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- Title
Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud’s phenomenon: a double-blind, randomized, cross-over study.
- Authors
Lee, Eun Young; Park, Jin Kyun; Lee, Whal; Kim, Yeo Koon; Park, Claire Su-Yeon; Giles, Jon T.; Park, Jun Won; Shin, Kichul; Lee, Jeong Seok; Song, Yeong Wook; Lee, Eun Bong
- Abstract
Objective. RP is a reversible vasoconstriction of digital arteries that causes pain and skin discoloration. This study compared the efficacy of the new phosphodiesterase type 5 inhibitor udenafil with that of the calcium channel blocker amlodipine in the treatment of secondary RP.Methods. A total of 29 patients with secondary RP associated with connective tissue diseases were enrolled in this double-blind, randomized, cross-over study. The patients were randomized to receive udenafil 100 mg/day or amlodipine 10 mg/day for 4 weeks. After a washout period they were crossed over to the other drug for another 4 weeks. The primary outcome was RP frequency before and after treatment. The secondary outcomes were RP condition scores, RP duration, number of digital ulcers, HAQ, physician global assessment and digital artery flow before and after treatment.Results. Amlodipine and udenafil both decreased the rate of RP attack significantly. The drugs did not differ in terms of RP frequency or any of the secondary outcomes except for digital blood flow; udenafil improved it significantly better than amlodipine (P = 0.021). Udenafil was well tolerated without serious adverse effects.Conclusion. Udenafil and amlodipine have comparable efficacy in improving RP attacks. In addition, udenafil improves the blood flow in digital arteries compared with amlodipine.Trial registration. www.clinicaltrials.gov, protocol number NCT01280266.
- Subjects
KOREA; ACADEMIC medical centers; DOPPLER ultrasonography; AMLODIPINE; ANALYSIS of covariance; CHI-squared test; COMPARATIVE studies; CROSSOVER trials; FISHER exact test; MEDICAL thermography; HEALTH outcome assessment; QUESTIONNAIRES; RAYNAUD'S disease; SAFETY; STATISTICS; T-test (Statistics); DATA analysis; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; PHOSPHODIESTERASE inhibitors; DESCRIPTIVE statistics; PHARMACODYNAMICS
- Publication
Rheumatology, 2014, Vol 53, Issue 4, p658
- ISSN
1462-0324
- Publication type
Article
- DOI
10.1093/rheumatology/ket417