Abstract
BackgroundIn this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension.MethodsA total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs.ResultsOM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P < 0.0001). The BP reductions were maintained throughout the 1-year observation period in all patients with different age groups and risk factors (diabetes mellitus, cardiovascular disease, and renal disease). The BP control rate (%) of < 140/90 mmHg was 65.9, 67.9, 68.9, and 70.6% at month 3, 6, 9, and 12, respectively. The mean MPR during the observation period was 0.96. The safety results were consistent with the previously reported safety profile of OM/AML/HCTZ.ConclusionsTreatment with the triple SPC of OM/AML/HCTZ demonstrated significant effectiveness in reducing SBP/DBP and achieving target BP control with high adherence over the 1-year observation period in Korean hypertensive patients and was well-tolerated.Trial registrationCRIS, KCT0002196, Registered 3 May 2016.
Highlights
In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension
The triple SPC of olmesartan, amlodipine and hydrochlorothiazide (OM/AML/HCTZ) consists of the combination recommended by current guidelines and has shown to improve patient medication adherence compared with an extemporaneous combination (55.1% vs. 15.9%, P < 0.0001, respectively) [7]
Since Real-world evidence (RWE) of the use of triple SPC in Korean patients is still limited, this study prospectively evaluated the effectiveness and safety of OM/AML/HCTZ in Koreans patients with essential hypertension in a real-world practice in conjunction with the retrospective cohort study (RESOLVE-PRO)
Summary
Multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. Multiple strategies have been developed to improve patient adherence and BP control It has been well-known that combining antihypertensive agents from different classes produces a synergistic effect in reducing BP, which is estimated approximately five times more effective than increasing the dose of a single agent [3, 4]. The triple SPC of olmesartan, amlodipine and hydrochlorothiazide (OM/AML/HCTZ) consists of the combination recommended by current guidelines and has shown to improve patient medication adherence compared with an extemporaneous combination (55.1% vs 15.9%, P < 0.0001, respectively) [7]
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