Woo-Baek Chung1, Sang-Hyun Ihm2, Sung-Won Jang3, Sung-Ho Her4, Chul Soo Park5, Jong-Min Lee6, Kiyuk Chang1, Doo-Soo Jeon7, Ki-Dong Yoo8, Ki-Bae Seung1. 1. Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 2. Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 3. Division of Cardiology, Department of Internal Medicine, St. Paul's Hospital. 4. Daejeon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 5. Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 6. Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 7. Division of Cardiology, Department of Internal Medicine, In-Cheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 8. Division of Cardiology, Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Abstract
PURPOSE: Head-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP. PATIENTS AND METHODS: Of the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks. RESULTS: Patients' mean age was 58.34±7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were -16.26±15.07 and -12.81±13.87 (p=0.0298) and SiDBP were -7.63±9.67 and -5.14±8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were -15.22±13.33 and -9.45±12.37 (p=0.0009), and ADBPs were -8.74±7.55 and -5.98±7.85 (p=0.0140). Reductions of night-time ASBPs were -16.80±15.81 and -10.32±14.88 (p=0.0012), and those of night-time ADBPs were -8.89±9.93 and -5.55±9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points. CONCLUSION: Fimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern. NCT NUMBER: NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).
PURPOSE: Head-to-head comparison of the blood pressure (BP) lowering effect of fimasartan versus valsartan, with olmesartan as a reference, on office blood pressure and ambulatory BP. PATIENTS AND METHODS: Of the 369 randomly assigned patients in this study, 365 hypertensive patients were referred as the full analysis set and divided into 3 groups with a 3:3:1 ratio (fimasartan group: 155, valsartan group: 157, olmesartan group: 53). After the 2-week single-blind placebo run-in period, initial standard doses of 60-mg fimasartan, 80-mg valsartan, and 10-mg olmesartan were administered for 2 weeks, then forcibly up-titrated higher doses (fimasartan 120 mg, valsartan 160 mg, olmesartan 20 mg) were given for 4 weeks. ABP was measured before and after the 6-week treatment. Primary endpoint was reduction of sitting office systolic BP (SiSBP) of fimasartan compared to valsartan after 6 weeks. Secondary endpoints were reduction of sitting office diastolic BP (SiDBP) and 24 hrs, day-time, and night-time mean systolic and diastolic ABP (ASBP, ADBP) after 6 weeks. RESULTS: Patients' mean age was 58.34±7.68 years, and 289 patients were male (79.18%). After the 6-week treatment, SiSBP reduction of fimasartan and valsartan were -16.26±15.07 and -12.81±13.87 (p=0.0298) and SiDBP were -7.63±9.67 and -5.14±8.52 (p=0.0211). Reductions in 24 hrs mean ASBP were -15.22±13.33 and -9.45±12.37 (p=0.0009), and ADBPs were -8.74±7.55 and -5.98±7.85 (p=0.0140). Reductions of night-time ASBPs were -16.80±15.81 and -10.32±14.88 (p=0.0012), and those of night-time ADBPs were -8.89±9.93 and -5.55±9.70 (p=0.0152). Reduction of BP in olmesartan group did not demonstrate significant difference with fimasartan group in all end-points. CONCLUSION: Fimasartan 120-mg treatment demonstrated superior efficacy in reduction of SiSBP, SiDBP, and 24 hrs ASBP and ADBP compared to valsartan 160 mg. Reduction of night-time ASBP from baseline was largest in fimasartan group, suggesting that fimasartan may be effective for recovering dipping pattern. NCT NUMBER: NCT02495324 (Fimasartan Achieving SBP Target (FAST) study).
Authors: Paul K Whelton; Robert M Carey; Wilbert S Aronow; Donald E Casey; Karen J Collins; Cheryl Dennison Himmelfarb; Sondra M DePalma; Samuel Gidding; Kenneth A Jamerson; Daniel W Jones; Eric J MacLaughlin; Paul Muntner; Bruce Ovbiagele; Sidney C Smith; Crystal C Spencer; Randall S Stafford; Sandra J Taler; Randal J Thomas; Kim A Williams; Jeff D Williamson; Jackson T Wright Journal: Hypertension Date: 2017-11-13 Impact factor: 10.190
Authors: T Hedner; S Oparil; K Rasmussen; A Rapelli; M Gatlin; P Kobi; J Sullivan; P Oddou-Stock Journal: Am J Hypertens Date: 1999-04 Impact factor: 2.689
Authors: Bryan Williams; Giuseppe Mancia; Wilko Spiering; Enrico Agabiti Rosei; Michel Azizi; Michel Burnier; Denis Clement; Antonio Coca; Giovanni De Simone; Anna Dominiczak; Thomas Kahan; Felix Mahfoud; Josep Redon; Luis Ruilope; Alberto Zanchetti; Mary Kerins; Sverre Kjeldsen; Reinhold Kreutz; Stephane Laurent; Gregory Y H Lip; Richard McManus; Krzysztof Narkiewicz; Frank Ruschitzka; Roland Schmieder; Evgeny Shlyakhto; Konstantinos Tsioufis; Victor Aboyans; Ileana Desormais Journal: J Hypertens Date: 2018-12 Impact factor: 4.844