COMPARATIVE-STUDY OF MISOPROSTOL AND NIFE DIPINE FOR THE TREATMENT OFRAYNAUD PHENOMENON SECONDARY TO SYSTEMIC-DISEASES - DOPPLER-DUPLEX HEMODYNAMIC EVALUATION

Objective. To evaluate the mid-term efficiency and therapeutic safety at a mid term of the orally administered misoprostol, a synthetic PGE( 1), analogue, compared with nifedipine for the treatment of RP seconda ry to autoimmune systemic diseases. Methods. A double blind, crossover study was designed. Patients were randomly distributed to receive eit her retard nifedipine (20 mg/12 hourly) and misoprostol (200 mu g/12 h ourly) in 10-day periods (washing period with placebo for 10 days). At the end of each period a clinical assessment was obtained on the freq uency and severity of symptoms as well as on secondary drug reactions. Simultaneously, blood flow changes in radial artery were Doppler-dupl ex investigated (pulsatility index, resistance index). Results. Twenty patients were studied (15 women and 5 men). The mean basal daily freq uency of attacks was 4.8 +/- 2.0 compared with 2.4 +/- 1.4 with nifedi pine (p < 0.001) and 2.6 +/- 1.2 with misoprostol (p < 0.001). The mea n basal severity of attacks, according to a pre-established scale decr eased from 3.7 +/- 0.6 to 1.9 +/- 0.9 with nifedipine (p < 0.001) and to 2.0 +/- 1.0 with misoprostol (p < 0.001). The mean basal value of b lood flow in radial artery was 24.9 +/- 14.4 ml/min; with nifedipine i t increased to 43.0 +/- 19.2 ml/min (p < 0.001) and with misoprostol t o 46.9 + 19.2 ml/min (p < 0.001). Five patients (25%) had secondary ef fects with nifedipine and three (15%) with misoprostol; in no case had therapy to be discontinued. Conclusions. Misoprostol was similar to n ifedipine for the treatment of Raynaud phenomenon secondary to systemi c diseases and can be a therapeutic alternative for these patients.