Hypertension research : official journal of the Japanese Society of Hypertension
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Randomized Controlled Trial
Risk of incident chronic kidney disease is better reduced by bedtime than upon-awakening ingestion of hypertension medications.
This trial investigated whether therapy with the entire daily dose of ≥1 hypertension medications at bedtime exerts a greater reduction in the risk of incident chronic kidney disease (CKD) than therapy with all medications upon awakening. We conducted a prospective, open-label, blinded endpoint trial of 2078 hypertensive patients without CKD (1017 men/1061 women, 53.6 ± 13.7 years of age) randomized to ingest all their prescribed hypertension medications upon awakening (n = 1041) or the entire daily dose of ≥1 of those medications at bedtime (n = 1037). ⋯ Greater benefit was observed for bedtime than awakening treatment, with angiotensin converting enzyme inhibitors and angiotensin receptor blockers. In hypertensive patients without CKD, ingestion of ≥1 BP-lowering medications at bedtime, mainly those modulating or blocking the effects of angiotensin II, compared with ingestion of all such medications upon-awakening, resulted in improved ambulatory BP control (significant further decrease of asleep BP and enhanced sleep-time relative BP decline) and reduced risk of incident CKD.
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Randomized Controlled Trial
Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension.
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral tadalafil in patients receiving background ambrisentan therapy. Current treatments for pulmonary arterial hypertension (PAH) remain insufficient, resulting in high mortality rates. The addition of oral tadalafil, a phosphodiesterase-5 inhibitor, to background ambrisentan may provide a safe and effective therapeutic strategy. ⋯ No significant differences were found in adverse events or changes in hemodynamic parameters between the placebo and tadalafil groups. Tadalafil 40 mg was well-tolerated as add-on therapy to background ambrisentan. However, the data from this study are insufficient to prove the additional therapeutic benefits of tadalafil add-on therapy.
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Randomized Controlled Trial Multicenter Study
Comparison of medium-dose losartan/hydrochlorothiazide and maximal-dose angiotensin II receptor blockers in the treatment of Japanese patients with uncontrolled hypertension: the Kobe-CONNECT Study.
The objective of this study is to examine the effects of thiazide diuretics, plus medium-dose losartan versus maximal-dose angiotensin II receptor blockers (ARBs) on blood pressure (BP) in Japanese patients with uncontrolled hypertension despite the use of medium-dose ARBs. Hypertensive patients in whom BP was inadequately controlled by treatment with medium-dose ARBs alone or with calcium-channel blockers were enrolled. Patients were randomly assigned to a fixed-dose combination of 50 mg per day losartan and 12.5 mg per day hydrochlorothiazide (HCTZ; n=98), or to a maximal dose of current ARBs (n=95). ⋯ The concomitant usage of losartan and HCTZ had no influence on glucose metabolism and lipid profiles. Declines in plasma N-terminal pro-brain natriuretic peptide levels and urinary albumin excretion were observed in the losartan/HCTZ group, but not in the maximal-dose ARB group. Switching from medium-dose ARBs to losartan plus HCTZ reduced both office and home BP efficiently in patients with uncontrolled hypertension.
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Randomized Controlled Trial Multicenter Study
Cardiovascular outcomes in the first trial of antihypertensive therapy guided by self-measured home blood pressure.
Hypertension guidelines recommend blood pressure self-measurement at home (HBP), but no previous trial has assessed cardiovascular outcomes in hypertensive patients treated according to HBP. The multicenter Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP; 2001-2010) trial involved 3518 patients (50% women; mean age 59.6 years) with an untreated systolic/diastolic HBP of 135-179/85-119 mm Hg. In a 2 × 3 design, patients were randomized to usual control (125-134/80-84 mm Hg (UC)) vs. tight control (<125/<80 mm Hg (TC)) of HBP and to initiation of drug treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers or calcium channel blockers. ⋯ In all patients combined, the risk of the primary end point independently increased by 41% (6-89%; P=0.019) and 47% (15-87%; P=0.0020) for a 1-s.d. increase in baseline (12.5 mm Hg) and follow-up (13.2 mm Hg) systolic HBP. The 5-year risk was minimal (≤1%) if on-treatment systolic HBP was 131.6 mm Hg or less. HOMED-BP proved the feasibility of adjusting antihypertensive drug treatment based on HBP and suggests that a systolic HBP level of 130 mm Hg should be an achievable and safe target.
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Randomized Controlled Trial Comparative Study
Rationale, design and patient baseline characteristics of OlmeSartan and calcium antagonists randomized (OSCAR) study: a study comparing the incidence of cardiovascular events between high-dose angiotensin II receptor blocker (ARB) monotherapy and combination therapy of ARB with calcium channel blocker in Japanese elderly high-risk hypertensive patients (ClinicalTrials. gov no. NCT00134160).
Higher doses of angiotensin II receptor blockers (ARBs) are expected to exert more protective effects against cardiovascular diseases. However, the significance of treatment of hypertension with high-dose ARB remains to be defined. The OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study was designed to determine whether high-dose ARB monotherapy is superior to the combination therapy of ARB plus calcium channel blocker (CCB) in the prevention of cardiovascular morbidity/mortality in Japanese elderly high-risk hypertensive patients. ⋯ The primary end points will be the composite of fatal and non-fatal cardiovascular events, and death from any cause. Recruitment for the OSCAR study (around 1200 patients) was completed by the end of May 2007. The OSCAR study is the first large clinical trial comparing the efficacy of high-dose ARB monotherapy with that of an ARB plus CCB combination therapy in elderly high-risk hypertensive patients.