1. Oral Prednisolone Followed by Inhaled Budesonide in Newly Diagnosed Pulmonary Sarcoidosis
- Author
-
Olof Selroos, Pentti Tukiainen, Tari Haahtela, Anne Pietinalho, and Tore Persson
- Subjects
Pulmonary and Respiratory Medicine ,Budesonide ,Erythema nodosum ,medicine.medical_specialty ,business.industry ,medicine.drug_class ,Critical Care and Intensive Care Medicine ,Placebo ,medicine.disease ,Gastroenterology ,Surgery ,Pulmonary function testing ,FEV1/FVC ratio ,Internal medicine ,Prednisolone ,Medicine ,Corticosteroid ,Sarcoidosis ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Study objective To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed ( Design Double-blind, placebo-controlled, parallel-group, multicenter study. Setting Twenty pulmonary medicine departments in Finland. Patients One hundred eighty-nine adult patients were randomized to treatment. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibrosis), and patients requiring immediate treatment with oral corticosteroids for extrapulmonary lesions or chronic illnesses were excluded. Treatment The patients received either oral prednisolone for 3 months (20 mg/d for 8 weeks, 15 mg/d for 2 weeks, and 10 mg/d for 2 weeks) followed by inhaled budesonide (Pulmicort Turbuhaler; Astra Draco; Lund, Sweden) for 15 months at 800 μg bid, or placebo tablets followed by placebo inhaler therapy. Measurements Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (D lco ), serum angiotensin-converting enzyme (SACE), and β 2 -microglobulin at 3-month intervals. Results After 3 months of treatment, radiographic improvements were seen in the active-treatment group when compared to the placebo-treatment group. At 6 months, the difference was still statistically significant. Later, no differences were found. In patients with initial stage I lesions, neither the FVC nor the D lco (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial stage II disease, the difference in the FVC mean values between the groups also remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in D lco became statistically significant; the largest differences were seen in patients with initial FVC values lco values Conclusion Treatment is not required for patients with stage I disease. An initial treatment with prednisolone followed by long-term inhalation of budesonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative treatment regimen for stage II sarcoidosis patients, rather than long-term oral corticosteroid therapy alone.
- Published
- 1999
- Full Text
- View/download PDF