Tolerability of risedronate in postmenopausal women intolerant of alendronate.
Bisphosphonates are effective treatments for osteoporosis, but some have been associated with upper gastrointestinal intolerance. This randomized, double-blind study assessed the upper gastrointestinal tolerability of risedronate in postmenopausal women who had discontinued alendronate treatment because of upper gastrointestinal adverse events. Sixty-six women who had previously discontinued treatment with alendronate 10 mg/day because of upper gastrointestinal symptoms received placebo (N=31) or risedronate 5 mg (N=35) daily for 3 months. The primary outcome was the rate of discontinuation due to upper gastrointestinal adverse events: 5/31 (16.1%) in the placebo group, and 4/35 (11.4%) in the risedronate group. Discontinuation rates were also similar in the two treatment groups among subgroups of patients with a history of gastrointestinal disorder, prior use of acid suppression drugs, and concomitant use of NSAIDs. The overall incidence of upper gastrointestinal events was comparable between the placebo (19.4%) and risedronate (20.0%) groups. Overall, risedronate 5 mg/day for 3 months was as well tolerated as placebo in patients who could not tolerate alendronate 10 mg. These results are consistent with, and complement those from previous studies showing that risedronate 5 mg has a gastrointestinal tolerability similar to that of placebo.
Adachi
J D
JD
Department of Medicine, St. Joseph's Hospital, McMaster University, Hamilton, Ontario, Canada,
Adami
S
S
Miller
P D
PD
Olszynski
W P
WP
Kendler
D L
DL
Silverman
S L
SL
Licata
A A
AA
Li
Z
Z
Gomez-Panzani
E
E
D019386:Alendronate / Q000009:adverse effects*; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010352:Patient Dropouts; D017698:Postmenopause; D000068296:Risedronic Acid; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D000068296:Risedronic Acid; D012968:Etidronic Acid; D019386:Alendronate