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Upper gastrointestinal tolerability of once weekly alendronate 70 mg with concomitant non‐steroidal anti‐inflammatory drug use
Author(s) -
Cryer B.,
Miller P.,
Petruschke R. A.,
Chen E.,
Geba G. P.,
Papp A. E.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02378.x
Subject(s) - medicine , concomitant , placebo , tolerability , adverse effect , drug , gastroenterology , aspirin , population , alendronic acid , osteoporosis , pharmacology , bisphosphonate , pathology , alternative medicine , environmental health
Summary Background : Both oral bisphosphonates and non‐steroidal anti‐inflammatory drugs have the potential to irritate the upper gastrointestinal mucosa, and are frequently used by the same patient population. Aim : To determine the rate of upper gastrointestinal adverse events with once weekly alendronate 70 mg and concomitant non‐steroidal anti‐inflammatory drug use. Methods : A post hoc analysis was performed on 222 patients who received both medications concomitantly during a 3‐month placebo‐controlled study. A total of 450 (224 alendronate; 226 placebo) postmenopausal women and men with osteoporosis were randomized. Concomitant non‐steroidal anti‐inflammatory drug users were defined as patients who received ≥7 continuous days of any dose of a dual cyclo‐oxygenase‐1 and cyclo‐oxygenase‐2 inhibiting non‐steroidal anti‐inflammatory drug, a selective cyclo‐oxygenase‐2 inhibitor, or aspirin. A survival analysis was performed, and significance assessed. Logistic regression was used to assess consistency of treatment effect on rate of upper gastrointestinal adverse events across non‐steroidal anti‐inflammatory drug subgroups. Results : Similar percentages of alendronate (52.7%) and placebo (46.0%) patients used non‐steroidal anti‐inflammatory drugs regularly. Among concomitant non‐steroidal anti‐inflammatory drug users, 11 alendronate and 11 placebo patients experienced upper gastrointestinal adverse events (9.3% and 10.8%, respectively, P = 0.744). Logistic regression revealed no significant interaction ( P = 0.722) between alendronate and concomitant non‐steroidal anti‐inflammatory drug use. Conclusion : Based on this subgroup analysis, once weekly alendronate 70 mg used concomitantly with non‐steroidal anti‐inflammatory drugs, did not increase upper gastrointestinal adverse events relative to placebo over 3‐months.