LONG-TERM KETANSERIN TREATMENT IN PATIENTS WITH SYSTEMIC-SCLEROSIS AND RAYNAUDS-PHENOMENON

Twenty-nine patients with systemic sclerosis (SS) (scleroderma) (27 women and two men), 24 with acrosclerosis and five with generalized skin sclerosis, were treated with ketanserin (60-120 mg/day) for periods varying from two to four years. The effect on Raynaud's phenomenon (RP) was evaluated by infrared thermography, Doppler ultrasound, nail-fold capillaroscopy, and healing of acral ulcers. The dynamics of skin and organ involvement before and after therapy were compared with a control (untreated) group of 29 patients with SS. In 21 of the ketanserin-treated patients a significant improvement in RP was noted. In eight patients there was marked improvement. The ketanserin effect was independent of the form and course of SS. No significant differences in changes in skin and other organ involvement, or in the disease course, between the treated and untreated group were seen. The therapeutic effect of ketanserin waned in seven patients within one-half to two years. In 12 patients side effects occurred (ie, fatigue, dizziness, weight gain, headache) that resolved completely (six patients) or partially (six patients) after the ketanserin dose was reduced from 120 mg/day to 60 mg/day. No adverse hepatic, hematologic, or renal effects were noted. We conclude that in patients with SS, long-term administration of ketanserin is effective in the treatment of RP and the healing of associated digital ulcers. Further invivo and in-vitro studies of this selective serotonin antagonist should contribute to an understanding of the role of serotonin in RP, and possibly in the fibroproductive processes and pathogenesis of the disease.