( Amlodipine, Valsartan, Amlodipine + Valsartan) (Taiwan HTN guideline) 3 90% 2-3 single pill combination ( ) Aliskiren Am

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1 三 合 一 降 血 壓 藥 的 療 效 和 安 全 秀 傳 紀 念 醫 院 藥 劑 藥 師 黃 美 嫆 秀 傳 紀 念 醫 院 醫 師 汪 忠 炫 摘 要 2-3 Sevikar HCT (olmesartan 20 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg fixed-dose combination) Sevikar HCT SPSS / / mmhg (53.9%) 44 (42.7%) ( ) 32 (31.1%) ( ) 26 (25.2%) 25 (24.3%) Sevikar HCT ( 16 vs 16 vs 17 mmhg P < 0.005) ( 8 vs 9 vs 9 mmhg P < 0.005) 3 (2.91%) 3 (2.91%) blood pressure anti-hypertension therapy fixed-dose combination therapy single pill combination triple therapy 壹 前 言 ( ) (2011) % 50 THE JOURNAL OF TAIWAN PHARMACY Vol.31 No.2 Jun

2 ( Amlodipine, Valsartan, Amlodipine + Valsartan) (Taiwan HTN guideline) 3 90% 2-3 single pill combination ( ) Aliskiren Amlodipine Hydrochlorothiazide (HCTZ) Olmesartan Amlodipine HCTZ 4,5 JNC European Society of Hypertension (ESH) guideline 2010 Taiwan HTN guideline 2011NICE guideline angiotensin receptor blocker (ARB) + calcium channel blocker (CCB) + Diuretics 6 ARB + CCB + Diuretics Single pill combination 29% 7 37% % 40% 30% % 37.7% 22.4% Sevikar HCT (FDA) Olmesartan Amlodipine HCTZ Sevikar HCT Sevikar HCT 貳 研 究 對 象 與 方 法 Sevikar HCT ( olmesartan medoxomil (OM)20 mg, amlodipine (AML)5 mg, hydrochlorothiazide (HTCZ) 12.5 mg fixeddose combination) mmhg Sevikar HCT Sevikar HCT Sevikar HCT SPSS 17 P < 0.05 藥 31 2 Jun 藥 雜 誌

3 參 結 果 54 (52.4%) 49 (47.6%) (33%) (31%) < (35.9%) 103 ( ) 48 (46.6%) 39 (37.8%) 2 55 (53.9%) 44 (42.7%) 36 (34.9%) 15 (14.5%) 103 Sevikar HCT mmhg mmhg ( mmhg) (24.3%) ( ) 26 (25.2%) ( ) 32 (31.1%) 2-3 ( ) % Sevikar HCT 4 47 / (166.8/92.8 mmhg 150.9/84.3 mmhg 15.9/8.4 mmhg P = 0.001/0.026) Sevikar HCT 8 73 ( mmhg P = 0.000) ( mmhg P = 0.001) mmhg mmhg ( 17.2 mmhg P = 0.000) 表 一 103 位 高 血 壓 病 人 基 本 資 料 年 齡 ( 歲 ) Age group no % < 65 y 37(35.9) 65 y 32(31) 75 y 34(33) 性 別 54(52.4) 49(47.6) 罹 患 慢 性 疾 病 數 16(15.5) 48(46.6) 39(37.8) 高 血 壓 合 併 慢 性 疾 病 的 種 類 2 55(53.9) 44(42.7) 36(34.9) 15(14.5) 改 Sevikar HCT 前 藥 治 療 種 類 8(7.8) 6(5.8) 25(24.3) ( ) + 32(31.1) ( ) 26(25.2) 6(5.8) 改 藥 前 基 本 血 壓 (mmhg) Calcium channel blocker(ccb) Angiotensin receptor blocker (ARB) Angiotensin Converting Enzyme Inhibitors (ACEI) Diuretic Beta-blockers (BBs) Co-Diovan (Valsartan 80 mg+ Hydrochlorothiazide 12.5 mg) Micardis (Telmisartan 40 mg+hydrochlorothiazide 12.5 mg) Sevikar (Olmesartan 20 mg+amlodipine besylate 5 mg) Amtrel (Benazepril HCl 10 mg+amlodipine besylate 5 mg) Exforge (Valsartan 80 mg+amlodipine besylate 5 mg) 90.8 mmhg 82.0 mmhg ( 8.8 mmhg P = 0.001) mmhg/8.8 mmhg ( ) Sevikar HCT 3 (2.91%) 3 (2.91%) 1 (0.97%) 1 52 THE JOURNAL OF TAIWAN PHARMACY Vol.31 No.2 Jun

4 (0.97%) 4 ( ) ( ) 表 二 病 人 改 用 單 錠 Sevikar HCT 治 療 後 血 壓 的 變 化 / (mmhg) 4 (n = 47) 8 (n = 73) Before After P value (n = 60) 表 三 藥 品 產 生 副 作 用 症 狀 no. (%) 3 (2.91%) 3 (2.91%) 1 (0.97%) 1 (0.97%) JNC SBP/DBP < 150 /90 mmhg 60 Sevikar HCT Sevikar HCT 160/90 mmhg Sevikar HCT /84.3 mmhg /82.3 mmhg /82.0 mmhg /8.1 mmhg Sevikar HCT JNC8 SBP/DBP < 150 /90 mmhg ( ) Sevikar HCT /89.6 mmhg /80.9 mmhg ( 11.8/8.7 mmhg P = 0.002/0.002) /89.6 mmhg /82.5 mmhg ( 13.4/7.1 mmhg P = 0.002/0.031) /92.1 mmhg /82.5 mmhg ( 14.9/9.6 mmhg P = 0.025/ 0.045) ( ) 表 四 60 歲 病 人 改 用 Sevikar HCT 治 療 後 血 壓 的 變 化 / (mmhg) 4 (n = 34) 8 (n = 55) Before After P value (n = 42) 表 五 分 析 合 併 不 同 疾 病 治 療 結 果 ( / ) / / /92.1 * P value < 0.05 (4,8,12 ) P value 157.1/85.2 ( 4 ) 8.3/ / /80.9 ( 8 ) 11.8/ */0.002* 152.4/83.9 ( 12 ) 12.4/ */ / / / / / */0.031* 141.7/ / */0.003* 148.3/ / */ 0.045* 145.2/ / */ 0.047* 143.9/ / */ 藥 31 2 Jun 藥 雜 誌

5 肆 討 論 2010 Single pill combination ( ) % 2003 WHO ( ) 2007 ESH guideline % 11 Sevikar HCT OM (ARB) 40 mg + AML (CCB) 10 mg + HTCZ (Thiazide) 25 mg (Single pill combination) mmhg 21.8 mmhg 69.9% 12 Sevikar HCT (OM)20 mg + (AML)5 mg + (HTCZ)12.5 mg /90.8 mmhg 147.7/82.0 mmhg (-17.2/-8.8 mmhg) TRINITY Study Sevikar HCT < 130/80 mmhg JNC8 18 SBP/DBP < 150 /90 mmhg 153/81 mmhg 29% 29% /90.8 mmhg 147.7/82.0 mmhg Sevikar HCT 40/10/25 mg 30 ml/min Sevikar HCT thiazides Sevikar HCT 伍 結 論 54 THE JOURNAL OF TAIWAN PHARMACY Vol.31 No.2 Jun

6 藥 Efficacy and Safety of Triple Therapy in Hypertension Mei-Jung Huang 1, Chung-Hsuan Wang 2 Department of Pharmacy 1, Department of Emergency Medicine 2 Show Chwan Memorial Hospital Abstract Hypertension is an increasingly prevalent cardiovascular risk factor associated with high rates of morbidity and mortality. Patients with hypertension may require a combination of 2 antihypertensive agents to achieve blood pressure (BP) control. Servikar HCT is a triple combination of olmesartan (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HTCZ) 12.5 mg, fixed-dose combination. The aim of this study was to determine a triple combination of Servikar HCT had a clinically significant efficacy and safety in patients with hypertension. We conducted a retrospective study data collected from July 2012 to February Totally 103 patients who hypertension which were treated with Sevikar HCT,SPSS 17.0 was used for statistical analysis. Results the 103 patients (52.4% male) had a mean (SD) age of years. At baseline, the mean seated systolic blood pressure (SeSBP)/ seated diastolic blood pressure (SeDBP) was / mmhg. Diabetes was present in 53.9% of the population, chronic cardiovascular disease 42.7%, and chronic kidney disease 14.5%. The 32 (31.1%) patients with (2 antihypertensive agents) single pill combination plus single agents, 26 (25.2%) with (2 antihypertensive agents) single- pill combination agents, 25 (24.3%) patient take three kinds of single agents. At week 4,8,12, triple combination treatment with significant decrease in SeSBP: -16 vs -16 vs -17 mmhg respectively [P < 0.005]; SeDBP: -8 vs -9 vs -9 mmhg [P < 0.005].The most common adverse events in the triple combination treatment group were peripheral edema (2.91%), gastrointestinal dysfunction (2.91%). In these adult patients with moderate hypertension, triple combination treatment with OM 20 mg + AML 5 mg + HCTZ 12.5 mg was associated with significant BP reductions. It is recommended when blood pressure were difficult to control, fixed-dose combination of antihypertensive drugs provide another option Jun 藥 雜 誌

7 參 考 資 料 : /4.1 ~ Guidelines of the Taiwan Society of Cardiology for the Management of Hypertension. J Formos Med Assoc 2010; : Judd E, Jaimes EA. Aliskiren, amlodipine and hydrochlorothiazide triple combination for hypertension. Expert Rev Cardiovasc Ther Mar;10(3): Weir MR, Hsueh WA, Nesbitt SD, et al: A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil hydrochlorothiazide. J Clin Hypertens (Greenwich). 2011; 13(6): CG127 Hypertension: NICE guideline Hypertension: Clinical management of primary hypertension in adults Issue date: August 2011 ( CG127) 7. AK Gupta, S Arshad, NR Poulter: Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension.2010 Feb; 55(2): Corrao G, Parodi A, Nicotra F, et al: Better compliance to antihypertensive medications reduces cardiovascular risk Journal of Hypertension 2011; 29: FDA Approves Tribenzor, A New Three-In-One Combination Product for the Treatment of High Blood Pressure. one-combination -product -bloodpressure-2225.html. 10. James PA, Oparil S, Carter BL, et al: 2014 Evidence- Based Guideline for the Management of High Blood Pressure in Adults Report From the Panel Members appointed to the Eighth Joint National Committee (JNC 8). JAMA Published online December 18, 2013 E1- E Calhoun DA, Lacourcière Y, Chiang YT et al: Triple Antihypertensive Therapy With Amlodipine, Valsartan, and Hydrochlorothiazide: A Randomized Clinical Trial. Hypertension 2009;54: Oparil S, Melino M, Lee J, et al: 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.Clinical Therapeutics. 2010; 32(7), THE JOURNAL OF TAIWAN PHARMACY Vol.31 No.2 Jun