Single Pill Regimen Leads to Better Adherence and Clinical Outcome in Daily Practice in Patients Suffering from Hypertension and/or Dyslipidemia: Results of a Meta-Analysis.

INTRODUCTION: Cardiovascular diseases (CVD) represent the first cause of mortality in western countries. Hypertension and dyslipidemia are strong risk factors for CVD, and are prevalent either alone or in combination. Although effective substances for the treatment of both factors are available, there is space for optimization of treatment regimens due to poor patient's adherence to medication, which is usually a combination of several substances. Adherence decreases with the number of pills a patient needs to take. A combination of substances in one single-pill (single pill combination, SPC), might increase adherence, and lead to a better clinical outcome. AIM: We conducted a meta-analysis to compare the effect of SPC with that of free-combination treatment (FCT) in patients with either hypertension, dyslipidemia or the combination of both diseases under conditions of daily practice. METHODS: Studies were identified by searching in PubMed from November 2014 until February 2015. Search criteria focused on trials in identical hypertension and/or dyslipidemia treatment as FCT therapy or as SPC. Adherence and persistence outcome included proportion-of-days-covered (PDC), medication possession ratio (MPR), time-to treatment gap of 30 and 60 days and no treatment gap of 30 days (y/n). Clinical outcomes were all cause hospitalisation, hypertension-related hospitalisation, all cause emergency room visits, hypertension-related emergency room visits, outpatient visits, hypertension-related outpatient visits, and number of patients reaching blood pressure goal. Randomized clinical studies were excluded because they usually do not reflect daily practice. RESULTS: 11 out of 1.465 studies met the predefined inclusion criteria. PDC ≥ 80% showed an odds ratio (OR) of 1.78 (95% CI: 1.30-2.45; p = 0.004) after 6 months and an OR of 1.85 (95% CI: 1.71; 2.37; p < 0.001) after ≥ 12 months in favour to the SPC. MPR ≥ 80% after 12 months also was in favour to SPC (OR 2.13; 95% CI: 1.30; 3.47; p = 0.003). Persistence was positively affected by SPC after 6, 12, and 18 months. Time to treatment gap of 60 days resulted in a hazard ratio (HR) of 2.03 (95% CI: 1.77; 2.33, p < 0.001). The use of SPC was associated with a significant improvement in systolic blood pressure reduction, leading to a higher number of patients reaching individual blood pressure goals (FCT vs SPC results in OR = 0.77; 95% CI: 0.69; 0.85, p < 0.001). Outpatient visits, emergency room visits and hospitalisations, both overall and hypertension-related were reduced by SPC: all-cause hospitalisation (SPC vs FCT: 15.0% vs 18.2%, OR 0.79, 95% CI 0.67; 0.94, p = 0.009), all-cause emergency room visits (SPC vs FCT: 25.7% vs 31.4%, OR 0.75, 95% CI 0.65; 0.87, p = 0.001) and hypertension related emergency room visits (SPC vs FCT: 9.7% vs 14.1%, OR 0.65, 95% CI 0.54; 0.80, p < 0.001). CONCLUSIONS: SPC improved medication adherence and clinical outcome parameter in patients suffering from hypertension and/or dyslipidemia and led to a better clinical outcome compared to FCT under conditions of daily practice.

Relationship between the frequency of blood pressure self-measurement and blood pressure reduction with antihypertensive therapy : results of the OLMETEL (OLMEsartan TELemonitoring blood pressure) study.

OBJECTIVES: This subanalysis of the OLMETEL (OLMEsartan TELemonitoring blood pressure) study in patients with essential hypertension assessed the relationship between the frequency of blood pressure self-measurement (BPSM) and the response to blood pressure (BP)-lowering therapy with olmesartan medoxomil, and the number of BP readings per week necessary to detect a mean systolic or diastolic BP reduction > or =5mm Hg. METHODS: A total of 53 patients with essential hypertension received treatment with olmesartan medoxomil 10, 20 or 40 mg daily for 12 weeks. BPSM was performed for the first 9 weeks using a TensioPhone TP2 device. Patients were instructed to measure BP at least twice daily (morning and evening). RESULTS: After the first 9 weeks of the 12-week treatment period, the extent of BP reduction correlated with the number of BPSMs. Systolic/diastolic BP reductions in patients with a 100% adherence to at least two BP measurements daily were -16.6/-8.0mm Hg compared with -0.2/-3.3mm Hg in patients with only a 75% adherence to at least one BP measurement daily. Obtaining five home BP readings per week resulted in a sensitivity of 94.8% and a specificity of 90.0% to detect a BP reduction of > or =5mm Hg. CONCLUSION: Patients adhering to the instructions for BPSM (at least two measurements daily) had a better response to antihypertensive treatment with olmesartan medoxomil. Whether BPSM per se resulted in an improved adherence to therapy or whether the number of recordings was an indicator of already existing adherence remains to be determined. Obtaining at least five home BP readings per week was identified as the threshold for correctly predicting response to olmesartan medoxomil treatment.

Telemonitoring of blood pressure self measurement in the OLMETEL study.

OBJECTIVE: To investigate the feasibility of blood pressure (BP) telemonitoring in previous uncontrolled hypertensives treated with olmesartan medoxomil in a clinical practice setting. METHODS: Patients (n = 53) with untreated, uncontrolled or insufficiently treated hypertension were selected by physicians to receive olmesartan medoxomil 10-40 mg/day for 12 weeks. Office BP values were determined by a physician at baseline and after 12 weeks' treatment; BP self-measurement (BPSM) was conducted throughout the 12-week treatment period using a TensioPhone TP2 telemonitoring device; BP values were stored and automatically downloaded to a remote service centre via standard telephone lines. RESULTS: Olmesartan medoxomil produced statistically significant reductions from baseline in both systolic and diastolic office BP and BPSM values. In contrast to office BP, telemonitoring of BPSM allowed the early identification of responders (e.g., after 2-3 weeks' treatment). Blood pressure reduction with olmesartan medoxomil was greater for office BP than for BPSM values. Normalization of BP was achieved in 64.2% of the patients using office BP measurement compared with 36.4% using BPSM. Blood pressure self-measurement showed no significant difference between morning and evening BP measurements or between the morning : evening BP ratio at baseline and after nine weeks of olmesartan medoxomil treatment. Compliance and tolerability were good or very good in most patients. CONCLUSION: In a 'real-life' clinical practice setting, telemonitoring of BPSM was an effective technique that was partially affected by patient non-compliance. Olmesartan medoxomil provided effective and reliable BP-lowering, which was maintained throughout the 24-hour period.