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

Objective, To compare the efficacy and tolerability of losartan, an antagon ist 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 p rimary RP (n = 25) or RP secondary to systemic sclerosis (SSc [scleroderma] ; n = 27) were allocated to receive 12 weeks' treatment with either losarta n (50 mg/day) or nifedipine (40 mg/day), Primary outcome variables were the severity and frequency of RP episodes and findings on vascular measurement s, including thermography and laser Doppler flowmetry. Serum levels of solu ble adhesion molecules, endothelin I, fibrinogen, von Willebrand factor, an d procollagen type I N-terminal propeptide (PINP) were also measured. Results, There was a reduction in the severity of RP episodes following tre atment with losartan and with nifedipine, but this effect was greater in th e losartan arm of the study (P < 0.05): episode frequency was reduced only in the losartan group (P < 0.01 versus baseline). Symptomatic improvement w as associated with a significant reduction in soluble vascular cell adhesio n molecule 1 and PINP (P < 0.01), Subgroup analysis suggested that although these biochemical changes occurred mainly in SSc patients, the clinical be nefit 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 evalu ation of this drug as a long-term treatment for SSc-associated RP should be considered, since it may have additional disease-modifying potential.