Characteristics and management of cyclosporine-associated adverse gastrointestinal events

Abstract

Background: Cyclosporine (CS) is widely used to treat various skin diseases. Gastrointestinal (GI) discomfort is the most common adverse effect of orally administered CS for dermatologic indications. However, few studies on CS-associated adverse GI events have been conducted. Objective: In this study, we aimed to describe the major features of adverse GI events associated with CS therapy using a validated symptom questionnaire, and to investigate the factors contributing to their development. We also evaluated the effectiveness of three empirical GI medications in relieving adverse GI events. Methods: This study consisted of 2 phases. Phase I was a prospective observational cohort study to investigate the characteristics of CS-associated adverse GI events in 942 consecutive patients treated with CS. Phase II was a randomized controlled trial to evaluate the efficacy of three different classes of GI medications. Results: CS-associated adverse GI events occurred in 119 patients (12.6%). GI complications were more common in female patients (p=0.04), patients with a history of GI disorders (p=0.02), and patients whose initial CS doses were greater than 3 mg/kg/day (p=0.05). In patients treated with any one of the three GI medications, the mean Gastrointestinal Symptom Rating Scale scores significantly decreased (p<0.001). Conclusion: This study demonstrated that adverse GI events are common during early CS treatment, especially in women, patients receiving high doses of CS, and those with a history of GI disorders. Our results suggest that new-onset CS-associated GI side effects can be effectively managed with the addition of GI medications.