Jack Mardekian

Validity of 24-h recall ratings of pain severity : Biasing effects of Peak and End pain

&NA; Despite the frequent use of pain recall ratings in clinical research, there remains doubt about the ability of individuals to accurately recall their pain. In particular, previous research indicates the possibility that the most pain experienced during a recall period and the most recent pain experienced (known as peak and end effects, respectively) might bias recall ratings. The current study used data from a published clinical trial to determine the relative validity of a 24‐h recall rating of average post‐operative pain and the nature and extent of any biasing influence of peak and end effects on nine separate 24‐h recall ratings. The results supported a statistically significant but small biasing influence of both peak and end pain. Also, the influence of peak pain was stronger than that of end pain. However, the biasing impact of both peak and end pain together was very small, suggesting that 24‐h recall ratings are adequately valid indicants of average pain for patients participating in post‐surgery clinical pain trials.

Trends in utilization of lipid- and blood pressure-lowering agents and goal attainment among the U.S. diabetic population, 1999-2008.

BackgroundFor patients with diabetes, clinical practice guidelines recommend treating to a low-density lipoprotein cholesterol (LDL-C) goal of <2.59 mmol/L (100 mg/dL) and a blood pressure (BP) target of <130/80 mmHg. This analysis assessed recent trends in the utilization of lipid-lowering and BP-lowering agents, as well as LDL-C and BP goal attainment, in the U.S. adult diabetic population.Methods9,167 men and nonpregnant women aged ≥20 years were identified from the fasting subsample of the 1999-2008 National Health and Nutritional Examination Survey. Diabetes was identified in 1,214 participants by self report, self-reported use of insulin or oral medications for diabetes, or fasting glucose ≥6.99 mmol/L (126 mg/dL).ResultsThe prevalence of diagnosed or undiagnosed diabetes increased significantly over the past decade, from 7.4% in 1999-2000 to 11.9% in 2007-2008 (P = 0.0007). During this period, the use of lipid-lowering agents by participants with diabetes increased from 19.5% to 42.2% (P < 0.0001), and the proportion at LDL-C goal increased from 29.7% to 54.4% (P < 0.0001). Although there was a significant increase in antihypertensive medication use (from 35.4% to 58.9%; P < 0.0001), there was no significant change in the proportion of participants at BP goal (from 47.6% to 55.1%; P = 0.1333) or prevalence of hypertension (from 66.6% to 74.2%; P = 0.3724).ConclusionsThe proportion of diabetic individuals taking lipid- and BP-lowering agents has increased significantly in recent years. However, while there has been a significant improvement in LDL-C goal attainment, nearly one-half of all U.S. adults with diabetes are not at recommended LDL-C or BP treatment goals.

Evaluation of cardiovascular disease burden and therapeutic goal attainment in US adults with chronic kidney disease: an analysis of national health and nutritional examination survey data, 2001–2010

BackgroundFor chronic kidney disease (CKD) patients, national treatment guidelines recommend a low-density lipoprotein cholesterol (LDL-C) goal <100 mg/dL and blood pressure (BP) target <130/80 mmHg. This analysis assessed the current status of cardiovascular (CV) risk factor treatment and control in US adults with CKD.MethodsWeighted prevalence estimates of CV-related comorbidities, utilization of lipid- and BP-lowering agents, and LDL-C and BP goal attainment in US adults with CKD were assessed among 9,915 men and nonpregnant women aged ≥20 years identified from the fasting subsample of the 2001–2010 National Health and Nutritional Examination Survey (NHANES). Analyses were performed using SAS survey procedures that consider the complex, multistage, probability sampling design of NHANES. All estimates were standardized to the 2008 US adult population (≥20 years). Data were stratified by CKD stage based on presence of albuminuria and estimated glomerular filtration rate (eGFR), calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Stage 3 CKD was subdivided into 3a (eGFR 45–59 mL/min/1.73 m2) and 3b (eGFR 30–44 mL/min/1.73 m2); Stage 5 CKD and dialysis recipients were excluded.ResultsOf the 9,915 NHANES participants identified for analysis, 1,428 had CKD (Stage 1–4), corresponding to a prevalence estimate for US adults aged ≥20 years of 10.2%. Prevalence of CV-related comorbidities increased markedly with CKD stage, with a ~6–12-fold increase in cardiovascular disease, coronary heart disease (CHD), stroke and congestive heart failure between CKD Stage 1 and 4; prevalence of diabetes, hyperlipidemia and hypertension increased by ~1.2–1.6-fold. Use of lipid-lowering agents increased with CKD stage, from 18.1% (Stage 1) to 44.8% (Stage 4). LDL-C goal attainment increased from 35.8% (Stage 1) to 52.8% (Stage 3b), but decreased in Stage 4 (50.7%). BP goal attainment decreased between Stage 1 and 4 (from 49.5% to 30.2%), despite increased use of antihypertensives (from 30.2% to 78.9%).ConclusionsIndividuals with CKD have a high prevalence of CV-related comorbidities. However, attainment of LDL-C or BP goals was low regardless of disease stage. These findings highlight the potential for intensive risk factor modification to maximize CV event reduction in CKD patients at high risk for CHD.

Evaluation of cardiovascular morbidity associated with adherence to atorvastatin therapy.

Long-term adherence to statins is poor. We assessed the relationship between cardiovascular (CV) risk and atorvastatin adherence in primary- and secondary-prevention patients, adjusting for healthy-adherer bias by incorporating preventive service use into the model. Medical and pharmacy claims from employee-based plans from 2002 to 2008 were analyzed for patients who initiated atorvastatin in 2003–2004. Adherent patients were defined as having ≥60% of days covered in the year after atorvastatin initiation and were required to have pill coverage in months 10–12. CV events were identified as hospitalizations with a primary CV diagnosis and assessed from month 13 after atorvastatin initiation until the end of follow-up (≤36 months). Cox proportional hazards models were used to examine the association between atorvastatin adherence and CV event risk, adjusting for covariates including preventive service use. The study included 94,287 atorvastatin users (79,010 primary- and 15,277 secondary-prevention patients). In both populations, nearly one-half of the patients discontinued atorvastatin after 1 year. During follow-up, ∼2% of primary-prevention and ∼9% of secondary-prevention patients experienced CV events. After adjusting for covariates, adherent patients in the primary-prevention population had a significantly lower risk of CV events compared with nonadherent patients (hazard ratio, 0.82; 95% confidence interval, 0.74–0.91). In the secondary-prevention population, adherence to atorvastatin was also associated with lower CV risk (hazard ratio, 0.74; 95% confidence interval, 0.66–0.82). Atorvastatin discontinuation rates were high 1 year after treatment initiation. Patients who adhered to atorvastatin treatment were at lower CV risk. Quality-of-care interventions should target improvements to therapy persistence.

Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: a "real-world" observational study in the United States

Limited data are available about the real‐world safety of non‐vitamin K antagonist oral anticoagulants (NOACs).

Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in "real-world" clinical practice: a propensity-matched analysis of 76,940 patients

Summary The ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA 2 DS 2 -VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59–0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54–0.65) than warfarin initiators. Different types of stroke/SE and major bleeding – including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding – were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA 2 DS 2 -VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest “real-world” study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard-and low-dose apixaban dose regimens. Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief. Supplementary Material to this article is available online at www.thrombosis-online.com .

Identifying Fibromyalgia‐Associated Symptoms and Conditions from a Clinical Perspective: A Step Toward Evaluating Healthcare Resource Utilization in Fibromyalgia

Objective:  The study aims to determine from the physicians perspective, the conditions and symptoms most relevant to the diagnosis of fibromyalgia (FM) for identifying International Classification of Diseases‐diagnosis codes and prescription medications to evaluate FM‐related healthcare resource utilization.

Prevalence of Diagnosed Opioid Abuse and its Economic Burden in the Veterans Health Administration

Evaluate prevalence and risk‐adjusted healthcare costs of diagnosed opioid abuse in the national Veterans Health Administration (VHA). Costs were compared between patients with and without diagnosed opioid abuse.

The prevalence of diagnosed opioid abuse in commercial and Medicare managed care populations.

To measure the prevalence of diagnosed opioid abuse and prescription opioid use in a multistate managed care organization.

Healthcare utilization and costs in diabetes relative to the clinical spectrum of painful diabetic peripheral neuropathy.

AIMS Diabetic peripheral neuropathy (DPN) accompanied by painful symptoms is known as painful DPN (pDPN). This study characterized healthcare resource utilization and costs in patients with DPN, pDPN, and severe pDPN relative to diabetes only. METHODS Four adult cohorts were identified from the Humedica database: type 2 diabetes without DPN (n=288,328); DPN (n=35,050); pDPN (DPN subjects with a pain score ≥1 on a 0-10 numeric rating scale; n=3449); and severe pDPN (pain scores 7-10; n=1824). Resource utilization and costs for 12-months post-diagnosis were compared for diabetes relative to the other cohorts. RESULTS Demographic characteristics were different across cohorts. Relative to diabetes alone, DPN, pDPN, and severe pDPN were characterized by significantly higher proportions of patients with resource utilization for all resource categories (all P<0.0001); the highest resource use generally observed for severe pDPN. Total annual direct medical costs were