In:
Cerebrovascular Diseases, S. Karger AG, Vol. 51, No. 4 ( 2022), p. 493-498
Abstract:
〈 b 〉 〈 i 〉 Purpose: 〈 /i 〉 〈 /b 〉 The aim of this study is to investigate the effect of gradual dipyridamole titration and the incidence of dipyridamole-induced headache in patients with ischemic stroke or transient ischemic attack (TIA). 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 A randomized, double-blind, double-placebo, parallel group, phase 4 clinical trial (KCT0005457) was conducted between July 1, 2019, and February 25, 2020, at 15 medical centers in South Korea. The study included patients aged & #x3e;19 years diagnosed with a noncardioembolic ischemic stroke or TIA within the previous 3 weeks. The participants were randomized 1:1:1 to receive Adinox® (aspirin 25 mg/dipyridamole 200 mg) and aspirin (100 mg) once daily for the first 2 weeks followed by Adinox® twice daily for 2 weeks (titration group), Adinox® twice daily for 4 weeks (standard group), and aspirin 100 mg once daily for 4 weeks (control group). The primary endpoint was incidence of headache over 4 weeks. The key secondary endpoint was mean cumulative headache. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Ninety-six patients were randomized into the titration ( 〈 i 〉 n 〈 /i 〉 = 31), standard ( 〈 i 〉 n 〈 /i 〉 = 32), and control ( 〈 i 〉 n 〈 /i 〉 = 33) groups. The titration and standard groups (74.1% vs. 74.2%, respectively) showed no difference in the primary endpoint. However, the mean cumulated headache was significantly lower in the titration group than in the standard group (0.31 ± 0.46 vs. 0.58 ± 0.51, 〈 i 〉 p 〈 /i 〉 = 0.023). Further, adverse drug reactions were more common in the standard group than in the titration group (28.1% vs. 9.7%, respectively, 〈 i 〉 p 〈 /i 〉 = 0.054), although not significantly different. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 The titration strategy was effective in lowering the incidence of cumulative dipyridamole-induced headache.
Type of Medium:
Online Resource
ISSN:
1015-9770
,
1421-9786
Language:
English
Publisher:
S. Karger AG
Publication Date:
2022
detail.hit.zdb_id:
1482069-9
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