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| |  ACG: No Increased Risk For Gastrointestinal Adverse Effects With Osteoporosis Drug Fosamax (Alendronate) NEW YORK, NY -- October 16, 2000 -- Analyses of records of 6,459 patients in the Fracture Intervention Trial (FIT) showed that patients who took the osteoporosis medicine Fosamax® (alendronate sodium) had an incidence of hospitalization for perforations, ulcers and bleeding (PUBs) that was no greater than the incidence in those who had osteoporosis but did not take the medicine. The new data on these serious gastrointestinal adverse events was presented at the American College of Gastroenterology meeting in New York. "Short-term endoscopic studies of a few weeks duration are widely used to generate hypotheses about the possible gastrointestinal effects of medicines. Although this technique has been useful, the results must be interpreted in the context of all available data, with greater weight given to outcomes data," said Brian Fennerty, M.D., professor of medicine and gastroenterology section chief, Oregon Health Sciences University. "These outcomes data show no such increased incidence of PUBs in women with osteoporosis receiving Fosamax compared to women with osteoporosis not receiving Fosamax. The clinical incidence of disease, which is what we should be concerned about, can only be demonstrated by outcomes studies such as this."
No increased incidence of hospitalization for PUBs found in large clinical trial In FIT, which followed 6,459 postmenopausal women with osteoporosis or low bone mineral density for an average of 3.8 years, all serious upper gastrointestinal adverse experiences, including those that led to hospitalization, were recorded by investigators. Follow-up information including hospital discharge summaries and endoscopic reports were also collected. The women enrolled in FIT were randomly assigned to receive treatment with Fosamax (5 mg once daily for two years and 10 mg once daily thereafter) or placebo. A total of 3,236 women were treated with Fosamax and 3,223 received placebo. Many of these women had one or more of the common factors seen in the general population which may be associated with an increased risk for gastrointestinal side effects, including a history of digestive and upper gastrointestinal disorders, or the concomitant use of nonsteroidal anti- inflammatory drugs (NSAIDs) or aspirin. Fifty-four percent of each treatment group had a history of digestive disease and 14.3 percent had a history of upper gastrointestinal disorders such as peptic ulcers or esophageal reflux prior to study entry. Similar numbers of patients in the two treatment groups used NSAIDs or aspirin (88.4 percent and 87.5 percent for the groups treated with Fosamax or placebo, respectively). The concomitant use of medicines to protect the stomach, such as medicines that reduce the production of acid in the stomach, was 22.4 percent in each treatment group. There were a total of 124 hospitalizations for upper gastrointestinal events in the FIT study population with 115 of these confirmed as PUBs by endoscopy, radiology or hospital discharge summaries. The incidence of hospitalization for PUBs in women treated with Fosamax was 0.5 percent as compared to an incidence of 0.6 percent in those women who received placebo. Fosamax, like other bisphosphonates, should be used with caution in people with certain stomach or digestive problems. Fosamax should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, Fosamax should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to Fosamax or in patients who are pregnant or nursing. Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in those patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience heartburn, difficulty or pain when swallowing, or chest pain should stop taking the drug and consult their doctor. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, patients must take Fosamax upon arising for the day, with a full glass of plain water (six to eight ounces). After swallowing Fosamax, patients must not lie down and should stay fully upright (sitting or standing) for at least 30 minutes and until after the first food of the day. Fosamax should not be taken at bedtime or before arising for the day. Patients should not chew or suck on the tablets. There have been post- marketing reports of gastric or duodenal ulcers, some severe and with complications, although no increased risk was observed in controlled clinical trials. Related Link: Fosamax (Alendronate).
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