Impact of lipoatrophy on quality of life in HIV patients receiving anti-retroviral therapy.

Metabolic and morphological side-effects occur in HIV-infected individuals receiving anti-retroviral treatment (ART). Peripheral fat loss that occurs particularly in the face, limbs and/or buttocks is referred to as lipoatrophy and has been found to be highly stigmatizing and to adversely impact the health-related quality of life (HRQL). Consumer Health Sciences Survey data collected between November 2003 and January 2006 were utilized to evaluate the impact of lipoatrophy on the HRQL in HIV-infected individuals receiving ART. This was evaluated using analysis of variance with item scores and mental component summary (MCS) and physical component summary (PCS) scores from the Medical Outcomes Trust questionnaire, SF-8 as dependent variables and lipoatrophy as the independent variable controlling for baseline age, sex and ethnicity. Clinical meaningfulness (mean difference divided by population standard deviation, delta/sigma) of differences between the groups with and without lipoatrophy was also evaluated. A cohort of 1124 subjects with at least six months of ART was selected based on the availability of data on whether or not lipoatrophy was present. Subjects were primarily male (80%), between the ages of 30 and 60 years (90%), Hispanic (37%) and about 25% each of African American and White. Overall, prevalence of lipoatrophy in this cohort of HIV patients was 18.9%. Statistically significant (p<0.001) differences in quality of life (as measured by SF-8 individual item scores and MCS and PCS scores) were observed between the two groups. The differences between the groups in item and summary scores were clinically meaningful in the small to near medium range (0.28-0.43). HIV-infected patients already experience a considerable deficiency in HRQL compared to general population; this study demonstrates that lipoatrophy further enhances that negative impact on HRQL.

Impact of change in high-density lipoprotein cholesterol from baseline on risk for major cardiovascular events.

INTRODUCTION: Low concentration of high-density lipoprotein cholesterol (HDL-C) has increasingly been recognized as a strong and independent predictor of cardiovascular risk. The aim of this study was to determine the association between change in HDL-C concentration from baseline and risk of a major cardiovascular event in a commercially insured population cohort with suboptimal HDL-C and low-density lipoprotein cholesterol (LDL-C) concentrations at baseline. METHODS: A retrospective longitudinal survival analysis was conducted using claims data from a large, commercial US health plan. To be included, patients had to be > or =50 years of age on the index date (laboratory test date between January 1, 2000 and December 31, 2003 on which both their LDL-C and HDL-C were not at goal), be continuously enrolled for a minimum of 6 months prior to and 12 months after the index date, and had to have at least one other laboratory panel result within 1 year prior to the cardiovascular event or study disenrollment. Cox proportional hazards analysis was conducted to assess the association between change in HDL-C concentrations and risk of a major cardiovascular event (defined as a > or =1-day hospitalization for a cardiovascular disease [CVD] diagnosis or an invasive cardiovascular procedure) within 5 years of the index date, after adjusting for covariates. RESULTS: A 0.026 mmol/L (1 mg/dL) increase in HDL-C from baseline was associated with a statistically significant 1.9% decreased risk of a major cardiovascular event (P<0.0001; hazard ratio: 0.981; 95% CI: 0.974, 0.989), after adjustment for covariates. CONCLUSION: Our finding of an inverse association between change in HDL-C concentrations and risk of a major cardiovascular event confirms previously reported results. Increasing HDL-C concentrations may serve as an effective measure for preventing future cardiovascular events.

Association between HDL-C concentration and risk for a major cardiovascular event.

OBJECTIVE: To determine the association between baseline HDL-C concentrations and risk of a major cardiovascular event (within 5 years) in a large US claims database. METHODS: A retrospective longitudinal analysis using claims data from the i3 Ingenix LabRx database was conducted. Patients were included if they had complete lipid panel lab results, were continuously enrolled for >or=6 months prior to and >or=12 months following the lab test (index date), and were >or=50 years of age. Cox proportional hazards analysis assessed the association between HDL-C concentrations and risk of a major cardiovascular event within 5 years of the index date, after adjusting for covariates. RESULTS: There was a statistically significant association between HDL-C and risk of a major cardiovascular event. A 0.026 mmol/L (1 mg/dL) increase in HDL-C from baseline was associated with a 1.3% decreased risk of a major cardiovascular event (e.g., a 0.13 mmol/L [5 mg/dL] increase in HDL-C above baseline concentrations was associated with a 6.5% decrease). This association became evident within 1 year of follow-up. CONCLUSIONS: HDL-C concentrations were inversely associated with the occurrence of cardiovascular events within 5 years. Women who were >or=0.26 mmol/L (10 mg/dL) below their target concentrations had cardiovascular risk similar to that of women with baseline ischemic heart disease and hypertension, and men who were >or=0.26 mmol/L (10 mg/dL) below their target concentrations had cardiovascular risk similar to that of men with baseline cardiovascular disease, diabetes, or cerebrovascular disease. Limitations inherent to claims-based analyses must be considered when interpreting these findings, such as the potential for miscoding or incomplete data, and the fact that the presence of a diagnosis code on a medical claim is not positive presence of disease. Furthermore, patients who suffered a fatal cardiovascular event at home during the study period, and therefore did not receive treatment, were not captured in this analysis.

Utilization pattern of etanercept and its cost implications in moderate to severe psoriasis in a managed care population.

OBJECTIVE: To describe the utilization patterns, particularly dosage-escalation patterns, and economic implications of etanercept in the treatment of moderate to severe psoriasis in a real-world setting. METHODS: Patients with psoriasis receiving etanercept were identified from the Integrated Health Care Information Services database and were observed for 12 months or until etanercept discontinuation (defined as gap of >60 days between prescriptions). Patients were excluded if they had other autoimmune conditions or received TNF antagonists within 6 months of the index date. Ratios of patients with dosage increase to total sample were calculated. Among patients continuing treatment for 1 year, etanercept dosage and drug costs (measured by average wholesale price) were compared for patients with and without dosage increase using the Wilcoxon signed rank test. RESULTS: 55.2% of patients discontinued during the study year; 51.6% of patients initiated at 100 mg/week; and 34.8% who initiated at 50 mg/week required dosage increases. Among patients continuously treated for 1 year, dosage increase resulted in incremental annual drug costs of $8,440 and $9,313 for 100 and 50 mg/week, respectively (both p < 0.0001). The annual dosage of etanercept in excess of the labeled amount translated into $2,040 and $3,032 greater etanercept costs per patient in the 100 and 50 mg/week groups, respectively. CONCLUSION: In this analysis, 33-50% of patients with psoriasis required dosage increases during their first year of etanercept therapy, resulting in increased annual treatment costs as compared with expected costs imputed from label indications. Because of patient selection criteria, the findings may not be representative of the entire population of patients with psoriasis.