The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure: COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study

Chrysant, Steven G.; Melino, Michael; Karki, Subhas S.; Lee, James; Heyrman, Reinilde

doi:10.1016/j.clinthera.2008.04.002

Cited by 250 publications

(270 citation statements)

References 31 publications

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“…Rates of vasodilatory events were lower for nifedipine GITS and candesartan combinations than for nifedipine GITS monotherapy in all baseline BP subgroups, and the incidence of these events was similar across the 4 subgroups. This finding is consistent with other studies of CCB/RAS blocker combination therapies, which show that RAS blockers predictably attenuate the vasodilatory side effects associated with CCBs through decreasing postcapillary resistance 20, 28, 35. As noted by other reviewers, CCB‐associated peripheral edema may be more common in clinical practice than is recorded in clinical trials, and these distressing effects are a common reason for lack of compliance with CCB therapy, especially among patients who require high doses to gain BP control 35, 36.…”

Section: Discussionsupporting

confidence: 92%

“…The nifedipine GITS formulation offers, in addition, the advantage of controlled drug release, making it suitable for once‐daily administration, and an observational study suggests that candesartan reduces the risk of cardiovascular disease and heart failure in comparison with another angiotensin receptor blocker (ARB), losartan 16, 18. A placebo arm was included in DISTINCT in accordance with the International Conference on Harmonisation guideline for evaluation of fixed‐dose combination products for the treatment of hypertension and similar to other multifactorial trials of combination antihypertensive therapies 20, 21, 22, 23. DISTINCT demonstrated that initial combination therapy with nifedipine GITS/candesartan cilexetil was more effective in lowering BP and meeting target BP goals (SBP <140 and DBP <90 mm Hg) vs respective monotherapies at the same doses in participants with hypertension.…”

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confidence: 99%

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Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses

Kjeldsen

Cha

Villa

et al. 2016

The Journal of Clinical Pharma

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DISTINCT was an 8‐week, double‐blind, randomized study to investigate the antihypertensive efficacy and safety of various nifedipine gastrointestinal treatment system (GITS)/candesartan cilexetil (N/C) dose combinations, vs respective monotherapies or placebo, in patients with diastolic blood pressure (DBP) ≥95 to <110 mm Hg. The current prespecified analysis compared BP reduction in participants with mild vs moderate baseline hypertension (ie, systolic [S]BP <160 mm Hg vs ≥160 mm Hg and DBP <100 mm Hg vs ≥100 mm Hg). A total of 1362 patients were analyzed by descriptive statistics. In all patient subgroups investigated, the NC combinations (ie, N: 20, 30, or 60 mg; C: 4, 8, 16, or 32 mg daily) provided greater SBP and DBP lowering and higher rates of BP control (defined as BP <140/90 mm Hg) than respective monotherapies or placebo, with greatest absolute BP reductions observed in the moderately elevated SBP or DBP subgroups. A trend to dose‐response relationship was observed in each subgroup. In each SBP and DBP subgroup, treatment‐related vasodilatory events (flushing, headache, or edema) were less frequent for patients receiving NC combination therapy than N monotherapy. These analyses support the use of calcium antagonist and angiotensin receptor blocker combination therapy in patients with both mild and moderate hypertension, for whom effective BP normalization and good drug tolerance would greatly reduce the risk of cardiovascular events.

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Section: Discussionsupporting

confidence: 92%

mentioning

confidence: 99%

Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses

Kjeldsen

Cha

Villa

et al. 2016

The Journal of Clinical Pharma

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“…In contrast, ARBs are the best-tolerated class of antihypertensive drugs and not only reduce BP without inducing a reflex increase in sympathetic nervous activity (and resulting tachycardia or palpitations) 35 but also, probably through inducing venous vasodilation, diminish the CCB-induced increase in hydrostatic pressure 36 and thereby reduce the frequency of edema. 8,37 This favorable safety profile of the CCB-ARB combination was clearly confirmed in our study where very few adverse events occurred even in subjects treated with the higher doses of both drugs. In particular, only one event of hypotension was reported as an adverse effect.…”

Section: Discussionsupporting

confidence: 79%

“…6 Single-pill combinations of CCBs and angiotensin II receptor blockers (ARBs) are now available and have been reported to be widely used, well tolerated and effective treatments for controlling BP. 7,8 One advantage of these combinations, as compared with a CCB and ACE-I, is that ARBs have been shown to be as effective as ACE-Is, but better tolerated. 9 An adequate level of BP control throughout the 24-h dosing period is important in the treatment of hypertensive patients, 10 because BP levels evaluated by ambulatory BP monitoring (ABPM) have consistently been shown to provide valuable information on cardiovascular risk, independently from clinic BP levels.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of olmesartan/amlodipine combination therapy in reducing ambulatory blood pressure in moderate-to-severe hypertensive patients not controlled by amlodipine alone

Bilo

Koch²,

Hoshide

et al. 2014

Hypertens Res

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This previously unpublished, preplanned analysis investigated the efficacy of the olmesartan/amlodipine combination at different doses on 24-h blood pressure (BP) control, as well as assessed trough estimation of trough-to-peak ratio (TPR) and smoothness index (SI). Ambulatory BP monitoring was performed in patients with moderate-to-severe hypertension whose BP was inadequately controlled after 8 weeks' treatment with amlodipine 5 mg. Patients were randomized to continue with amlodipine 5 mg or to receive olmesartan/amlodipine 10/5, 20/5 or 40/5 mg for 8 weeks (Period II). Patients not achieving BP control were uptitrated to a more powerful regimen for another 8 weeks (Period III). During Period II, each olmesartan/ amlodipine combination reduced 24-h systolic and diastolic BP (SBP/DBP), as well as morning and early morning SBP/DBP, significantly more than amlodipine 5 mg (Po0.001 for all). TPRs were higher in each olmesartan/amlodipine group than with amlodipine 5 mg, and SI values showed dose-related increases; olmesartan/amlodipine 40/5 mg produced a significantly higher SI for SBP and DBP (1.55 and 1.33, respectively) than amlodipine 5 mg (0.96 and 0.77, respectively, Po0.0001 for each). During Period III, uptitrated patients showed further BP reductions, which were largest in those on olmesartan/amlodipine 40/10 mg. SI values increased in uptitrated patients and were highest with olmesartan/amlodipine 40/10 mg (SBP 1.62/DBP 1.41). The olmesartan/amlodipine combination effectively reduces BP over 24 h, including the morning hours, in a dose-related manner. Compared with amlodipine alone, the olmesartan/amlodipine combination has a better 24-h coverage (TPR) and a dose-related improvement in BP lowering homogeneity (SI).

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“…A combination of the angiotensin receptor blocker olmesartan medoxomil with amlodipine has recently been shown to be effective and well tolerated in a range of patients, including those with moderate-to-severe hypertension. [15][16][17] One of the studies that established the efficacy of the olmesartan/amlodipine combination used a nonresponder design. Patients who failed to achieve an adequate level of BP control after 8 weeks' treatment with amlodipine (5 mg per day) were randomized to 8 weeks of treatment with one of three dose combinations of olmesartan (10,20 or 40 mg per day) plus amlodipine (5 mg per day), or to continue with amlodipine (5 mg) monotherapy.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of olmesartan medoxomil plus amlodipine in age, gender and hypertension severity defined subgroups of hypertensive patients

Schmieder

Böhm

2010

J Hum Hypertens

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Effective antihypertensive therapy is crucial for preventing cardiovascular events; however, blood pressure (BP) control rates remain poor. The objective of this analysis was to determine the efficacy of olmesartan/ amlodipine in age, severity and gender-based subgroups of patients with moderate-to-severe hypertension uncontrolled by amlodipine monotherapy. Patients with uncontrolled BP after 8 weeks' amlodipine 5 mg monotherapy (n ¼ 755) were randomized to continue amlodipine 5 mg or receive olmesartan (10-40 mg) plus amlodipine 5 mg for 8 weeks. Patients whose BP remained suboptimal were uptitrated to olmesartan/ amlodipine 20/5, 40/5 or 40/10 mg. Changes in BP and numbers of controlled patients were calculated separately to assess efficacy in patients aged o65 or X65 years, in those with moderate or severe hypertension, and in males and females. The antihypertensive effects of olmesartan/amlodipine were similar in patients aged o65 and X65 years of age. Compared with patients with moderate hypertension at baseline, those with severe hypertension tended to show higher decreases in BP, but achieved lower goal rates despite this. Females showed larger mean reductions in diastolic (1.61 mm Hg; P ¼ 0.003) and systolic BP (1.72 mm Hg; P ¼ 0.053) than males, independent of age and dose. This gender difference appeared to be higher and more consistent across dose groups for patients o50 years of age, but the difference in the pattern between both age groups was not statistically significant (P ¼ 0.1526). These results suggest that olmesartan/amlodipine is effective and safe in a wide range of patients, regardless of age or hypertension severity. Small differences in responsiveness between females and males may exist, which require further investigation.

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The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure: COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study

Cited by 250 publications

References 31 publications

Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses

Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses

Efficacy of olmesartan/amlodipine combination therapy in reducing ambulatory blood pressure in moderate-to-severe hypertensive patients not controlled by amlodipine alone

Efficacy and safety of olmesartan medoxomil plus amlodipine in age, gender and hypertension severity defined subgroups of hypertensive patients

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