Off label pharmacological therapy in patients with short bowel syndrome

Abstract

BACKGROUND: Short bowel syndrome is a disabling disease requiring long-term nutritional support and ancillary drugs. Aiming to analyze the most commonly prescribed drugs, a retrospective analysis was conducted is an outpatient cohort. PATIENTS AND METHODS: Stable patients (N= 37, 59.5% males, age 51.1 +/- 20.1 years, body mass index 20.1 +/- 7.9 kg/m(2)) with three or more appointments in the Outpatient Service during the last 18 months were retrospectively analyzed. regarding oral pharmacologic prescriptions. Medications were classified as on label or off label. RESULTS: A total of 257 oral prescriptions were retrieved from computer files, encompassing 17 different preparations. The majority was employed on label however 28.8% (74/257) were classified as off label and scrutinized with regard to indications. The main categories were pharmacologic modulators of gastrointestinal secretions and motility, along with antibiotics. Virtually all patients required one or more of such drugs, without differences regarding demographic or clinical variables. Adverse effects or premature drug discontinuation were not observed. CONCLUSIONS: This is the first study to our knowledge highlighting the importance of adjuvant drugs, particularly with unconventional indications, in the management of short bowel syndrome. Antidiarrheic agents, pancrelipase micropellets, antacids and antibiotics represented the most relevant off label prescriptions for this population.