Side-effects hamper effectiveness of drug
Studies find problems with osteoporosis drug
Two new studies by researchers at Kaiser Permanente’s division of research in Oakland, CA, found that gastrointestinal (GI) problems occur with surprising frequency in women taking the osteoporosis drug, alendronate. An estimated 3 million women worldwide currently take the drug.
The GI disorders cause many women to seek medical care or stop taking the medication within a matter of months. In addition, the studies found that roughly 56% of women fail to comply with dosing guidelines designed to help their bodies properly absorb alendronate, potentially reducing or eliminating the skeletal benefit of the drug.
Both studies used data from surveys and prescription data collected for 812 women, average age 69, who were members of Kaiser Permanente in northern California. Nearly one in three women using alendronate daily to treat osteoporosis complained of new GI symptoms, a frequency far greater than reported in clinical trials of the drug, according to a study published in the Journal of Managed Care Pharmacy.1 Of the group complaining of new symptoms, 46% discontinued use of the drug within 10 months, more than half of them citing problems such as ulcers, nausea, abdominal pain, and heartburn as the reasons.
Almost one in eight women using the drug sought medical care for GI disorders, particularly women 70 or older, according to a related study in the American Journal of Managed Care.2 "Doctors need to warn women at the outset about the potential side effects of alendronate," says Bruce Ettinger, MD, senior investigator at Kaiser Permanente’s division of research. "The problems with the drug appear far more widespread than had been previously assumed. Unless it can be made more tolerable, many women aren’t going to obtain the benefits alendronate can provide in preventing and treating osteoporosis."
Women with previously diagnosed GI disorders or those taking nonsteroidal anti-inflammatory drugs also had significantly higher rates of GI problems when they began using alendronate. "These women are typically age 70 or older," says Ettinger. "Physicians should really think twice about giving them alendronate. If elderly women are placed on the drug, they need to be monitored carefully because the risk of gastrointestinal problems is quite high."
References
1. Ettinger B, Pressman A, Schein J, et al. Alendronate use among 812 women: Prevalence of gastrointestinal complaints, noncompliance with patient instructions, and discontinuation. J Man Care Pharm 1998; 4:488-492.
2. Clinic visits and hospital admission for care of acid-related upper gastrointestinal disorders in women using alendronate for osteoporosis. Am J Man Care 1998; 4:1,377-1,382.
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