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Article: A randomised, double-blind study of Cicaprost, an oral prostacyclin analogue, in the treatment of Raynaud's phenomenon secondary to systemic sclerosis

TitleA randomised, double-blind study of Cicaprost, an oral prostacyclin analogue, in the treatment of Raynaud's phenomenon secondary to systemic sclerosis
Authors
Issue Date1993
PublisherPacini Editore SpA. The Journal's web site is located at http://www.clinexprheumatol.org
Citation
Clinical And Experimental Rheumatology, 1993, v. 11 n. 1, p. 35-40 How to Cite?
AbstractCicaprost is a new synthetic prostacylin analogue which is metabolically stable and bioavailable after oral administration; in previous studies it has been shown to have vasodilator antiplatelet effects. In this pilot study, we investigated the clinical efficacy of and patient tolerance to two dosage levels of cicaprost (2.5 μg tds and 5 μg tds) in the treatment of Raynaud's phenomenon secondary to systemic sclerosis (SSc). This was a three centre, double-blind, placebo controlled study of 49 patients carried out over four winter months. For a period of 10 days, 16 patients were given a placebo, 16 received cicaprost 2.5 μg tds and 17 received cicaprost 5 μg tds. Response was assessed based on the total number and duration of Raynaud's attacks, the average severity of the attacks, the number of painful attacks as a proportion of all attacks, a digital ulcer count, and the patients' opinion of the treatment. Although the clinical and laboratory parameters of digital vasospasm did not show statistically significant improvement in those who received cicaprost compared with those on the placebo, the severity of attacks lessened in the patients who received cicaprost 5 μg tds, and a statistically significant difference was seen in the average severity at week 2 post-treatment (p=0.02). The apparent lack of overall significance was probably related to the short treatment period and relatively low doses of cicaprost used in this exploratory study. Longer studies with dose titration are probably needed to demonstrate the beneficial effects, if any, of cicaprost in patients with Raynaud's secondary to SSc, and these are being planned.
Persistent Identifierhttp://hdl.handle.net/10722/161994
ISSN
2015 Impact Factor: 2.495
2015 SCImago Journal Rankings: 0.953
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorLau, CSen_US
dc.contributor.authorBelch, JJFen_US
dc.contributor.authorMadhok, Ren_US
dc.contributor.authorCappell, Hen_US
dc.contributor.authorHerrick, Aen_US
dc.contributor.authorJayson, Men_US
dc.contributor.authorThompson, JMen_US
dc.date.accessioned2012-09-05T05:16:31Z-
dc.date.available2012-09-05T05:16:31Z-
dc.date.issued1993en_US
dc.identifier.citationClinical And Experimental Rheumatology, 1993, v. 11 n. 1, p. 35-40en_US
dc.identifier.issn0392-856Xen_US
dc.identifier.urihttp://hdl.handle.net/10722/161994-
dc.description.abstractCicaprost is a new synthetic prostacylin analogue which is metabolically stable and bioavailable after oral administration; in previous studies it has been shown to have vasodilator antiplatelet effects. In this pilot study, we investigated the clinical efficacy of and patient tolerance to two dosage levels of cicaprost (2.5 μg tds and 5 μg tds) in the treatment of Raynaud's phenomenon secondary to systemic sclerosis (SSc). This was a three centre, double-blind, placebo controlled study of 49 patients carried out over four winter months. For a period of 10 days, 16 patients were given a placebo, 16 received cicaprost 2.5 μg tds and 17 received cicaprost 5 μg tds. Response was assessed based on the total number and duration of Raynaud's attacks, the average severity of the attacks, the number of painful attacks as a proportion of all attacks, a digital ulcer count, and the patients' opinion of the treatment. Although the clinical and laboratory parameters of digital vasospasm did not show statistically significant improvement in those who received cicaprost compared with those on the placebo, the severity of attacks lessened in the patients who received cicaprost 5 μg tds, and a statistically significant difference was seen in the average severity at week 2 post-treatment (p=0.02). The apparent lack of overall significance was probably related to the short treatment period and relatively low doses of cicaprost used in this exploratory study. Longer studies with dose titration are probably needed to demonstrate the beneficial effects, if any, of cicaprost in patients with Raynaud's secondary to SSc, and these are being planned.en_US
dc.languageengen_US
dc.publisherPacini Editore SpA. The Journal's web site is located at http://www.clinexprheumatol.orgen_US
dc.relation.ispartofClinical and Experimental Rheumatologyen_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdulten_US
dc.subject.meshAntineoplastic Agents - Administration & Dosage - Adverse Effects - Therapeutic Useen_US
dc.subject.meshDose-Response Relationship, Drugen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshEpoprostenol - Administration & Dosage - Adverse Effects - Analogs & Derivatives - Therapeutic Useen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshPilot Projectsen_US
dc.subject.meshRaynaud Disease - Drug Therapy - Etiologyen_US
dc.subject.meshScleroderma, Systemic - Complicationsen_US
dc.subject.meshSeverity Of Illness Indexen_US
dc.subject.meshTime Factorsen_US
dc.titleA randomised, double-blind study of Cicaprost, an oral prostacyclin analogue, in the treatment of Raynaud's phenomenon secondary to systemic sclerosisen_US
dc.typeArticleen_US
dc.identifier.emailLau, CS:cslau@hku.hken_US
dc.identifier.authorityLau, CS=rp01348en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.pmid8453795-
dc.identifier.scopuseid_2-s2.0-0027415056en_US
dc.identifier.volume11en_US
dc.identifier.issue1en_US
dc.identifier.spage35en_US
dc.identifier.epage40en_US
dc.identifier.isiWOS:A1993KL92900006-
dc.publisher.placeItalyen_US
dc.identifier.scopusauthoridLau, CS=14035682100en_US
dc.identifier.scopusauthoridBelch, JJF=7101752870en_US
dc.identifier.scopusauthoridMadhok, R=7102565951en_US
dc.identifier.scopusauthoridCappell, H=7003312846en_US
dc.identifier.scopusauthoridHerrick, A=20534171800en_US
dc.identifier.scopusauthoridJayson, M=7101624049en_US
dc.identifier.scopusauthoridThompson, JM=7405817802en_US

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