Identifying Patients with Group 3 Pulmonary Hypertension Associated with COPD or ILD Using an Administrative Claims Database.

BACKGROUND: Group 3 pulmonary hypertension (PH) describes a subpopulation of patients with PH due to chronic lung disease and/or hypoxia, with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) being two large subgroups. Claims database studies provide insights into the real-world treatment patterns and outcomes among these patients. However, claims data do not provide sufficient detail to assign the clinical subtype of PH required for identifying these patients. METHODS: A panel of PH clinical experts and researchers was convened to discuss methodologies to identify patients with Group 3 PH associated with COPD or ILD in retrospective claims databases. To inform the discussion, a literature review was conducted to identify claims-based studies of Group 3 PH associated with COPD or ILD published from 2010 through June 2020. RESULTS: Targeted title and abstract review identified 11 claims-based studies and two conference abstracts (eight based in the United States [US] and five conducted outside the US) that met search criteria. Based on insights from the panel and literature review, the following components were detailed across studies in the identification of Group 3 PH associated with COPD and ILD: (a) COPD or ILD identification, (b) PH identification, (c) defining the sequence between COPD/ILD and PH, and (d) other PH Group and Group 3 PH exclusions. CONCLUSION: This article provides recommended approaches and considerations for identifying and studying patients with Group 3 PH associated with COPD or ILD using administrative claims data that provide the foundation for future validation studies.

Healthcare Costs and Resource Utilization Associated with the Use of Empagliflozin Versus Other Antihyperglycemic Agents Among Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease: A Real-World Retrospective Cohort Analysis.

INTRODUCTION: Empagliflozin has demonstrated lower rates of cardiovascular outcomes vs. standard of care among patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). However, the impact of empagliflozin compared to other branded antihyperglycemic agents (AHAs) on total cost of care has yet to be quantified. METHODS AND RESULTS: This retrospective cohort study evaluated the impact of empagliflozin (n = 441) on costs and healthcare resource utilization (HCRU) vs. other branded AHAs (n = 13,122) among patients with T2DM and CVD, using the IQVIA PharMetrics® Plus Claims Database (1 August 2013-31 December 2017). Date of the first prescription (index date) for empagliflozin or other branded AHAs was used to classify patients into study cohorts. All-cause costs and HCRU were computed on a per patient per month (PPPM) basis and compared across study cohorts using outcome-appropriate statistical models. Overall, the empagliflozin cohort was younger and had a lower comorbidity burden. After covariate adjustment, the total all-cause costs (mean difference - $412 PPPM; 95% CI - $593, - $214) were significantly lower for the empagliflozin cohort. These cost differences were mainly driven by lower all-cause medical costs (mean difference - $400 PPPM; 95% CI - $577, - $196). For HCRU, the mean adjusted all-cause visits in the physician office and other outpatient settings were lower with empagliflozin vs. other branded AHAs (p < 0.001). CONCLUSIONS: This study demonstrated that the all-cause healthcare costs and HCRU were significantly lower for patients with T2DM and CVD who initiated empagliflozin vs. other branded AHAs. Along with the positive clinical evidence base of empagliflozin, these results can guide healthcare decision makers during therapy selection.

Recent real-world treatment patterns and outcomes in US patients with relapsed/refractory multiple myeloma.

BACKGROUND: In patients with relapsed/refractory multiple myeloma (RRMM) previously receiving 1-3 therapy lines, newer agents demonstrated improved outcomes versus older agents. Real-world treatment pattern data are limited. We assessed real-world treatment patterns and outcomes in patients with RRMM (≥2 prior therapy lines). RESEARCH DESIGN AND METHODS: An electronic medical record (EMR) analysis and chart review were conducted using International Oncology Network (ION) EMR data. Patients ≥18 years old initiating first-line MM treatment 1 January 2011, to 31 May 2017, were stratified into older/newer treatment cohorts (approval date before vs during/after 2012). Treatment patterns and outcomes were described; no statistical tests were performed. RESULTS: In the EMR analysis (n = 1601) and chart review (n = 456), bortezomib, lenalidomide, and bortezomib-lenalidomide combinations dominated first-line treatment. Median real-world progression-free survival (rwPFS) was 12.0 to 3.5 months (first- to fifth-line), and median real-world overall survival (rwOS) was 48.2 to 5.8 months. A trend for increased rwPFS/rwOS with newer versus older treatments was observed. Most common AEs were fatigue, bone pain, and anemia. EXPERT OPINION: Real-world data describing treatment patterns in relapsed/refractory multiple myeloma are limited. Evaluation of new treatments on patient outcomes will influence treatment patterns and patient outcomes in the real-world setting. CONCLUSIONS: Although a trend for improved rwPFS and rwOS with newer versus older treatments was suggested, additional treatment options to improve patient outcomes are needed.

Correction to: Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

Changes within text are indicated in bold.

Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

BACKGROUND: Given the improved convenience of oral prostacyclins, there is a shift toward their use in treating pulmonary arterial hypertension (PAH). OBJECTIVES: Our objective was to compare patient characteristics, medication adherence, healthcare resource use (HCRU), and costs among patients receiving oral treprostinil or selexipag. METHODS: We used Truven Health MarketScan Commercial and Medicare databases to identify patients with PAH with a diagnosis code for pulmonary hypertension (PH) plus a prescription for oral treprostinil or selexipag from July 2013 to September 2017. Medication adherence, persistence, and all-cause and PAH-related HCRU and costs were compared between cohorts during the 6-month follow-up. Adjusted healthcare costs were obtained using recycled predictions and bootstrapped samples. RESULTS: A total of 256 (130 oral treprostinil, 126 selexipag) patients fulfilled the study criteria. The oral treprostinil cohort was more likely to be male, to have previously used parenteral prostacyclins, and to have higher outpatient costs at baseline than the selexipag cohort. During follow-up, both cohorts had similar proportions of patients who were adherent to and persistent with their respective therapies. All-cause and PAH-related medical utilization was generally similar between cohorts. The oral treprostinil cohort had 66.9% lower total PAH-related healthcare costs (mean difference - $75,183; 95% confidence interval [CI] - 102,584 to - 49,771) and 70.6% lower PAH-related pharmacy costs (mean difference - $76,439; 95% CI - 104,512 to - 51,458) than the selexipag cohort, with similar differences in all-cause healthcare and pharmacy costs. CONCLUSIONS: Lower all-cause and PAH-related total healthcare and pharmacy costs were observed in patients receiving oral treprostinil compared with those receiving selexipag. It will be important to study longer-term costs and clinical outcomes.

Direct Costs Incurred Among Women Undergoing Surgical Procedures to Treat Uterine Fibroids.

BACKGROUND: Uterine fibroids (UF) affect up to 70%-80% of women by 50 years of age and represent a substantial economic burden on patients and society. Despite the high costs associated with UF, recent studies on the costs of UF-related surgical treatments remain limited. OBJECTIVE: To describe the health care resource utilization (HCRU) and all-cause costs among women diagnosed with UF who underwent UF-related surgery. METHODS: Data from the IBM MarketScan Commercial Claims and Encounters database and Medicaid Multi-State database were independently, retrospectively analyzed from January 1, 2009, to December 31, 2015. Women aged 18-64 years with ≥ 1 UF claim from January 1, 2010, to December 31, 2014, a claim for a UF-related surgery (hysterectomy, myomectomy, uterine artery embolization [UAE], or ablation) from January 1, 2010, to November 30, 2015, and continuous enrollment for ≥ 1 year presurgery and ≥ 30 days postsurgery qualified for study inclusion. A 1-year period before the date of the first UF-related surgical claim after the first UF diagnosis was used to report baseline demographic and clinical characteristics. Surgery characteristics were reported. All-cause HCRU and costs (adjusted to 2017 U.S. dollars) were described by the 14 days pre-, peri-, and 30 days postoperative periods, and independently by the inpatient or outpatient setting. RESULTS: Overall, 113,091 patients were included in this study: commercial database, n = 103,814; Medicaid database, n = 9,277. Median time from the initial UF diagnosis to first UF-related surgical procedure was 33 days for the commercial population and 47 days for the Medicaid population. Hysterectomy was the most common UF-related surgery received after UF diagnosis (commercial, 68% [n = 70,235]; Medicaid, 75% [n = 6,928]). In both populations, 97% of patients had ≥ 1 outpatient visit from 14 days presurgery to 30 days postsurgery (commercial, n = 100,402; Medicaid, n = 9,023), and the majority of all UF-related surgeries occurred in the outpatient setting (commercial, 64% [n = 66,228]; Medicaid, 66% [n = 6,090]). Mean total all-cause costs for patients with UF who underwent any UF-related surgery were $15,813 (SD $13,804) in the commercial population (n = 95,433) and $11,493 (SD $26,724) in the Medicaid population (n = 4,785). Mean total all-cause costs for UF-related surgeries for the commercial/Medicaid populations were $17,450 (SD $13,483)/$12,273 (SD $19,637) for hysterectomy, $14,216 (SD $16,382)/$11,764 (SD $15,478) for myomectomy, $17,163 (SD $13,527)/$12,543 (SD $23,777) for UAE, $8,757 (SD $9,369)/$7,622 (SD $50,750) for ablation, and $12,281 (SD $10,080)/$5,989 (SD $5,617) for myomectomy and ablation. Mean total all-cause costs for any UF-related surgery performed in the outpatient setting in the commercial and Medicaid populations were $14,396 (SD $11,466) and $6,720 (SD $10,374), respectively, whereas costs in the inpatient setting were $18,345 (SD $16,910) and $21,805 (SD $43,244), respectively. CONCLUSIONS: This retrospective analysis indicated that surgical treatment options for UF continue to represent a substantial financial burden. This underscores the need for alternative, cost-effective treatments for the management of UF. DISCLOSURES: This study was sponsored by Allergan, Dublin, Ireland. Allergan played a role in the conduct, analysis, interpretation, writing of the report, and decision to publish this study. Harrington and Ye are employees of Allergan. Stafkey-Mailey, Fuldeore, and Yue are employees of Xcenda. Ta was a contractor at Allergan at the time the study was conducted and is currently supported by a training grant from Allergan. Bonine, Shih, and Gillard are employees of Allergan and have stock, stock options, and/or restricted stock units as employees of Allergan. Banks has no disclosures to report. This study was presented as a poster at Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

Healthcare resource utilization and costs among women diagnosed with uterine fibroids compared to women without uterine fibroids.

Objective: To perform a retrospective, matched-cohort, longitudinal evaluation of annual pre- and post-diagnosis costs incurred among women with uterine fibroids (UF) (cases) compared to controls without UF. Methods: Data were derived from the IBM Watson Health MarketScan Commercial Claims and Encounters and Medicaid Multi-State databases. Women aged 18-64 years with ≥1 inpatient or outpatient medical claim with an initial UF diagnosis (index date) from 1 January 2010 to 31 December 2014 were included. Healthcare resource utilization (HCRU) data including pharmacy, outpatient and inpatient hospital claims were collected for 1 year pre-index and ≤5 years post-index. All-cause costs (adjusted to 2017 $US) were compared between cases and controls using multivariable regression models. Results: Analysis included 205,098 (Commercial) and 24,755 (Medicaid) case-control pairs. HCRU and total all-cause healthcare costs were higher for cases versus controls during the pre-index year and all years post-index. Total unadjusted mean all-cause costs were $1197 higher (p < .0001; Commercial) and $2813 higher (standardized difference 0.08; Medicaid) for cases during the pre-index year. Total adjusted mean all-cause costs in the first year post-index were $14,917 for cases versus $5717 for controls in the Commercial population, and $20,244 versus $10,544, respectively, in the Medicaid population. In Years 2-5 post-index, incremental mean adjusted total costs decreased, but remained significantly higher for cases versus controls at all time points in both populations (all p < .05). Conclusions: Costs were higher for women with UF compared to women without UF during the pre-index year and over 5 years post-index; differences were greatest in the first year post-index.

The cost of cardiovascular-disease-related death in patients with type 2 diabetes mellitus.

OBJECTIVES: To assess the magnitude of difference in all-cause healthcare resource utilization (HCRU) and costs between patients with type 2 diabetes mellitus (T2DM) who died from a cardiovascular disease (CVD)-related cause in the year preceding death vs. those who did not die during this same period. METHODS: A large US administrative claims database was used to identify patients with T2DM who died of a CVD-related cause from July 2012 to April 2015. These patients were matched 1:1 to patients with T2DM who did not die, using direct matching methods. HCRU and costs were assessed in each of the four quarters (Q4: 12-10 months; Q3: 9-7 months; Q2: 6-4 months; and Q1: 3-0 months) prior to death and compared between patient cohorts using paired t-tests and McNemar's tests. RESULTS: A final matched cohort of 7648 patients who died and 7648 patients who did not die were identified. A significantly higher proportion of patients who died utilized inpatient services vs. those who did not die (Q4: 12.6% vs. 4.6%, p < .001; Q3: 14.6% vs. 4.6%, p < .001; Q2: 17.6% vs. 5.5%, p < .001; and Q1: 65.0% vs. 10.1%, p < .001). In addition, patients who died incurred significantly higher all-cause costs (Q4: $8882 vs. $3970, p < .001; Q3: $10,462 vs. $3661, p < .001; Q2: $12,564 vs. $4169, p < .001; and Q1: $36,076 vs. $6319, p < .001). CONCLUSIONS: T2DM patients with a CVD-related death had significantly greater HCRU and costs in the year including and preceding death compared to those who did not die.

Incremental burden of type 2 diabetes in patients experiencing cardiovascular hospitalizations.

OBJECTIVE: To evaluate the incremental economic burden of type 2 diabetes in patients experiencing cardiovascular (CV) hospitalizations. RESEARCH DESIGN AND METHODS: Adults with ≥1 CV hospitalization were identified using a US-based healthcare claims database from 1 July 2011 to 30 June 2014. Outcomes for patients surviving the index hospitalization were compared between patients with vs. without type 2 diabetes (cohorts were identified in the pre-index period). Subsequent CV hospitalizations were evaluated using Cox proportional hazards models. All-cause and CV-related healthcare resource utilization (HCRU) and costs captured on a per-patient per-month (PPPM) basis during a variable follow-up period were evaluated using appropriate multivariable regression models. RESULTS: Of 316,207 patients with ≥1 CV hospitalization, 23% had comorbid type 2 diabetes. The mean age ± SD was 62.6 ± 12.3 years and 64.4% were male. During follow-up, the type 2 diabetes cohort had a 19% higher risk of subsequent CV hospitalizations compared to the non-type-2-diabetes cohort (p < .001). This difference in risk was highest in patients aged 35-44 years. Subsequent all-cause hospitalizations for the type 2 diabetes cohort were longer (mean length of stay, 6.7 vs. 6.3 days; p < .001), with higher total bed-days PPPM (mean, 0.52 vs. 0.43; p < .001), compared to the non-type-2-diabetes cohort. The type 2 diabetes cohort had a significantly higher incremental cost for both the index CV hospitalization (mean cost difference, $1046; p < .001) and all-cause costs PPPM following discharge (mean cost difference, $749; p < .001). CONCLUSIONS: Comorbid type 2 diabetes was associated with an increased risk of subsequent CV hospitalizations and higher costs and HCRU during the follow-up period.

Cardiometabolic comorbidities, readmission, and costs in schizophrenia and bipolar disorder: a real-world analysis.

BACKGROUND: Serious mental illnesses are associated with increased risk of cardiometabolic comorbidities. The objective of this study was to evaluate the prevalence of cardiometabolic comorbidity and its association with hospitalization outcomes and costs among inpatients with schizophrenia or bipolar disorder. METHODS: This retrospective database analysis reviewed patients with an inpatient diagnosis of schizophrenia or bipolar disorder from the Premier Perspective® Database (4/1/2010-6/30/2012). Patients were categorized into 4 cohorts based on the number of ICD-9-CM cardiometabolic comorbidities (i.e., 0, 1, 2, or 3+). Outcomes included length of stay, mortality during the index hospitalization, healthcare costs, and 30-day all-cause readmission rates. RESULTS: Of 57,506 patients with schizophrenia, 66.1% had at least one cardiometabolic comorbidity; 39.3% had two or more comorbidities. Of 124,803 patients with bipolar disorder, 60.5% had at least one cardiometabolic comorbidity; 33.4% had two or more. Average length of stay was 8.5 (for patients with schizophrenia) and 5.2 (for patients with bipolar disorder) days. Each additional cardiometabolic comorbidity was associated with an increase in length of stay for patients with bipolar disorder (p < .001) but not for patients with schizophrenia. Mortality rates during the index hospitalization were 1.2% (schizophrenia) and .7% (bipolar disorder). Each additional cardiometabolic comorbidity was associated with a significant increase in mortality for patients with bipolar disorder (OR 1.218, p < .001), and a numerical increase in mortality for patients with schizophrenia (OR 1.014, p = .727). Patients with more cardiometabolic comorbidities were more likely to have a 30-day readmission (schizophrenia = 9-13%; bipolar disorder = 7-12%), and to incur higher costs (schizophrenia = $10,606-15,355; bipolar disorder = $7126-13,523) (all p < .01). CONCLUSIONS: Over 60% of inpatients with schizophrenia or bipolar disorder had cardiometabolic comorbidities. Greater cardiometabolic comorbidity burden was associated with an increased likelihood of readmission and higher costs among patients with schizophrenia or bipolar disorder, and an increase in length of stay and mortality for patients with bipolar disorder.

Treatment patterns and outcomes among patients with high-intermediate/high-risk diffuse large B-cell lymphoma in the USA.

Objective Clinical trials have demonstrated improved outcomes for patients with diffuse large B-cell lymphoma (DLBCL) treated with regimens containing rituximab, but variations in real-world treatment patterns and outcomes have not been studied. The objective of this study was to characterize real-world treatment patterns and outcomes in higher risk DLBCL patients. Methods Patients with an International Prognostic Index score (IPI) ≥3 who received initial rituximab-based therapy from 2005 to 2012 were identified via electronic medical record data from the International Oncology Network. Initial therapy, rates of complete response (CR), post-CR treatments, and outcomes were evaluated. Results Among 257 eligible patients, 75% achieved a CR: 77% (158/206) of patients receiving R-CHOP compared to 71% (36/51) of patients receiving initial therapies other than R-CHOP. Post-CR, 78% of the 158 patients receiving R-CHOP underwent active surveillance; 13% received maintenance rituximab-based treatment; and 6% received radiation therapy. Relapse rates among patients receiving maintenance rituximab, active surveillance, and radiation therapy were 28% (6/21), 19% (24/124), and 0%, (0/10), respectively (P = 0.08). Discussion This study found that active surveillance continues to be the most commonly utilized treatment regimen among DLBCL patients with an IPI score ≥3 achieving a CR on first-line R-CHOP. Other approaches aimed at increasing the time to relapse are being utilized as well, but the clinical benefit of these modalities is unclear. Conclusion Results of this study are consistent with the results from clinical trials and suggest the need for further evaluation of maintenance therapy options for patients at higher risk of relapse.

Cost-effectiveness of natalizumab vs fingolimod for the treatment of relapsing-remitting multiple sclerosis: analyses in Sweden.

OBJECTIVE: To assess the cost-effectiveness of natalizumab vs fingolimod over 2 years in relapsing-remitting multiple sclerosis (RRMS) patients and patients with rapidly evolving severe disease in Sweden. METHODS: A decision analytic model was developed to estimate the incremental cost per relapse avoided of natalizumab and fingolimod from the perspective of the Swedish healthcare system. Modeled 2-year costs in Swedish kronor of treating RRMS patients included drug acquisition costs, administration and monitoring costs, and costs of treating MS relapses. Effectiveness was measured in terms of MS relapses avoided using data from the AFFIRM and FREEDOMS trials for all patients with RRMS and from post-hoc sub-group analyses for patients with rapidly evolving severe disease. Probabilistic sensitivity analyses were conducted to assess uncertainty. RESULTS: The analysis showed that, in all patients with MS, treatment with fingolimod costs less (440,463 Kr vs 444,324 Kr), but treatment with natalizumab results in more relapses avoided (0.74 vs 0.59), resulting in an incremental cost-effectiveness ratio (ICER) of 25,448 Kr per relapse avoided. In patients with rapidly evolving severe disease, natalizumab dominated fingolimod. Results of the sensitivity analysis demonstrate the robustness of the model results. At a willingness-to-pay (WTP) threshold of 500,000 Kr per relapse avoided, natalizumab is cost-effective in >80% of simulations in both patient populations. LIMITATIONS: Limitations include absence of data from direct head-to-head studies comparing natalizumab and fingolimod, use of relapse rate reduction rather than sustained disability progression as the primary model outcome, assumption of 100% adherence to MS treatment, and exclusion of adverse event costs in the model. CONCLUSIONS: Natalizumab remains a cost-effective treatment option for patients with MS in Sweden. In the RRMS patient population, the incremental cost per relapse avoided is well below a 500,000 Kr WTP threshold per relapse avoided. In the rapidly evolving severe disease patient population, natalizumab dominates fingolimod.

Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States.

PURPOSE: Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. MATERIALS AND METHODS: Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book "Dangerous Doses," LexisNexis (search terms "counterfeit" and "erythropoietin") and the FDA database. RESULTS: Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical "gray market" to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. CONCLUSION: Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals.

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.

Impact of patient selection criteria and treatment history on comparisons of alternative therapies: a case study of atypical antipsychotics.

BACKGROUND: Comparative effectiveness analyses using retrospective databases may be highly sensitive to common design decisions employed by researchers. OBJECTIVE: To test the sensitivity of statistical results to common research methods in retrospective database analyses. Comparisons of time to all-cause discontinuation (TTAD) across antipsychotic drug therapies are used to illustrate these effects. METHODS: Data from the California Medicaid Program were used to identify 231,635 episodes of antipsychotic drug therapy. Four sequential analyses of TTAD were performed on all patients, patients with 1 year of post-treatment data, and patients with schizophrenia and using models that included variables documenting drug treatment history. RESULTS: Patients using atypical antipsychotics consistently achieve longer TTAD than patients treated with conventional antipsychotics. Nevertheless, estimated differences narrowed when analyses included only patients with schizophrenia. Risperidone performed better than olanzapine when diagnosis was not limited to schizophrenia, and quetiapine outperformed olanzapine and risperidone when the analysis did not control for treatment history. This latter result reflects the disproportionate use of quetiapine in long-duration augmentation episodes. There were no statistical differences across alternative atypical antipsychotics once the analysis excluded patients without a diagnosis of schizophrenia and included patient treatment history in the analysis. CONCLUSIONS: Comparative effectiveness analyses of alternative drug therapies are sensitive to diagnosis and patient drug treatment history. Data on these factors can be derived from paid claims data and should be used to provide more accurate comparisons of effectiveness across drugs and to provide results that cover the full range of clinical scenarios that clinicians face.

Adherence to medications by patients after acute coronary syndromes.

BACKGROUND: Nonadherence to medication may lead to poor medical outcomes. OBJECTIVE: To describe medication-taking behavior of patients with a history of acute coronary syndromes (ACS) for 4 classes of drugs and determine the relationship between self-reported adherence and patient characteristics. METHODS: Consenting patients with the diagnosis of ACS were interviewed by telephone approximately 10 months after discharge. The survey elicited data characterizing the patient, current medication regimens, beliefs about drug therapy, reasons for discontinuing medications, and adherence. The survey included the Beliefs About Medicine Questionnaire providing 4 scales: Specific Necessity, Specific Concerns, General Harm, and General Overuse, and the Medication Adherence Scale (MAS). Multivariate regression was used to determine the independent variables with the strongest association to the MAS. A p value < or = 0.05 was considered significant for all analyses. RESULTS: Two hundred eight patients were interviewed. Mean +/- SD age was 64.9 +/- 13.0 years, with 60.6% male, 95.7% white, 57.3% with a college education, 87.9% living with > or =1 other person, and 42% indicating excellent or very good health. The percentage of patients continuing on medication at the time of the survey category ranged from 87.4% (aspirin) to 66.0% (angiotensin-converting enzyme inhibitors). Reasons for stopping medication included physician discontinuation or adverse effects. Of patients still on drug therapy, the mean MAS was 1.3 +/- 0.4, with 53.8% indicating nonadherence (score >1). The final regression model showed R(2) = 0.132 and included heart-related health status and Specific Necessity as significant predictor variables. CONCLUSIONS: After ACS, not all patients continue their drugs or take them exactly as prescribed. Determining beliefs about illness and medication may be helpful in developing interventions aimed at improving adherence.