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| |  ENDO 99: Novartis Questions Relevance Of Merck's Osteoporosis Study EAST HANOVER, N.J. -- June 15 -- A statement from Novartis Pharmaceuticals Corporation says Merck & Co.’s study comparing Fosamax® (alendronate sodium) to Miacalcin® Nasal spray (calcitonin-salmon) does not show clinical relevance and does not include critical measurement of fracture rate in its methodology. The results of the study sponsored by Merck were released at the annual meeting of The Endocrine Society in San Diego. The study examined bone mineral density (BMD) as well as tolerability. "The scientific community recognizes that BMD is not the efficacy endpoint physicians should look to when evaluating therapeutic success of osteoporosis treatments," the Novartis statement says. "Fracture reduction is widely recognized by the scientific community and the U.S. Food and Drug Administration as the primary efficacy endpoint for any osteoporosis therapy." According to the press release, Miacalcin Nasal Spray’s BMD results have been well documented and are included in the package insert. In addition, the drug’s positive impact on fracture reduction has been documented. The final results of a five-year placebo controlled study in more than 1,200 women with post-menopausal osteoporosis and at least one previous spinal fracture were presented at the American Society on Bone Mineral Research meeting in December, 1998. This data was submitted to the U.S. Food and Drug Administration as part of a supplemental new drug application for the use of Miacalcin Nasal Spray for the prevention of new spinal fractures. "We believe the data show a significant reduction in the rate of new spinal fractures in patients taking one spray of 200 IUs per day," the statement says. Since Miacalcin Nasal Spray has shown a significant impact on spinal fracture reduction with a relatively modest increase in BMD, a study to define the effects of Miacalcin Nasal Spray on bone quality and bone architecture and thereby determine Miacalcin Nasal Spray’s mechanism of action is underway. It is speculated that at the microscopic level, Miacalcin Nasal Spray affects bone quality and trabecular structure to reduce microfractures, and subsequent macrofractures. This study is being led by Dr. Charles H. Chesnut III, professor of radiology and medicine at The University of Washington in Seattle. According to Dr. Chesnut, other hormonal therapies for osteoporosis appear to have similar effects on fracture reduction, and BMD, as Miacalcin Nasal Spray.
Real World Use Tolerability Not Addressed The statement from Novartis says that under the strict guidelines of the Merck study protocol, the findings on tolerability showed no statistical significance between Fosamax and a placebo tablet. Adverse experiences related to the gastrointestinal tract were reported more commonly in both Fosamax and placebo tablet treated groups than in the group given open-label Miacalcin Nasal Spray. What was not evaluated in this study was the real world use of Miacalcin Nasal Spray and Fosamax, according to the Novartis release. Miacalcin is administered by nasal spray-one spray a day-and there are no food or drink restrictions or requirements. And Miacalcin Nasal Spray has a favorable safety profile-no contraindications, precautions or restrictions for patients with gastrointestinal, esophageal or renal disorders. On the other hand, Fosamax must be used with caution to facilitate delivery to the stomach and thus reduce the potential for esophageal irritations. In fact, the FDA recently added to the warning section of the Fosamax package insert, to include (new text in italics-see below): "Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture, have been reported in patients receiving treatment with Fosamax." Patients must comply with multiple requirements including: Taking Fosamax upon arising for the day with a full glass of plain water (six to eight ounces). Staying fully upright (sitting or standing) for at least 30 minutes after taking Fosamax and until after their first food of the day. Refraining from taking Fosamax at bedtime or before arising for the day.
A retrospective study of 812 women from the Kaiser Medical Care program in Northern California revealed: -- Nearly one in three patients using Fosamax complained of new upper gastrointestinal symptoms-a frequency greater than that reported in clinical trials. -- Of this group, 46 percent discontinued use of the drug within ten months, and 52 percent of those citing gastrointestinal problems as the reason for discontinuation. -- Almost one in eight sought medical care for GI disorders. -- 56 percent of women took their Fosamax incorrectly, failing to comply with at least one of the dosing instructions. The researchers concluded that failure to comply with instructions for taking Fosamax may result in side effects of the drug.
Osteoporosis Expert Comments on Study Findings "These data in the Merck study do not address the most critical factor for any osteoporosis treatment, which is the reduction of spine fractures," says Dr. Chesnut. "If fracture reduction can be clearly measured in patients with only modest BMD improvement, we must recognize that BMD is not the most critical endpoint for osteoporosis therapy. Spinal fracture reduction might have more to do with therapeutic effects on bone quality, rather than on bone quantity. This is a new and perhaps quite innovative concept, which is currently under investigation with the ongoing bone quality study at our institution." About Miacalcin Nasal Spray Miacalcin Nasal Spray has been on the market since 1995. It is currently indicated for the treatment of postmenopausal osteoporosis in women more than five years after menopause with low bone mass who refuse or cannot tolerate estrogens, or in whom estrogens are not an option. Patients should be sure to take adequate amounts of calcium and vitamin D along with therapy. The most common side effects are nasal symptoms (runny nose, crusting, nosebleed, etc.), back and/or joint pain, and headache. Because calcitonin-salmon is a protein, the potential for a systemic allergic reaction exists.
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