Dima M. Qato

National Trends in Oral Anticoagulant Use in the United States, 2007 to 2011

Background—Little is known regarding the adoption of direct thrombin inhibitors in clinical practice. We examine trends in oral anticoagulation for the prevention of thromboembolism in the United States. Methods and Results—We used the IMS Health National Disease and Therapeutic Index, a nationally representative audit of office-based providers, to quantify patterns of oral anticoagulant use among all subjects and stratified by clinical indication. We quantified oral anticoagulant expenditures using the IMS Health National Prescription Audit. Between 2007 and 2011, warfarin treatment visits declined from ≈2.1 million (M) quarterly visits to ≈1.6M visits. Dabigatran use increased from 0.062M quarterly visits (2010Q4) to 0.363M visits (2011Q4), reflecting its increasing share of oral anticoagulant visits from 3.1% to 18.9%. In contrast to warfarin, the majority of dabigatran visits have been for atrial fibrillation, though this proportion decreased from 92% (2010Q4) to 63% (2011Q4), with concomitant increases in dabigatran’s off-label use. Among atrial fibrillation visits, warfarin use decreased from 55.8% visits (2010Q4) to 44.4% (2011Q4), whereas dabigatran use increased from 4.0% to 16.9%. Of atrial fibrillation visits, the fraction not treated with any oral anticoagulants has remained unchanged at ≈40%. Expenditures related to dabigatran increased rapidly from

Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011

16M in 2010Q4 to

Sexuality Among Middle-Aged and Older Adults With Diagnosed and Undiagnosed Diabetes: A national, population-based study

166M in 2011Q4, exceeding expenditures on warfarin (

Medication Data Collection and Coding in a Home-Based Survey of Older Adults

144M) in 2011Q4. Conclusions—Dabigatran has been rapidly adopted into ambulatory practice in the United States, primarily for treatment of atrial fibrillation, but increasingly for off-label indications. We did not find evidence that it has increased overall atrial fibrillation treatment rates.

Racial and ethnic disparities in cardiovascular medication use among older adults in the United States

IMPORTANCE Prescription and over-the-counter medicines and dietary supplements are commonly used, alone and together, among older adults. However, the effect of recent regulatory and market forces on these patterns is not known. OBJECTIVES To characterize changes in the prevalence of medication use, including concurrent use of prescription and over-the-counter medications and dietary supplements, and to quantify the frequency and types of potential major drug-drug interactions. DESIGN, SETTING, AND PARTICIPANTS Descriptive analyses of a longitudinal, nationally representative sample of community-dwelling older adults 62 to 85 years old. In-home interviews with direct medication inspection were conducted in 2005-2006 and again in 2010-2011. The dates of the analysis were March to November 2015. We defined medication use as the use of at least 1 prescription or over-the-counter medication or dietary supplement at least daily or weekly and defined concurrent use as the regular use of at least 2 medications. We used Micromedex to identify potential major drug-drug interactions. MAIN OUTCOMES AND MEASURES Population estimates of the prevalence of medication use (in aggregate and by therapeutic class), concurrent use, and major drug-drug interactions. RESULTS The study cohort comprised 2351 participants in 2005-2006 and 2206 in 2010-2011. Their mean age was 70.9 years in 2005-2006 and 71.4 years in 2010-2011. Fifty-three percent of participants were female in 2005-2006, and 51.6% were female in 2010-2011. The use of at least 1 prescription medication slightly increased from 84.1% in 2005-2006 to 87.7% in 2010-2011 (P = .003). Concurrent use of at least 5 prescription medications increased from 30.6% to 35.8% (P = .02). While the use of over-the-counter medications declined from 44.4% to 37.9%, the use of dietary supplements increased from 51.8% to 63.7% (P < .001 for both). There were clinically significant increases in the use of statins (33.8% to 46.2%), antiplatelets (32.8% to 43.0%), and omega-3 fish oils (4.7% to 18.6%) (P < .05 for all). In 2010-2011, approximately 15.1% of older adults were at risk for a potential major drug-drug interaction compared with an estimated 8.4% in 2005-2006 (P < .001). Most of these interacting regimens involved medications and dietary supplements increasingly used in 2010-2011. CONCLUSIONS AND RELEVANCE In this study, the use of prescription medications and dietary supplements, and concurrent use of interacting medications, has increased since 2005, with 15% of older adults potentially at risk for a major drug-drug interaction. Improving safety with the use of multiple medications has the potential to reduce preventable adverse drug events associated with medications commonly used among older adults.

Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval

OBJECTIVE To describe sexual activity, behavior, and problems among middle-age and older adults by diabetes status. RESEARCH DESIGN AND METHODS This was a substudy of 1,993 community-residing adults, aged 57–85 years, from a cross-sectional, nationally representative sample (N = 3,005). In-home interviews, observed medications, and A1C were used to stratify by diagnosed diabetes, undiagnosed diabetes, or no diabetes. Logistic regression was used to model associations between diabetes conditions and sexual characteristics, separately by gender. RESULTS The survey response rate was 75.5%. More than 60% of partnered individuals with diagnosed diabetes were sexually active. Women with diagnosed diabetes were less likely than men with diagnosed diabetes (adjusted odds ratio 0.28 [95% CI 0.16–0.49]) and other women (0.63 [0.45–0.87]) to be sexually active. Partnered sexual behaviors did not differ by gender or diabetes status. The prevalence of orgasm problems was similarly elevated among men with diagnosed and undiagnosed diabetes compared with that for other men, but erectile difficulties were elevated only among men with diagnosed diabetes (2.51 [1.53 to 4.14]). Women with undiagnosed diabetes were less likely to have discussed sex with a physician (11%) than women with diagnosed diabetes (19%) and men with undiagnosed (28%) or diagnosed (47%) diabetes. CONCLUSIONS Many middle-age and older adults with diabetes are sexually active and engage in sexual behaviors similarly to individuals without diabetes. Women with diabetes were more likely than men to cease all sexual activity. Older women with diabetes are as likely to have sexual problems but are significantly less likely than men to discuss them.

Drug–Alcohol Interactions in Older U.S. Adults

OBJECTIVES To describe the collection, coding, and validity of medication data from the National Social Life, Health and Aging Project (NSHAP)-a survey of a national probability sample of adults aged 57-85 years. METHODS Medication data were collected during an in-home interview by direct observation using a computer-based log and included prescription, over-the-counter, and nutritional supplements. The Multum drug database was used for coding drug names and for mapping those names to therapeutic categories. Drugs not included in Multum were assigned to medication classes by extending Multums typology. Internal and external validity of the medication data are examined and analytic use of the medication data is discussed. RESULTS Only 0.9% of respondents refused to participate in the medication log. Ninety-nine percent of all entries were identified and mapped to a medication class. Use of medication classes correlated highly with the presence of corresponding health conditions and related biological measures. The prevalence of use of common therapeutic classes of medications in NSHAP is comparable to that found in other national studies. DISCUSSION Nearly all NSHAP respondents cooperated with the medication use data collection protocol. Medication data obtained by the in-home, direct observation medication log method were found to be internally and externally valid.

Improving the Food and Drug Administration's Mandate to Ensure Postmarketing Drug Safety

Despite persistent racial/ethnic disparities in cardiovascular disease (CVD) among older adults, information on whether there are similar disparities in the use of prescription and over‐the‐counter medications to prevent such disease is limited. We examined racial and ethnic disparities in the use of statins and aspirin among older adults at low, moderate, and high risk for CVD.

Effect of direct-to-consumer advertising on asthma medication sales and healthcare use

Evaluate dabigatran adverse event reports with a reported bleeding event and/or reported fatal outcome compared with warfarin.

Prevalence of Prescription Medications With Depression as a Potential Adverse Effect Among Adults in the United States

To characterize the extent and nature of drug–alcohol interactions in older U.S. adults.