RESUMO
BACKGROUND: 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. METHODS: A 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. RESULTS: OM/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. CONCLUSIONS: Treatment 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 REGISTRATION: CRIS, KCT0002196 , Registered 3 May 2016.
RESUMO
BACKGROUND: The efficacy and safety of a single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) have been established previously through multiple studies. However, the real-world data in Korean patients are still limited. This study evaluated the effectiveness and safety of SPC of OLM/AML/HCTZ in a real practice setting in Korean patients with essential hypertension. METHODS: This was an observational, retrospective, multi-center, non-comparative cohort study. Medical records of 9749 patients with essential hypertension who had been prescribed OLM/AML/HCTZ within 1 year of the study were analyzed. The primary outcome was the achievement rate (%) of the target blood pressure goal of a systolic blood pressure (SBP) of < 140 mmHg and a diastolic blood pressure (DBP) of < 90 mmHg following administration of OLM/AML/HCTZ. The secondary outcomes included the rate of BP control measured at each visit, the amount of BP reduction compared to the index date, and the prescribing patterns of OLM/AML/HCTZ. Safety and tolerability were assessed by the incidence rate of adverse events (AEs) and discontinuation. RESULTS: In the effectiveness analysis set (n = 9604), the overall achievement rate of target BP was 82.56%. The mean SBP/DBP was significantly reduced compared to baseline at all visits (all p < 0.0001), with the greatest reduction occurring at week 2. The achievement rate of target BP was above 71%, regardless of the presence of risk factors (diabetes mellitus, DM; cardiovascular disease, CVD; chronic kidney disease, CKD). Patients with CVD and aged > 65 years showed a significantly higher achievement rate (p < 0.05). A significant relationship existed between the primary outcome and age (p < 0.0001). The achievement rate exceeded 74% in all different age groups. In the safety analysis set (n = 9661), AEs were reported in 8.46% of patients, with the most frequent AE being dizziness. Serious adverse events (SAEs) and unexpected adverse events (UAEs) occurred in 0.96% and 3.73% patients, respectively. This was consistent with the previously reported safety profile of OLM/AML/HCTZ. The majority of AEs were mild to moderate and resolved during the observation period. The discontinuation rate of OLM/AML/HCTZ due to AEs was 1.67%. CONCLUSION: This study demonstrated significant effectiveness of OLM/AML/HCTZ in achieving target BP in Korean patients with essential hypertension. OLM/AML/HCTZ was well tolerated.