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Ketanserin for Raynaud's phenomenon in progressive systemic sclerosis
1Medicine (Division of Rheumatology), University of Western Ontario, LHSC-South Campus, 375 South Street Room 309;Colborne Bldg., London, Ontario, Canada, N6A 4G5. jpope@julian.uwo.ca
The Cochrane Database of Systematic Reviews
|May 5, 2000
Summary
Ketanserin showed some benefit for Raynaud's phenomenon (RP) in scleroderma patients, improving outcomes in more individuals. However, it did not significantly reduce attack severity and led to more side effects compared to placebo.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Trials
Background:
- Scleroderma is an autoimmune disease that can cause Raynaud's phenomenon (RP), a condition characterized by vasospasm in the extremities.
- Ketanserin, a serotonin antagonist, has been investigated for its potential to treat RP.
Purpose of the Study:
- To evaluate the efficacy and safety of ketanserin compared to placebo for treating Raynaud's phenomenon in patients with scleroderma.
Main Methods:
- A systematic review and meta-analysis of randomized controlled trials (RCTs) comparing ketanserin with placebo.
- Searched major databases (Cochrane, Medline) for relevant trials up to April 1997.
- Included trials with clinical outcomes and excluded those with >35% dropout rates; analyzed dichotomous and continuous outcomes using odds ratios and weighted mean differences.
Main Results:
- Three trials involving 66 patients were analyzed.
- A significantly higher proportion of patients improved with ketanserin (OR 4.80).
- Ketanserin use was associated with significantly more side effects (OR 5.96), though attack duration decreased.
Conclusions:
- Ketanserin may offer some benefit in treating Raynaud's phenomenon secondary to scleroderma, evidenced by improved patient outcomes.
- Despite some improvements, ketanserin did not significantly reduce RP attack severity and was linked to increased adverse events.
- The overall clinical benefit of ketanserin for Raynaud's phenomenon in scleroderma is questionable due to the increased side effect profile.