Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis: a multicentre, placebo-controlled, dose-comparison study

Black, Carol M.; Halkier-Sørensen, L; Belch, J. J. F.; Ullman, S; Madhok, Rajan; Smit, Angelique; Banga, Jan Dirk; Watson, H.R.

doi:10.1093/rheumatology/37.9.952

Cited by 118 publications

(69 citation statements)

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“…However, reported placebo responses for clinical outcome variables in other RP studies is usually Ͻ20% from baseline (20), which is substantially less than the 49% reduction in severity and 50% reduction in frequency of RP episodes observed for losartan in the present study. That the clinical benefit of losartan was less evident in scleroderma patients is in keeping with the results from other studies which have suggested that treatment with vasodilators is less effective for secondary RP (8,21,22).…”

Section: Discussioncontrasting

confidence: 80%

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Losartan therapy for Raynaud's phenomenon and scleroderma: Clinical and biochemical findings in a fifteen-week, randomized, parallel-group, controlled trial

Dziadzio

Denton

Smith

et al. 1999

Arthritis & Rheumatism

277

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Objective. To compare the efficacy and tolerability of losartan, an antagonist of angiotensin II receptor type 1, with nifedipine for the treatment of primary and secondary Raynaud's phenomenon (RP) in a pilot study.Methods. In a randomized, parallel-group, controlled trial, patients with primary RP (n ‫؍‬ 25) or RP secondary to systemic sclerosis (SSc [scleroderma]; n ‫؍‬ 27) were allocated to receive 12 weeks' treatment with either losartan (50 mg/day) or nifedipine (40 mg/day). Primary outcome variables were the severity and frequency of RP episodes and findings on vascular measurements, including thermography and laser Doppler flowmetry. Serum levels of soluble adhesion molecules, endothelin 1, fibrinogen, von Willebrand factor, and procollagen type I N-terminal propeptide (PINP) were also measured.Results. There was a reduction in the severity of RP episodes following treatment with losartan and with nifedipine, but this effect was greater in the losartan arm of the study (P < 0.05): episode frequency was reduced only in the losartan group (P < 0.01 versus baseline). Symptomatic improvement was associated with a significant reduction in soluble vascular cell adhesion molecule 1 and PINP (P < 0.01). Subgroup analysis suggested that although these biochemical changes occurred mainly in SSc patients, the clinical benefit was greater in the primary RP group.Conclusion. This study confirms the tolerability of short-term treatment of RP with losartan, and our data suggest its clinical benefit. Further evaluation of this drug as a long-term treatment for SSc-associated RP should be considered, since it may have additional disease-modifying potential.Episodic digital ischemia provoked by cold and emotion was first described by Maurice Raynaud over 130 years ago (1). When it occurs in isolation, it is designated primary Raynaud's phenomenon (RP) to distinguish it from those cases in which there is an underlying or associated pathology. It affects ϳ10% of the adult population, with a predilection for females, and up to 5% of patients presenting with this condition later develop an autoimmune rheumatic disorder, such as systemic sclerosis (SSc; scleroderma) (2). Successful treatment is often difficult, and although clinical trials suggest that vasodilators can be effective, the responses of individual patients to a particular agent are often idiosyncratic.The pathogenesis of the vascular dysfunction underlying RP is incompletely understood, and relatively few well-controlled clinical trials with vasoactive drugs have been undertaken. Lack of distinction between primary and secondary RP in some of these studies makes their interpretation difficult. Calcium channel antagonists such as nifedipine have been shown to be effective (3-6), although striking differences in individual responses have been described (3,7). Moreover, efficacy is often particularly limited in patients with RP

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Section: Discussioncontrasting

confidence: 80%

“…Although subjective, self-reporting of RP symptoms appears to be a reliable assessment tool, particularly when combined with longitudinal analysis of the data (20). The results for serum markers provide additional indirect evidence that losartan could benefit the underlying pathologic processes in individuals with secondary RP.…”

Section: Discussionmentioning

confidence: 94%

Losartan therapy for Raynaud's phenomenon and scleroderma: Clinical and biochemical findings in a fifteen-week, randomized, parallel-group, controlled trial

Dziadzio

Denton

Smith

et al. 1999

Arthritis & Rheumatism

277

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“…A dose-dependent improvement of skin microcirculation and of transcutaneous oxygen tension is observed in the affected ischemic extremity [19, 20]. Iloprost is also the treatment of choice for digital necrosis associated with systemic sclerosis [21, 22, 23]. Our observation supports the hypothesis that Raynaud’s phenomenon and digital necrosis due to thromboangiitis obliterans can be cured by this drug.…”

Section: Discussionsupporting

confidence: 81%

Thromboangiitis obliterans:A Rare Cause of a ReversibleRaynaud’s Phenomenon

Noël

Krayenbühl²,

Cerottini³

et al. 2000

Dermatology

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A 25-year-old woman with progressive Raynaud’s phenomenon and digital necrosis is presented. Systemic sclerosis and other connective tissue disorders as well as atherosclerosis and arterial emboli were excluded with appropriate laboratory examinations. Arteriography revealed multiple palmar and digital occlusions with corkscrew-shaped vessels. Based on these characteristic arteriographic and clinical findings, the diagnosis of thromboangiitis obliterans was finally retained. With intravenous perfusion of the prostacyclin analogue iloprost (2 ng/kg/min, 6 h daily during 21 days), a complete healing of Raynaud’s phenomenon and of the digital necrosis was observed. There was no recurrence during the 1-year follow-up. This observation demonstrates that thromboangiitis obliterans is a potential reversible cause of severe Raynaud’s phenomenon in young women even in the absence of lower limb involvement. Early recognition is important to avoid irreversible complications such as loss of digits.

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“…Randomized controlled trials evaluating use of intravenous iloprost for PAH have not been conducted (Provencher and Sitbon, 2009). An oral iloprost preparation has been used in investigational studies of Raynaud's phenomenon secondary to systemic sclerosis (Black et al, 1998); its value in PAH is not known.…”

Section: Clinical Studies (Inhalation)mentioning

confidence: 99%

The Pharmacological Treatment of Pulmonary Arterial Hypertension

Frumkin

2012

Pharmacol Rev

106

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Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis: a multicentre, placebo-controlled, dose-comparison study

Abstract: The results on the daily duration of Raynaud's attacks suggest that both 50 and 100 microg oral iloprost twice daily may be effective in the treatment of Raynaud's phenomenon secondary to systemic sclerosis. The 50 microg iloprost dose was better tolerated in this patient group.

Cited by 118 publications

References 1 publication

Losartan therapy for Raynaud's phenomenon and scleroderma: Clinical and biochemical findings in a fifteen-week, randomized, parallel-group, controlled trial

Losartan therapy for Raynaud's phenomenon and scleroderma: Clinical and biochemical findings in a fifteen-week, randomized, parallel-group, controlled trial

Thromboangiitis obliterans:A Rare Cause of a ReversibleRaynaud’s Phenomenon

The Pharmacological Treatment of Pulmonary Arterial Hypertension

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