Prospective evaluation of medication-induced esophageal injury and its relation to esophageal function.

ABSTRACT

BACKGROUND: Few prospective studies are available on the incidence of medication-induced esophageal injury (MIEI). AIMS: To prospectively study the occurrence of MIEI with indomethacin and doxycycline and the predictive factors for its development. METHODS: In an operator-blinded study, 51 patients (age 16-65 y) requiring indomethacin (n = 24) or doxycycline (27) underwent symptom evaluation, endoscopy and scintigraphy before and after 7 days of therapy. MIEI was defined as de novo occurrence or worsening of pre-existing esophagitis or development of esophageal ulcer. RESULTS: Pre-therapy endoscopy was normal in 32 patients and revealed esophagitis in 19 (grade I--11, grade II--8). Post-therapy, 16 patients developed esophageal symptoms, which appeared earlier with doxycycline (2.0 [0.8] vs 4.1 [1.7] days, p = 0.016). MIEI developed in 23 patients--de novo esophagitis in 16, worsening of esophagitis in 6; 5 patients developed ulcer. Seven of 12 patients with hiatus hernia developed MIEI. Presence of pre-therapy gastroesophageal reflux disease did not predict MIEI. There was no difference in pre- or post-therapy transit values between patients with and without MIEI; patients who developed ulcers had significantly slower esophageal transit (p < 0.05). There was no difference in esophageal transit or occurrence of MIEI between patients who received indomethacin or doxycycline; however, 5 of 8 patients with hiatus hernia who received doxycycline developed MIEI (p = 0.02; relative risk 3.96 [CI 1.2-12.7]). CONCLUSIONS: 40% of patients receiving doxycycline or indomethacin developed MIEI; 10% developed ulcers. Hiatus hernia increased the risk for MIEI.