The purpose of this study was to determine compliance with dosing instructions, and the prevalence of possible adverse events, when risedronate is used in clinical practice. 219 patients were studied. We found that despite counseling one in four patients were non-compliant with dosing instructions. Those patients who did not stay upright after taking risedronate were more likely to have an adverse event and to discontinue the drug. Adverse events were experienced by 38% of patients, the commonest being gastrointestinal. Upper GI adverse events occurred in 21% of patients. A previous history of upper GI symptoms applied to 44% of patients and significantly more of them experienced upper GI adverse events than those with no history of GI problems. Forty two (19%) of patients taking risedronate stopped therapy due to adverse events, but only ten of these patients had contacted the Osteoporosis Unit about these symptoms. Approximately one third of the patients who experienced adverse events in this study had attempted a rechallenge with the drug. This was worthwhile, however, as in almost 50% of these patients their symptoms settled and they continued with therapy. This study has highlighted the importance of following up patients on long-term osteoporosis medication to ensure optimal compliance. The use of specialized osteoporosis nurses in clinics or primary care to follow up patients needs to be addressed.
Risedronate sodium is a pyridinyl bisphosphonate effective for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis. Some bisphosphonates have been associated with upper gastrointestinal (GI) tract adverse effects. The objective of this study was to determine the frequency of upper GI tract adverse events associated with risedronate, especially among high-risk patients. The GI tract adverse events reported during 9 multicenter, randomized, double-blind, placebo-controlled studies of risedronate conducted from November 1993 to April 1998 were pooled and evaluated. The evaluation included 10,068 men and women who received placebo (n=5048) or 5 mg of risedronate sodium (n=5020) for up to 3 years (intent-to-treat population). Studies incorporated a comprehensive, prospective evaluation of GI tract adverse events. Adverse event information was collected every 3 months. The treatment groups were similar with respect to baseline GI tract disease and use of concomitant treatments during the studies. At study entry, 61.0% of patients had a history of GI tract disease and 38.7% had active GI tract disease; 20.5% used antisecretory drugs during the studies. Sixty-three percent used aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs) during the studies. Upper GI tract adverse events were reported by 29.6% of patients in the placebo group compared with 29.8% in the risedronate group. The risk of experiencing such an event in the risedronate group was 1.01 (95% confidence interval, 0.94-1.09) relative to the placebo group (P=.77). The rate of upper GI tract adverse events per 100 patient-years was 19.2 in the placebo group compared with 20.0 in the risedronate group (P=.30). Risedronate-treated patients with active heartburn, esophagitis, other esophageal disorders, or peptic ulcer disease at study entry did not experience worsening of their underlying conditions or an increased frequency of upper GI tract adverse events overall. Concomitant use of NSAIDs, requirement for gastric antisecretory drugs, or the presence of active GI tract disease did not result in a higher frequency of upper GI tract adverse events in the risedronate-treated patients compared with controls. Endoscopy, performed in 349 patients, demonstrated no statistically significant differences across treatment groups. The results of this extensive evaluation indicate that daily treatment with 5 mg of risedronate sodium is not associated with an increased frequency of adverse GI tract effects, even among patients at high risk for these events.
SHORT REPORTS Fatal cholestatic jaundice in elderly patients taking benoxaprofen Benoxaprofen is a relatively new propionic acid derivative that is extensively prescribed for patients with arthritis. The most important adverse effect so far reported is a photosensitivity skin reaction. We report five cases of cholestatic jaundice with fatal outcome in elderly women taking this preparation. Case reports All patients were women over the age of 80 years and were treated with benoxaprofen 600 mg daily. Case 1-An 86-year-old woman presented in January 1981 with a confusional state. She had a smooth firm liver palpable 6 cm below the costal margin, erythrocyte sedimentation rate of 75 mm in first hour, and a slightly raised alkaline phosphatase activity. She recovered spontaneously and was not seen until June 1981 when benoxaprofen was started for longstanding rheumatoid arthritis. Her final illness began in November 1981, when she
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