Intravenous Iloprost Infusion in Patients with Raynaud Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Placebo-controlled, Double-Blind Study

Wigley, Fredrick M.; Wise, Robert A.; Seibold, James R.; McCloskey, Deborah A.; Kujala, Gregory A.; Medsger, Thomas A.; Steen, Virginia D.; Varga, John; Jimenez, Sergio A.; Mayes, Maureen D.; Clements, Philip J.; Weiner, Saul J.; Porter, John B.; Ellman, Michael H.; Wise, Christopher M.; Kaufman, Lee D.; Williams, John W; Dole, William P.

doi:10.7326/0003-4819-120-3-199402010-00004

Cited by 368 publications

(189 citation statements)

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“…The side eff ects of therapy are usually reversible with a reduction in dose. In a multicentre, placebo-controlled, double-blind study including 131 secondary RP patients with SSc, iloprosttreated patients experienced signifi cantly greater benefi t compared to placebo over a nine-week follow-up [65]. A systematic review and meta-analysis involving 332 patients in 7 RCTs showed benefi ts in patients with SSc-associated secondary RP, with evidence for decreasing the frequency and severity of RP attacks [71].…”

Section: Intravenous Prostanoidsmentioning

confidence: 99%

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

Linnemann

Erbe

2016

Vasa

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Summary:The primary goal of therapy is to reduce the frequency and intensity of Raynaud's attacks and to minimize the related morbidity rather than to cure the underlying condition. Treatment strategies depend on whether Raynaud's phenomenon (RP) is primary or secondary. All patients should be instructed about general measures to maintain body warmth and to avoid triggers of RP attacks. Pharmacologic intervention can be useful for patients with severe and frequent RP episodes that impair the patient's quality of life. Calcium channel blockers are currently the most prescribed and studied medications for this purpose. There has been limited evidence for the effi cacy of alpha-1-adrenergic receptor antagonists, angiotensin receptor blockers, topical nitrates or fl uoxetine to treat RP. The intravenously administered prostacyclin analogue iloprost can reduce the frequency and severity of RP attacks and is considered a second-line therapy in patients with markedly impaired quality of life, critical digital ischaemia and skin ulcers who are at risk for substantial tissue loss and amputation. Phosphodiesterase inhibitors (e.g., sildenafi l) can also improve RP symptoms and ulcer healing whereas endothelin-1 receptor antagonists (e.g., bosentan) are mainly considered treatment options in secondary prevention for patients with digital skin ulcers related to systemic sclerosis. However, their use in clinical practice has been limited by their high cost. Antiplatelet therapy with low-dose aspirin is recommended for all patients who suffer from secondary RP due to ischaemia caused by structural vessel damage. Anticoagulant therapy can be considered during the acute phase of digital ischaemia in patients with suspected vascular occlusive disease attributed to the occurrence of new thromboses. In patients with critical digital ischaemia, consideration should be given to hospitalisation, optimisation of medical treatment in accordance with the underlying disease and evaluation for a secondary, possibly reversible process that is causing or aggravating the clinical symptoms.

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Section: Intravenous Prostanoidsmentioning

confidence: 99%

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

Linnemann

Erbe

2016

Vasa

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“…It has been reported that iloprost improves RP as well as the healing of already existing DU, reduces the frequency, duration, and severity of RP attacks, and inhibits the formation of new ulcers, with a beneficial effect beyond 9 weeks 16,17,18 .…”

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confidence: 99%

Vasoactive Therapy in Systemic Sclerosis: Real-life Therapeutic Practice in More Than 3000 Patients

Moinzadeh¹,

Riemekasten²,

Siegert³

et al. 2015

J Rheumatol

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Objective.Vasculopathy is a key factor in the pathophysiology of systemic sclerosis (SSc) and the main cause for Raynaud phenomenon (RP), digital ulcers (DU), and/or pulmonary arterial hypertension (PAH). It is so far unknown how patients with SSc are treated with vasoactive agents in daily practice. To determine to which extent patients with SSc were treated with different vasoactive agents, we used data from the German Network for Systemic Scleroderma registry.Methods.The data of 3248 patients with SSc were analyzed.Results.Patients were treated with vasoactive drugs in 61.1% of cases (1984/3248). Of these, 47.6% received calcium channel inhibitors, followed by 34.2% treated with angiotensin-converting enzyme (ACE) inhibitors, 21.1% treated with intravenous (IV) prostanoids, 10.1% with pentoxifylline, 8.8% with angiotensin 1 receptor antagonists (AT1RA), 8.7% with endothelin 1 receptor antagonists (ET1RA), 4.1% with phosphodiesterase type 5 (PDE5) inhibitors, and 5.3% with others. Patients with RP received vasoactive therapy in 63.3% of cases, with DU in 70.1%, and with PAH in 78.2% of cases. Logistic regression analysis revealed that patients with PAH were significantly more often treated with PDE5 inhibitors and ET1RA, and those with DU with ET1RA and IV prostanoids. In addition, 41.8% of patients were treated with ACE inhibitors and/or AT1RA. Patients registered after 2009 received significantly more often ET1RA, AT1RA, and IV prostanoids compared with patients registered prior to 2005.Conclusion.These data clearly indicate that many patients with SSc do not yet receive sufficient vasoactive therapy. Further, in recent years, a marked change of treatment regimens can be observed.

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“…Compared with placebo, treatment with the intravenous form of the prostacyclin analog, iloprost, resulted in a 15% improvement in the RCS in patients with SSc (22). Although effective, treatment with intravenous iloprost resulted in headaches in 84% of patients and flushing in 50% of patients treated with the active medication (22).…”

Section: Discussionmentioning

confidence: 99%

MQX‐503, a novel formulation of nitroglycerin, improves the severity of Raynaud's phenomenon: A randomized, controlled trial

Chung¹,

Shapiro²,

Fiorentino³

et al. 2009

Arthritis & Rheumatism

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103

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Objective. Raynaud's phenomenon (RP) affects 3-9% of the general population and >90% of patients with systemic sclerosis. Nitrates are often prescribed for the treatment of RP, but currently available formulations are limited by side effects, particularly headaches, dizziness, and skin irritation. The purpose of this study was to evaluate the tolerability and efficacy of a novel formulation of topical nitroglycerin, MQX-503, in the treatment of RP in an ambulatory setting.Methods. We conducted a multicenter, randomized, placebo-controlled study with a 2-week single-blind run-in period to determine baseline severity, followed by a 4-week double-blind treatment phase. Two hundred nineteen adult patients with a clinical diagnosis of primary or secondary RP received 0.9% MQX-503 gel or matching placebo during the treatment period. Gel was applied immediately before or within 5 minutes of the beginning of an episode of RP (maximum of 4 applications daily). End points included the change in the mean Raynaud's Condition Score (RCS; scale 0-10), the frequency and duration of episodes, and subjective assessments at the target week (the week during the treatment phase that most closely matched the run-in period in terms of ambient temperature) compared with baseline.Results. The mean (%) change in the RCS at the target week compared with baseline was significantly ClinicalTrials.gov identifier: NCT00419419.

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Intravenous Iloprost Infusion in Patients with Raynaud Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Placebo-controlled, Double-Blind Study

Abstract: Iloprost is effective for the short-term palliation of severe Raynaud phenomenon in patients with systemic sclerosis.

Cited by 368 publications

References 0 publications

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

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

Vasoactive Therapy in Systemic Sclerosis: Real-life Therapeutic Practice in More Than 3000 Patients

MQX‐503, a novel formulation of nitroglycerin, improves the severity of Raynaud's phenomenon: A randomized, controlled trial

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