Postdischarge Health Care Costs and Readmission in Patients With Hyperkalemia-Related Hospitalizations.

INTRODUCTION: Limited evidence is available regarding the postdischarge economic and readmission burdens of hyperkalemia. METHODS: Using the IBM MarketScan Commercial and Medicare-Supplemental Claims database (January 1, 2010-December 31, 2014), adult patients with a hospitalization with a hyperkalemia diagnosis (ICD-9-CM 276.7, hyperkalemia cohort) were 1:1 matched with patients with a hospitalization without evidence of hyperkalemia (nonhyperkalemia cohort) on age, chronic kidney disease stage, heart failure, dialysis, renin-angiotensin-aldosterone system inhibitor use, and major diagnostic categories of the hospitalization. All-cause health care costs and health care resource utilization measures were compared between cohorts during the 1-year postdischarge period. Postdischarge readmission and length of stay (LOS) were compared between hyperkalemia-related hospitalizations from the hyperkalemia cohort and matched hospitalizations unrelated to hyperkalemia from the nonhyperkalemia cohort. RESULTS: Patients with hyperkalemia-related hospitalizations (n = 4426) incurred $30,379 (95% confidence interval, $25,423-$35,335) higher 1-year total all-cause costs ($68,861 vs. $38,482) and had higher rates of inpatient admissions (1.0 vs. 0.4), emergency department visits (2.0 vs. 1.2), and outpatient visits (49.6 vs. 39.1) than the nonhyperkalemia cohort during the 1-year postdischarge study period (all P < 0.001). Hyperkalemia-related hospitalizations (n = 5377) were associated with significantly higher readmission rates (within 30 days: 0.15 vs. 0.09; 60 days: 0.25 vs. 0.16; 90 days: 0.36 vs. 0.23; all P < 0.001), longer LOS per readmission (8.1 vs. 7.1 days), and longer total inpatient days (10.5 vs. 5.8 days) compared with hospitalizations unrelated to hyperkalemia (all P < 0.001). Similar trends were observed across comorbidity subgroups. CONCLUSION: Hyperkalemia-related hospitalizations were associated with significant economic and readmission burdens during the 1-year postdischarge period.

Prevalence and economic burden of hyperkalemia in the United States Medicare population.

Objective: To estimate the prevalence and economic burden of hyperkalemia in the United States (US) Medicare population.Methods: Patients were selected from a 5% random sample of Medicare beneficiaries (01 January 2010-31 December 2014) to estimate the prevalence and economic burden of hyperkalemia. The prevalence for each calendar year was calculated as the number of patients with hyperkalemia divided by the total number of eligible patients per year. To estimate the economic burden of hyperkalemia, patients with hyperkalemia (cases) were matched 1:1 to patients without hyperkalemia (controls) on age group, chronic kidney disease [CKD] stage, dialysis treatment, and heart failure. The incremental 30-day and 1-year resource utilization and costs (2016 USD) associated with hyperkalemia were estimated.Results: The estimated prevalence of hyperkalemia was 2.6-2.7% in the overall population and 8.9-9.3% among patients with CKD and/or heart failure. Patients with hyperkalemia had higher 1-year rates of inpatient admissions (1.28 vs. 0.44), outpatient visits (30.48 vs. 23.88), emergency department visits (2.01 vs. 1.17), and skilled nursing facility admissions (0.36 vs. 0.11) than the matched controls (all p < .001). Patients with hyperkalemia incurred on average $7208 higher 30-day costs ($8894 vs. $1685) and $19,348 higher 1-year costs ($34,362 vs. $15,013) than controls (both p < .001). Among patients with CKD and/or heart failure, the 30-day and 1-year total cost differences between cohorts were $7726 ($9906 vs. $2180) and $21,577 ($41,416 vs. $19,839), respectively (both p < .001).Conclusions: Hyperkalemia had an estimated prevalence of 2.6-2.7% in the Medicare population and was associated with markedly high healthcare costs.

The Cost of Hyperkalemia in the United States.

INTRODUCTION: There are limited data on the cost of hyperkalemia. METHODS: This retrospective analysis of the Truven MarketScan claims database assessed the economic burden of hyperkalemia among selected adult patients with hyperkalemia and matched controls. RESULTS: A total of 39,626 cases (patients with hyperkalemia) were matched to 39,626 controls (patients without hyperkalemia) based on age, dialysis, chronic kidney disease (CKD) stage, heart failure, and renin-angiotensin aldosterone system inhibitor use. Compared with controls, cases incurred $4128 (95% confidence interval [CI] $3893-$4363) higher 30-day total health care costs ($5994 vs. $1865) and $15,983 (95% CI $15,026-$16,940) higher 1-year costs ($31,844 vs. $15,861). Among 11,221 matched pairs of patients with CKD and/or heart failure, cases incurred $5553 (95% CI $5059-$6047) higher 30-day total health care costs ($8165 vs. $2612) and $24,133 (95% CI $21,748-$26,518) higher 1-year costs ($48,994 vs. $24,861) than controls. The multivariable adjusted 1-year total health care cost difference was $15,606 (95% CI $14,648-$16,576) among all patients and $25,156 (95% CI $23,529-$26,757) among patients with CKD and/or heart failure. Cases had higher resource utilization rates including inpatient admissions (30-day: 0.14 vs. 0.03; 1-year: 0.44 vs. 0.19), outpatient visits (30-day: 3.33 vs. 2.28; 1-year: 26.58 vs. 18.53), and emergency department visits (30-day: 0.16 vs. 0.06; 1-year: 0.86 vs. 0.50) (all P < 0.001). When hospitalized, cases stayed 1.51 days (95% CI 1.22-1.80) longer and were 40% more likely to be readmitted. CONCLUSION: These data indicate that hyperkalemia is associated with a significant economic burden on afflicted patients and the health care system.

The prevalence of hyperkalemia in the United States.

OBJECTIVE: The retrospective study aimed to estimate prevalence of hyperkalemia using a large US commercial claims database. METHODS: Adults with serum potassium lab data (2010 to 2014) and ≥1 calendar year of data were included from a large US commercial claims database. Hyperkalemia was defined as ≥2 serum potassium measurements >5.0 mEq/L or one hyperkalemia diagnosis code (ICD-9-CM, 276.7) or one sodium polystyrene sulfonate fill. Hyperkalemia prevalence was estimated for the overall population and subgroups with hyperkalemia-related comorbidities by calendar year. Hyperkalemia prevalence was also standardized to the US population to estimate the number of US adults with hyperkalemia. RESULTS: The analysis included 2,270,635 patients (2010-2014). The annual prevalence of hyperkalemia in the overall population was 1.57% in 2014, with higher rates observed in patients with chronic kidney disease (CKD), heart failure, diabetes and hypertension. Among patients with CKD and/or heart failure, the 2014 annual prevalence was 6.35%. Among patients with hyperkalemia, 48.43% had CKD and/or heart failure in 2014. The prevalence of hyperkalemia was higher in patients with more severe CKD, as well as older patients and men. Extrapolating those results to the US population supports that 1.55% or 3.7 million US adults had hyperkalemia in 2014. CONCLUSIONS: An estimated 3.7 million US adults had hyperkalemia in 2014, and this prevalence rate has increased since 2010. In patients with CKD and/or heart failure, the annual prevalence of hyperkalemia was 6.35% in 2014, and about half of all patients with hyperkalemia have either CKD and/or heart failure.

PCSK9 Loss-of-Function Variants, Low-Density Lipoprotein Cholesterol, and Risk of Coronary Heart Disease and Stroke: Data From 9 Studies of Blacks and Whites.

BACKGROUND: PCSK9 loss-of-function (LOF) variants allow for the examination of the effects of lifetime reduced low-density lipoprotein cholesterol (LDL-C) on cardiovascular events. We examined the association of PCSK9 LOF variants with LDL-C and incident coronary heart disease and stroke through a meta-analysis of data from 8 observational cohorts and 1 randomized trial of statin therapy. METHODS AND RESULTS: These 9 studies together included 17 459 blacks with 403 (2.3%) having at least 1 Y142X or C679X variant and 31 306 whites with 955 (3.1%) having at least 1 R46L variant. Unadjusted odds ratios for associations between PCSK9 LOF variants and incident coronary heart disease (851 events in blacks and 2662 events in whites) and stroke (523 events in blacks and 1660 events in whites) were calculated using pooled Mantel-Haenszel estimates with continuity correction factors. Pooling results across studies using fixed-effects inverse-variance-weighted models, PCSK9 LOF variants were associated with 35 mg/dL (95% confidence interval [CI], 32-39) lower LDL-C in blacks and 13 mg/dL (95% CI, 11-16) lower LDL-C in whites. PCSK9 LOF variants were associated with a pooled odds ratio for coronary heart disease of 0.51 (95% CI, 0.28-0.92) in blacks and 0.82 (95% CI, 0.63-1.06) in whites. PCSK9 LOF variants were not associated with incident stroke (odds ratio, 0.84; 95% CI, 0.48-1.47 in blacks and odds ratio, 1.06; 95% CI, 0.80-1.41 in whites). CONCLUSIONS: PCSK9 LOF variants were associated with lower LDL-C and coronary heart disease incidence. PCSK9 LOF variants were not associated with stroke risk.

The Clinical and Economic Burden of Hyperkalemia on Medicare and Commercial Payers.

BACKGROUND: Hyperkalemia (serum potassium >5.0 mEq/L) may be caused by reduced kidney function and drugs affecting the renin-angiotensin-aldosterone system and is often present in patients with chronic kidney disease (CKD). OBJECTIVE: To quantify the burden of hyperkalemia in US Medicare fee-for-service and commercially insured populations using real-world claims data, focusing on prevalence, comorbidities, mortality, medical utilization, and cost. METHODS: A descriptive, retrospective claims data analysis was performed on patients with hyperkalemia using the 2014 Medicare 5% sample and the 2014 Truven Health Analytics MarketScan Commercial Claims and Encounter databases. The starting study samples required patient insurance eligibility during ≥1 months in 2014. The identification of hyperkalemia and other comorbidities required having ≥1 qualifying claims in 2014 with an appropriate International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code in any position. To address the differences between patients with and without hyperkalemia, CKD subsamples were analyzed separately. Mortality rates were calculated in the Medicare sample population only. The claims were grouped into major service categories; the allowed costs reflected all costs incurred by each cohort divided by the total number of member months for that cohort. RESULTS: The prevalence of hyperkalemia in the Medicare and commercially insured samples was 2.3% and 0.09%, respectively. Hyperkalemia was associated with multiple comorbidities, most notably CKD. The prevalence of CKD in the Medicare and the commercially insured members with hyperkalemia was 64.8% and 31.8%, respectively. After adjusting for CKD severity, the annual mortality rate for Medicare patients with CKD and hyperkalemia was 24.9% versus 10.4% in patients with CKD without hyperkalemia. The allowed costs in patients with CKD and hyperkalemia in the Medicare and commercially insured cohorts were more than twice those in patients with CKD without hyperkalemia. Inpatient care accounted for >50% of costs in patients with CKD and hyperkalemia. CONCLUSION: Hyperkalemia is associated with substantial clinical and economic burden among US commercially insured and Medicare populations.

Migraine Prophylaxis and Acute Treatment Patterns Among Commercially Insured Patients in the United States.

OBJECTIVES: To describe prophylactic and acute medication treatment patterns, including timing, medication type, and duration of use in migraine patients initiating prophylaxis. BACKGROUND: Patients with migraine can be treated with acute and prophylactic therapies. Current treatment options for migraine prophylaxis are associated with poor tolerability and low adherence and persistence. METHODS: This retrospective cohort study used the Truven Health Analytics MarketScan® Research Databases to identify adults in the United States with a migraine diagnosis who initiated migraine prophylactic medication (index event) between January 1, 2008, and December 31, 2011. Prescribed prophylactic medications evaluated included topiramate, beta-blockers, and tricyclic antidepressants. Patients were required to have 12 months of pre- and post-index continuous enrollment. Patient characteristics, migraine-specific prescribed prophylactic treatment patterns (including gaps in therapy, treatment switches, and additions of index medications), and prescribed acute medication utilization were assessed. RESULTS: The study population comprised 107,122 patients, with 52,275 (49%) initiating topiramate, 22,658 (21%) initiating beta-blockers, and 32,189 (30%) initiating tricyclic antidepressants. Mean (SD) age was 41 (12) years and 83% were female. Persistence with migraine prophylactic medication was low; 81% of patients had gaps of >90 days in their migraine prophylaxis in the first year. The gap in therapy occurred early in treatment (mean, 95 days), and only 10% of patients restarted prophylactic therapy within that year. Switching from index medication to another prophylactic medication or adding prophylaxis was uncommon (13% and 5%, respectively). One year after initiating prophylaxis, 65% of patients were not receiving any prophylactic therapies. Most patients initiating migraine prophylaxis also utilized acute treatments (81%); opioid use was more frequent than triptan use (53% vs 48%) and was common (40%) among patients without other chronic pain conditions (eg, arthritis, fibromyalgia, and lower back pain). CONCLUSION: Patients with migraine who initiated prophylactic therapy had poor persistence with early gaps in therapy, were unlikely to switch prophylactic treatments, and most discontinued prophylaxis by the end of the first year.

LDL cholesterol response and statin adherence among high-risk patients initiating treatment.

OBJECTIVES: The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol treatment guideline recommends monitoring percent reduction in low-density lipoprotein cholesterol (LDL-C) among patients initiating statins as an indication of response and adherence. We examined LDL-C reduction and statin adherence among high-risk patients initiating statins in a real-world setting. STUDY DESIGN: Retrospective cohort study. METHODS: The study population included Kaiser Permanente Georgia members (n = 1066) with a history of coronary heart disease or risk equivalent(s) initiating statins in 2011. Percent change in LDL-C was defined using measurements before and 60 to 450 days after statin initiation. Statin adherence was defined by proportion of days covered, categorized as high (≥80%), intermediate (50%-79%), and low (< 50%). RESULTS: Overall, 58.4% of patients failed to achieve a ≥ 30% LDL-C reduction after statin initiation. The prevalences of high, intermediate, and low statin adherence were 41.3%, 23.2%, and 35.6%, respectively. Of patients with high adherence, 42.3% did not achieve a ≥ 30% reduction in LDL-C compared with 54.7% and 79.7% of those with intermediate and low statin adherence, respectively. After multivariable adjustment, and compared with those with high adherence, the risk ratios for not achieving a ≥ 30% LDL-C reduction were 1.31 (95% CI, 1.13-1.52) and 1.88 (95% CI, 1.67-2.11), for those with intermediate and low adherence. Women and African Americans were less likely to have high adherence, whereas having cardiologist visits was associated with high adherence. CONCLUSIONS: In a real-world setting, many patients did not achieve a 30% or larger LDL-C reduction. These data support the ACC/AHA recommendation to monitor LDL-C response among patients initiating statins.

Characterizing the severe asthma population in the United States: claims-based analysis of three treatment cohorts in the year prior to treatment escalation.

OBJECTIVES: Little is known about the disposition of severe patients prior to treatment escalation. To classify patients by treatment step using pharmacy data and describe their economic and healthcare utilization, insurance status, and sociodemographic characteristics in the year prior to escalation to Global Initiative for Asthma (GINA) steps 4 and 5. METHODS: This was a retrospective claims cohort study of asthma patients (age 12-75 years) newly initiated on "stable therapy" (three consecutive months of therapy) with omalizumab, high intensity corticosteroids (HICS; ≥1000 µg/d inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; ≥500-<1000 µg/d fluticasone equivalent) from 2002 to 2011. Other asthma treatments were compared as a reference. RESULTS: Of 25,297 patients, 856 initiated omalizumab, 6926 initiated HICS, and 11,445 initiated HDICS. In the year prior to treatment escalation to omalizumab, HICS, and HDICS, respectively, individuals had high annual mean medical expenditures ($14,071, $12,030, and $7570), utilization (27 outpatient and 10 specialty care visits; 19 outpatient and three specialty; 15 outpatient and two specialty), asthma-related prescription drugs (11.74, 7.8, and 5.17) and chronic comorbidities (2.68, 2.67, and 2.19). Prior to omalizumab treatment, patients were more likely to be salaried, full-time employees with commercial PPO/POS insurance. CONCLUSIONS: Prior to escalating treatment to GINA steps 4 and 5, individuals experienced significant annual medical expenditures, healthcare resource utilization and polypharmacy burden, which may reflect poorly controlled asthma and the need to escalate treatment. Medical claims data and utilization-based measures may be helpful in classifying individuals by GINA treatment step.

Statin underuse and low prevalence of LDL-C control among U.S. adults at high risk of coronary heart disease.

BACKGROUND: Statins reduce the risk of coronary heart disease (CHD) in individuals with a history of CHD or risk equivalents. A 10-year CHD risk >20% is considered a risk equivalent but is frequently not detected. Statin use and low-density lipoprotein cholesterol (LDL-C) control were examined among participants with CHD or risk equivalents in the nationwide Reasons for Geographic and Racial Differences in Stroke study (n = 8812). METHODS: Participants were categorized into 4 mutually exclusive groups: (1) history of CHD (n = 4025); (2) no history of CHD but with a history of stroke and/or abdominal aortic aneurysm (AAA) (n = 946); (3) no history of CHD or stroke/AAA but with diabetes mellitus (n = 3134); or (4) no history of the conditions in (1) through (3) but with 10-year Framingham CHD risk score (FRS) >20% calculated using the third Adult Treatment Panel point scoring system (n = 707). RESULTS: Statins were used by 58.4% of those in the CHD group and 41.7%, 40.4% and 20.1% of those in the stroke/AAA, diabetes mellitus and FRS >20% groups, respectively. Among those taking statins, 65.1% had LDL-C <100 mg/dL, with no difference between the CHD, stroke/AAA, or diabetes mellitus groups. However, compared with those in the CHD group, LDL-C <100 mg/dL was less common among participants in the FRS >20% group (multivariable adjusted prevalence ratio: 0.72; 95% confidence interval: 0.62-0.85). Results were similar using the 2013 American College of Cardiology/American Heart Association cholesterol treatment guideline. CONCLUSIONS: These data suggest that many people with high CHD risk, especially those with an FRS >20%, do not receive guideline-concordant lipid-lowering therapy and do not achieve an LDL-C <100 mg/dL.

Declines in coronary heart disease incidence and mortality among middle-aged adults with and without diabetes.

PURPOSE: The purpose of the study was to investigate secular changes in coronary heart disease (CHD) incidence and mortality among adults with and without diabetes and to determine the effect of increased lipid-lowering medication use and reductions in low-density lipoprotein cholesterol (LDL-C) levels on these changes. METHODS: We analyzed data on participants aged 45 to 64 years from the Atherosclerosis Risk in Communities Study in 1987-1996 (early period) and the Reasons for Geographic and Racial Differences in Stroke Study in 2003-2009 (late period). Hazard ratios (HRs) for the association of diabetes and period with incident CHD and CHD mortality were obtained after adjustment for sociodemographics cardiovascular risk factors, lipid-lowering medication use, and LDL-C. RESULTS: After multivariable adjustment, diabetes was associated with an increased CHD risk during the early (HR = 1.99, 95% confidence interval = 1.59-2.49) and late (HR = 2.39, 95% confidence interval = 1.69-3.35) periods. CHD incidence and mortality declined between the early and late periods for individuals with and without diabetes. Increased use of lipid-lowering medication and lower LDL-C explained 33.6% and 27.2% of the decline in CHD incidence and CHD mortality, respectively, for those with diabetes. CONCLUSIONS: Although rates have declined, diabetes remains associated with an increased risk of CHD incidence and mortality, highlighting the need for continuing diabetes prevention and cardiovascular risk factor management.

Discordance between high non-HDL cholesterol and high LDL-cholesterol among US adults.

BACKGROUND: Although low-density lipoprotein cholesterol (LDL-C) is recommended as the primary marker to guide lipid-lowering therapy, some data suggest non-high-density lipoprotein cholesterol (non-HDL-C) may better reflect coronary heart disease risk. Discordance between these measures has not been evaluated. METHODS: We used data from the National Health and Nutrition Examination Surveys 2005-2010 (n = 4986) to examine the discordance between these lipid parameters. Elevated levels of non-HDL-C and LDL-C were defined by using the 2004 Adult Treatment Panel III guidelines. RESULTS: The prevalence of high non-HDL-C and LDL-C was 22.7% and 24.5%, respectively. Of participants with high non-HDL-C, 9.7% had normal LDL-C, whereas 15.7% of participants with high LDL-C had normal non-HDL-C. We estimate 3.9 million US adults had high non-HDL-C and normal LDL-C, whereas 6.8 million US adults had high LDL-C and normal non-HDL-C. Persons with high non-HDL-C and normal LDL-C were older, more likely to be men, Hispanic, and have impaired fasting glucose, diabetes metabolic syndrome, and more risk factors for coronary heart disease. CONCLUSIONS: Substantial discordance exists between high non-HDL-C and high LDL-C among US adults. Reliance on either single measure could result in failure to classify cardiovascular heart disease risks appropriately.

Trends in the prevalence, awareness, treatment and control of high low density lipoprotein-cholesterol among United States adults from 1999-2000 through 2009-2010.

Marked increases in the awareness, treatment, and control of high low-density lipoprotein (LDL) cholesterol occurred among United States (US) adults from 1988-1994 to 1999-2004. An update to the Third Adult Treatment Panel guidelines was published in 2004, and it is unknown if these improvements have continued since the publication of these revised treatment recommendations. The aim of this study was to determine trends in the awareness, treatment, and control of high LDL cholesterol among US adults from 1999-2000 to 2009-2010 using nationally representative samples of US adults aged ≥20 years from 6 consecutive National Health and Nutrition Examination Surveys (NHANES) in 1999-2000 (n = 1,659), 2001-2002 (n = 1,897), 2003-2004 (n = 1,698), 2005-2006 (n = 1,692), 2007-2008 (n = 2,044), and 2009-2010 (n = 2,318). LDL cholesterol was measured after an overnight fast, and high LDL cholesterol and controlled LDL cholesterol were defined using the 2004 updated Third Adult Treatment Panel guidelines. Awareness and treatment of high cholesterol were defined using self-report. Among US adults, the prevalence of high LDL cholesterol did not change from 1999-2000 (37.2%) to 2009-2010 (37.8%). Awareness of high LDL cholesterol increased from 48.9% in 1999-2000 to 62.8% in 2003-2004 but did not increase further through 2009-2010 (61.5%). Among those aware of having high LDL cholesterol, treatment increased from 41.3% in 1999-2000 to 72.6% in 2007-2008 and was 70.0% in 2009-2010. Among US adults receiving treatment for high LDL cholesterol, the percentage with controlled LDL cholesterol increased from 45.0% in 1999-2000 to 65.3% in 2005-2006 and had decreased slightly by 2009-2010 (63.6%). In conclusion, high LDL cholesterol remains common among US adults. Additional efforts are needed to prevent high LDL cholesterol and increase the awareness, treatment, and control of high LDL cholesterol among US adults.

Awareness, treatment, and control of LDL cholesterol are lower among U.S. adults with undiagnosed diabetes versus diagnosed diabetes.

OBJECTIVE: Diabetes is often undiagnosed, resulting in incorrect risk stratification for lipid-lowering therapy. We conducted a cross-sectional analysis of the National Health and Nutrition Examination Survey (NHANES) 2005-2010 to determine the prevalence, awareness, treatment, and control of elevated LDL cholesterol (LDL-C) among U.S. adults with undiagnosed diabetes. RESEARCH DESIGN AND METHODS: Fasting NHANES participants 20 years of age or older who had 10-year Framingham coronary heart disease (CHD) risk scores <20% and were free of CHD or other CHD risk equivalents (n = 5,528) were categorized as having normal glucose, impaired fasting glucose, undiagnosed diabetes, or diagnosed diabetes. High LDL-C was defined by the 2004 Adult Treatment Panel (ATP) III guidelines. RESULTS: The prevalence of diagnosed and of undiagnosed diabetes was 8 and 4%, respectively. Mean LDL-C was 102 ± 2 mg/dL among those with diagnosed diabetes and 117 ± 3 mg/dL for those with undiagnosed diabetes (P < 0.001). The prevalence of high LDL-C was similar among individuals with undiagnosed (81%) and diagnosed (77%) diabetes. Among individuals with undiagnosed diabetes and high LDL-C, 38% were aware, 27% were treated, and 16% met the ATP III LDL-C goal for diabetes. In contrast, among individuals with diagnosed diabetes and high LDL-C, 70% were aware, 61% were treated, and 36% met the ATP III goal. Subjects with undiagnosed diabetes remained less likely to have controlled LDL-C after multivariable adjustment (prevalence ratio, 0.42; 95% CI, 0.23-0.80). CONCLUSIONS: Improved screening for diabetes and reducing the prevalence of undiagnosed diabetes may identify individuals requiring more intensive LDL-C reduction.

Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction.

OBJECTIVE: To evaluate changes in function as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) and the meaningfulness of the changes, in importance and satisfaction, in patients with psoriatic arthritis (PsA). METHODS: HAQ-DI was assessed at baseline and at Weeks 4, 12, and 24 in a randomized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo. Concurrently, patients rated the importance of and satisfaction with their change in function on a 7-point scale (1 = not at all important/satisfied; 7 = extremely important/satisfied). Mean HAQ-DI improvement corresponding to ratings of minimally (2-3) or very (6-7) important or satisfied was determined using a posthoc linear mixed-model analysis. Patient importance ratings were used as an anchor to estimate minimally important difference (MID) for HAQ-DI; distribution-based estimates were also calculated. RESULTS: A total of 161 patients (69 placebo; 92 etanercept) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating. HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 (95% CI 0.214, 0.455) and 0.360 (95% CI 0.263, 0.456), respectively, suggesting an MID of about 0.35. HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 (95% CI 0.230, 0.357) and 0.360 (95% CI 0.307, 0.413). For a given change in HAQ-DI, nearly two-thirds of patients indicated a lower rating for satisfaction than for importance. This trial was registered in the ClinicalTrials.gov registry (NCT00317499). CONCLUSION: Our study suggests the MID for HAQ-DI in PsA is about 0.35. The results may also provide insight into patient satisfaction with changes in function and expectations for therapy.

Patient-reported outcomes in a randomized trial of etanercept in psoriatic arthritis.

OBJECTIVE: To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA). METHODS: A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patient pain assessment. RESULTS: Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period. CONCLUSION: Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.

Effect of anakinra on functional status in patients with active rheumatoid arthritis receiving concomitant therapy with traditional disease modifying antirheumatic drugs: evidence from the OMEGA Trial.

OBJECTIVE: To assess changes in functional status in patients with rheumatoid arthritis (RA) receiving the interleukin-1 receptor antagonist anakinra in addition to a disease modifying antirheumatic drug (DMARD). METHODS: In this large, multicenter, open-label, single-arm study, adult patients with RA receiving methotrexate, sulfasalazine, or hydroxychloroquine for > or = 3 months were given anakinra 100 mg once daily for up to 36 weeks. The primary objective was to evaluate changes from baseline to week 36 in the Health Assessment Questionnaire (HAQ) disability index and subscales. Changes in the 28-joint Disease Activity Score (DAS28), proportion of patients meeting European League Against Rheumatism (EULAR) response criteria, and the safety of each combination regimen were also assessed. RESULTS: A total of 1207 patients were enrolled, received > or = 1 dose of anakinra, and were included in the efficacy and safety analyses. A statistically significant change in the HAQ disability index was observed (p = 0.0001); no significant differences were seen among the 3 DMARD groups. A clinically meaningful improvement in HAQ (> 0.22) was observed in 51% of patients. Mean improvement in DAS28 was 1.5 (p < 0.0001), and 64% of patients achieved a good or moderate EULAR response score. Injection site reaction was the most frequently (62%) reported adverse event. The incidence of infections (24%), most commonly respiratory infection, was similar across treatment groups. No notable changes were observed in laboratory findings and vital signs. CONCLUSION: These findings indicate that anakinra 100 mg/day in combination with DMARD therapy safely improved functional status in patients with active RA.

Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov, the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

Etanercept improves psoriatic arthritis patient-reported outcomes: results from EDUCATE.

Experience Diagnosing, Understanding Care, and Treatment With Etanercept (EDUCATE) is a multicenter, phase 4, 24-week, open-label study of the safety and efficacy of etanercept therapy in patients with psoriatic arthritis (PsA) in routine dermatologic practice. We present data on patient-reported outcomes (PROs) from EDUCATE, which demonstrate that subjects with PsA achieved clinically meaningful improvements in both skin- and joint-related PROs after 24 weeks of treatment.