Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.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. 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. 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. CRIS, KCT0002196 , Registered 3 May 2016.
Abstract
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.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. 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. 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. CRIS, KCT0002196 , Registered 3 May 2016.
참고문헌 (18)
- Mills KT, "Global disparities of hypertension prevalence and control : a systematic analysis of population-based studies from 90 countries", Circulation, 134(6), pp.441~450 (2016)[DOI]
- Hae-Young Lee, "2018 Korean Society of Hypertension Guidelines for the management of hypertension: part II-diagnosis and treatment of hypertension", Clinical Hypertension, 25(4), pp.51~74 (2019), 대한고혈압학회[DOI]
- Wald DS, "Combination therapy versus monotherapy in reducing blood pressure : meta-analysis on 11, 000participants from 42 trials", Am J Med, 122(3), pp.290~300 (2009)[DOI]
- Neutel JM, "The role of combination therapy in the management of hypertension", Nephrol Dial Transplant, 21(6), pp.1469~1473 (2006)[DOI]
- Williams N, "2018ESC", ESH guidelines for the management of arterial hypertension : the task force for the management of arterial hypertension of the European Society of Cardiology(ESC)and the European Society of Hypertension(ESH), 2018, pp.39(33), 3021~3104
- Ishag Adam, "Red cell distribution width and preeclampsia: a systematic review and meta-analysis", Clinical Hypertension, 25(4), pp.16~23 (2019), 대한고혈압학회[DOI]
- Levi M, "Patient adherence to olmesartan", amlodipine combinations : fixed versus extemporaneous combinations, 2016, pp.22(3), 255~262
- Oparil S, "Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension : the TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study", Clin Ther, 32(7), pp.1252~1269 (2010)[DOI]
- Kereiakes DJ, "Long-term efficacy and safety of triple-combination therapy with olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide for hypertension", J Clin Hypertens(Greenwich), 14, pp.149~157 (2012)
- Bramlage P, "Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice", Vasc Health Risk Manag, 11, pp.1~8 (2014)
- Mohan JC, "Short term safety and tolerability of a fixed dose combination of olmesartan, amlodipine and hydrochlorothiazide", J Clin Diagn Res, 9(8), pp.OC10~OC13 (2015)[DOI]
- Park SJ, "Real-world effectiveness and safety of a single-pill combination of olmesartan", amlodipine, Adv Ther, pp.2020, 37(8)[DOI]
- Volpe M, "Is early and fast blood pressure control important in hypertension management?", Int J Cardiol, 254, pp.328~332 (2018)[DOI]
- Ishisaka DY, "Disparities in adherence to and persistence with antihypertensive regimens : an exploratory analysis from a community-based provider network", J Am Soc Hypertens, 6(3), pp.201~209 (2012)[DOI]
- Panjabi S, "Treatment adherence, clinical outcomes, and economics of triple-drug therapy in hypertensive patients", J Am Soc Hypertens, 7(1), pp.46~60 (2013)[DOI]
- Julius S, "VALUE trial group Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine : the VALUE randomised trial", Lancet, 363(9426), pp.2022~2031 (2004)[DOI]
- ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group, "Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)", JAMA, 288(23), pp.2981~2997 (2002)[DOI]
- Dahlof B, "Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm(ASCOT-BPLA) : a multicentre randomised controlled trial", Lancet, 366(9489), pp.895~906 (2005)[DOI]