Topically applied beta-blockers are a mainstay of glaucoma treatment. While there exist good data concerning the efficacy of topical beta-blockers in reducing intraocular pressure, very little is known about the epidemiology of systemic adverse effects from this common therapy, particularly in the elderly. This study will analyze the pharmaco-epidemiology of ophthalmic beta-blocker side effects in a population of over 1 million patients in New Jersey, through computer-assisted investigation of a dataset of all recipients in the New Jersey Medicaid program (N=975,700), as well as int the Pharmacy Assistance for the Aged and Disabled program (PAAD) (N=250,000). These complete records of medication use data and all other reimbursed health care services (including office visits, emergency services, hospitalizations, and long-term care) will be tracked on a patient- specific basis and supplemented with all Medicare claims data (Parts A and B, also on a person-specific basis). Epidemiologic analysis will take the form of follow-up (cohort) studies, after exposure to an ophthalmic beta-blocker, either timolol or betaxolol. Outcomes of interest will be the rate of health care encounters for clinical events such as congestive heart failure, bronchospasm, depression, or confusion. These will be tracked not only by measures such as physician visits or hospital stays, but also by tracing the pattern of use of medications prescribed to treat these conditions (e.g. diuretics, digoxin, bronchodilators, antidepressants, etc.). Standard epidemiologic techniques will be used to answer the following questions: (1) Is there an increased risk of the systemic side effects studied in glaucoma patients using topical beta-blockers, and what is the magnitude of such risk? (2) Are there important co-factors that predict elevated risk among certain subgroups of glaucoma patients, such as age, specific comorbidity, co-existing medication use, etc.? (3) Is there a clinically important difference between betaxolol and timolol in regard to the outcomes studied? (4) If differences in adverse effect risk are found in patients using these medications, what are its implications for practice in the care of glaucoma patients?
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