Fosamax Linked To Greater Need For GI Symptom Treatment

Doctor's Guide October 1, 1999

EAST HANOVER, N.J. -- October 1, 1999 -- Women taking the osteoporosis medication Fosamax (alendronate sodium) incur higher costs to treat gastrointestinal disorders such as dyspepsia, esophagitis and GERD caused by its usage, according to a new study conducted by researchers at the Kaiser Permanente Medical Care Program of Northern California (KPNC). The study was presented today at the American Society for Bone and Mineral Research (ASBMR) annual meeting.

Researchers found that outpatient care was the chief source of excess costs, which were $40-$67 per member/per month higher than that of three separate control groups not using the medication. Further, gastrointestinal bleeding caused almost one-third (29 percent) of acid-related disorder treatment costs incurred by Fosamax patients.

"With the intense scrutiny on cost in the managed care setting, these new data will be of great interest to physicians, patients and health maintenance organizations nationwide, given the growing patient population at risk for osteoporosis," says lead investigator, T.R. Levin, M.D., assistant clinical professor at the University of California School of Medicine, San Francisco, and adjunct investigator, Health Services Research Section, Kaiser Permanente Division of Research.

Researchers observed the direct health care costs of 792 women enrolled in a large health maintenance organization (HMO) who started alendronate therapy (10 mg once daily) for the treatment of osteoporosis between October 1995 and September 1996. The results were compared with three distinct control groups - osteoporotic patients, osteopenic patients (those who have a level of bone mineral density below normal range but above the osteoporotic level) and a population-based sample of the health plan's membership.

The new results unveiled at the ASBMR meeting come on the heels of a previous study published last year in the Journal of Managed Care Pharmacy that found nearly one in three women using alendronate complained of new upper gastrointestinal symptoms. Of that group, 46 percent discontinued use of the drug within 10 months (the drug must be taken for an extended period to be effective). Furthermore, almost one in eight women using the drug sought medical care for gastrointestinal disorders, particularly women age 70 and older, according to a related study in The American Journal of Managed Care.

In addition to increased outpatient care costs, researchers also found that alendronate users incurred approximately $3.91, $2.80 and $3.80 more in monthly acid-related disorder inpatient expenses compared to the control groups (osteoporotic, osteopenia and population-based sample, respectively). Excess pharmacy costs to treat acid-related disorders were also higher per month among the study group ($3.89, $5.09 and $2.80 more, respectively).

Osteoporosis, which primarily affects women after they have reached menopause, is a disease of the bone in which excessive loss of bone tissue results in decreased bone mineral density and increased susceptibility to fracture. An estimated 28 million Americans - 80 percent of whom are women - suffer from osteoporosis. In 1995, total osteoporosis-related costs were $13.8 billion in the United States. As the population ages, this cost is expected to increase dramatically.

The study was supported by an unrestricted grant from Novartis Pharmaceuticals Corporation.

Related Links: Fosamax and Novartis Pharmaceuticals Corporation

Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved

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