Background: Nebivolol is a highly selective beta-adrenoreceptor antagonist with vasodilating properties. This study investigated its effect on quality of life (QoL) and blood pressure (BP) in real life conditions. In total, 1468 patients were enrolled, 12% diabetics. Nebivolol was prescribed as monotherapy, add-on or switch medication.
Methods: In this open-label, prospective study, the JNC-VII BP target values were used: < 140/90 and < 130/80 mmHg for diabetics. The responder rate and the QoL was determined at baseline and after 4 and 8 weeks.
Results: After 4 weeks, 27% of subjects reached target BP, 45% after 8 weeks. The responder rates were 92, 90 and 83% for the monotherapy, add-on and switch groups. Compared with baseline, all showed statistical significance at 8 weeks. Similarly to results for the QoL after 8 weeks, the mean improvement in QoL for all three groups was 9-10 points (total range: 0-88).
Conclusions: The study demonstrates that nebivolol in mild to moderate hypertension is associated with overall improvements in QoL, with a marked BP-lowering effect, in monotherapy, add-on or switch, irrespective of the glucose tolerance status. It may be hypothesized that its dual mode of action explains its BP-lowering effect as well as the tolerability.
Objective: Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the International Protocol of the European Society of Hypertension (ESH) in four separate studies. The Pic Indolor Personal Check, Comfort Check and My Check measure blood pressure (BP) at the brachial level; the Travel Check measures radial BP at the wrist level.
Methods: The International Protocol includes a total number of 33 subjects. In each study and for each subject, four BP measurements were performed simultaneously by two observers using mercury sphygmomanometers alternately with three measurements by the tested device. The difference between the observers and the device BP values (99 pairs) were classified into three categories (< or =5, < or =10, < or =15 mmHg).
Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were 0.1 +/- 2.9 and -0.1 +/- 3.8 mmHg for systolic and diastolic BP respectively for the Personal Check; -1.0 +/- 3.7 and 0.2 +/- 3.2 mmHg for the Comfort Check; -0.6 +/- 4.5 and -1.5 +/- 4.3 mmHg for the My Check; -0.1 +/- 2.0 and 0.6 +/- 1.7 mmHg for the Travel Check.
Conclusion: Readings of the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check devices differing by less than 5, 10 and 15 mmHg fulfill the International Protocol requirements and therefore can be used by patients for SBPM.
Objective: To describe the real-world effectiveness of amlodipine add-on therapy for hypertensive patients receiving valsartan.
Methods: Retrospective cohort study based on USA electronic medical records. The study population included hypertensive patients who, between January 1998 and December 2005, were receiving valsartan and subsequently initiated add-on therapy with amlodipine. Change in systolic blood pressure (SBP)/diastolic blood pressure (DBP), and attainment of goal SBP/DBP (i.e. < 140/90 mmHg), were examined based on last available reading prior to day 180 following initiation of amlodipine.
Results: Mean (+/- SD) baseline SBP/DBP of study subjects (n=155) was 152.5 (+/- 21.1)/84.0 (+/- 13.5) mmHg. Add-on therapy with amlodipine reduced SBP by 13.3 mmHg (95% CI 9.4-17.1) and DBP by 6.1 mmHg (95% CI 4.2-8.1). Among patients with baseline SBP/DBP > or = 160/100 mmHg (n=69), corresponding reductions were 28.8 mmHg (95% CI 23.4-34.2) and 11.4 mmHg (95% CI 8.4-14.3). Goal SBP/DBP was achieved by 46% (95% CI 37.7-55.6) of subjects; rates of goal attainment were similar for patients with and without diabetes or chronic kidney disease, and those aged > or = 65 years versus younger.
Conclusions: Adding amlodipine to valsartan for treatment of hypertension results in clinically meaningful reductions in blood pressure, on an overall basis and in high-risk subgroups who may benefit the most from blood pressure control.
Aim: To evaluate the efficacy and tolerability of candesartan cilexetil 32 mg in combination with hydrochlorothiazide (HCT) 12.5 mg or 25 mg in hypertensive patients not optimally controlled with candesartan monotherapy.
Patients and methods: A total of 3521 patients with treated or untreated hypertension and sitting diastolic blood pressure (DBP) 90-114 mmHg, entered a single-blind run-in phase with candesartan (16 mg for 2 weeks, followed by 32 mg for 6 weeks). At the end of the run-in phase, 1975 patients who still had DBP 90-114 mmHg were randomized to 8 weeks' double-blind treatment with either candesartan 32 mg (n=654), or candesartan-HCT 32/12.5 mg (n=656), or candesartan-HCT 32/ 25 mg (n=665).
Principal results: At randomization, the mean blood pressure was similar in the three treatment groups (approximately 153/97 mmHg). It was reduced during the double-blind treatment phase by 6.1/5.6 mmHg in the candesartan 32 mg group, by 13.0/8.8 mmHg in the candesartan-HCT 32/12.5 mg group, and by 15.5/10.0 mmHg in the candesartan-HCT 32/25 mg group (p<0.01 for all between treatment comparisons). All study treatments were generally well tolerated.
Conclusion: Candesartan-HCT 32/12.5 mg and candesartan-HCT 32/25 mg are highly effective and provide improved blood pressure reduction and blood pressure control relative to candesartan 32 mg monotherapy, with maintained tolerability, in hypertensive patients whose blood pressure is not optimally controlled with candesartan monotherapy. Furthermore, candesartan-HCT 32/25 mg is more effective than candesartan-HCT 32/12.5 mg in this population.
Objectives: To evaluate the efficacy, safety and tolerability of a single-pill combination of the direct renin inhibitor aliskiren and hydrochlorothiazide (HCT) in patients with hypertension and an inadequate BP response to aliskiren monotherapy (mean sitting diastolic BP [msDBP] > 90 and < or = 110 mmHg following 4 weeks of aliskiren 300 mg).
Methods: In this study, 880 patients with hypertension and an inadequate BP response to aliskiren monotherapy were randomized to once-daily, double-blind treatment with a single-pill combination of aliskiren/HCT 300/25 mg or 300/12.5 mg, or aliskiren 300 mg monotherapy. At the week 8 endpoint, least-squares mean changes in mean sitting systolic/diastolic BP (msSBP/DBP) from baseline were analyzed for the intent-to-treat population.
Results: Aliskiren/HCT 300/25 mg and 300/12.5 mg provided significantly greater msSBP/DBP reductions from baseline (15.9/11.0 mmHg and 13.5/10.5 mmHg, respectively) than aliskiren 300 mg alone (8.0/7.4 mmHg; both p<0.001). Rates of BP control (<140/90 mmHg) were significantly higher with aliskiren/HCT 300/25 mg (60.2%) and 300/12.5 mg (57.9%) than with aliskiren 300 mg alone (40.9%; both p<0.001). Aliskiren/HCT single-pill combination treatment showed similar tolerability to aliskiren monotherapy.
Conclusions: Aliskiren/HCT single-pill combinations provide clinically significant additional BP reductions and improved BP control rates over aliskiren alone in patients who are non-responsive to aliskiren 300 mg monotherapy.
Aims: This multicenter, open-label, single-arm trial assessed the efficacy of the combination of amlodipine 10 mg and valsartan 160 mg to provide additional blood pressure reduction and tolerability in patients with moderate hypertension not adequately responding to the combination of ramipril 5 mg and felodipine 5 mg.
Results: Of 133 patients treated for 5 weeks with ramipril 5 mg and felodipine 5 mg, 105 failed to achieve mean sitting systolic blood pressure <140 mmHg. These non-responders were then treated for an additional 5 weeks with amlodipine 10 mg and valsartan 160 mg, which resulted in clinically and statistically significant additional reductions in mean sitting systolic blood pressure of 15.4 mmHg (p<0.0001) and mean sitting diastolic blood pressure of 7.0 mmHg (p<0.0001). Adverse event rates were low with both treatment regimens.
Conclusions: In hypertensive patients not controlled at 5 weeks by ramipril 5 mg and felodipine 5 mg, significant additional blood pressure reductions were observed after 5 weeks of treatment with amlodipine 10 mg and valsartan 160 mg. The combination of amlodipine 10 mg and valsartan 160 mg was well tolerated.
Aims: This study sought to compare the antihypertensive efficacy and tolerability of a fixed-dose combination with amlodipine/benazepril with that of amlodipine monotherapy in Chinese hypertensive subjects.
Results: This multicenter, double-blind, 8-week study randomized 111 patients to fixed-dose amlodipine besylate/benazepril HCl (2.5/5 mg/day titrated to 5/10 mg/day as needed at week 4 to reach goal blood pressure (BP) <140/90 mmHg) or amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed). At week 8, patients randomized to combination therapy compared with monotherapy had a comparable BP control rate (56.0% vs. 46.2%; p = 0.32). Fixed-dose combination resulted in similar reductions in sitting systolic (SBP) and diastolic BP (DBP) compared with monotherapy (SBP: -19.3 +/- 12.5 vs. -20.9 +/- 13.3 mmHg; DBP: -9.2 +/- 10.4 vs. -11.3 +/-9.3 mmHg; both p=NS). Safety profiles did not differ between groups, but cough was more common in the combination group (11.0% vs. 0%; p = 0.013).
Conclusions: In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.