Esophagitis and Alendronate

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Abstract
Post-marketing reports of severe esophagitis associated with the use of alendronate sodium, reported in this issue of the Journal by de Groen et al.,1 prompted us to reexamine in detail adverse esophageal effects in our three-year osteoporosis studies (Nov. 30, 1995, issue).2 In these studies, 994 patients were randomly assigned to receive placebo, 5 or 10 mg of alendronate daily for three years, or 20 mg of alendronate for two years followed by 5 mg daily in year 3 (ratio of assignments to the four groups, 2:1:1:1, respectively). We used the same terms suggesting esophageal irritation that de Groen et al. used in their analysis of post-marketing reports, and like de Groen et al., we considered a serious adverse effect to involve hospitalization. However, the severity of adverse effects (mild, moderate, or severe, according to the intensity of the effect and its influence on the patient's functioning), as well as the causal relation to medication use, was rated by study investigators who were unaware of the treatment assignments. Patients were seen on average every three months (range, one to six), and dosing instructions (which formed the basis for the initial product labeling3) were usually reviewed at each visit. The incidence of adverse effects was compared among the treatment groups with the use of the unadjusted, two-tailed Tukey test for trend.4

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