Enalapril (10 mg/day) in systemic sclerosis. One year, double blind, randomised study (ESS-1): pulmonary...

The ESS-1 study is designed to evaluate the long-term effects of enalapril on cardiopulmonary system of patients with systemic sclerosis (SSc). During the one year study period 5 visits are scheduled at 3 months 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 volumes (TLC, ITGV and RV), spirometry for FEV1 and FVC and we measured flow parameters (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 values of Rtot, ITGV and RV did not differ significantly in the enalapril group or in the placebo group before and after treatment but FVC, FEV1 and FEF50 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 observe any changes in lung functions in the control group in the same three month period.