Aging, comorbidity, and reduced rates of drug treatment for diabetes mellitus.

Advanced age and its related comorbidity may affect both the patterns and goals of diabetes treatment. We examined the relationships of demographic variables and comorbidity with drug treatment for diabetes in the elderly. We studied both the 81,700 residents of New Jersey, aged 65-99 years, who were hospitalized between July 1, 1989 and June 30, 1991 and had prescription drug coverage either through Medicaid or the Pharmacy Assistance for the Aged and Disabled program, and a sample of 80,000 nonhospitalized elderly beneficiaries in these programs. Rates of utilization of insulin or oral hypoglycemic drugs in the 120 days before admission were substantially lower in those aged > or = 85 or in nursing homes. Among patients with previously treated and diagnosed diabetes, the likelihood of treatment after discharge declined with older age (odds ratio [OR] for treatment in those aged > or =85 relative to 65-74 years: 0.57; 95% confidence interval [CI]: 0.45-0.72), nursing home residence (OR: 0.30; CI: 0.22-0.41), and higher levels of comorbidity (OR for modified Charlson index > or = 5 relative to 0: 0.43; CI: 0.27-0.67). In patients who had a discharge diagnosis of diabetes but no prior treatment, those in nursing homes and those with greater comorbidity also had lower rates of diabetes treatment after discharge. Although the prevalence of diabetes increases with age and the risks of many consequences of diabetes remain high, the rate of drug treatment for diabetes declines with older age and greater comorbidity, perhaps because of concern about side effects or reduced treatment benefits due to competing risks of death. Absence of data from randomized clinical trials of diabetes treatment in the elderly appears to have resulted in considerable physician ambivalence on the benefits and risks of glycemic control in older diabetics.

Definition of race and ethnicity in older people in Medicare and Medicaid.

BACKGROUND: Race and ethnicity are important predictors of health care access and outcomes, but quality of their documentation in the healthcare system is often problematic. OBJECTIVES: To study the agreement between Medicare and Medicaid descriptions of race and ethnicity in older beneficiaries. DESIGN: Quasiexperimental design in a natural practice setting. SETTING: New Jersey. PARTICIPANTS: 153,241 dually enrolled participants in Medicare and Medicaid. MEASUREMENTS: Agreement rates between administrative databases on recipients' race and ethnicity. RESULTS: Agreement between Medicare and Medicaid on the recipients' race and ethnicity was modest (kappa = .58; 95% CI, .57-.58) for men and women alike and across different age groups. Depending on whether Medicare or Medicaid was used as the reference standard, the relative agreement rates for race and ethnic group assignments varied. For example, using Medicare as the reference, the relative agreement rate was 84% for whites, 74% for blacks, 61% for others, 23% for Hispanics, and only 5% for Asians. Using Medicaid as the reference, a different pattern emerged. However, such gradients of agreement rates across racial groups were observed in both programs. Medicare and Medicaid reported different percentages of all race and ethnicity groups, with Medicaid reporting greater proportions of White and Black beneficiaries, and Medicare reporting greater proportions of Hispanic, Asian, and Other groups. CONCLUSIONS: Depiction of race and ethnicity data in large government health insurance programs is approximate at best and often contradictory from one program to another. This can impede efforts to study the relationship between these important characteristics and health care utilization and outcomes.

Agreement between drug treatment data and a discharge diagnosis of diabetes mellitus in the elderly.

The authors examined agreement between drug treatment data and a discharge diagnosis of diabetes, considered whether agreement was modified by demographic variables and measures of comorbidity, and evaluated construct validity through consideration of relations with subsequent mortality. The study sample comprised 81,700 residents of New Jersey aged 65-99 years who had prescription drug coverage either through Medicaid or that state's Pharmacy Assistance for the Aged and Disabled program and had at least one hospitalization between July 1, 1989, and June 30, 1991. In this population, 16.4% filled a prescription for insulin or an oral hypoglycemic agent during the 120 days before admission, and 16.3% had a discharge diagnosis of diabetes. Overall agreement between these two indicators was modest (kappa = 0.67, 95% confidence interval 0.66-0.67) and was weaker in those aged 85 years and above (kappa = 0.58, 95% confidence interval 0.56-0.60), those in nursing homes (kappa = 0.42, 95% confidence interval 0.39-0.44), and those with a high level of comorbidity (modified Charlson index > or =5; kappa = 0.59, 95% confidence interval 0.56-0.62). Presence of a diagnosis of diabetes was associated with an apparent 24% reduction in the risk of death during the study interval (p<0.001), while prior treatment for diabetes had little relation to mortality (p = 0.15). These paradoxical associations with mortality and the lower agreement between discharge diagnoses and drug treatments associated with older age, nursing home residence, and comorbidity suggest limitations in the use of claims data to identify diabetes in the elderly.

Prophylactic use of factor VIII: an economic evaluation.

BACKGROUND: Since the introduction of exogenous factor VIII therapy, several studies have explored the clinical benefits of prophylactic use of factor VIII. Little research, though, has focused on the economic aspects of this regimen. We conducted a cost analysis using data from the Orthopedic Outcomes Study, a prospective, cross-national study of the clinical outcomes associated with different patterns of factor VIII utilization to examine the health care costs incurred and expenditures averted in patients receiving on-demand versus prophylactic use of factor VIII in hemophilia. METHODS AND ANALYSIS: 831 patients with severe hemophilia aged 1 to 31 years, from 19 centers around the world were included in the cost analysis. Patients were categorized into three groups according to the number of weeks during the study years in which they received prophylactic regimens of factor VIII. For each subject, we estimated the costs of hospitalization, surgery, days lost from school or work, and factor VIII utilization. Costs were then stratified by age and by joint score to assess confounding, and a multivariate model developed to determine the relationship between use of factor VIII prophylaxis and total costs, while controlling for potential confounders. RESULTS: Patients who received factor VIII episodically incurred substantially greater disability-related costs (days lost from school or work, days hospitalized due to hemophilia, surgery) than patients who received factor VIII prophylactically for some or all of the study period. For all treatment regimens, most disability-related costs were accounted for by hospitalization for hemophilia-related conditions. The cost of factor VIII itself was substantial in all treatment categories but was highest among patients who received year-round prophylaxis, exceeding the savings resulting from reduced disability and other health care expenditures. CONCLUSIONS: Reductions in non-factor health care costs and disability associated with prophylactic use of factor VIII in hemophilia were substantial and helped somewhat to offset the much higher costs of this regimen. For certain subgroups, frequent episodic treatment may be more expensive than full-time prophylaxis. However, because of the very high cost of year-round prophylactic use of factor VIII, total health care expenditures were highest among patients receiving this therapeutic regimen. However, because prophylaxis clearly offers important clinical benefits, this approach may be warranted on medical rather than economic grounds.

The impact of ibuprofen on the efficacy of antihypertensive treatment with hydrochlorothiazide in elderly persons.

BACKGROUND: Nonsteroidal antiinflammatory drugs (NSAIDs) may alter blood pressure through their inhibitory effects on prostaglandin biosynthesis. Such potential hypertensive effects of NSAIDs have not been adequately examined in the elderly, who are the largest group of NSAID users. METHODS: We performed a randomized, double-blind, two-period crossover trial of ibuprofen (1800 mg per day) vs placebo treatment in patients older than 60 years of age with hypertension controlled with hydrochlorothiazide. While continuing their usual thiazide dosage, subjects were randomized to a 4-week treatment period (ibuprofen or placebo) followed by a 2-week placebo wash-out period and a second 4-week treatment period with the alternative therapy. Supine and standing systolic and diastolic blood pressures were measured weekly. RESULTS: Of 25 randomized subjects, 22 completed the study protocol (mean age = 73 +/- 6.7 years). Supine systolic blood pressure and standing systolic blood pressure were increased significantly with ibuprofen treatment, compared with placebo. Mean supine systolic blood pressures were 143.8 +/- 21.0 and 139.6 +/- 15.9 mmHg on ibuprofen and placebo, respectively (p = .004). Mean standing systolic blood pressures were 148.1 +/- 19.9 and 143.4 +/- 17.9 mmHg on ibuprofen and placebo, respectively (p = .002). CONCLUSION: We conclude that 1800 mg per day of ibuprofen does induce a significant increase in systolic blood pressure in older hypertensive patients treated with hydrochlorothiazide. NSAID therapy may negatively impact the control of hypertension in elderly patients.

Correlates of regular laxative use by frail elderly persons.

PURPOSE: To examine the demographic, clinical, and pharmacological correlates of regular laxative use in elderly persons residing in a long-term care setting. METHODS: This was a cross-sectional study using retrospective record review undertaken in an academically affiliated long-term care facility in the United States. All individuals residing in the institution for at least 1 month (n = 694) were characterized regarding use of laxatives. Regular laxative use was defined as more than 30 doses of laxatives, stool softeners, or enemas taken over the most recent 1-month period. RESULTS: Residents with regular laxative use (n = 349) were compared with those who received no laxatives (n = 227). Factors significantly associated with regular laxative use at the P < 0.05 significance level were simultaneously included in a multiple logistic regression model. Factors associated with regular laxative use were immobility, Parkinson's disease, diabetes mellitus, and use of iron supplements, calcium channel blockers, and antidepressants with moderate to strong anticholinergic properties. CONCLUSION: Regular laxative use is often associated with neurologic dysfunction that directly or indirectly affects the gut, or medications known to depress colonic motility. Identification of potentially modifiable correlates of regular laxative use in older individuals may suggest management strategies to avoid or reduce laxative, stool softener, and enema requirements, improve constipation symptoms, and enhance quality of life for the frail elderly population.

Epidemiologic and diagnostic aspects of bacteriuria: a longitudinal study in older women.

OBJECTIVE: To examine month-by-month variability of bacteriuria in a cohort of older women and to evaluate the performance of rapid diagnostic tests commonly used to indicate the presence of significant bacteriuria. DESIGN: Prospective, observational study. SETTING: Community housing sites and a long-term care institution. PARTICIPANTS: Sixty-one women, mean age 77.6, took part in the study. MEASUREMENTS: Midstream clean-catch urine samples and medical information on subjects were collected at baseline, and then monthly for 6 months. RESULTS: Bacteriuria alone (> or = 10(5) organisms per mL) occurred in 17% of all urine samples (28% of patients), bacteriuria with pyuria in 15% (26% of patients), and bacteriuria with symptoms in 3% (10% of patients). Spontaneous clearance of bacteriuria with pyuria was common (P = .30), as were new occurrences (P = .12) over 6 months of follow-up. For the outcome of bacteriuria with symptoms, sensitivity of urinary diagnostic tests such as bacteria and pyuria on microscopic analysis, and leukocyte esterase on dipstick testing, ranged from 79 to 93%. Negative predictive values of these tests approached 100%. CONCLUSIONS: Bacteriuria was a very common event, occurring in almost one-fifth of all urine samples and one-third of all subjects during 6 months of follow-up. Month-by-month follow-up indicates that the natural history of bacteriuria is marked by frequent spontaneous alternation between positive and negative events. The high negative predictive value of many simple diagnostic tests commonly used for urinary tract disease suggests that they can quickly and cost-effectively rule out bacteriuria in the older female patient.

Constipation: assessment and management in an institutionalized elderly population.

OBJECTIVES: To examine prescribing and utilization patterns of laxatives, stool softeners, and enemas in a large, long-term care facility, to compare self-reports of constipation with specific, bowel-related symptoms in residents of this facility, and to examine concordance between bowel symptoms reported by residents and the assessments of the nursing staff. DESIGN: Cross-sectional study. SETTING AND SUBJECTS: All individuals residing in an academically oriented long-term care facility in the United States for at least 1 month (n = 694). MEASUREMENTS: Clinical, functional, and medication data were abstracted from the medical and nursing records. Individual interviews regarding bowel-related symptoms were conducted with all able participants (n = 456 (66%)) and their respective primary nurses, and concordance was determined. The study definition of symptom-specific constipation was no more than 2 bowel movements per week and/or straining on more than 1 in 4 bowel movements. RESULTS: Fifty percent (n = 367) of all residents used at least 1 daily laxative, stool softener or enema during a 1-month study period. Over half of all laxative users (n = 200) took more than 60 doses per month. Stool softeners were most commonly prescribed, followed by saline laxatives, stimulant laxatives, hyperosmolar laxatives, and bulk laxatives. Forty-seven percent (n = 213) of the 456 interview responders reported constipation ("self-reporters"), but only 62% of self-reporters met the study criteria for symptom-specific constipation. Concordance between resident's and nurse's report regarding specific bowel symptoms was only fair to slight (kappa 0.12-0.38). Self-reporters of constipation took almost twice as many laxatives, stool softeners, and enemas as residents who did not report constipation.

Reduction of bacteriuria and pyuria after ingestion of cranberry juice.

OBJECTIVE: To determine the effect of regular intake of cranberry juice beverage on bacteriuria and pyuria in elderly women. DESIGN: Randomized, double-blind, placebo-controlled trial. SUBJECTS: Volunteer sample of 153 elderly women (mean age, 78.5 years). INTERVENTION: Subjects were randomly assigned to consume 300 mL per day of a commercially available standard cranberry beverage or a specially prepared synthetic placebo drink that was indistinguishable in taste, appearance, and vitamin C content but lacked cranberry content. OUTCOME MEASURES: A baseline urine sample and six clean-voided study urine samples were collected at approximately 1-month intervals and tested quantitatively for bacteriuria and the presence of white blood cells. RESULTS: Subjects randomized to the cranberry beverage had odds of bacteriuria (defined as organisms numbering > or = 10(5)/mL) with pyuria that were only 42% of the odds in the control group (P = .004). Their odds of remaining bacteriuric-pyuric, given that they were bacteriuric-pyuric in the previous month, were only 27% of the odds in the control group (P = .006). CONCLUSIONS: These findings suggest that use of a cranberry beverage reduces the frequency of bacteriuria with pyuria in older women. Prevalent beliefs about the effects of cranberry juice on the urinary tract may have microbiologic justification.

Topical glaucoma medications and cardiovascular risk in the elderly.

OBJECTIVE: To determine the frequency of congestive heart failure and cardiac conduction disturbances in elderly patients treated with topical glaucoma medications. METHODS: These case-control studies were conducted among participants in the New Jersey Medicaid and Medicare program from 1986 to 1990. A total of 35,445 subjects (ages 65 to 99 years) were included in the congestive heart failure analysis, and 4278 subjects were included in the conduction disorder analysis. RESULTS: The frequency of initiation of congestive heart failure therapy, defined as the new use of digoxin or furosemide, was not increased for users of topical glaucoma medications. The frequency of pacemaker placement was also not increased for topical glaucoma medication users. Analyses were adjusted for age, race, gender, nursing home or hospital status, number of prescription medications, and selected medication exposures. Advanced age and heavy use of other prescription medications were associated with an increased likelihood of both cardiovascular outcomes. CONCLUSION: Major cardiovascular side effects did not occur at an increased rate among patients using topical beta-blockers or other glaucoma medications compared with control subjects. This population-based study places findings from case reports and small clinical trials in a broader context to help with clinical assessment of the risks and benefits of glaucoma therapy in the elderly.

Old age and race as determinants of initiation of glaucoma therapy.

Demographic differences in the prevalence of blindness may be partly due to undertreatment of susceptible population subgroups. The authors examined the relation of age, race, and other demographic characteristics with initiation of treatment for glaucoma and compared treatment rates with expected rates based on known disease prevalence. Data were from Medicaid enrollees aged 65-99 years in New Jersey between March 1981 and February 1990. Based on review of all claims for prescription medications and laser and incisional surgery, there were 6,173 cases with at least 6 months of documented system eligibility before their initial treatment for glaucoma. The overall rate of new treatment was 11.5 cases per 1,000 person-years, and increased throughout the 1980s. The age-adjusted relative rate of new treatment was 1.58 times higher in blacks compared with whites; however, this was less than half the relative rate expected based on estimated relative incidence rates. Similarly, enrollees aged 70-99 years had only 7% to 27% higher treatment rates than those aged 65-69 years, substantially less than expected. Treatment for glaucoma was also less likely to be initiated in nursing home residents, compared with those living in the community. Blacks and the very old are much less likely to have treatment for glaucoma initiated than would be predicted based on the magnitude of disease burden in these populations.

Adverse pulmonary effects of topical Beta blockers used in the treatment of glaucoma.

We conducted a case-control study to measure the risk of pulmonary side effects following the use of topical glaucoma medications, particularly the beta blockers, and to identify patients at highest risk for such side effects. Patients over age 55 who were active users of the New Jersey Medicaid system during the years 1981-1989 composed the study population. Two case groups were identified: (a) 21,096 patients who began new use of bronchodilator medications and (b) 3,382 patients who were users of a xanthine bronchodilator or inhaled steroid whose regimen was intensified through addition of another medication (generally a sympathomimetic). Controls were Medicaid enrollees with documented use of the Medicaid system. Use of glaucoma medications was measured in the 45 days preceding occurrence of the outcome for cases, and during a comparable period for controls. We found no consistent association between ongoing glaucoma therapy and new use of a bronchodilator; a definitive null result was obtained for timolol (odds ratio = 0.95; 95% CI = 0.84-1.09). However, nonselective topical beta blockers remained commonly used among patients already on a bronchodilator regimen. Timolol users were 47% more likely to require addition of another class of bronchodilator than were patients using no glaucoma therapy (odds ratio = 1.47; 95% CI 1.04-2.09; p = 0.03). No increase in risk was found for other glaucoma drugs. These findings suggest that patients with bronchospasm requiring xanthines or inhaled steroids who are prescribed topical timolol for glaucoma may be at significantly increased risk of pulmonary symptom exacerbation requiring additional bronchodilator therapy. No risk was found for the initiation of bronchodilators in previously untreated patients.

Aging and the anticoagulant response to warfarin therapy.

OBJECTIVE: To assess the effect of aging on the anticoagulant response to warfarin. DESIGN: Retrospective cohort study. SETTING: A university hospital outpatient anticoagulation clinic. PATIENTS: All patients (n = 530) monitored in the anticoagulation clinic over a 10-year period (1980 to 1990). The 530 study patients had a mean age of 61.5 (+/- 14.7) years (age range, 12 to 90 years). The patients were stratified into four age groups: younger than 50 years (n = 97); 50 to 59 years (n = 107); 60 to 69 years (n = 149); and 70 years or older (n = 177). MEASUREMENTS: For each patient, a dose-adjusted mean prothrombin time ratio was calculated by dividing the mean prothrombin time ratio by the mean daily warfarin dose. RESULTS: Older patients were more likely to be female (P less than 0.001), to have more medical problems (P less than 0.001), to be taking more medications (P less than 0.001), and to weigh less than younger patients (P less than 0.001). Across age groups, there were no significant differences in the use of medications that potentiated or inhibited the anticoagulant effects of warfarin. The prothrombin time ratio, when adjusted for dose, was significantly increased in older patients (P less than 0.001). The increased anticoagulant response to warfarin seen with increasing patient age persisted even after simultaneously controlling for relevant demographic and clinical variables in a multivariate model. Other factors significantly associated with an increased sensitivity to warfarin included use of a medication with a potentiating interactive effect with warfarin, female gender, and overall medication use. Increased body weight and duration of warfarin use exceeding 6 months were found to be inversely related to anticoagulant response. CONCLUSION: The anticoagulant response to warfarin is exaggerated with advancing age. This finding emphasizes the need for close monitoring of older patients treated with warfarin therapy.

Effects of Medicaid drug-payment limits on admission to hospitals and nursing homes.

BACKGROUND: Many state Medicaid programs limit the number of reimbursable medications that a patient can receive. We hypothesized that such limitations may lead to exacerbations of illness or to admissions to institutions where there are no caps on drug reimbursements. METHODS: We analyzed 36 months of Medicaid claims data from New Hampshire, which had a three-drug limit per patient for 11 of those months, and from New Jersey, which did not. The study patients in New Hampshire (n = 411) and a matched comparison cohort in New Jersey (n = 1375) were Medicaid recipients 60 years of age or older who in a base-line year had been taking three or more medications per month, including at least one maintenance drug for certain chronic diseases. Survival (defined as remaining in the community) and time-series analyses were conducted to determine the effect of the reimbursement cap on admissions to hospitals and nursing homes. RESULTS: The base-line demographic characteristics of the cohorts were nearly identical. In New Hampshire, the 35 percent decline in the use of study drugs after the cap was applied was associated with an increase in rates of admission to nursing homes; no changes were observed in the comparison cohort (RR = 1.8; 95 percent confidence interval, 1.2 to 2.6). There was no significantly increased risk of hospitalization. Among the patients in New Hampshire who regularly took three or more study medications at base line, the relative risk of admission to a nursing home during the period of the cap was 2.2 (95 percent confidence interval, 1.2 to 4.1), and the risk of hospitalization was 1.2 (95 percent confidence interval, 0.8 to 1.6). When the cap was discontinued after 11 months, the use of medications returned nearly to base-line levels, and the excess risk of admission to a nursing home ceased. In general, the patients who were admitted to nursing homes did not return to the community. CONCLUSIONS: Limiting reimbursement for effective drugs puts frail, low-income, elderly patients at increased risk of institutionalization in nursing homes and may increase Medicaid costs.