Efficacy and Safety of Olmesartan Medoxomil 40 mg/Hydrochlorothiazide 12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Moderate to Severe Hypertension

Fogari, Roberto; Taddei, Stefano; Holm-Bentzen, M.; Baszak, Jacek; Melani, Lorenzo; Schumacher, Kai

doi:10.2165/11536710-000000000-00000

Cited by 15 publications

(13 citation statements)

References 26 publications

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“…Fogari et al reported 3.9% of patients in an olmesartan/HCTZ 40/12.5 mg/day group had drug related adverse events compared to 0.7% in the olmesartan 40 mg/day monotherapy treatment arm. About 2.3% patients and 1.4% patients discontinued from the study due to adverse events in the combination group and monotherapy group, respectively (114). …”

Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The 8 available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure (BP) lowering effects have been demonstrated when ARBs are combined with thiazide diuretics or dihydropyridine calcium channel blockers, augmenting hypertension control. Furthermore, therapeutic use of ARBs goes beyond their antihypertensive effects with evidence-based benefits in heart failure and diabetic renal disease particularly among ACE inhibitor intolerant patients. On the other hand, combining renin-angiotensin system blocking agents, a formerly common practice among medical subspecialists focusing on the management of hypertension, have ceased to do so as there is not only evidence of cardiovascular benefit, but modest evidence of harm, particularly with regard to renal dysfunction. The ARBs are very well tolerated as monotherapy as well as in combination with other anti-hypertensive medications that improve adherence to therapy and have become a mainstay in the treatment of stage 1 and 2 hypertension.

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Section: Safety and Tolerability Of Arbs In Hypertensionmentioning

confidence: 99%

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

2014

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“…Characteristics of the studies included in the metaanalysis are outlined in Table 1 and data about baseline systolic and diastolic blood pressure is presented in Table 2. All 15 studies [20][21][22][23][24][25][26][27][28][29][32][33][34][35][36] are randomized and all but 3 [23,27,36] are double blinded. There are 10 studies comparing ARB/HCTZ with HCTZ [20-22, 24-29, 32], one study comparing ARB/CTLD with CTLD [33] and 4 studies comparing ARB/CTLD with ARB/HCTZ [23,34,36].…”

Section: Resultsmentioning

confidence: 99%

“…There are 10 studies comparing ARB/HCTZ with HCTZ [20-22, 24-29, 32], one study comparing ARB/CTLD with CTLD [33] and 4 studies comparing ARB/CTLD with ARB/HCTZ [23,34,36]. In 4 studies, the ARB used is olmesartan [20,[34][35][36], in 3 [21,26,27] it is valsartan, in 3 [22,23,27] it is candesartan, and in 3 it is telmisartan [24,25,27]. There is one study discussing each of the following: fimasartan [28], eprosartan [29], and losartan [32].…”

Section: Resultsmentioning

confidence: 99%

“…Combination therapy with a renin-angiotensin system (RAS) inhibitor (either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker [ARB]) plus a diuretic is a widely used and effective approach that has become an established component of evidence-based hypertension treatment guidelines [16][17][18]. The combination of an ARB with a thiazide diuretic has been shown to be efficacious and well tolerated in numerous clinical trials [19][20][21][22][23][24][25][26][27][28][29]. This combination could be of particular value in hypertensive patients with additional cardiovascular risk factors or in populations whose BP is traditionally poorly controlled, such as elderly persons, persons with diabetes mellitus and black patients [19,30].…”

Section: Introductionmentioning

confidence: 99%

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Combining angiotensin receptor blockers with chlorthalidone or hydrochlorothiazide – which is the better alternative? A meta-analysis

et al. 2020

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Background: Hypertension is a disease with significant clinical and socioeconomic consequences. The reduction in cardiovascular mortality and morbidity in patients treated for hypertension is directly related to the magnitude of blood pressure reduction. Diuretics have proven useful for the prevention of cardiovascular complications in addition to a long history of safety and efficacy. The main aim for this meta-analysis is to compare the efficacy of the combination of angiotensin receptor blocker (ARB) and chlorthalidone (CTLD) to the combination of ARB and hydrochlorothiazide (HCTZ) in patients with hypertension. Methods: A comprehensive literature search was conducted through electronic databases PubMed, MEDLINE, Scopus, PsyInfo, Cochrane, eLIBRARY.ru, http://ClinicalTrials.gov and http://www.clinicaltrialsregister.eu in July 2020 to identify studies that investigate the effect of the combination of angiotensin receptor blocker with chlorthalidone or hydrochlorothiazide on the systolic and diastolic blood pressure in patients with hypertension. Changes in systolic and diastolic blood pressure (BP) expressed as a weighted mean difference (WMD) were our primary outcomes. The random-effects method was chosen as the primary analysis and results were presented with a 95% confidence interval (CI). Sensitivity analysis was performed and bias was assessed. Results: Our search returned 2745 titles. Of them, 51 full-text articles remained to be subjected to assessment. Comparisons of ARB/HCTZ versus ARB showed changes in BP of −6.89 (−8.09, −5.69) mmHg for systolic BP and − 3.67 (−4.15, −3.19) mmHg for diastolic BP. For the ARB/CTLD versus ARB/HCTZ comparison changes were − 6.30 (−7.30, −5.29) mmHg for systolic BP and − 3.57 (−4.17, 2.98) mmHg for diastolic BP. Conclusion: Our analysis suggests a small but significant favor for CTLD in blood pressure control when compared to HCTZ. We believe it should be considered as a valuable alternative for HCTZ and an option for fixed dose combinations with an ARB although further research is required.

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“…Fogari et al reported 58.5% BP target achievement after 8 weeks of a combination of olmesartan 40 mg and HCTZ 12.5 compared with olmesartan 40 mg monotherapy 23. Another study investigating the combination of olmesartan 40 mg and HCTZ using HCTZ doses up to 50 mg/day found a 70.4% BP target achievement with HCTZ 25 mg after 8 weeks, increasing to 77.5% with HCTZ 50 mg after a further 4 weeks 24.…”

Section: Discussionmentioning

confidence: 99%

Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice

Bramlage

Zemmrich²,

Ketelhut³

et al. 2013

VHRM

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BackgroundThe safety and efficacy of olmesartan 40 mg and hydrochlorothiazide (HCTZ) as a fixed-dose combination has been investigated in clinical trials leading to its approval. The aims of the present study were to confirm these data in an unselected patient population in daily practice and to determine the impact of physical activity on blood pressure control.MethodsIn a multicenter, noninterventional study, 3,333 patients with either insufficient blood pressure control on olmesartan 40 mg alone or on a fixed/free combination of olmesartan 40 mg and HCTZ 12.5/25 mg were primarily assessed for safety and tolerability of the fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg at 24 ± 2 weeks. Secondary objectives were blood pressure reduction, treatment compliance, and impact of physical activity as measured by the sum of weekly energy costs.ResultsThe mean patient age was 63.2 ± 11.46 years, mean baseline blood pressure was 159.6 ± 15.28/93.5 ± 9.52 mmHg, and 70.9% had at least one additional cardiovascular risk factor. Adverse drug reactions were rare (n = 19), and no serious adverse drug reactions occurred. Compliance with drug therapy was at least sufficient in more than 99% of patients at the end of the study. Blood pressure at the last available visit was reduced by 26.1 ± 15.5/13.0 ± 10.1 mmHg versus baseline (P < 0.0001), but had reduced effectiveness in patients ≥75 years with diabetes or impaired renal function. In 69% of patients, blood pressure was normalized (<140/90 mmHg). No noteworthy differences in baseline characteristics or baseline blood pressure were found between patients with an activity level (sum of weekly energy costs) above or below the median of 9,460.6. A higher versus lower physical activity score had no impact on blood pressure reduction.ConclusionOur data confirm randomized trial data concerning safe and efficient blood pressure reduction using a fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg in a large, unselected patient population, independent of physical activity level.

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Efficacy and Safety of Olmesartan Medoxomil 40 mg/Hydrochlorothiazide 12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Moderate to Severe Hypertension

Abstract: NCT00441350 (ClinicalTrials.gov Identifier)].

Cited by 15 publications

References 26 publications

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

The Comparative Efficacy and Safety of the Angiotensin Receptor Blockers in the Management of Hypertension and Other Cardiovascular Diseases

Combining angiotensin receptor blockers with chlorthalidone or hydrochlorothiazide – which is the better alternative? A meta-analysis

Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice

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