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| |  ASBMR: Postmenopausal Osteoporosis Patients Prefer Fosamax Once Weekly Over Fosamax Once Daily PHOENIX, AZ -- October 15, 2001 -- A new study that examined dosing preference and convenience found that nearly nine out of 10 postmenopausal women with osteoporosis preferred a 70 mg once-weekly dosing regimen of Fosamax® (alendronate sodium) over a 10 mg once-daily regimen of Fosamax. Results of this study were reported here at the American Society for Bone and Mineral Research 23rd Annual Meeting. "In our study, the overwhelming majority of patients preferred the once-weekly dosing option and considered it more convenient compared to once-daily dosing," said Michael Lewiecki, M.D., osteoporosis director, New Mexico Clinical Research & Osteoporosis Center, Inc., Albuquerque, New Mexico. "We conducted this study to learn more about patient preference and convenience, which can be important factors in disease treatment." Fosamax, a prescription medicine from Merck & Co., Inc., is the first and only oral medication available in a once-weekly dosing regimen for the treatment (70 mg) and prevention (35 mg) of postmenopausal osteoporosis. Fosamax also is available in once-daily dosages for the treatment (10 mg) and prevention (5 mg) of postmenopausal osteoporosis. A nine-week multi-center, open-label study in postmenopausal women with osteoporosis assessed the preference and convenience of two dosing regimens. Women entering the study had not previously been treated for osteoporosis with standard therapies including bisphosphonates, calcitonin or selective estrogen receptor modulators (SERMS) and were generally in good health. Patients were randomized to: -- Fosamax 70 mg once weekly for four weeks, followed by one week off therapy, and then four weeks on Fosamax 10 mg once daily, or: -- Fosamax 10 mg once daily for four weeks, followed by one week off therapy, and then four weeks on Fosamax 70 mg once weekly. Both groups received calcium and vitamin D supplements daily, which is recommended practice in osteoporosis management. At the conclusion of the study, 272 participants completed a questionnaire to identify which treatment routine they preferred and which routine they found more convenient. Results showed: -- Fosamax once weekly was preferred by 86.4 percent of patients compared to 9.2 percent who preferred Fosamax once daily. No preference was reported by 4.4 percent of patients. -- Fosamax once weekly was considered more convenient by 89 percent of patients compared to 7.7 percent who considered Fosamax once daily more convenient. Both regimens were reported equally convenient by 3.3 percent of patients. In a separate, 12-week, double-blind study, researchers randomized 450 men and postmenopausal women with osteoporosis to Fosamax 70 mg once weekly (n equal to 224) or placebo (n equal to 226) and evaluated incidence of upper gastrointestinal (GI) adverse events, including nausea, abdominal pain, dyspepsia, heartburn, vomiting and gastroesophageal reflux. The study excluded participants who had a history of severe esophagitis or esophageal ulcer related to previous bisphosphonate use. Half of the patients had previously been treated with a bisphosphonate. Ninety-two percent of the patients were female and the average age was 67 years old. Upper GI adverse event rates (without regard to causality) were 11.2 percent in the group receiving Fosamax, and 13.4 percent in the placebo group. Upper GI adverse event rates as determined by investigators to be drug-related were 7.2 percent in the group receiving Fosamax and 7.6 percent in the placebo group. In patients with no prior bisphosphonate use, there were higher rates of upper GI adverse events (regardless of randomization to Fosamax or placebo) compared to those patients who had prior bisphosphonate use. In each of the subgroups (prior or no prior bisphosphonate use), the incidence of upper GI adverse events in the group receiving Fosamax was equivalent to placebo. Upper GI adverse events reported equal to or greater than one percent in either treatment group without regard to causality included: -- Nausea (1.8 percent Fosamax; 5.8 percent placebo); -- Abdominal pain (3.1 percent Fosamax; 3.5 percent placebo); -- Dyspepsia (1.8 percent Fosamax; 2.7 percent placebo); -- Heartburn (2.2 percent Fosamax; 1.8 percent placebo); -- Vomiting (1.3 percent Fosamax; 0.9 percent placebo); and -- Gastroesophageal reflux (1.3 percent Fosamax; 0.4 percent 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 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. The most commonly reported side effects with the Fosamax once-weekly or once-daily regimens have been abdominal pain, musculoskeletal pain, indigestion, regurgitation and nausea. SOURCE: Merck & Co. Inc.
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