Comparison of intravenous infusions of iloprost and oral nifedipine in treatment of Raynaud's phenomenon in patients with systemic sclerosis: a double blind randomised study.

Abstract

Objective-To compare the long term effects of short term intravenous infusions of iloprost with those of oral nifedipine in patients with Raynaud's phenomenon associated with systemic sclerosis.Design-Double blind, placebo controlled, randomised group comparison.Setting-Dermatology outpatient clinic.Patients-Twenty three patients with Raynaud's phenomenon associated with well documented systemic sclerosis (American Rheumatism Association criteria) and with typical abnormalities in fingernail folds on capillaroscopy.Interventions-Twelve patients were randomised to receive intravenous infusions of iloprost starting at 0 5 ng/kg/min and increased by 0 5 ng/kg/min every 15 minutes to a maximum of 2-0 ng/kg/min for eight hours on three consecutive days with a further single infusion at week 8. Placebo capsules were given concurrently. Eleven patients were randomised to receive nifedipine, starting at 30 mg daily and increased to 60 mg daily after four weeks for another 12 weeks. Infusions of placebo were given in the same manner as the infusions of iloprost. One patient from each group withdrew because of social reasons and three patients receiving nifedipine withdrew because of side effects.End point-Reduction in number, duration, and severity of attacks of Raynaud's phenomenon, reduction in number of digital lesions, increase in digital blood flow.Measurements and main results-Measurements were taken at 0, 4, 8, 12, and 16 weeks. Both regimens produced a reduction in the number, duration, and severity of attacks of Raynaud's phenomenon. The mean (SE) number of digital lesions was reduced with iloprost (from 3-5 (1-6) to 0-6 (0-3)) and with nifedipine (from 4-3 (0.8) to 1-4 (0.5)) after 16 weeks. Hand temperature and digital and microcirculatory blood flow were increased with iloprost but not with nifedipine.Conclusion-Both iloprost and nifedipine are beneficial in the treatment of Raynaud's phenomenon. With nifedipine, however, side effects are common. Short term infusions of iloprost provide longlasting relief of symptoms, and side effects occur only during the infusions and are dose dependent.

To compare the efficacy and safety of nifedipine sustained release with Ginkgo biloba extract to treat patients with primary Raynaud’s phenomenon in South Korea; Korean Raynaud study (KOARA study)

“…Although some clinical trials on patients with primary or secondary RP using nifedipine have been performed intermittently [16][17][18][19], this study was the first clinical trial using South Korean patients with primary RP as its subjects.…”

Trial of a novel prostacyclin analog, UT-15, in patients with severe intermittent claudication

“…19,20 In placebo-controlled studies, both prostacyclin and iloprost were effective in reducing pain and promoting ulcer healing in patients with Raynaud's phenomena. [21][22][23][24][25] Other studies demonstrated the effectiveness of prostanoids in the treatment of patients with ulcers due to thromboangiitis obliterans (Buerger's disease). 26 In a crossover design, bioavailability study in 15 healthy volunteers, the mean half-life of UT-15 administered intravenously was 0.9 h and subcutaneously was 1.4 h (unpublished data, M Wade, United Therapeutics).…”

Raynaud’s phenomenon and digital ischaemia - pharmacologic approach and alternative treatment options

“…In a study comparing the eff ects of nifedipine and the prostacyclin analogue iloprost in SSc-related secondary RP, hand temperature and digital and microcirculatory blood fl ow were increased with iloprost but not with nifedipine [64]. In the case of an acute ischaemic crisis, a rapid reversal of symptoms can usually be achieved with the administration of iloprost.…”