2012 6 3 2 1 4 13 15 ( Amlodipine, Valsartan, Amlodipine + Valsartan) 2 2010 (Taiwan HTN guideline) 3 90% 2-3 single pill combination ( ) Aliskiren Am

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) 2012 7 2013 2 103 Sevikar HCT 4 8 12 SPSS 17 103 65.4 13.3 / 164.1 20.1/90.6 16.3 mmhg 103 2 55 (53.9%) 44 (42.7%) ( ) 32 (31.1%) ( ) 26 (25.2%) 25 (24.3%) Sevikar HCT 4 8 12 ( 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 2012 1 ( ) (2011) 2007 20 27.7% 50 THE JOURNAL OF TAIWAN PHARMACY Vol.31 No.2 Jun. 30 2015

2012 6 3 2 1 4 13 15 ( Amlodipine, Valsartan, Amlodipine + Valsartan) 2 2010 (Taiwan HTN guideline) 3 90% 2-3 single pill combination ( ) Aliskiren Amlodipine Hydrochlorothiazide (HCTZ) Olmesartan Amlodipine HCTZ 4,5 JNC7 2007 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% 8 2010 30% 40% 30% 3 2010 39.9% 37.7% 22.4% Sevikar HCT 2010 7 (FDA) 9 2012 4 Olmesartan Amlodipine HCTZ Sevikar HCT 2012 7 Sevikar HCT 4 8 12 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) 2012 7 2013 2 130 mmhg Sevikar HCT Sevikar HCT Sevikar HCT 4 8 12 103 4 12 SPSS 17 P < 0.05 藥 31 2 Jun. 30 2015 藥 雜 誌 123 51

參 結 果 54 (52.4%) 49 (47.6%) 65.4 13.3 75 34 (33%) 65 32 (31%) < 65 37 (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 164.1 20.1 mmhg 90.6 16.3 mmhg (160-179 mmhg) 8 6 25 (24.3%) ( ) 26 (25.2%) ( ) 32 (31.1%) 2-3 ( ) 103 87 84.4% 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 (165.8 149.4 16.4 mmhg P = 0.000) (91.0 82.3 8.7 mmhg P = 0.001) 12 60 164.9 mmhg 147.7 mmhg ( 17.2 mmhg P = 0.000) 表 一 103 位 高 血 壓 病 人 基 本 資 料 年 齡 ( 歲 ) 65.4 13.3 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) 164.1 20.1 90.6 16.3 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) 12 17.2 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. 30 2015

(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 166.8 22.2 150.9 21.7 15.9 0.001 92.8 19.0 84.3 16.7 8.4 0.026 165.8 20.6 149.4 18.6 16.4 0.000 91.0 16.7 82.3 14.2 8.7 0.001 164.9 15.7 147.7 20.7 17.2 0.000 12 (n = 60) 90.8 13.6 82.0 14.6 8.8 0.001 表 三 藥 品 產 生 副 作 用 症 狀 no. (%) 3 (2.91%) 3 (2.91%) 1 (0.97%) 1 (0.97%) JNC8 10 60 SBP/DBP < 150 /90 mmhg 60 Sevikar HCT 103 60 74 Sevikar HCT 160/90 mmhg Sevikar HCT 4 34 150.9/84.3 mmhg 8 55 149.4/82.3 mmhg 12 42 147.7/82.0 mmhg 4 18.3/8.1 mmhg 74 60 Sevikar HCT JNC8 SBP/DBP < 150 /90 mmhg ( ) Sevikar HCT 55 2 164.8/89.6 mmhg 8 153.0/80.9 mmhg ( 11.8/8.7 mmhg P = 0.002/0.002) 43 160.8/89.6 mmhg 8 147.4/82.5 mmhg ( 13.4/7.1 mmhg P = 0.002/0.031) 36 163.2/92.1 mmhg 4 148.3/82.5 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 165.2 22.6 146.9 21.7 18.3 0.001 86.1 14.2 78.8 13.3 7.3 0.038 164.7 20.7 149.0 18.4 15.7 0.000 86.1 13.0 78.9 12.5 7.2 0.005 164.9 13.7 147.1 21.8 17.8 0.000 12 (n = 42) 86.4 10.5 78.3 12.3 8.1 0.002 表 五 分 析 合 併 不 同 疾 病 治 療 結 果 ( / ) 2 164.8/89.6 160.8/89.6 163.2/92.1 * P value < 0.05 (4,8,12 ) P value 157.1/85.2 ( 4 ) 8.3/4.4 0.087/0.290 153.0/80.9 ( 8 ) 11.8/8.7 0.002*/0.002* 152.4/83.9 ( 12 ) 12.4/5.7 0.003*/0.062 151.5/87.0 9.3/2.6 0.128/0.598 147.4/82.5 13.4/7.1 0.002*/0.031* 141.7/79.3 19.1 /10.3 0.000*/0.003* 148.3/82.5 14.9/9.6 0.025*/ 0.045* 145.2/83.2 18.0/8.9 0.003*/ 0.047* 143.9/ 86.3 19.3/5.8 0.012*/ 0.145 藥 31 2 Jun. 30 2015 藥 雜 誌 123 53

肆 討 論 2010 Single pill combination ( ) 2010 22.4% 2003 WHO ( ) 2007 ESH guideline 8 70.8% 11 Sevikar HCT OM (ARB) 40 mg + AML (CCB) 10 mg + HTCZ (Thiazide) 25 mg (Single pill combination) 12 37.1 mmhg 21.8 mmhg 69.9% 12 Sevikar HCT (OM)20 mg + (AML)5 mg + (HTCZ)12.5 mg 12 164.9 /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% 7 2-3 1 2-3 1 12 164.9 /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. 30 2015

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 2013. 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 65.4 13.3 years. At baseline, the mean seated systolic blood pressure (SeSBP)/ seated diastolic blood pressure (SeDBP) was 164.1 20.1/90.6 16.3 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. 31 2 Jun. 30 2015 藥 雜 誌 123 55

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