title: Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan.
abstract: Prospective postmarketing surveillance of Selara (eplerenone), a selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan. The change in blood pressure after initiation of eplerenone treatment was also examined. Patients with essential hypertension who were eplerenone-naïve were recruited regardless of the use of other antihypertensive drugs. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. Patients received 50-100 mg of eplerenone once daily and were observed for 12 weeks. No treatments including antihypertensive drugs were restricted during the surveillance period. Across Japan, 3,166 patients were included for safety analysis. The incidence of adverse drug reactions was 2.4%. The major adverse drug reactions observed were hyperkalemia (0.6%), dizziness, renal impairment, and increased serum potassium (0.2% each). The mean systolic blood pressure decreased from 152.1 ± 19.0 mmHg to 134.8 ± 15.2 mmHg at week 12, and the mean diastolic blood pressure decreased from 85.8 ± 13.7 mmHg to 77.7 ± 11.4 mmHg. There were no significant new findings regarding the type or incidence of adverse reactions, and eplerenone had a clinically significant antihypertensive effect, leading to favorable blood pressure control.
authors.affiliation: Medical Affairs, Global Established Pharma Business, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Shoko
authors.identifier: 0000-0003-4050-8100
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: PMS Planning & Operation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Megumi
authors.identifier: 0000-0001-9229-3354
authors.initials: M
authors.lastname: Hiramatsu
authors.affiliation: Clinical Informatics and Innovation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Shinichi
authors.identifier: 0000-0001-5667-3990
authors.initials: S
authors.lastname: Hotta
authors.affiliation: Clinical Informatics and Innovation, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Yukie
authors.identifier: 0000-0002-8713-9456
authors.initials: Y
authors.lastname: Watanabe
authors.affiliation: Medical Writing and Document Management, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Suga
authors.affiliation: Clinical Statistics, Pfizer Japan Inc., Shinjuku Bunka Quint Building, 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
authors.forename: Yutaka
authors.identifier: 0000-0003-2006-7707
authors.initials: Y
authors.lastname: Endo
authors.affiliation: University of Fukui, 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui Prefecture 910-1193, Japan.
authors.forename: Isamu
authors.identifier: 0000-0002-9362-8395
authors.initials: I
authors.lastname: Miyamori