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Helen Mogun

Publications and source records attributed to Helen Mogun.

14 recordsLinked to original sources

Statins and the risk of lung, breast, and colorectal cancer in the elderly.

BACKGROUND: Although most randomized trials and meta-analyses suggest a slight or no increase in the risk of cancer in statin users, results from observational studies have been conflicting, and some have even suggested a large protective effect of statins on certain cancers. Long-term statin users tend to be healthier, less frail, and more adherent to therapy than nonusers, however. This could explain such apparent "protective" effects. METHODS AND RESULTS: We conducted the present cohort study by linking data from a large state drug benefit program with cancer registry data and Medicare healthcare utilization data. We identified all initiators of statins; initiators of glaucoma medications, another preventive drug, served as a comparison group. Outcomes included all registry-identified cases of colorectal, lung, and breast cancer. Multivariable Cox proportional models were used to adjust for confounding. Patient characteristics were similar in both groups, but statin initiators (n=24,439) were slightly younger and used some services more frequently than glaucoma drug initiators (n=7284). The mean follow-up was 2.9 years, with the longest follow-up being 8.4 years. Incidence rates of colorectal, lung, and breast cancers in both groups were very similar to rates in the general population. Adjusted hazard ratios were 0.96 (95% CI, 0.70 to 1.31) for colorectal cancer, 1.11 (95% CI, 0.77 to 1.60) for lung cancer, and 0.99 (95% CI, 0.74 to 1.33) for breast cancer. CONCLUSIONS: These data from a large population of typical older patients who began using statins indicate that it is unlikely that statins confer a clinically important decrease or increase in the risk of colorectal, lung, or breast cancer over the durations studied.

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Prescription opioid use among older adults with arthritis or low back pain.

OBJECTIVE: To examine patterns of chronic opioid use in selected groups with arthritis and low back pain and compare them with patterns among persons with ischemic heart disease. METHODS: The study database consisted of Medicare beneficiaries who were enrolled in a drug benefit program for low-to-moderate income Pennsylvania residents. We identified selected patients who had a diagnosis of rheumatoid arthritis, osteoarthritis, chronic low back pain, or ischemic heart disease since 1995. Chronic opioid use, defined as at least six 30-day prescriptions in a year, was the endpoint of interest. We examined the proportion of patients meeting this definition during the period 1996-2001 and determined predictors based on multivariable Cox proportional hazards models. RESULTS: Four percent of subjects with rheumatoid arthritis used opioids chronically in 2001, compared with <1% in each of the other groups. There was no increase in the chronic use of opioids over the 6-year study period. Low-potency opioids were the most commonly prescribed preparations for chronic users from all patient groups. The prior use of medicines for psychiatric illness, including benzodiazepines or barbiturates, was associated with chronic prescription opioid use across all diagnoses. However, subjects with a prior diagnosis of psychiatric illness were less likely to receive chronic opioids. CONCLUSION: Chronic opioid use is relatively uncommon, even among older individuals with arthritis or low back pain. The proportion of these individuals receiving such medicines has not increased in the late 1990s. There seems to be a complex relationship between psychiatric medication use, psychiatric diagnoses, and the use of chronic opioids among these individuals.

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Cardiovascular outcomes in new users of coxibs and nonsteroidal antiinflammatory drugs: high-risk subgroups and time course of risk.

OBJECTIVE: Controversy persists regarding the cardiovascular risks of treatment with selective cyclooxygenase 2 inhibitors (coxibs) and nonselective nonsteroidal antiinflammatory drugs (NSAIDs). This study was undertaken to examine, in a large group of new users of coxibs and NSAIDs, the rate of cardiovascular events, their time course, and whether baseline cardiovascular risk modified the rate ratios (RRs) for future events. METHODS: This cohort study included Medicare beneficiaries who enrolled in a state-run prescription drug plan that fully covered NSAIDs and coxibs without restriction. All study patients started use of a coxib or NSAID after January 1, 1999. The primary composite end point was a hospital admission for either myocardial infarction or ischemic stroke. Predefined exposure groups included the 3 coxibs available in the US during the study period (celecoxib, rofecoxib, and valdecoxib), as well as oral formulations of diclofenac, ibuprofen, naproxen, and a composite of all other NSAIDs. We compared the rate of cardiovascular events associated with each of these agents with that in a reference group of patients who did not use NSAIDs or coxibs, but started other medications unrelated to cardiovascular risk. Daily exposure to all study drugs was assessed based on filled prescription data. A Cox proportional hazards model stratified on calendar year that included other baseline cardiovascular risk factors constituted the primary analysis. RESULTS: We identified 74,838 users of NSAIDs or coxibs, and 23,532 comparable users of other drugs comprised the reference group. Adjusted models demonstrated a significant elevation in the event rate for rofecoxib (RR 1.15, 95% confidence interval [95% CI] 1.06-1.25) and a significant reduction in the rate for naproxen (RR 0.75, 95% CI 0.62-0.92). No other coxib or NSAID was associated with a significant increase or decrease in cardiovascular event rate. The increased rate associated with rofecoxib was seen in the first 60 days of use (adjusted RR 1.14, 95% CI 1.01-1.29) and thereafter (adjusted RR 1.14, 95% CI 1.02-1.28). Kaplan-Meier event curves showed a similar pattern of risk (early and persistent separation of the event curves) among long-term rofecoxib users at low or high baseline cardiovascular risk. CONCLUSION: We found an increased cardiovascular event rate among users of rofecoxib, and a decreased rate with naproxen use. Other coxibs and NSAIDs did not appear to be associated with a difference in event rate compared with users of other drugs. The increase in rate associated with rofecoxib was seen within the first 60 days and persisted. There was no important modification of the event rate based on the patient's baseline cardiovascular risk.

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Risk of death in elderly users of conventional vs. atypical antipsychotic medications.

BACKGROUND: Recently, the Food and Drug Administration (FDA) issued an advisory stating that atypical antipsychotic medications increase mortality among elderly patients. However, the advisory did not apply to conventional antipsychotic medications; the risk of death with these older agents is not known. METHODS: We conducted a retrospective cohort study involving 22,890 patients 65 years of age or older who had drug insurance benefits in Pennsylvania and who began receiving a conventional or atypical antipsychotic medication between 1994 and 2003. Analyses of mortality rates and Cox proportional-hazards models were used to compare the risk of death within 180 days, less than 40 days, 40 to 79 days, and 80 to 180 days after the initiation of therapy with an antipsychotic medication. We controlled for potential confounding variables with the use of traditional multivariate Cox models, propensity-score adjustments, and an instrumental-variable analysis. RESULTS: Conventional antipsychotic medications were associated with a significantly higher adjusted risk of death than were atypical antipsychotic medications at all intervals studied (< or =180 days: relative risk, 1.37; 95 percent confidence interval, 1.27 to 1.49; <40 days: relative risk, 1.56; 95 percent confidence interval, 1.37 to 1.78; 40 to 79 days: relative risk, 1.37; 95 percent confidence interval, 1.19 to 1.59; and 80 to 180 days: relative risk, 1.27; 95 percent confidence interval, 1.14 to 1.41) and in all subgroups defined according to the presence or absence of dementia or nursing home residency. The greatest increases in risk occurred soon after therapy was initiated and with higher dosages of conventional antipsychotic medications. Increased risks associated with conventional as compared with atypical antipsychotic medications persisted in confirmatory analyses performed with the use of propensity-score adjustment and instrumental-variable estimation. CONCLUSIONS: If confirmed, these results suggest that conventional antipsychotic medications are at least as likely as atypical agents to increase the risk of death among elderly persons and that conventional drugs should not be used to replace atypical agents discontinued in response to the FDA warning.

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Effects of noncardiovascular comorbidities on antihypertensive use in elderly hypertensives.

Although the benefits of antihypertensive drugs have been clearly established, they remain underused by vulnerable older populations. We examined whether the presence of noncardiovascular comorbidity deters use of antihypertensives in elderly with hypertension. We conducted a retrospective cohort study among 51,517 patients > or =65 years of age in the Pennsylvania Pharmaceutical Assistance Contract for the Elderly (PACE) Program during 1999 and 2000. All were hypertensive and had diagnoses and used treatments during 1999 to qualify for entry into 1 of the following 5 mutually exclusive cohorts: asthma/chronic obstructive pulmonary disease (COPD), depression, gastrointestinal (GI) disorders, osteoarthritis, or none of the 4 comorbidities. Proportions using antihypertensives in 2000 were assessed. Logistic regression analysis was used to identify the independent effects on antihypertensive use of the 4 comorbidities of interest, sociodemographic characteristics, other cardiovascular and noncardiovascular comorbidity, and health care utilization variables. After adjustments in multivariable analyses, antihypertensive use was consistently lower in patients with asthma/COPD (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.40 to 0.47), depression (OR, 0.50; 95% CI, 0.45 to 0.55), GI disorders (OR, 0.59; 95% CI, 0.54 to 0.64), and osteoarthritis (OR, 0.63; 95% CI, 0.59 to 0.67) relative to those without these conditions. Reduced antihypertensive use was also associated with older age, female gender, white race, more severe other comorbidities, absence of some cardiovascular indications, hospitalizations, nursing home care, physician visits, and use of fewer other medications. Highly prevalent, noncardiovascular conditions appear to deter use of antihypertensives in elderly with hypertension.

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Identification of individuals with CKD from Medicare claims data: a validation study.

BACKGROUND: Medicare claims data might provide an efficient source for outcomes research in patients with chronic kidney disease (CKD). However, in the absence of laboratory data, one would need to identify patients with CKD from diagnosis codes associated with health care claims. The validity of this approach to identify patients with CKD has not been sufficiently studied. METHODS: From chart abstraction, we obtained the first serum creatinine measurement of 1,852 elderly Medicare beneficiaries upon hospitalization for myocardial infarction and estimated each patient's glomerular filtration rate. We then searched all Medicare claims of the preceding year for the presence of a diagnosis code for diabetic nephropathy, hypertensive nephropathy, chronic renal insufficiency, acute renal failure, and miscellaneous other renal diseases. Using the gold standard of an estimated glomerular filtration rate less than 60 mL/min/1.73 m2 (<1.00 mL/s/1.73 m2) for definition of CKD, we calculated the sensitivity, specificity, and positive and negative predictive values for each of these diagnoses and combinations of these diagnoses. RESULTS: The sensitivity of individual diagnosis algorithms ranged from 2.7% for diabetic nephropathy to 17.5% for miscellaneous. However, miscellaneous had a lower specificity (95.5%) than all other individual diagnosis algorithms (all > or =99%). Using combinations of these algorithms improved sensitivity up to 26.6%, but at the cost of lower specificity. Positive predictive values generally were high (85.7% to 97.5%), but negative predictive values were low (32.4% to 37.4%). CONCLUSION: High positive predictive values indicate that Medicare claims data can be used to accurately identify patients with CKD for study. However, the utility of such databases for comparison of patients with CKD versus lesser degrees of CKD is limited.

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Suboptimal antidepressant use in the elderly.

Ongoing changes in available agents and health care delivery systems have made it imperative to study the quality of antidepressant use in vulnerable and traditionally underserved elderly. We conducted a retrospective cohort study among 12,130 new antidepressant users aged > or =65 years with a recent diagnosis of depression in the Pennsylvania Pharmaceutical Assistance Contract for the Elderly Program from January 1, 1994, to December 31, 1999. Additional use information was available through Medicare data. Potentially hazardous antidepressant regimens were defined as use of highly anticholinergic agents or daily dosages in excess of geriatric prescribing guidelines. Low-intensity regimens were defined by lower than recommended daily dosages, too-short durations of therapy, or lack of follow-up. Of all elderly antidepressant users, 43.3% were taking suboptimal regimens. Potentially hazardous regimens were used by 11.9%, including 7.3% taking highly anticholinergic agents and 5.3% using excessively high daily dosages. Low-intensity regimens were used by 34.8% of patients, including 7.6% with excessively low daily dosages, 19.3% with short durations of therapy, and 14.8% with inadequate follow-up. Potentially hazardous regimens were associated with ages 65 to 74 years, nursing home residence, cancer diagnoses, less comorbidity, use of other psychiatric medications, making more physician visits, and earlier calendar years. Low-intensity regimens were associated with ages > or =85 years, nonwhite race, greater comorbidity, fewer physician visits or inpatient days in the baseline 6 months, and not using other psychiatric medications. Suboptimal antidepressant use remains common in the elderly, especially the use of inadequately intensive regimens. Interventions are needed to improve the quality and outcomes of antidepressant use in this vulnerable population.

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Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults.

BACKGROUND: Although cyclooxygenase-2 inhibitors (coxibs) were developed to cause less gastrointestinal hemorrhage than nonselective nonsteroidal antiinflammatory drugs (NSAIDs), there has been concern about their cardiovascular safety. We studied the relative risk of acute myocardial infarction (AMI) among users of celecoxib, rofecoxib, and NSAIDs in Medicare beneficiaries with a comprehensive drug benefit. METHODS AND RESULTS: We conducted a matched case-control study of 54 475 patients 65 years of age or older who received their medications through 2 state-sponsored pharmaceutical benefits programs in the United States. All healthcare use encounters were examined to identify hospitalizations for AMI. Each of the 10 895 cases of AMI was matched to 4 controls on the basis of age, gender, and the month of index date. We constructed matched logistic regression models including indicators for patient demographics, healthcare use, medication use, and cardiovascular risk factors to assess the relative risk of AMI in patients who used rofecoxib compared with persons taking no NSAID, taking celecoxib, or taking NSAIDs. Current use of rofecoxib was associated with an elevated relative risk of AMI compared with celecoxib (odds ratio [OR], 1.24; 95% CI, 1.05 to 1.46; P=0.011) and with no NSAID (OR, 1.14; 95% CI, 1.00 to 1.31; P=0.054). The adjusted relative risk of AMI was also elevated in dose-specific comparisons: rofecoxib < or =25 mg versus celecoxib < or =200 mg (OR, 1.21; 95% CI, 1.01 to 1.44; P=0.036) and rofecoxib >25 mg versus celecoxib >200 mg (OR, 1.70; 95% CI, 1.07 to 2.71; P=0.026). The adjusted relative risks of AMI associated with rofecoxib use of 1 to 30 days (OR, 1.40; 95% CI, 1.12 to 1.75; P=0.005) and 31 to 90 days (OR, 1.38; 95% CI, 1.11 to 1.72; P=0.003) were higher than >90 days (OR, 0.96; 95% CI, 0.72 to 1.25; P=0.8) compared with celecoxib use of similar duration. Celecoxib was not associated with an increased relative risk of AMI in these comparisons. CONCLUSIONS: In this study, current rofecoxib use was associated with an elevated relative risk of AMI compared with celecoxib use and no NSAID use. Dosages of rofecoxib >25 mg were associated with a higher risk than dosages < or =25 mg. The risk was elevated in the first 90 days of use but not thereafter.

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How well do patients report noncompliance with antihypertensive medications?: a comparison of self-report versus filled prescriptions.

PURPOSE: To address poor patient compliance with antihypertensives, clinicians and researchers need accurate measures of adherence with prescribed regimens. Although self-reports are often the only means available in routine practice, their accuracy and agreement with other data sources remain questionable. METHODS: A telephone survey was conducted on 200 hypertensive patients treated with a single antihypertensive agent in a large health maintenance organization (HMO) or a Veterans Affairs medical center (VAMC) to obtain self-reports of the frequency of missing antihypertensive therapy. We then analyzed records of all filled prescriptions to calculate the number of days that patients actually had antihypertensive medications available for use. Agreement between the two data sources was measured with correlation coefficients and kappa statistics. Logistic regression models were used to identify demographic, clinical and psychosocial correlates of overstating compliance. RESULTS: There was very poor agreement between self-reported compliance and days actually covered by filled prescriptions (Spearman correlation coefficient = 0.15; 95%CI: 0.01, 0.28). Very poor agreement was also observed between a categorical measure of self-reported compliance (ever vs. never missing a dose) and categories of actual compliance defined by filled prescriptions (< 80% vs > 80% of days covered; kappa = 0.12, 95%CI: -0.02, 0.26). Surprisingly, few factors were associated with inaccurate self-reporting in either crude or adjusted analyses; fewer visits to health care providers was significantly associated with overstating compliance. CONCLUSIONS: Compliance was markedly overstated in this sample of patients and few characteristics identified those who reported more versus less accurately. Clinicians and researchers who rely on self-reports should be aware of these limits and should take steps to enhance their accuracy.

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Use of the case-crossover design to study prolonged drug exposures and insidious outcomes.

PURPOSE: The case-crossover design was originally intended to study brief exposures with immediate and transient effects, and acute outcomes with abrupt onsets. We investigated whether case-crossover methods can be used to study prolonged exposures and insidious outcomes. METHODS: We conducted a case-crossover study of 8220 patients aged > or = 65 years enrolled in several health benefits programs in New Jersey during the period between 1991 and 1995. All had episodes of central nervous system (CNS) adverse events (e.g., delirium). Drug exposures were assessed during case time periods and control time periods lasting 1, 2, 3, or 4 months. Exposures included 3 active regimens with established deleterious CNS effects (corticosteroids, digoxin, and opiates) and 2 inactive regimens without such effects (multivitamins and statins). RESULTS: In conditional logistic regression models, significantly elevated risks were observed for all three active drugs, regardless of which time windows were used. The magnitude of these risks generally increased with longer time windows. No significantly increased risks were observed for the 2 inactive drugs, regardless of the window duration. CONCLUSIONS: These results suggest that with lengthened exposure assessment windows, case-crossover methods may be useful for studying exposures with prolonged effects and outcomes with insidious onsets.

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Trends in knee magnetic resonance imaging.

OBJECTIVE: To assess trends in knee magnetic resonance imaging (MRI) use and accompanying management changes to determine whether indications for this test have changed over time. DATA SOURCES: Large administrative database containing health care information for 587,010 people living in 1 state who were enrolled in the Medicare or Medicaid programs. They all had used health services during 3 consecutive years between 1991 to 1995. METHODS: We performed a retrospective cohort study examining the rates of lower extremity MRI in successive years and calculated the proportion of patients who were seen by a knee specialist or underwent knee surgery subsequent to the MRI. RESULTS: The annual rate of knee MRI was 1.4 per 1000 person-years in 1991 and increased by 140% to 3.4 per 1000 person-years by 1995 (P = 0.001). Approximately half of patients who underwent a knee MRI in 1991 had a diagnosis of internal derangement of the knee in the prior year; this figure dropped to 35% in 1995 (P < 0.001). The percentage of patients undergoing a knee MRI who had no record of any knee diagnosis in the prior year grew from 13% in 1991 to 33% in 1995 (P < 0.001). Over the 5 years of the study, the percentage of patients whose knee MRI was followed by specialist care or knee surgery decreased from 68% to 58%, a relative change of 15% (P < 0.005). CONCLUSION: Knee MRI use increased sharply during the study period, but the proportion of such patients who had a prior diagnosis of internal derangement or subsequently saw a knee specialist or underwent knee surgery decreased. This finding indicates that the criteria for knee MRI appear to have broadened substantially during this period.

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Noncompliance with antihypertensive medications: the impact of depressive symptoms and psychosocial factors.

OBJECTIVE: Addressing the epidemic of poor compliance with antihypertensive medications will require identifying factors associated with poor adherence, including modifiable psychosocial and behavioral characteristics of patients. DESIGN: Cross-sectional study, comparing measured utilization of antihypertensive prescriptions with patients' responses to a structured interview. STUDY POPULATION: Four hundred ninety-six treated hypertensive patients drawn from a large HMO and a VA medical center. DATA COLLECTION: We developed a survey instrument to assess patients' psychosocial and behavioral characteristics, including health beliefs, knowledge, and social support regarding blood pressure medications, satisfaction with health care, depression symptom severity, alcohol consumption, tobacco use, and internal versus external locus of control. Other information collected included demographic and clinical characteristics and features of antihypertensive medication regimens. All prescriptions filled for antihypertensive medications were used to calculate actual adherence to prescribed regimens in a 365-day study period. MAIN OUTCOME OF INTEREST: Adjusted odds ratios (ORs) of antihypertensive compliance, based on ordinal logistic regression models. RESULTS: After adjusting for the potential confounding effects of demographic, clinical, and other psychosocial variables, we found that depression was significantly associated with noncompliance (adjusted OR per each point increase on a 14-point scale, 0.93; 95% confidence interval [95% CI], 0.87 to 0.99); in unadjusted analyses, the relationship did not reach statistical significance. There was also a trend toward improved compliance for patients perceiving that their health is controlled by external factors (adjusted OR per point increase, 1.14; 95% CI, 0.99 to 1.33). There was no association between compliance and knowledge of hypertension, health beliefs and behaviors, social supports, or satisfaction with care. CONCLUSIONS: Depressive symptoms may be an underrecognized but modifiable risk factor for poor compliance with antihypertensive medications. Surprisingly, patient knowledge of hypertension, health beliefs, satisfaction with care, and other psychosocial variables did not appear to consistently affect adherence to prescribed regimens.

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Long-term persistence in use of statin therapy in elderly patients.

CONTEXT: Knowledge of long-term persistence with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy is limited because previous studies have observed patients for short periods of time, in closely monitored clinical trials, or in other unrepresentative settings. OBJECTIVE: To describe the patterns and predictors of long-term persistence with statin therapy in an elderly US population. DESIGN, SETTING, AND PATIENTS: Retrospective cohort study including 34 501 enrollees in the New Jersey Medicaid and Pharmaceutical Assistance to the Aged and Disabled programs who were 65 years of age and older, initiated statin treatment between 1990 and 1998, and who were followed up until death, disenrollment, or December 31, 1999. MAIN OUTCOME MEASURES: Proportion of days covered (PDC) by a statin in each quarter during the first year of therapy and every 6 months thereafter; predictors of suboptimal persistence during each interval (PDC <80%) were identified using generalized linear models for repeated measures. RESULTS: The mean PDC was 79% in the first 3 months of treatment, 56% in the second quarter, and 42% after 120 months. Only 1 patient in 4 maintained a PDC of at least 80% after 5 years. The proportion of patients with a PDC less than 80% increased in a log-linear manner, comprising 40%, 61%, and 68% of the cohort after 3, 12, and 120 months, respectively. Independent predictors of poor long-term persistence included nonwhite race, lower income, older age, less cardiovascular morbidity at initiation of therapy, depression, dementia, and occurrence of coronary heart disease events after starting treatment. Patients who initiated therapy between 1996-1998 were 21% to 25% more likely to have a PDC of at least 80% than those who started in 1990. CONCLUSIONS: Persistence with statin therapy in older patients declines substantially over time, with the greatest drop occurring in the first 6 months of treatment. Despite slightly better persistence among patients who began treatment in recent years, long-term use remains low. Interventions are needed early in treatment and among high-risk groups, including those who experience coronary heart disease events after initiating treatment.

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