Limitations for the inclusion of patients in the Roflu-2011 study

INTRODUCTION: Chronic Obstructive Pulmonary Disease(COPD) is characterized by the presence of exacerbations that decrease the quality of life and increase the risk of death. Roflumilast is a potent and selective phosphodiesterase type 4(PDE4) inhibitor that has been shown to prevent exacerbations in severe COPD patients. OBJECTIVE: Assess the most common limitations to begin the treatment with roflumilast. METHODS: Transversal analysis of the exclusion criteria of COPD patients included in the ROFLU-2011 study. This is a multicenter Andalusian study where the following variables were analyzed: age, gender, FEV1, chronic bronchitis criteria, packs-year,exacerbations in the previous year,clinical stability in last month, pregnancy/breastfeeding,psychiatric,immunologic,rheumatologic,and gastrointestinal comorbidities, so concomitant medication and inability to understand or undertake lung function tests. RESULTS: 131 patients were analyzed: 128 men(97%). 37 patients did not meet the inclusion criteria. 3.1% refused to participate and 24.5% had been already treated with roflumilast. Among the 68 patients remaining, evaluated the most common limitation was the presence of gastroduodenal ulcer(22%). Other limitations identified were: neoplasia(19.1%) being bladder cancer the most common type, gastroesophageal reflux(13.2%), hiatal hernia(12%), serious psychiatric disorders(5.8%) and inability to carry out lung function tests(6.8%). CONCLUSIONS: The most common limitations to begin the roflumilast treatment in our patients were gastrointestinal diseases(47%) especially peptic ulcer. Therefore, the gastrointestinal pathology is a limitation for the start of the treatment as well as a frequent cause of treatment discontinuation.