Calcium-channel blockers for Raynaud's phenomenon in systemic sclerosis

Thompson, Alexandra; Shea, Beverley; Welch, Vivian; Fenlon, Deborah; Pope, Janet

doi:10.1002/1529-0131(200108)44:8<1841::aid-art322>3.0.co;2-8

Cited by 252 publications

(115 citation statements)

References 26 publications

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“…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.…”

Section: Discussionmentioning

confidence: 99%

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)

Choi

Kim

et al. 2009

Clin Rheumatol

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This study examined the efficacy and safety of nifedipine sustained release (nifedipine SR) compared with Ginkgo biloba extract as treatment for primary Raynaud's phenomenon (RP) in Korea. Primary RP were screened and assigned to either the nifedipine SR group (Group N) or the Ginkgo biloba extract group (Group G) in the ratio of 2:1. After a run-in period of 2 weeks, patients received treatment for 8 weeks. We observed the percent improvement of the RP attack rate between before and after the 8-week treatment. Ninety-three subjects were randomly assigned. The percent improvement in Group N was 50.1% at 8 weeks after treatment, while it was 31.0% in Group G (p=0.03). No serious adverse events occurred, and almost adverse events were mild and improved without specific treatment. nifedipine SR was more effective than Ginkgo biloba extract for treatment of primary RP in Korean patients. Both drugs were tolerable with primary RP patients.

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Section: Discussionmentioning

confidence: 99%

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)

Choi

Kim

et al. 2009

Clin Rheumatol

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“…A recent meta-analysis identifi ed 6 RCTs including 244 patients and found a modest but signifi cant benefi t of PDE-5 inhibitors on the frequency and duration of RP attacks [53]. These agents reduced the frequency of RP episodes by approximately 3 -4 attacks per week, comparable to the reduction reported for CCBs [27,29]. So far, none of these agents has been approved for use in RP patients, and their defi nite role in the treatment of RP must be defi ned in the future.…”

Section: Other Oral Vasodilatorsmentioning

confidence: 94%

“…In a 2014 Cochrane review including data from 7 RCTs with 296 participants -4 studies assessing nifedipine and 3 using nicardipine versus placebo -treatment with oral CCBs was only minimally eff ective in patients with primary RP and was associated with an average of 1.7 (95 % CI 0.6 -2.8; p = 0.003) fewer attacks per week [28]. Two further systemic reviews evaluated the eff ectiveness of CCBs in patients with secondary RP and revealed clear improvement in both the frequency and severity of RP attacks [29,30].…”

Section: Calcium Channel Blockersmentioning

confidence: 99%

“…These favourable eff ects were confi rmed by an open-label trial that followed 10 SSc patients with secondary RP treated with atorvastatin 10 mg per day for 24 months [ ESM 2,27]. The benefi cial effects of the use of statins has been attributed to their pleiotropic eff ects, which include improvement in endothelial function, anti-oxidative eff ects, inhibition of vascular smooth muscle cell proliferation, eff ects of plaque stabilization, and anti-thrombotic and anti-infl ammatory properties [ESM 2,28,29]. However, evidence for the use of statins in SSc patients with recurrent digital ulcers is limited, and further studies are needed to defi ne their role in secondary RP.…”

Section: Additional Treatment Optionsmentioning

confidence: 99%

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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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“…These trials showed a reduction in the number and severity of RP episodes in patients treated with the active medications. However, these 2 studies, as well as other trials evaluating calciumchannel blockers, ␣-adrenergic inhibitors, and selective serotonin reuptake inhibitors, did not use the RCS, a now accepted and valid measure of severity of RP (5,11,(16)(17)(18)(19)(20). In addition, most previous studies used paper diaries rather than electronic diaries that prompted patients to input their daily RCS.…”

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

105

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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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Calcium-channel blockers for Raynaud's phenomenon in systemic sclerosis

Cited by 252 publications

References 26 publications

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)

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)

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

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

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