Enalapril (10 mg/day) in systemic sclerosis. One year, double blind, randomised study (ESS-1): pulmonary substudy--effects of three month treatment.

The ESS-l study is designed to evaluate the long-term effects of enalapril on cardio­ pulmonary system of patients with systemic sclerosis (SSc). During the one year study pe­ riod 5 visits are scheduled at 3 month intervals. The effect of 3 months treatment with enalapril (10 mg per day) on lung function was studied in 18 patients with SSc (enalapril group) and compared with controls-23 patients with Ssc (placebo group), mean age, SSc duration, gender and % of patients with dcSSc did not differ significantly in both groups. We performed body plethysmography for total airways resistance (Rtot), and static lung vol­ umes (TLC, ITGV and RV), spirometry for FEVI and FVC and we measured flow parame­ ters (PEF, FEF). We compared initial lung function (first examination) with results after 3 months treatment (second examination) in the enalapril and in the placebo group. Mean val­ ues of Rtot, ITGV and RV did not differ significantly in the enalapril group or in the placebo group before and after treatment but FVC, FEVI and FEFso were significantly lower in the enalapril group and did not change in the placebo group after three months. We conclude that 3 month treatment with enalapril worsens spirometry of SSc patients. We did not ob­ serve any changes in lung functions in the control group in the same three month period.