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A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in patients with vasospastic angina

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Author(s)
Eun-Seok ShinJae-Hwan LeeSang-Yong YooYongwhi ParkYoung Joon HongMoo Hyun KimJong-Young LeeChang-Wook NamSeung-Jea TahkJeong-Su KimYoung-Hoon JeongCheol Whan LeeHwa Kyoung ShinJune-Hong Kim
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Heart
Issued Date
2014
Volume
100
Issue
19
Abstract
Objectives We conducted a randomised, double blind,
placebo controlled trial to assess the efficacy and safety
of cilostazol, a selective inhibitor of phosphodiesterase 3,
in patients with vasospastic angina (VSA).
Background Cilostazol has been shown to induce
vascular dilatation, but its efficacy in patients with VSA
is unknown.
Methods Between October 2011 and July 2012, 50
patients with confirmed VSA who had ≥1 angina
episodes/week despite amlodipine therapy (5 mg/day)
were randomly assigned to receive either cilostazol (up
to 200 mg/day) or placebo for 4 weeks. All patients
were given diaries to record the frequency and severity of
chest pain (0–10 grading). The primary endpoint was
the relative reduction of the weekly incidence of chest
pain.
Results Baseline characteristics were similar between
the two groups. Among 49 evaluable patients (25 in the
cilostazol group, 24 in the placebo group), the primary
endpoint was significantly greater in the cilostazol group
compared with the placebo group (−66.5±88.6% vs
−17.6±140.1%, respectively, p=0.009). The secondary
endpoints, including a change in the frequency of chest
pain (−3.7±0.5 vs −1.9±0.6, respectively, p=0.029), a
change in the chest pain severity scale (−2.8±0.4 vs
−1.1±0.4, respectively, p=0.003), and the proportion of
chest pain-free patients (76.0% vs 33.3%, respectively,
p=0.003) also significantly favoured cilostazol. Headache
was the most common adverse event in both groups
(40.0% vs 20.8%, respectively, p=0.217).
Conclusions Cilostazol is an effective therapy for
patients with VSA uncontrolled by conventional
amlodipine therapy, and has no serious side effects.
Trial registration number NCT01444885.
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine
Citation
Eun-Seok Shin et al. (2014). A randomised, multicentre, double blind, placebo
controlled trial to evaluate the efficacy and safety
of cilostazol in patients with vasospastic angina. Heart, 100(19), 1531–1536. doi: 10.1136/heartjnl-2014-305986
Type
Article
ISSN
1355-6037
Source
http://heart.bmj.com/content/100/19/1531
DOI
10.1136/heartjnl-2014-305986
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35811
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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