Validation of the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) chronic kidney disease risk score in HIV-infected patients in the USA.

OBJECTIVES: The aim of the study was to assess the validity of an easy-to-calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. METHODS: PLWH (2002-2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco-Epidemiology Research and Analysis (OPERA® ) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft-Gault (C-G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to < 60 mL/min/1.73 m2 (stages 3-5). Poisson models estimated the association between CKD incidence and a one-point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. RESULTS: There were 19 444, 22 727 and 22 748 PLWH in the OPERA C-G, CKD-EPI and MDRD samples, respectively. The median (minimum-maximum) follow-up duration was 6.1 (0.3-9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2-15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person-years [95% confidence interval (CI) 6.8, 7.9 per 1000 person-years] in OPERA C-G to 11.0 (95% CI 10.4, 11.6 per 1000 person-years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c-statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. CONCLUSIONS: The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3-5) probability in an exclusively USA-based sample regardless of eGFR method.

Prevalence of clinical venous thromboembolism in the USA: current trends and future projections.

The U.S.-wide prevalence of venous thromboembolism (VTE) is unclear, with reported VTE incidence estimates varying widely. This retrospective analysis of healthcare claims data from patients in the Thomson Reuters national MarketScan(®) Commercial and Medicare databases (January 2002-December 2006) estimates the U.S. prevalence of VTE, and assesses associated temporal trends. Of 12.7 million study-eligible patients, 200,007 had VTE. The overall prevalence of VTE (cases per 100,000) increased by 33.1% during the study period: from 317 in 2002 to 422 in 2006. VTE was more prevalent in women than men throughout the study. The annual prevalence of VTE increased with age: 1,382 in patients ≥65 years versus 231 in patients <65 (2006 data). The number of U.S. adults with VTE is projected to more than double from 0.95 million in 2006 to 1.82 million in 2050. These data confirm that VTE remains a major healthcare burden in the US, particularly among the elderly, and highlight a continuing increase in prevalence of the disease. Greater efforts are required to improve awareness of VTE and improve standards of VTE prevention in healthcare organizations.

Clinical and economic outcomes with appropriate or partial prophylaxis.

INTRODUCTION: Despite the existence of evidence-based guidelines for venous thromboembolism (VTE) prevention, prophylaxis is often inappropriately prescribed. This study compared the efficacy, safety, and cost of appropriate (ACCP-recommended) prophylaxis with partial prophylaxis (not completely conforming to ACCP guidelines) in patients at-risk of VTE receiving enoxaparin or unfractionated heparin. METHODS: The MarketScan((R)) Hospital Drug Database from Thomson Reuters (January 2004-March 2007), was queried for medical and surgical patients at high risk of VTE, aged > or =40years, and with a hospital stay > or =6days. Univariate and multivariate analyses compared hospital-acquired VTE events, adverse events, and hospital costs between appropriate or partial prophylaxis discharges. RESULTS: Of the 21,001 discharge records included, appropriate prophylaxis was received by 5136 (24.5%) patients. Compared with partial prophylaxis, appropriate prophylaxis was associated with significantly lower incidences of hospital-acquired pulmonary embolism (0.9% vs 0.5%; adjusted odds ratio [OR] 0.55, 95% confidence intervals [CI] 0.35-0.87, P=0.010), and bleeding events (10.7% vs 5.1%; adjusted OR 0.57, 95% CI 0.50-0.66, P<0.001). Total costs per discharge were lower for appropriate prophylaxis ($17,386+/-12,004) than partial prophylaxis ($23,823+/-19,783) with an adjusted mean difference of $6370 in favor of appropriate prophylaxis (P<0.001). CONCLUSION: This retrospective study suggests that ACCP-guideline recommended appropriate prophylaxis reduces hospital-acquired pulmonary embolism and bleeding events in patients at-risk of VTE and is cost-saving when total direct medical costs are considered. The substantial US clinical and economic VTE burden may, therefore, be reduced by improving prophylaxis adherence with guideline recommendations.