Pankaj A. Patel

Gout Medication Treatment Patterns and Adherence to Standards of Care From a Managed Care Perspective

OBJECTIVE To determine allopurinol treatment patterns and adherence to published standards of care for patients with gout. PATIENTS AND METHODS This retrospective claims analysis in a managed care database included patients 18 years or older, with continuous eligibility for 1 year before and after the start date and 2 or more visits during which the gout disease code (274.xx) was assigned or 1 or more pharmacy prescriptions for a gout-specific medication between January 1, 2000, and December 31, 2002 (intake period). Factors associated with compliance with allopurinol therapy were measured based on the medication possession ratio, and adherence to 2 quality-of-care indicators for gout management was assessed using multivariable logistic regression analysis. RESULTS A total of 64.9% of allopurinol users had a modal daily dose or the most commonly observed daily dose of 300 mg/d, median length of therapy was 3 months, and a high proportion of patients had a medication possession ratio of 10% or less. Suggested quality-of-care Indicators for gout had low performance: 53% of patients with renal impairment received a modal daily dose of 300 mg or greater, and 83% of patients who started taking allopurinol did not have their serum urate levels measured within 180 days. Patients with gout flares were less likely to be compliant with allopurinol (odds ratio, 0.50; 95% confidence interval, 0.40-0.63). Patients with renal impairment at baseline were 3.2 times more likely to undergo serum urate testing than patients without renal impairment (odds ratio, 3.20; 95% confidence Interval, 1.25-8.23). CONCLUSION There was low compliance with allopurinol therapy for treatment of gout. Patients potentially received suboptimal quality of care as measured by serum urate testing and appropriateness of allopurinol dosing in patients with renal impairment.

Serum urate levels and gout flares: analysis from managed care data.

Background:The desired serum urate level (SUA) for prevention of gout attacks is widely recommended to be in the subsaturating range, <6.0 mg/dL. Objectives:The objectives of this study were to evaluate attainment of this target SUA among gout patients on allopurinol in a naturalistic setting and to assess its impact on gout flare risk. Methods:This was a retrospective, observational study in a southeastern U.S. managed care organization of approximately 2.2 million members. The first gout claim/prescription within the intake period (January 1, 2000–December 31, 2002) was the index date. Included patients had ≥2 visits with gout International Classification of Diseases, 9th Revision code (274.xx) or ≥1 pharmacy script(s) for allopurinol, colchicine, probenecid, or sulfinpyrazone. Excluded patients were <18 years and/or did not have a 1-year continuous eligibility pre-/postindex date. Gout flares were defined by office/emergency room visit with gout or joint pain code(s) and ≥1 of the following within 7 days of the visit: intraarticular aspiration/injection, joint fluid microscopy, or pharmacy claim for nonsteroidal antiinflammatory drug, colchicine, corticosteroid, or ACTH. Multivariable regression analyses were conducted to evaluate gout flare risk/rate and association with target SUA. Results:Approximately 40% of 5942 gout patients identified used allopurinol postindex. Among allopurinol users with pre-/postindex SUA data (n = 162), mean SUA was lowered from 8.7 mg/dL to 7.1 mg/dL; reduction was significant (P < 0.001). Among allopurinol users who did not have SUA <6.0 mg/dL preindex (n = 147), only 25% reached target levels during postindex. Despite pharmacotherapy, patients with nontarget levels were 59% more likely to flare than those at target. Allopurinol users who were not at target were 75% more likely to flare. Conclusion:The failure of allopurinol users to achieve target SUA levels of <6.0 mg/dL may be attributed to lack of awareness of optimal SUA, allopurinol dosing, compliance, and efficacy. Patients who did not achieve target SUA were at increased flare risk.

The effect of serum urate on gout flares and their associated costs: an administrative claims analysis.

Background:Increased serum urate (sUA) levels (≥6.0 mg/dL) are associated with increased likelihood of acute gout attacks, or “flares.” Objectives:Identify gout flares with administrative claims data; examine the relationship between sUA and flares; examine the association between sUA and flare-related costs. Methods:This retrospective administrative claims analysis examined subjects with gout (≥2 medical claims with ICD-9-CM diagnosis code 274.xx or ≥1 claim with a gout diagnosis and ≥1 pharmacy claim for allopurinol, probenecid, colchicine, or sulfinpyrazone) between January 1, 2002 and March 31, 2004. Each subject was observed during 1-year baseline and 1-year follow-up periods. Gout flares were identified with an algorithm using claims for services associated with flares. Outcomes were sUA (mg/dL) and flare-related health care costs. Logistic regression examined the likelihood of flare; generalized linear modeling regression measured the impact of baseline sUA on flare costs, controlling for demographic and health status variables. Results:The study sample comprised 18,243 subjects with mean age of 53.9 years. sUA was available for 4277 (23%) subjects. Sixty-two percent (11,253) of subjects had ≥1 flare. The number of mean, unadjusted flares increased with sUA. Logistic results showed subjects with baseline sUA ≥6.0 relative to sUA <6.0 had 1.3 times the odds of gout flare (P <0.05). Generalized linear modeling results showed that baseline sUA ≥6.0 was associated with 2.1 to 2.2 times higher flare costs than was baseline sUA <6.0 (P <0.05). Conclusions:sUA was a significant predictor both of gout flare and related costs. This highlights the importance of gout management strategies aimed at controlling sUA.

Frequency, Risk, and Cost of Gout-related Episodes Among the Elderly: Does Serum Uric Acid Level Matter?

Objective. We examined the association between serum uric acid (SUA) level and the frequency, risk, and cost of gout flares among the elderly. Methods. Data were extracted from the Integrated Healthcare Information Services claims database (1999–2005). Patients were included if they had gout, were aged 65 years and older and had both medical and pharmacy benefits, and electronic laboratory data. Patients with gout and gouty episodes were identified using algorithms based on ICD-9-CM codes and medications. Logistic regression and negative binomial regressions were used to study the relationship between SUA concentration and the annual frequency and one-year risk of gout episodes. Generalized linear models were used to examine the direct healthcare costs associated with gout episodes in the 30 days following each episode. Results. Elderly patients with gout (n = 2237) with high (6–8.99 mg/dl) and very high (> 9 mg/dl) SUA concentrations were more likely to develop a flare within 12 months compared to patients with normal (< 6 mg/dl) SUA levels (OR 2.1, 95% CI 1.7–2.6; OR 3.4, 95% CI 2.6–4.4, respectively). In multivariate regressions, the average annual number of flares increased by 11.9% (p < 0.001) with each unit-increase in SUA level above 6 mg/dl (p < 0.001). Among patients with very high SUA levels, average adjusted total healthcare and gout-related costs per episode were

Impact of noncompliance with urate-lowering drug on serum urate and gout-related healthcare costs: administrative claims analysis*

2,555 and

Metabolic syndrome-related conditions among people with and without gout: prevalence and resource use

356 higher, respectively, than those of patients with normal SUA levels (both p < 0.001). Conclusion. Higher SUA levels are associated with increased frequency and risk of gout episode, and with higher total and gout-related direct healthcare costs per episode.

Risk of recurrent emergency department visits or hospitalizations in children with asthma receiving nebulized budesonide inhalation suspension compared with other asthma medications.

ABSTRACT Objective: To determine the association between allopurinol compliance and serum urate (sUA) level; and examine the association between sUA and gout-related healthcare costs in a large managed care population. Research design and methods: This retrospective administrative claims analysis examined subjects with gout (≥2 medical claims with ICD-9-CM diagnosis code 274.xx or ≥1 claim with a gout diagnosis and ≥1 pharmacy claim for allopurinol, probenecid, colchicine, or sulfinpyrazone) between January 1, 2002 and March 31, 2004. Each subject was observed during 1-year pre-index and 1-year post-index periods. Main outcome measures: Outcomes were allopurinol medication possession ratio (MPR) and compliance (MPR ≥ 0.80), sUA (mg/dL), and gout-related healthcare costs. ‘Post-allopurinol’ sUA was measured during three periods after the first observed allopurinol fill: 30–89 days; 90–149 days; ≥150 days. A baseline sUA on or before the start of the post-index period was also identified. Outcomes were stratified by post-allopurinol or baseline sUA and compliance. Generalized linear modeling (GLM) regression measured the impact of baseline sUA on gout-related healthcare costs, controlling for demographic and health status variables. Results: The study sample comprised 18 243 subjects with mean age of 53.9 years. In all, 55% (n = 10 073) of subjects used allopurinol. There were 1473 (8.1%) subjects with a post-allopurinol sUA and 2438 (13.4%) subjects with a baseline sUA result. Among all subjects with a post-allopurinol sUA, 45.6% were compliant; between 49.3% and 56.8% of compliant subjects had an sUA < 6.0 mg/dL compared with 22.5–27.8% of non-compliant subjects, depending on the post-allopurinol time period (all p < 0.001). GLM results showed gout-related costs associated with baseline sUA ≥ 6.0 and < 9.0 mg/dL were 58% higher (95% confidence interval (CI): 1.012 –2.456; p = 0.044) than were costs for sUA < 6.0 mg/dL. There was no significant difference in gout-related costs between baseline sUA < 6.0 mg/dL and ≥9.0 mg/dL. Conclusions: Analysis revealed an important associations between allopurinol compliance, sUA, and gout-related costs: compliance was positively associated with favorable sUA (<6.0 mg/dL) in unadjusted comparisons. GLM showed that baseline sUA < 6.0 was inversely associated with gout-related costs relative to baseline sUA ≥ 6.0 and <9.0 mg/dL. Nevertheless, a substantial portion of subjects, even compliant ones, did not achieve sUA < 6.0 mg/dL. These results should be interpreted carefully in light of study limitations, including incomplete laboratory data, the potentially incorrect inference that medications were taken as prescribed, and lack of generalizability from Medicare managed care enrollees to the broader Medicare population.

Major depressive disorder with subthreshold hypomanic (mixed) features: A real-world assessment of treatment patterns and economic burden

ABSTRACT Objective: A cohort of employees with gout were compared to those without to evaluate the differences in prevalence of disorders associated with metabolic syndrome (both those considered underlying and those associated with end-stage morbidity and mortality) as well as the cost of annual medical services (AMS) required for treatment of these conditions. Methods: Employees with gout were identified by International Classification of Diseases‑9 (ICD‑9) code during the calendar years of 2001–2004 and compared to propensity-score matched employees without gout using the Human Capital Management Services Research Reference Database. T‑tests were then used to compare prevalence and average AMS of comorbid disorders defined from Agency for Healthcare and Research Quality (AHRQ) diagnostic categories. Results: ‘Hyperlipidemia’, ‘essential hypertension’, and ‘diabetes mellitus without complications’ ranked in the top 10 categories of mean number of AMS for employees with gout using AHRQ specific categories; the values were higher than found for those without gout (all p < 0.0001). ‘Essential hypertension’, ‘hyperlipidemia’, ‘diabetes mellitus without complications’, and ‘coronary atherosclerosis’ showed an approximate 2:1 prevalence ratio for employees with gout over those without ( p ≤ 0.05). Main study limitations include the small number of subjects with gout, retrospective study design, and possible miscoding and/or non-coding of individuals with the studied disorders. Conclusion: These results support the continued need for patients with gout and their clinicians to be aware of the possibility of the increased risk of associated metabolic syndrome and related comorbidities in these individuals, emphasizing the need for prevention when possible and treatment when necessary.

Lurasidone compared to other atypical antipsychotic monotherapies for bipolar depression: A systematic review and network meta-analysis

ABSTRACT Objective: To examine whether nebulized budesonide inhalation suspension treatment reduces asthma-related emergency department visit/hospitalization recurrence risk in children compared with other asthma medications, particularly non-nebulized inhaled corticosteroids. Research design and methods: Longitudinal, retrospective claims analysis of data from a managed care organization database in the United States (July 1, 2000–June 30, 2002). Participants were children aged ≤ 8 years with an asthma diagnosis and asthma-related emergency department visit or hospitalization (index event). Asthma medication use, evaluated by asthma-related prescriptions ≤ 30 days after the index event, determined treatment groups. Main outcome measure: Emergency department visit/hospitalization recurrence risk from post-index day 31–180 across treatment groups. Results: Of 10 176 patients with an index event, 13% experienced a post-index recurrence. For patients receiving asthma prescriptions ≤ 30 days after the index event, those receiving budesonide inhalation suspension showed a significant reduction in emergency department visit/hospitalization recurrence risk compared with those not prescribed this treatment (adjusted hazard ratio, 0.71; 95% confidence interval, 0.57–0.89). For patients receiving asthma controller medication in the post-index period, those receiving budesonide inhalation suspension had a significantly lower recurrence risk than patients receiving prescriptions for other controller medications (hazard ratio, 0.71; 95% confidence interval, 0.52–0.97). Recurrence risk was significantly reduced (53%) in patients receiving budesonide inhalation suspension prescriptions compared with non-nebulized inhaled corticosteroid prescriptions (hazard ratio, 0.47; 95% confidence interval, 0.28–0.78). Conclusion: For children aged ≤ 8 years, budesonide inhalation suspension treatment after an asthma-related emergency department visit/hospitalization was associated with a significantly reduced risk of recurrence compared with other asthma medications and with non-nebulized inhaled corticosteroids. Because this was an observational study, results should be interpreted cautiously. However, this study allowed evaluation of treatment in real-world practice settings not often included in clinical trials.

Disease-Related and All-Cause Health Care Costs of Elderly Patients With Gout

BACKGROUND To compare outcomes for individuals with major depressive disorder (MDD) with or without subthreshold hypomania (mixed features) in naturalistic settings. METHODS Using the Optum Research Database (1/1/2009─10/31/2014), a retrospective analysis of individuals newly diagnosed with MDD was conducted. Continuous enrollment for 12-months before and after the initial MDD diagnosis was required. MDD with subthreshold hypomania (mixed features) (MDD-MF) was defined based on ≥1 hypomania diagnosis within 30 days after an MDD diagnosis during the one-year follow-up period, in the absence of bipolar I diagnoses. Psychiatric medication use, healthcare utilization, and costs during the one-year follow-up period were compared using multivariate logistic and gamma regressions, controlling for baseline differences. RESULTS Of 130,626 MDD individuals, 652 (0.5%) met the operational definition of MDD-MF. Compared to the MDD-only group, the MDD-MF group had more suicidality (2.0% vs. 0.5%), anxiety disorders (46.8% vs. 34.0%), and substance use disorders (15.5% vs. 6.1%, all P<0.001). More individuals with MDD-MF were treated with antidepressants (83.6% vs. 71.6%), mood stabilizers (50.5% vs. 2.7%), atypical antipsychotics (39.0% vs. 5.5%), and polypharmacy with multiple drug classes (72.1% vs. 22.7%, all P<0.001). Individuals with MDD-MF had higher hospitalizations rates (24.2% vs. 10.5%) and total healthcare costs (mean: