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Benzodiazepines and hip fractures
Benzodiazepines, Falls and Fractures
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Anita K. Wagner, PharmD, MPH, DrPH Department of Ambulatory Care and Prevention, Harvard Medical School and harvard Pilgrim Health Care, Dennis Ross-Degnan, ScD, Jerry H. Gurwitz, MD, Stephen B. Soumerai, ScD
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awagner{at}hms.harvard.edu Anita K. Wagner, et al.
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Dr. Lesser supports our conclusion (1) of the possible lack of a relationship between use of benzodiazepines and hip fractures in the elderly with additional data from the published literature. Since the landmark studies of 1987 (2) and 1989,(3) results of research on the benzodiazepine hip-fracture relationship have become increasingly contradictory. We concur with Dr. Lesser that differences in results are likely due to study design issues, such as benzodiazepine exposure misclassification in prospective cohort studies, (4) and the imperfect control for potential confounders in large claims data-based case-control studies.(5) Based on these results and our study, we believe that broad- based policies like the payment restrictions encompassed in Medicare Part D, which are in part based on these controversial results, are misdirected. The ideal randomized controlled study of the benzodiazepine-hip fracture relationship is unlikely to ever be conducted, for at least two reasons: Benzodiazepines are inexpensive drugs which have been on the market for a long time, making funding of a costly randomized controlled trial unlikely; and benzodiazepines have proven efficacy; therefore the equipoise principle required for randomizing patients would not be met. In the absence of a randomized trial, quasi-experimental studies like ours are the best research design option to assess the relationship. Potential confounders of a longitudinal quasi-experimental study would need to be related to the outcome of interest (hip fractures) and happen at the same time as the policy change that gave rise to the quasi- experiment. We believe that no such confounders could have explained our finding of stable rates of hip fractures at a time when use of benzodiazepines suddenly declined by about 60% after a state-wide policy restricting access to the drugs. However, we also believe that clinicians should evaluate risks and benefits of all medications, including benzodiazepines, based on each patient’s unique clinical circumstances and caution against over- interpreting the findings of our study in applying them to individual patient clinical decision-making. (1) Wagner AK, Ross-Degnan D, Gurwitz JH, Zhang F, Gilden DB, Cosler L, et al. Effect of New York State regulatory action on benodiazepine prescribing and hip fracture rates. Ann Intern Med. 2007;146:96-103. (2) Ray WA, Griffin MR, Schaffner W, Baugh DK, Melton LJ 3rd. Psychotropic drug use and the risk of hip fracture. N Engl J Med.1987;316:363-369. (3) Ray WA, Griffin MR, Downey W. Benzodiazepines of long and short elimination half-life and the risk of hip fracture. JAMA.1989;262:3303- 3307. (4) Ray WA, Thapa PB, Gideon P. Misclassification of current benzodiazepine exposure by use of a single baseline measurement and its effects upon studies of injuries. Pharmacoepidemiology and Drug Saf 2002;11:663-669. (5) Schneeweiss S, Wang S. Claims data studies of sedative-hypnotics and hip fractures in older people: Exploring residual confounding using survey information. J Am Geriatr Soc.2005;53:948-954. Conflict of Interest:None declared |
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Gerson T. Lesser, MD Mount Sinai School of Medicine and The Jewish Home and Hospital, New York, NY
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glesser{at}jhha.org Gerson T. Lesser
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The use of hypnotics in general, and benzodiazepines in particular, have been largely proscribed in geriatric teaching and practice for some years. Wagner and co-workers (1) have served us well by showing definitively that intervention effecting major reduction of benzodiazepine use in a large, vulnerable population failed to lower the incidence of hip fractures. The authors sensibly conclude that discrepancies between their observations and earlier reports are likely explained by the existence of unmeasured confounders. In a 1999 review and meta-analysis of psychotropic drugs and falls, Leipzig, et al (2) similarly noted the need for further adjustment for potential confounders. In fact, data presented in recent years have put forth several reasonable and pertinent confounders. In 2000, Brassington and co-workers (3) found that depression, "stress" and sleep difficulties were strongly associated with increased falling in an elderly community-based population. When adjusted for the various risk factors and for medication use, sleep problems were significantly related to falls, but with similar adjustments the use of psychotropic medication was not. A more recent analysis based on over 34,000 Michigan nursing home residents (4) confirmed and extended Brassington's observations. With adjustment for confounders, falls were strongly related to insomnia, but the relationship of falls and hypnotics use was no longer significant. With the same statistical adjustments, their data did not show any association with hip fracture for either insomnia or hypnotics use. Obviously, well designed, randomized prospective trials are necessary to establish firm conclusions in this area. Perhaps the ideal control subjects would be well matched elders with similar frequencies of insomnia and psychiatric disorders. In any case, the findings of Wagner and her colleagues suggest it is time to reconsider the use of sedatives and hypnotics. We may be needlessly depriving some older patients of comfort from the sufferings of chronic anxiety and severe insomnia. In addition, there are hints that insomniac nursing home residents not using hypnotics may have even slightly greater frequency of falls than insomniacs using hypnotics (4; Table 2). This may be one more instance in the history of medicine that a practice that seems quite rational proves to be adverse for overall patient care. References: 1. Wagner AK, Ross-Degnan D, Gurwitz JH, Zhang F, Gilden DB, Cosler L, et al. Effect of New York State regulatory action on benodiazepine prescribing and hip fracture rates. Ann Intern Med. 2007;146:96-103. 2. Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: I. Psychotropic drugs. J Am Geriatr Soc. 1999;47:30-39. 3. Brassington GS, King AC, Bliwise DL. Sleep problems as a risk factor for falls in a sample of community-dwelling adults aged 64 to 99 years. J Am Geriatr Soc. 2000;48:1234-1240. 4. Avidan AY, Fries BE, James ML, Szafara KL, Wright GT, Chervin RD. Insomnia and hypnotic use, recorded in the minimum data set, as predictors of falls and hip fractures in Michigan nursing homes. J Am Geriatr Soc. 2005;53:955-962. Conflict of Interest:None declared |
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