Kafi N. Sanders

Findings of a U.S. National Cardiometabolic Screening Program Among 10,084 Psychiatric Outpatients

OBJECTIVE A national cardiometabolic screening program for patients in a variety of public mental health facilities, group practices, and community behavioral health clinics was funded by Pfizer Inc. between 2005 and 2008. METHODS A one-day, voluntary metabolic health fair in the United States offered patients attending public mental health clinics free cardiometabolic screening and same-day feedback to physicians from a biometrics testing third party that was compliant with the Health Insurance Portability and Accountability Act. RESULTS This analysis included 10,084 patients at 219 sites; 2,739 patients (27%) reported having fasted for over eight hours. Schizophrenia or bipolar disorder was self-reported by 6,233 (62%) study participants. In the overall sample, the mean waist circumference was 41.1 inches for men and 40.4 inches for women; 27% were overweight (body mass index [BMI] 25.0-29.9 kg/m(2)), 52% were obese (BMI >or=30.0 kg/m(2)), 51% had elevated triglycerides (>or=150 mg/dl), and 51% were hypertensive (>or=130/85 mm Hg). In the fasting sample, 52% had metabolic syndrome, 35% had elevated total cholesterol (>or=200 mg/dl), 59% had low levels of high-density lipoprotein cholesterol (<40 mg/dl for men or <50 mg/dl for women), 45% had elevated triglycerides (>or=150 mg/dl), and 33% had elevated fasting glucose (>or=100 mg/dl). Among the 1,359 fasting patients with metabolic syndrome, 60% were not receiving any treatment. Among fasting patients who reported treatment for specific metabolic syndrome components, 33%, 65%, 71%, and 69% continued to have elevated total cholesterol, low levels of high-density lipoprotein, high blood pressure, and elevated glucose levels, respectively. CONCLUSIONS The prevalence of metabolic syndrome and cardiometabolic risk factors, such as overweight, hypertension, dyslipidemia, and glucose abnormalities, was substantial and frequently untreated in this U.S. national mental health clinic screening program.

Dose trends for second-generation antipsychotic treatment of schizophrenia and bipolar disorder

BACKGROUND Antipsychotic dosing used in clinical practice can differ from dosing originally recommended in product labeling. This has been reported for olanzapine and quetiapine, where higher doses are commonly used. This may be the case for ziprasidone as well. METHOD To characterize changes over time in dosing for the initial and subsequent prescriptions of first-line second-generation antipsychotics used during treatment episodes for outpatients with schizophrenia and bipolar disorder, the 2001-2005 Thomson MarketScan Medicaid Database (Medicaid) and the 2001-2006 MarketScan Commercial Claims and Encounters Database (Commercial) were analyzed. Dose trends were evaluated using autoregressive time-series models. RESULTS Data were available for 49180 treatment episodes of schizophrenia (4683 Commercial and 44497 Medicaid) and 83289 treatment episodes of bipolar disorder (57961 Commercial and 25328 Medicaid). The initial prescription mean daily and overall mean daily doses of ziprasidone in schizophrenia episodes significantly increased across the Medicaid and Commercial populations, with similar trends observed for bipolar episodes. The first (May 2001) and last (December 2005) observed 3-month mean daily doses for ziprasidone were 112 mg/d and 138 mg/d for patients with schizophrenia and 93 mg/d and 113 mg/d for those with bipolar disorder in the Medicaid cohort, with similar findings for the Commercial cohort. Consistently significant trends in dose changes were not observed for the other medications, although quetiapine and olanzapine doses generally increased while aripiprazole and risperidone doses generally decreased. CONCLUSIONS There remains a need for controlled randomized clinical trials that test fixed doses of antipsychotics to ascertain the dose-response relationship within the dose range used in contemporary clinical practice.

Adherence, Persistence of Use, and Costs Associated With Second-Generation Antipsychotics for Bipolar Disorder

OBJECTIVE A retrospective study using Medicaid claims identified patients with bipolar disorder for whom oral second-generation antipsychotics were prescribed and compared rates of adherence, persistence of use, and costs across five groups of patients taking aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone. METHODS Medicaid claims data for 2,446 bipolar patients were analyzed from eight states. The 18-month observation period included the six months before and the 12 months after the index prescription date. Adherence was defined as a medication possession ratio >80%. Persistence of use was measured by the number of days of medication therapy before a 30-day gap. Mental health-related prescription costs, total prescription costs, total mental health-related costs, and total costs were assessed. Ziprasidone was the comparator. RESULTS Clinically recommended doses of second-generation antipsychotic medications were prescribed for 45% of the patients (N = 1,102). Of these, 58% (N = 642 of 1,102) were adherent with the prescribed medication, with no significant differences between medication groups. Median time to nonpersistence of use averaged 96 days. Patients taking olanzapine were about 35% more likely than patients taking ziprasidone to discontinue taking their medication (hazard ratio = 1.34, 95% confidence interval = 1.02-1.76, p = .04). Mental health-related prescription costs and total prescription costs were lower for risperidone than ziprasidone. No statistically significant differences were found between the groups for all mental health-related costs or total costs. CONCLUSIONS Among patients in a sizeable Medicaid cohort for whom a second-generation antipsychotic medication was prescribed, less than half had a clinically recommended dose, and less than two-thirds with a clinically recommended dose were adherent to the medication, confirming that many patients with bipolar disorder do not receive clinically recommended doses of second-generation antipsychotics.

Medication adherence and utilization in patients with schizophrenia or bipolar disorder receiving aripiprazole, quetiapine, or ziprasidone at hospital discharge: a retrospective cohort study.

BackgroundSchizophrenia and bipolar disorder are chronic debilitating disorders that are often treated with second-generation antipsychotic agents, such as aripiprazole, quetiapine, and ziprasidone. While patients who are hospitalized for schizophrenia and bipolar disorder often receive these agents at discharge, comparatively little information exists on subsequent patterns of pharmacotherapy.MethodsUsing a database linking hospital admission records to health insurance claims, we identified all patients hospitalized for schizophrenia (ICD-9-CM diagnosis code 295.XX) or bipolar disorder (296.0, 296.1, 296.4-296.89) between January 1, 2001 and September 30, 2008 who received aripiprazole, quetiapine, or ziprasidone at discharge. Patients not continuously enrolled for 6 months before and after hospitalization (“pre-admission” and “follow-up”, respectively) were excluded. We examined patterns of use of these agents during follow-up, including adherence with treatment (using medication possession ratios [MPRs] and cumulative medication gaps [CMGs]) and therapy switching. Analyses were undertaken separately for patients with schizophrenia and bipolar disorder, respectively.ResultsWe identified a total of 43 patients with schizophrenia, and 84 patients with bipolar disorder. During the 6-month period following hospitalization, patients with schizophrenia received an average of 101 therapy-days with the second-generation antipsychotic agent prescribed at discharge; for patients with bipolar disorder, the corresponding value was 68 therapy-days. Mean MPR at 6 months was 55.1% for schizophrenia patients, and 37.3% for those with bipolar disorder; approximately one-quarter of patients switched to another agent over this period.ConclusionsMedication compliance is poor in patients with schizophrenia or bipolar disorder who initiate treatment with aripiprazole, quetiapine, or ziprasidone at hospital discharge.

Impact of real-world ziprasidone dosing on treatment discontinuation rates in patients with schizophrenia or bipolar disorder

BACKGROUND The purpose of this study is to evaluate the relationship between maximum dose of ziprasidone and time to discontinuation in the treatment of schizophrenia/schizoaffective disorder and bipolar disorder in clinical practice. METHOD The 2001-2006 MarketScan Commercial and Medicare Databases were analyzed for maximum ziprasidone doses achieved in patients with schizophrenia/schizoaffective disorder or bipolar disorder. Ziprasidone maximum-dose groups were defined as low (20-60 mg/d), medium (61-119 mg/d), or high (120-160 mg/d). Patients receiving >160 mg/d were excluded. Mean time to discontinuation was evaluated across propensity score-matched dosing groups. Cox proportional hazard models were used to adjust for confounding when comparing the high- and medium-dose groups with the low-dose group. RESULTS Data were available for 33,340 patients with schizophrenia/schizoaffective disorder, of whom 16.6% received low dose of ziprasidone, 22.0% medium dose, and 61.4% high dose. Of those subjects with bipolar disorder (n=27,751), 26.1% were receiving a low dose of ziprasidone, 25.7% a medium dose, and 48.3% a high dose. Among the propensity score-matched dosing groups, the respective mean time to discontinuation for low, medium, and high doses was 90.5, 117.2, and 201.6d within the schizophrenia/schizoaffective disorder cohort and 84.6, 110.7, and 173.2d within the bipolar cohort (p<0.0001 for all comparisons). The hazard ratios for discontinuing therapy were significantly lower for the medium- (0.84, 0.84) and high-dose (0.57, 0.60) groups relative to the low-dose group in schizophrenia/schizoaffective disorder and bipolar disorder, respectively. CONCLUSIONS Patients with schizophrenia/schizoaffective or bipolar disorders receiving ziprasidone 120-160 mg/d experienced a statistically significant lower discontinuation rate compared with those receiving lower doses.

Burden of Disease in Patients with Glaucoma in Brazil.

METHODS: Patients’ self-reported data were collected from 2011-2012 National Health and Wellness Survey (NHWS Kantar Health global self-reported general population survey in healthcare). QOL was measured by the physical component score (PCS) and mental component score (MCS) of the Short Form-12 (SF-12) (mean score of 50 for general population). Loss of work/productivity was measured by the validated Work Productivity and Activity Impairment (WPAI) instrument. MRU was measured by healthcare provider, emergency room (ER) visits and hospitalization in the past 6 months. Comparisons were made between respondents who were diagnosed with glaucoma versus respondents without glaucoma (nonglaucoma group). Since glaucoma typically affects adult population, respondents with age 35 and above were included in the analysis.

Associations Between Sildenafil Use and Changes in Days of Hospitalization in a Population With Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

PURPOSE Pulmonary arterial hypertension (PAH) can be a complication in patients with connective tissue disease (CTD). Although the phosphodiesterase-5 inhibitor sildenafil shows evidence of efficacy and tolerability among patients with PAH associated with CTD in clinical trials, no studies have examined the association between its use and health care resource utilization in clinical practice. The objective of this study was to assess the associations between the use of sildenafil and health care resource utilization, specifically days of hospitalization, in a population with PAH associated with CTD. METHODS A retrospective, matched, case-control analysis was conducted using data from a commercial claims database. Patients with a claim dated between 2003 and 2009 were selected. Cases and controls were matched on age, sex, and baseline total days of hospitalization. A longitudinal, zero-inflated, negative binomial model was used for analyzing the data after control for age, sex, region, Charlson comorbidity score, and use of PAH-specific medication other than sildenafil. FINDINGS A total of 420 individuals, 210 cases and 210 controls, were included in the sample. The sample was 85.71% women, and the mean age was 57.6 years. Estimates for variances of an intercept random effect (5.08 × 10(-13)) and for a time-variable random effect (2.84 × 10(-16)) were both essentially zero. Thus a zero-inflated negative binomial model without random effects was used. When individuals were not using sildenafil, each 1-month interval was associated with a 2.8% increase in the mean number of days of hospitalization. In contrast, when individuals were using sildenafil, each 1-month interval was associated with a decrease of 3.3% in days of hospitalization. IMPLICATIONS In this data analysis of the association between sildenafil use and days of hospitalization among individuals with PAH associated with CTD in a large-scale population, sildenafil use in the treatment of PAH associated with CTD was associated with reduced days of hospitalization during the year after the initiation of treatment.