Open-Label Study Assessing the Long-term Efficacy and Safety of Triple Olmesartan/Amlodipine/Hydrochlorothiazide Combination Therapy for Hypertension

Volpe, Massimo; Sierra, Alejandro de la; Ammentorp, B.; Laeis, Petra

doi:10.1007/s12325-014-0117-9

Cited by 9 publications

(18 citation statements)

References 32 publications

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“…This extension, designed to reflect general clinical practice, showed that BP reductions were maintained over the long-term and associated with a high BP control rate (78.1%). 15 The present results add to these findings by demonstrating that adding HCTZ can increase BP-lowering in patients with inadequate BP control on a dual combination.…”

Section: Discussionsupporting

confidence: 71%

“…After completing the double‐blind study described by Volpe and colleagues, patients entered a long‐term open‐label extension in which they were treated, according to investigators' preferences, with the aim of maintaining BP control. This extension, designed to reflect general clinical practice, showed that BP reductions were maintained over the long‐term and associated with a high BP control rate (78.1%) . The present results add to these findings by demonstrating that adding HCTZ can increase BP‐lowering in patients with inadequate BP control on a dual combination.…”

Section: Discussionsupporting

confidence: 64%

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Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Rump

Ammentorp

Laeis

et al. 2015

J of Clinical Hypertension

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This randomized, parallel‐group study in patients inadequately controlled on olmesartan medoxomil/amlodipine (OLM/AML) 40/10 mg assessed the effects of adding hydrochlorothiazide (HCTZ) 12.5 mg and 25 mg, using seated blood pressure (SeBP) measurements and ambulatory blood pressure (BP) monitoring. Enrolled patients were screened and tapered off of therapy if required. All patients received OLM/AML 40/10 mg and those with mean seated BP (SeBP) ≥140/90 mm Hg after 8 weeks (n=808) were randomized (1:1:1) to continue with OLM/AML 40/10 mg or receive OLM/AML/HCTZ 40/10/12.5 or 40/10/25 mg for a further 8 weeks. The primary endpoint was the change in seated diastolic BP (SeDBP) from the start to the end of the randomized treatment period. The addition of HCTZ 25 mg significantly reduced SeDBP (−2.8 mm Hg; P<.0001), lowered seated systolic BP (SeSBP) and ambulatory DBP and SBP, and improved BP goal rates. In patients uncontrolled on OLM/AML 40/10 mg, adding HCTZ led to further BP reductions, particularly in ambulatory BP.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionsupporting

confidence: 64%

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Rump

Ammentorp

Laeis

et al. 2015

J of Clinical Hypertension

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“…The rate of ADRs in the present study was low, with the most frequent ADRs being peripheral edema, dizziness, and hypotension, which is consistent with the safety profile of the three-drug combination in clinical trials. 14 , 16 , 17 In the TRINITY clinical trial, in which all patients received 12 weeks’ treatment with the highest dose level of each drug (40/10/25 mg), dizziness and peripheral edema were the most common ADRs, followed by headache and fatigue. 14 Similarly, in the 4-week study of the FDC tablet, the most prevalent treatment-emergent adverse events were peripheral edema and dizziness.…”

Section: Discussionmentioning

confidence: 99%

“… 16 With regard to effectiveness, attainment of a BP goal of <140/90 mmHg was experienced by 67% of patients in the present study, 70% in the TRINITY clinical trial, 14 and 78% in a 36-week open-label extension study that assessed the three-drug separate-tablet combination of olmesartan, amlodipine, and HCT. 17 Of note, subanalyses of the TRINITY trial revealed that the rate of BP goal attainment was lower among patients with diabetes mellitus (41.1%) or chronic cardiovascular disease (38.9%). 15 Given that the proportion of patients with diabetes mellitus was approximately twofold higher in the present study, this may have contributed to the slightly lower rate of BP goal attainment.…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice

Bramlage

Fronk²,

Wolf³

et al. 2014

VHRM

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BackgroundClinical trials indicate that the use of fixed-dose combinations (FDCs) is associated with a higher level of treatment adherence and prolonged blood pressure (BP) control. The aim of this study was to document the safety and effectiveness of the FDC olmesartan/amlodipine/hydrochlorothiazide in patients with essential hypertension in clinical practice.MethodsThis multicenter, prospective, 24-week, noninterventional study enrolled 5,831 patients from primary care offices in Germany and Austria. Inclusion criteria were a diagnosis of essential hypertension and newly initiated treatment with the FDC.ResultsThe mean age of patients was 63.5 years, almost 50% of patients had a time since diagnosis of essential hypertension of over 5 years, and approximately 70% of patients had at least one cardiovascular risk factor, including 29.4% of patients with diabetes mellitus. Following approximately 24 weeks of treatment, the mean reduction in systolic/diastolic BP was 29.0/14.0 mmHg, a BP response was observed by 94.2% of patients, and a target BP of <140/90 mmHg was attained in 67.5% of patients. At least one adverse drug reaction (ADR) was experienced by 1.2% of patients, with the most common being peripheral edema. Subanalyses demonstrated that the following factors did not have a significant influence on the ADR rate: age (<65 years versus ≥65 years), diabetes mellitus (no/yes), cardiovascular risk (low/high), and concomitant medication (no/yes).ConclusionThis study demonstrates that in clinical practice, treatment with the three-drug combination as an FDC tablet resulted in a very high proportion of patients with a BP response and control, accompanied by a very low rate of ADRs.

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“…Of the 2,543 patients who completed the double-blind phase, 2,540 patients initially underwent 8 weeks of single-blind treatment with OLM/AML/HCTZ (20 mg/5 mg/12.5 mg), after which 2,509 were entered into an open-label treatment phase. Of these, 2,439 patients (97.2%) completed the study [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension

Silva

Haag²,

Guest

et al. 2015

Health Qual Life Outcomes

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BackgroundA post-hoc analysis was performed on the data from a 54 weeks phase III study (ClinicalTrials.gov identifier: NCT00923091) to measure changes in the health-related quality of life (HRQoL) of 2,690 patients aged ≥18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ), using the MINICHAL and EQ-5D instruments.MethodsDescriptive statistics were used to assess blood pressure and HRQoL scores over the study period. Analysis of covariance (ANCOVA) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores.ResultsPatients’ baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6. Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33%. Patients’ baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively, increasing by 6% and 12% over the study period. Patients’ QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs. The ANCOVA showed that changes in patients’ HRQoL was likely to have been influenced by patients’ achievement of blood pressure control, the amount of concomitant medication and patients’ last used dosage strength of antihypertensive. Linear regression showed that blood pressure improvement may have been associated with improved HRQoL.ConclusionsThis study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients’ HRQoL. Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients’ HRQoL.

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Open-Label Study Assessing the Long-term Efficacy and Safety of Triple Olmesartan/Amlodipine/Hydrochlorothiazide Combination Therapy for Hypertension

Abstract: In patients with Grade 2-3 hypertension, long-term treatment with OLM/AML/HCTZ triple combination therapy was well tolerated and effective. A high level of BP control and a substantial reduction in the level of hypertension severity were achieved.

Cited by 9 publications

References 32 publications

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Adding Hydrochlorothiazide to Olmesartan/Amlodipine Increases Efficacy in Patients With Inadequate Blood Pressure Control on Dual‐Combination Therapy

Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice

Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension

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