Setareh A. Williams

Depression and risk of heart failure among the elderly: a prospective community-based study.

Objective Although the association between depression and the incidence of coronary heart disease has been established in many studies, the impact of depression on the incidence of heart failure has not been previously investigated. Methods We examined the effect of depression (assessed by means of the Center for Epidemiological Studies Depression Scale (CES-D) with a cutoff point of ≥21) on the incidence of heart failure in a community sample of persons aged ≥65 years who were participants in the New Haven cohort of the Established Populations for Epidemiological Studies in the Elderly. Results At baseline 2501 individuals were free of heart failure. Of these, 188 (132 women and 56 men) scored as depressed. Depressed participants were significantly more likely to have hypertension, diabetes, and mobility-related functional limitations and were less likely to be male or married. During the 14-year follow-up period, 313 participants (146 men and 167 women) developed heart failure, defined as hospital admission for heart failure or mortality with heart failure as the underlying cause of death. After adjusting for baseline differences in demographic and comorbidity factors and functional status using Cox regression, depression tended to be associated with a greater risk of heart failure (hazard ratio (HR) = 1.52, 95% confidence interval (CI) = 0.94–2.43, p = .09). This effect was significant in women (HR = 1.96, 95% CI = 1.11–3.46, p = .02) but not in men (HR = 0.62, 95% CI = 0.23–1.71, p = .05 for the interaction term between sex and depression). Conclusions Depression is an independent risk factor for heart failure among elderly women but not elderly men.

Patient-reported tolerability issues with oral antidiabetic agents: Associations with adherence; treatment satisfaction and health-related quality of life.

AIMS The studys aim was to quantify prevalence of tolerability issues among patients with T2DM currently treated with OADs and to assess its association with treatment adherence, satisfaction and health-related quality of life (HRQL). METHODS Data were collected from the 2006-2008 US National Health and Wellness Survey and the Ailment Panel of Lightspeed Online Research, an internet-based questionnaire. Participants (N=2074) self-reported a diagnosis of T2DM, were >18 years of age and currently taking >1 OADs but not insulin, and spoke English. RESULTS The majority (71.7%) experienced at least 1 tolerability issue in the past 2 weeks; 49.7% experienced >2. Tolerability issues included signs/symptoms of hypoglycemia (57.2%), constipation/diarrhea (28%), headaches (25.6%), weight gain (22.9%) and water retention (21.0%). There was a significant association between the number of tolerability issues and both the likelihood of non-adherence (r=0.20, p<0.01) and reduced treatment satisfaction (r=-0.42, p<0.01). Each additional tolerability issue was associated with 28% greater likelihood of medication non-adherence. Constipation/diarrhea (b=-0.02, p<0.01) and symptoms of hypoglycemia (b=-0.08, p<0.01) were significantly associated with lower HRQL scores. CONCLUSIONS Optimizing OAD therapy of T2DM by improving tolerability may increase patient satisfaction, medication adherence and HRQL, and may increase the likelihood of attaining treatment goals.

The association between asthma control and health care utilization, work productivity loss and health-related quality of life.

Objective: To determine the association between asthma control and health outcomes. Methods: Cross-sectional data on asthmatic patients were from the 2006 U.S. National Health and Wellness Survey. Asthma control was determined by the Asthma Control Test. Outcomes assessed included work productivity loss/activity impairment, health-related quality of life, and resource utilization. Effects of asthma control on outcomes were determined with linear and Poisson regression models. Results: There were 2767 uncontrolled asthmatics and 2912 controlled asthmatics. Adjusting for confounders, controlled asthmatics reported (P < 0.001) higher physical and mental health-related quality of life scores (SF-8); fewer emergency room visits, hospitalization days, and medical provider visits; lower levels of overall work productivity loss and activity impairment. Conclusion: Results indicate that asthma control is associated with better health outcomes. Management with therapies optimizing asthma control may reduce direct and indirect costs of treatment.

Effects of hypoglycemia on health-related quality of life, treatment satisfaction and healthcare resource utilization in patients with type 2 diabetes mellitus

AIMS To quantify patient-reported rates of hypoglycemia and its association with health-related quality of life (HRQL), treatment satisfaction, and healthcare resource utilization. METHODS Data were collected from 2006 to 2008 US National Health and Wellness Survey and the Ailment Panel of Lightspeed Online Research, an internet-based questionnaire. Adults (≥ 18 years) with type 2 diabetes taking ≥ 1 oral antidiabetic agent (OAD), but not insulin, were included (n=2074). Multivariate analyses included logistic regression and generalized linear models. RESULTS Overall, patients who reported experiencing hypoglycemia symptoms (n=286; 13.78%) were significantly more likely to have a lower HRQL on several parameters including: increased limitations on mobility (b=0.66, OR=1.93, p<0.0001) and usual activities (b=0.58, OR=1.78, p<0.0001), increased pain/discomfort (b=0.69, OR=2.00, p<0.0001) and anxiety/depression (b=0.84, OR=2.31, p<0.0001). They also had a lower total treatment satisfaction score as measured by the DiabMedSat tool (b=-7.66, p<0.0001). Self-reported rates of diabetes-related emergency room (b=0.98, p=0.004) and physician visits (b=0.30, p<0.0001) were also higher among these patients. CONCLUSION Among OAD-treated type 2 diabetes patients, symptoms of hypoglycemia tend to be correlated with significantly lower HRQL, lower treatment satisfaction and higher levels of healthcare resource utilization.

A retrospective cohort study of correlates of response to pharmacologic therapy for hyperlipidemia in members of a managed care organization.

BACKGROUND Few studies have examined the effectiveness of statins in a managed care setting. OBJECTIVE The aim of this study was to identify demographic, clinical, and pharmacotherapy-related factors associated with response to drug therapy for hyperlipidemia among members of a managed care organization. METHODS Claims data from a large US managed care organization from July 1, 1998, through June 30, 2000, were analyzed for adult members with continuous enrollment, >or=1 prescription drug claim, >or=2 sets of fasting low-density lipoprotein cholesterol (LDL-C) laboratory results, and no lipid-lowering prescription claims at any time <or=12 months before the date of the first set of LDL-C laboratory results. Relative lipid-lowering regimen efficacy categories were created based on percentage reduction in LDL-C listed in product package inserts (low, <or=30%; moderate, 31%-40%; high, >or=41%). Multiple regression and logistic regression models were developed to identify significant predictors of percentage change in LDL-C from baseline and of >or=10% reduction in LDL-C. RESULTS A total of 6247 members met the inclusion criteria. The mean (SD) age was 59.6 (12.4) years (range, 21-93 years), and 3003 individuals (48.1%) were women. Furthermore, 337 members (5.4%) received high-efficacy statins, 2633 (42.1%) received moderate-efficacy statins, 934 (15.0%) received low-efficacy statins, and 86 (1.4%) received low-efficacy lipid-lowering drugs from other therapeutic classes during the study period. Compliance with therapy was high (range, 85%-92%), and upward titration of therapy was found in only 160 members (2.6%). Multiple regression analysis indicated that receiving statin therapy compared with other lipid-lowering therapy was a significant predictor of percentage reduction in LDL-C (P < 0.001). Logistic regression analysis indicated that compared with high-efficacy statin regimens, low-efficacy statin regimens (odds ratio [OR] = 0.619; 95% CI, 0.436-0.877) and low-efficacy regimens from other therapeutic classes (OR = 0.171; 95% CI, 0.099-0.295) were less effective in lowering LDL-C by >or=10%. Similar results were observed for subanalyses of subjects with diabetes mellitus or coronary heart disease (CHD); individuals who received more efficacious statin regimens were more likely to reach the National Cholesterol Education Program Adult Treatment Panel II LDL-C goal of <or=100 mg/dL (P < 0.05 for moderate- or low-efficacy regimens vs high-efficacy statins in each model). CONCLUSION The results of the present study suggest that improvement is needed in hyperlipidemia management, especially in identification and use of lipid-lowering therapy in individuals at high risk for CHD.

An evaluation of the effects of an angiotensin receptor blocker on health-related quality of life in patients with high-normal blood pressure (prehypertension) in the Trial of Preventing Hypertension (TROPHY).

The Trial of Preventing Hypertension (TROPHY) demonstrated the feasibility of possibly reducing the incidence of hypertension with the angiotensin receptor blocker candesartan compared with placebo. The long‐term benefits of pharmacologic therapy in high‐normal blood pressure, or prehypertension are not known, and the long‐term effect on health‐related quality of life (HRQL) has not been determined. An analysis of covariance model was used to assess treatment differences from baseline in the HRQL scores using Short Form (SF)‐36, and component measures at subsequent visits. Of the 809 randomized patients, 734 had both baseline and ≥1 HRQL follow‐up assessment: 95% (379 of 397) of patients receiving candesartan and 91% (355 of 388) of patients receiving placebo. There were no statistically significant between‐group differences in least‐squares mean physical component survey and mental component survey scores or the individual scales at each scheduled visit relative to baseline values (P >.05). In TROPHY, patients with prehypertension had relatively high baseline HRQL, and HRQL was maintained with the angiotensin receptor blocker candesartan over both the 2‐year treatment period and a total 4‐year trial period.

The relationship between patient-reported tolerability issues with oral antidiabetic agents and work productivity among patients having type 2 diabetes.

Objective: To investigate the association between reported oral antidiabetic tolerability issues and work productivity, activity impairment, and indirect costs. Methods: Data were collected from the 2006 to 2008 US National Health and Wellness Survey and the Lightspeed Research, using an Internet-based questionnaire (N = 2074). Results: Absenteeism, presenteeism, overall work impairment, and activity impairment increased as the number of tolerability issues increased. Similar results were observed using a diabetes-specific productively measure. Total annual adjusted indirect costs (absenteeism and presenteeism costs summed) were

A projection of the impact of lipid-lowering therapy on high-risk employee disability and medical costs.

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Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population.

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The Performance Gap between Clinical Trials and Patient Treatment for Dyslipidemia: A Comprehensive Review

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