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Gastrointestinal Events Rare With Bisphosphonates, Less Likely With Risedronate: Presented at AACE

By Paula Moyer

SAN DIEGO, CA -- May 21, 2003 -- Patients who take a bisphosphonate to treat or prevent osteoporosis are unlikely to have related gastrointestinal (GI) problems, but a prior history of such problems may affect their physicians' prescribing preference.

"These events are more likely to occur in the first 4 months of therapy," said Joseph Doyle, RPh, senior manager of health economics and outcomes research, Aventis Pharmaceuticals. He presented the findings here on May 16^th at the American Association of Clinical Endocrinologists 12^th Annual Meeting and Clinical Congress.

Because GI events are a known adverse event of bisphosphonate treatment, Mr. Doyle and colleagues evaluated the occurrence of GI events in patients taking risedronate (Actonel), and alendronate (Fosamax) for the treatment of osteoporosis. They reviewed the records of 3947 women and men who were older than 65 years, and had begun bisphosphonate therapy from November 2000 to August 2001.

The investigators excluded patients who had bisphosphonate prescriptions during the 6 months prior to this round of treatment.

The risedronate dose was 5 mg daily, and the alendronate dose was 5 mg or 10 mg daily, or a weekly dose of 35 mg or 70 mg per week.

The investigators correlated GI events during the 6 months before the patients began treatment with bisphosphonates, as well as 4 months after treatment began. They compared the GI event rates for the various formulations after adjusting for previous GI history.

Among patients on alendronate regimens, 7.8% on daily treatment, and 8.4% on weekly treatment had GI events after beginning treatment. Among patients taking risedronate, 5.2% experienced such events after starting treatment.

Mr. Doyle said that the difference was significantly higher for the alendronate formulations (relative risk [RR] = 1.57, P=0.021 for daily; RR = 1.66; P= 0.004 for weekly).

He noted that patients who were taking risedronate were 23% more likely to have had a history of GI diagnoses before treatment than those on daily alendronate, and 15% more likely than those on weekly alendronate.

"Therefore, clinicians may prefer to prescribe risedronate for patients at increased risk of GI events," he said.

The study was funded by Aventis, which manufactures Actonel with Procter & Gamble Pharmaceuticals.


[Study title: Incidence of Gastrointestinal Events Among Patients With Osteoporosis Treated With Alendronate Versus Risedronate. Abstract 29]

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