTS: At study end, 38% (up from 4.7% at baseline) of CHD and 35% (up from 3.3% at baseline) of diabetic patients achieved the target LDL value <100 mg/dl (2.6 mmol/l) after treatment with a fixed-dose ezetimibe-simvastatin combination. In both studies, concomitant atherosclerotic disease was associated with good control. Conversely, factors associated with poor control were, among others, high baseline LDL-C values, pretreatment with certain statins, and (in the DM study) high HbA(1c), and high body mass index. CONCLUSION: Under real world, general practice conditions, a substantial proportion of high-risk patients with CHD and/or DM met LDL-C target levels on dual cholesterol inhibition with ezetimibe/simvastatin. A limited number of easily recognisable factors allow physicians to identify high risk patients whose LDL-C is likely to be difficult to control. Early identification of this patient group may have profound clinical benefits in general practice by enabling specific early interventions such as counselling on physical activity, dietary support and/or follow up visits to the GP.

Dual cholesterol inhibition with ezetimibe/simvastatin in pre-treated hypercholesterolaemic patients with coronary heart disease or diabetes mellitus: prospective observational cohort studies in clinical practice.

OBJECTIVE: Patients with primary hypercholesterolaemia and concomitant coronary heart disease (CHD) and/or diabetes mellitus (DM), who are at particularly high risk of cardiovascular events such as stroke or myocardial infarction, benefit from aggressive lipid lowering strategies. The present studies investigated the incremental efficacy and safety of dual cholesterol inhibition with ezetimibe/simvastatin in such high-risk patients pre-treated with statins but not reaching the 100 mg/dL (2.6 mmol/L) low density cholesterol (LDL-C) cholesterol threshold in the primary care setting. METHODS: Two open-label, prospective, non-randomised, observational studies (study 1 with n = 19 194 patients, predominantly with CHD; study 2 with n = 19 484 patients, predominantly with DM). Patients received--almost all after statin pre-treatment--ezetimibe 10 mg plus simvastatin 10 mg (study 1: 15%, study 2: 16%), 20 mg (in 68% each), 40 mg (12%/10%) or 80 mg (1%/1%) as fixed dose combinations over 3 months (dosage at investigator's discretion). RESULTS: Mean LDL-C was reduced by 28%/27% (study 1/ study 2) compared with baseline values (on statin monotherapy). Mean total cholesterol was decreased by 22% in each study, mean triglycerides by 16/17%, and mean high density cholesterol (HDL-C) was increased by 9/10%. Adverse events were reported in 0.3% and 0.2% of patients, respectively. CONCLUSION: Dual cholesterol inhibition with ezetimibe/simvastatin was effective and well tolerated under real practice conditions in high-risk patients with CHD and/or DM.