Upper gastrointestinal tolerability of once weekly alendronate 70 mg with concomitant non-steroidal anti-inflammatory drug use.
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.


OBJECTIVE
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 > or =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.


CONCLUSIONS
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.
Cryer
B
B
Department of Medicine, University of Texas Southwestern Medical School, Dallas, TX 75216, USA. byron.cryer@utsouthwestern.edu
Miller
P
P
Petruschke
R A
RA
Chen
E
E
Geba
G P
GP
Papp
A E
AE
D000368:Aged; D019386:Alendronate / Q000009:adverse effects*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy; D017698:Postmenopause
D000894:Anti-Inflammatory Agents, Non-Steroidal; D019386:Alendronate