US Health Insurance Database Research Articles

Risk of venous thromboembolism during the use of oral estrogen-progestogen hormone therapies in light of most recent research findings.

Two important studies evaluating the safety profile of oral estrogen-progestogen hormonal therapies conducted in standard clinical practice with respect to the venous system were recently published.A large prospective controlled cohort study (PRO-E2) based on the non-inferiority design has shown that the relative risk of developing venous thrombosis (VTE) in women using combined oral hormonal contraceptives (COHC) containing 17β-estradiol (1.5 mg) and nomegestrol acetate (2.5 mg) (E2/NOMAC) was not statistically different from that in users of COHC containing ethinylestradiol and levonorgestrel (EE/LNG).The aim of the recently presented study was to compare the risk of VTE in patients treated with a product for oral continuous combined menopausal hormone therapy containing 1 mg of 17ß-estradiol and 100 mg of micronized progesterone (1 mgE2/100 mgP4) with patients taking conjugated equine estrogens and medroxyprogesterone acetate (CEE/MPA). The study was based on an analysis of records retrieved from a US health insurance database, and was therefore concerned the real-life clinical practice. The hazard ratio of VTE when comparing 1 mgE2/100 mgP4 with CEE/MPA was 0.70 (95% CI: 0.53–0.92). The difference was found to be statistically significant (p < 0.05).The rewieved studies provide further evidence that the use of hormones bioidentical with endogenous steroids in oral contraception and menopausal hormone therapy creates an opportunity to combine high efficacy with a favorable safety profile.

The Health Care Resource Utilization and Costs Among Patients With Type 2 Diabetes and Either Cardiovascular Disease or Cardiovascular Risk Factors An Analysis of a US Health Insurance Database

Health care costs and cardiovascular (CV) outcomes were evaluated among US patients with type 2 diabetes (T2D) and cardiovascular disease (CVD) or CV risk factors. Patients with ≥24 months of continuous enrollment were selected from the MarketScan Commercial and Medicare databases from January 1, 2014, to September 30, 2018. For the first qualifying 24-month period, months 1 to 12 defined the baseline period and months 13 to 24 defined the follow-up period. All patients had ≥2T2D diagnoses during baseline. Two cohorts were created: (1) patients with ≥1 CVD diagnosis during baseline ("CVD cohort"); and (2) patients with ≥1 CV risk factor ("CV risk cohort") and no diagnosed CVD during baseline. The percentage of patients with subsequent CVD diagnoses and annual all-cause, T2D-related, and CV-related costs in baseline and follow-up periods were reported. In total, 1,106,716 patients met inclusion criteria: CVD cohort, 224,018 patients; CV risk cohort, 812,144 patients; and no diagnosed CVD or CV risk factors, 70,554. During baseline, 40.2% of the CVD cohort had 2 or more CVD diagnoses. During follow-up, 10.5% of the CV risk cohort had evidence of CVD (ie, emergent CVD). During baseline, the CVD cohort had mean (SD) all-cause costs of $38,985 ($69,936); T2D-related costs, $16,208 ($34,104); and CV-related annual costs, $18,842 ($44,457). The CV risk cohort had mean all-cause costs of $13,207 ($27,057); T2D-related costs, $5226 ($12,268); and CV-related costs, $2754 ($10,586). During follow-up, the CV risk cohort with emergent CVD had higher mean all-cause, T2D-related, and CV-related annual costs than costs among patients without CVD (all-cause, $39,365 [$67,731] vs $13,401 [$27,530]; T2D related, $18,520 [$37,256] vs $5732 [$12,540]; and CV related, $18,893 [$43,584] vs $2650 [$10,501], respectively). Costs for patients with T2D and either CVD or CV risk are substantial. In this analysis, ∼10% of patients with CV risk were diagnosed with emergent CVD. All-cause costs among patients with emergent CVD were nearly 3 times higher than those among patients with CV risk only. Because costs associated with CVD in the T2D population are high, preventing CVD events in patients with T2D has the potential to decrease overall health care costs and avoid additional disease burden for these patients.

Prediction of severe immune-related adverse events requiring hospital admission in patients on immune checkpoint inhibitors: study of a population level insurance claims database from the USA

BackgroundImmune-related adverse events (irAEs) are a serious side effect of immune checkpoint inhibitor (ICI) therapy for patients with advanced cancer. Currently, predisposing risk factors are undefined but understanding which patients...

Patterns of Postpartum Ambulatory Care Follow-up Care Among Women With Hypertensive Disorders of Pregnancy.

BackgroundPreeclampsia and gestational hypertension are hypertensive disorders of pregnancy (HDP) that identify an increased risk of developing chronic hypertension and cardiovascular disease later in life. Postpartum follow‐up may facilitate early screening and treatment of cardiovascular risk factors. Our objective is to describe patterns of postpartum visits with primary care and women's health providers (eg, family medicine and obstetrics) among women with and without HDP in a nationally representative sample of commercially insured women.Methods and ResultsWe conducted a retrospective cohort study using insurance claims from a US health insurance database to describe patterns in office visits in the 6 months after delivery. We identified 566 059 women with completed pregnancies between 2005 and 2014. At 6 months, 13% of women with normotensive pregnancies, 18% with HDP, and 23% with chronic hypertension had primary care visits (P<0.0001 for comparing HDP and chronic hypertension groups with control participants). Only 58% of women with HDP had 6‐month follow‐up with any continuity provider compared with 47% of women without hypertension (P<0.0001). In multivariable analysis, women with severe preeclampsia were 16% more likely to have postpartum continuity follow‐up (adjusted odds ratio, 1.16; 95% CI, 1.2–1.21). Factors associated with a lower likelihood of any follow‐up included age ≥30 years, Black race, Hispanic ethnicity, and having multiple gestations.ConclusionsRates of continuity care follow‐up after a pregnancy complicated by hypertension were low. This represents a substantial missed opportunity to provide cardiovascular risk screening and management to women at increased risk of future cardiovascular disease.

Characterizing idiopathic pulmonary fibrosis patients using US Medicare-advantage health plan claims data

BackgroundIdiopathic pulmonary fibrosis (IPF) is a rare life-threating interstitial lung disease (ILD). This study characterizes demographics, health care utilization, and comorbidities among elderly IPF patients and estimates prevalence and incidence rates for selected outcomes.MethodsCohort study using a large US health insurance database (Optum’s Medicare Advantage plan). Inclusion criteria: ≥ 1 diagnosis code for IPF (2008 - 2014), age ≥65 years, no diagnosis of IPF or other ILD in prior 12 months. Demographics, health care utilization, comorbidities and incidence rates for various outcomes were estimated. Follow-up continued until the earliest of: health plan disenrollment, death, a claim for another known cause of ILD, or end of the study period.Results4,716 patients were eligible; 53.4% had IPF diagnostic testing. Median age was 77.5 years, 50.3% were male, median follow-up time was 0.8 years. Incidence rates ranged from 1.0/1,000 person-years (lung transplantation) to 374.3/1,000 person-years (arterial hypertension). Baseline characteristics and incidence rates were similar for cohorts of patients with and without IPF diagnostic testing.ConclusionsElderly IPF patients experience a variety of comorbidities before and after IPF diagnosis. Therapies for IPF and for the associated comorbidities may reduce morbidity and associated health care utilization of these patients.

Pregnancy and Birth Outcomes among Women with Idiopathic Thrombocytopenic Purpura.

Objective. To examine pregnancy and birth outcomes among women with idiopathic thrombocytopenic purpura (ITP) or chronic ITP (cITP) diagnosed before or during pregnancy. Methods. A linkage of mothers and babies within a large US health insurance database that combines enrollment data, pharmacy claims, and medical claims was carried out to identify pregnancies in women with ITP or cITP. Outcomes included preterm birth, elective and spontaneous loss, and major congenital anomalies. Results. Results suggest that women diagnosed with ITP or cITP prior to their estimated date of conception may be at higher risk for stillbirth, fetal loss, and premature delivery. Among 446 pregnancies in women with ITP, 346 resulted in live births. Women with cITP experienced more adverse outcomes than those with a pregnancy-related diagnosis of ITP. Although 7.8% of all live births had major congenital anomalies, the majority were isolated heart defects. Among deliveries in women with cITP, 15.2% of live births were preterm. Conclusions. The results of this study provide further evidence that cause and duration of maternal ITP are important determinants of the outcomes of pregnancy.

Abstract P3-10-06: Real-world efficacy and safety outcomes of nab-paclitaxel (nab-P) in patients (pts) with metastatic breast cancer (MBC): Results from a US health insurance database

Abstract Background: nab-P, an albumin-bound formulation of paclitaxel, was approved in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 mo of adjuvant chemotherapy based on clinical trials. nab-P demonstrated efficacy and safety when administered weekly in phase II trials and every 3 weeks (q3w) in an international phase III trial. Little is known about the treatment patterns and outcomes of nab-P in the real-world setting. Using health insurance claims data, this study was conducted to characterize efficacy and safety of nab-P in pts with MBC treated in US clinical practices. Methods: This retrospective claims analysis used data in the Optum Research Database (United Health affiliate). Data were supplemented by Social Security Death Index sources. The analysis included women aged ≥ 18 y with MBC diagnosis (≥ 2 claims of BC diagnosis separated by ≥ 30 d and ≥ 2 claims of metastatic spread) prior to nab-P initiation. Pts had ≥ 6 mo of continuous enrollment in the health plan from January 2005-September 2012, complete medical coverage and pharmacy benefits, no other primary malignancy, and no prior chemotherapy. Cohorts were determined by line of therapy, nab-P regimen, and schedule. Endpoints included treatment patterns, time to next therapy or death (TNTD), overall survival (OS), and safety. Results: Of the 664 eligible pts, most were between 40-69 y of age (88%) and had received nab-P as ≥ second-line therapy (74%), monotherapy (61%), and weekly dosing (71%). In combination, nab-P was most often given with bevacizumab (58%) or human epidermal growth factor receptor 2 (HER2)–targeted therapy (24%) vs another cytotoxic agent (19%). Median TNTD and OS were 6.1 and 17.4 mo, respectively. By line of therapy (first, second, and ≥ third), TNTD was 7.1, 6.6, and 5.3 mo, and OS was 22.7, 17.4, and 15.1 mo. The OS data are comparable with published clinical trial results (Table). In a subgroup of pts (n = 400) with aggressive disease features (≤ 50 y of age or having ≥ 3 metastases), median OS was 15.6 mo. These data are comparable with a retrospective analysis of pts with visceral dominant metastasis (VDM) or a short disease-free interval (SDFI; Table). Toxicities reported in healthcare claims were consistent with those previously published. Conclusions: Consistent with clinical trial data, outcomes of this analysis demonstrated the efficacy and safety of nab-P across lines of therapy in a real-world population of patients with MBC. Clinical Trial Experience in MBC for Pts Treated With nab-PTrialnab-P dose (mg/m2) and schedulenMedian OS, moCA0121 (Ph III)ITT (all lines)260 q3w22915.0≥ second line260 q3w13113.0CA0242 (Ph II, first line)300 q3w7627.7100 qw 3/47622.2150 qw 3/47433.8Median OS, moSubgroups With Aggressive Disease FeaturesnVDMnSDFICA0123 (first line)260 q3w7415.14214.6CA0243 (first line)300 q3w6127.72016.6100 qw 3/46019.62119.1150 qw 3/45932.11418.6qw 3/4, weekly for the first 3 of 4 weeks. 1 Gradishar WJ, et al. J Clin Oncol. 2005;23:7794-7803. 2 Gradishar WJ, et al. Clin Breast Cancer. 2012;12:313-321. 3 O’Shaughnessy J, et al. Breast Cancer Res Treat. 2013;138:829-837. Citation Format: Debra A Patt, Caihua Liang, Ling Li, Amy Ko, Cindy Duval Fraser, Deyanira Corzo, Cheryl Enger. Real-world efficacy and safety outcomes of nab-paclitaxel (nab-P) in patients (pts) with metastatic breast cancer (MBC): Results from a US health insurance database [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-10-06.

Impact of Metastatic Colorectal Cancer Stage and Number of Treatment Courses on Patient Health Care Costs and Utilization

Background: Advances in colorectal cancer (CRC) treatment and improved survival rates have led to higher costs associated with treating CRC. Objective: To examine health care costs and utilization by initial CRC stage at diagnosis and the number of lines of treatment received by patients with metastatic CRC. Methods: Adult patients with a diagnosis of CRC made from January 1, 2005 to May 31, 2010 were identified from the Oncology Management registry. Patients with stage IV CRC at initial diagnosis or who had advanced to stage IV CRC at the time of the study were included. Registry data included initial CRC stage and the date of diagnosis. Linked health care claims from a large US health insurance database affiliated with Optum were used to identify health care costs and patient characteristics. Multivariate regression analysis was used to estimate total 4-year health care costs stratified by stage and adjusted for patient characteristics. Follow-up ended at patient death, disenrollment from the health care plan, or study end (November 30, 2010). Results: A total of 598 patients, followed for an average of 653 days after first evidence of metastasis, were included. At initial diagnosis, 91 patients had stages 0 to III CRC, 310 patients had stage IV CRC, and 197 patients had an unknown stage of CRC. The mean unadjusted total cost per patient (medical + pharmaceutical costs) was $252 200; outpatient hospital visits (excluding radiation and surgery) contributed most to the total cost, at a mean cost of $71 334. Hospitalization costs, with or without surgery (mean, $56 862), accounted for 33% of the $176135 unadjusted mean cost for medical services (ambulatory visits [office and outpatient], emergency department visits, laboratory/radiology services, and inpatient admission). Chemotherapy and biologics were also costly (mean, $31 112 and $38 276, respectively). A general linear model analysis of estimated 4-year total costs showed that both CRC stage at diagnosis and the number of lines of treatment after metastasis had a statistically significant association with cost (P < 0.001). Conclusion: Variables that had a statistically significant association with cost (P < 0.05) were sex, age group, and follow-up Charlson Comorbidity Index score after metastases. After adjusting for the number of lines of treatment received, total 4-year costs were highest among patients who presented with stage IV CRC and lowest among patients who presented with stage III CRC and developed metastatic disease.

Change in healthcare utilization and costs following initiation of benzodiazepine therapy for long-term treatment of generalized anxiety disorder: a retrospective cohort study

BackgroundSelective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and benzodiazepine anxiolytics are used in the US to treat generalized anxiety disorder (GAD). While benzodiazepines typically provide rapid symptomatic relief, long-term use is not recommended due to risks of dependency, sedation, falls, and accidents.MethodsUsing a US health insurance database, we identified all persons with GAD (ICD-9-CM diagnosis code 300.02) who began a long-term course of treatment (≥90 days) with a benzodiazepine anxiolytic between 1/1/2003 and 12/31/2007, We compared healthcare utilization and costs over the six-month periods preceding and following the date of treatment initiation (“pretreatment” and “post-treatment”, respectively), and focused attention on accident-related encounters (e.g., for treatment of fractures) and care received for other reasons possibly related benzodiazepine use (e.g., sedation, dizziness).ResultsA total of 866 patients met all study entry criteria; 25% of patients began treatment on an add-on basis (i.e., adjunctive to escitalopram, paroxetine, sertraline, or venlafaxine), while 75% of patients did not receive concomitant therapy. Mean total healthcare costs increased by $2334 between the pretreatment and post-treatment periods (from $4637 [SD=$9840] to $6971 [$17,002]; p<0.01); costs of accident-related encounters and other care that was possibly related to use of benzodiazepines increased by an average of $1099 ($1757 [$7656] vs $2856 [$14,836]; p=0.03).ConclusionsHealthcare costs increase in patients with GAD beginning long-term (≥90 days) treatment with a benzodiazepine anxiolytic; a substantial proportion of this increase is attributable to care associated with accidents and other known sequelae of long-term benzodiazepine use.

Treatment of new‐onset ulcerative colitis and ulcerative proctitis: a retrospective study

Although guidelines recommend use of oral 5-aminosalicylates (5-ASAs) as first-line therapy in patients with mild to moderate ulcerative colitis (UC) and ulcerative proctitis (UP) and steroids with or without 5-ASAs in those more severely ill, little is known about how UC and UP are actually treated. To document treatment of new-onset UC and UP in routine clinical practice. Using a large US health insurance database, we identified all persons with new-onset UC or UP between 1 January 2005 and 31 December 2007, based on: (i) initial receipt of an oral 5-ASA, mesalazine (mesalamine) suppository, 5-ASA enema, steroid, antimetabolite, budesonide or TNF inhibitor; (ii) sigmoidoscopy/colonoscopy in prior 30days resulting in a new diagnosis of UC or UP and (iii) no prior encounters for Crohn's disease. We examined patterns of pharmacotherapy over 1year. We identified 1516 UC patients and 636 UP patients who met study entry criteria. In UC, initial therapies most frequently used were oral 5-ASAs (53% of patients), oral 5-ASAs and systemic steroids (12%), systemic steroids (8%) and mesalazine suppositories (6%); in UP, mesalazine suppositories (42%) and oral 5-ASAs (19%) were most often used, followed by combination therapy (14%), mesalazine enema(11%) and rectal steroids (10%). Few patients received maintenance therapy, and there was limited use of antimetabolites and biological agents. Oral 5-ASAs and systemic steroids are the mainstay of treatment in patients with new-onset ulcerative colitis; in those with new-onset ulcerative proctitis, it is mesalazine suppositories. Care of these patients appears consistent with treatment guidelines.

Treatment patterns among metastatic colorectal cancer patients by line of therapy and original stage of diagnosis.

e14013 Background: National Comprehensive Cancer Network (NCCN) guidelines recommend use of approved biologics combined with common chemotherapy agents for treatment of metastatic colorectal cancer (CRC). Five classes of chemotherapy/biologics are available for treatment of CRC. Methods: Adult patients with a diagnosis of CRC between 01/01/05 and 05/31/10 were identified from the Impact Intelligence Oncology Management (IIOM) registry. Patients with either stage 4 CRC at original diagnosis or development of a metastasis were included. Registry data included original date of diagnosis and stage information. Linked healthcare claims from a large US health insurance database affiliated with OptumInsight were used to identify lines of therapy and patient characteristics (e.g., development of metastases). Lines of therapy were based on patients’ use of chemotherapy/biologic agents after becoming metastatic. Treatment regimens were assessed and stratified by line of therapy (1st, 2nd, 3rd, 4th) and stage at diagnosis (0-2, 3, 4, unknown). Results: 16% of the 598 study patients who developed metastasis received no chemotherapy. Of those who did, 84%, 52%, 27%, and 14% received a 1st, 2nd, 3rd, and 4th line of therapy, respectively. 71% of patients who progressed from stage 0-2 or 3 received a 2nd line compared to 90% of patients who initially presented with stage 4 CRC. In the 1st line, 59% received an oxaliplatin-based regimen, 15% received an irinotecan-based regimen, and 11% received 5-FU alone. In 2nd and 3rd line therapy, percentages of patients treated with irinotecan-based regimens increased to 45% and 50%, respectively, and use of oxaliplatin-based regimens dropped to 27% and 16%, respectively. Overall, use of anti-EGFR agents increased steadily from 4% in the 1st line to 12%, 29%, and 38%, respectively in the 2nd, 3rd, and 4th lines. Conclusions: Patients who presented with stage 4 CRC had the highest rates of chemotherapy use. Despite NCCN guidelines, 11% of patients received 5-FU monotherapy as 1st line treatment.

Differences in survival for metastatic colorectal cancer patients by lines of therapy received.

e14016 Background: Improvements in survival for advanced-stage CRC patients who receive chemotherapy have been reported. We compared survival rates for patients with 3+ vs. &lt;3 lines of therapy. Methods: Adult patients with a diagnosis of CRC between 01/01/05 and 05/31/10 were identified from the Impact Intelligence Oncology Management (IIOM) registry. Patients with either stage 4 CRC at original diagnosis or development of metastasis were included. Registry data included original stage and date of diagnosis. Linked healthcare claims from the Life Sciences Research Database, a large US health insurance database affiliated with OptumInsight, were used to identify lines of therapy after metastases and patient characteristics. Death data were obtained from the Social Security Administration’s master death file. Patients were categorized by number of lines of therapy received (0, 1, 2, 3+) and original stage at diagnosis (0-2, 3, 4, unknown). Survival following metastases was evaluated using Cox proportional hazards models controlling for lines of therapy received, stage, and other patient characteristics. Results: 598 patients, followed for a mean of 653 days after becoming metastatic, were included. Mean unadjusted length of follow-up was lowest among patients who received no chemotherapy (516 days) or only 1 line (511 days), and increased to 627 days for those with 2 lines and 930 days for those with 3+ lines. However, multivariate analysis indicated that patients with 3+ lines had comparable survival vs. those with 0 (HR=0.79), 1 (HR=1.59), or 2 (HR=1.15) lines of therapy (p&gt;0.05 for all comparisons). Compared to patients who presented with stage 4 CRC, those who progressed from stage 0-2 (HR=1.22), stage 3 (HR=0.83), or unknown stage (HR=1.18) had similar survival after metastases (p&gt;0.05 for all comparisons). After excluding 94 patients who didn’t receive chemotherapy, patients treated with an oxaliplatin-based regimen (HR=1.28; p=0.24) in first line had similar survival compared to patients treated with an irinotecan-based or anti-EGFR regimen in first line. Conclusions: Lines of therapy received and initial stage were not associated with survival after development of metastases.

Healthcare utilization and costs in patients beginning pharmacotherapy for generalized anxiety disorder: a retrospective cohort study

BackgroundPatterns of healthcare utilization and costs in patients beginning pharmacotherapy for generalized anxiety disorder (GAD) have not been well characterized.MethodsUsing a large US health insurance database, we identified all patients with evidence of GAD (ICD-9-CM diagnosis code 300.02) who initiated pharmacotherapy with medications commonly used to treat GAD (eg, selective serotonin reuptake inhibitors [SSRIs], venlafaxine, benzodiazepines) between 1/1/2003 and 12/31/2007. We examined healthcare utilization and costs over the 12-month periods preceding and following date of initial receipt of such therapy ("pretreatment" and "follow-up", respectively). Patients with incomplete data were excluded.ResultsA total of 10,275 patients met all study inclusion criteria. Forty-eight percent of patients received SSRIs; 34%, benzodiazepines; and 6%, venlafaxine. SSRIs and venlafaxine were about three times more likely to be used on a long-term basis (> 90 days) than benzodiazepines (p < 0.01). In general, levels of healthcare utilization were higher during follow-up than pretreatment. Mean (SD) total healthcare costs increased from $4812 ($10,006) during pretreatment to $7182 ($22,041) during follow-up (p < 0.01); costs of GAD-related pharmacotherapy during follow-up were $420 ($485).ConclusionsMore than one-half of patients initiating pharmacotherapy for GAD receive either SSRIs or venlafaxine. Levels of healthcare utilization and costs are greater in the year following initiation of therapy than in the immediately preceding one.

Health Care Utilization and Costs in Patients with Generalized Anxiety Disorder Initiating Add-on Therapy with Benzodiazepines

ObjectivesTo examine patterns of health care utilization and costs in patients with generalized anxiety disorder (GAD) who begin treatment with benzodiazepine anxiolytics as add-on therapy. Study DesignIn a large US health insurance database, we identified all patients with evidence of GAD (International Classification of Diseases, 9th Revision, Clinical Modification diagnosis code 300.02) who received ≥90 days of therapy with a selective serotonin reuptake inhibitor or venlafaxine between January 1, 2003 and December 31, 2007. Among these patients, we selected those who initiated a course of benzodiazepine add-on therapy. Designating the date of initial receipt of a benzodiazepine as the “index date,” we examined health care utilization and costs over the 6-month period preceding this date (“pre-index”) and the 12-month period following it (“follow-up”). ResultsA total of 2131 patients met all study inclusion criteria. Patients averaged 32 days of therapy with benzodiazepines (median [interquartile range] = 20 [10-30]); 13% of patients received >90 days of therapy, however. In general, levels of health care utilization during the first 6 months of follow-up were higher than those during the pre-index period; between months 7 and 12 of follow-up, however, they were somewhat lower than pre-index levels. Mean (SD) total health care costs were $5148 ($10,658), $6325 ($15,741), and $5373 ($11,230) during pre-index, months 1-6 of follow-up, and months 7-12 of follow-up, respectively. ConclusionsLevels of health care utilization and costs increase following initiation of add-on therapy with a benzodiazepine in patients with GAD receiving selective serotonin reuptake inhibitors or venlafaxine. Although duration of add-on therapy is typically brief, some patients are treated for >90 days, raising potential concerns about risks of dependency and sedation.

Historical Performance of Asset Location Strategies and Its Implications for Investors’ Retirement Portfolios

<h3>Background</h3> Immune-related adverse events (irAEs) are a serious side effect of immune checkpoint inhibitor (ICI) therapy for patients with advanced cancer. Currently, predisposing risk factors are undefined but understanding which patients are at increased risk for irAEs severe enough to require hospitalization would be beneficial to tailor treatment selection and monitoring. <h3>Methods</h3> We performed a retrospective review of patients with cancer treated with ICIs using unidentifiable claims data from an Aetna nationwide US health insurance database from January 3, 2011 to December 31, 2019, including patients with an identified primary cancer and at least one administration of an ICI. Regression analyses were performed. Main outcomes were incidence of and factors associated with irAE requiring hospitalization in ICI therapy. <h3>Results</h3> There were 68.8 million patients identified in the national database, and 14 378 patients with cancer identified with at least 1 administration of ICI in the study period. Patients were followed over 19 117 patient years and 504 (3.5%) developed an irAE requiring hospitalization. The incidence of irAEs requiring hospitalization per patient ICI treatment year was 2.6%, rising from 0% (0/71) in 2011 to 3.7% (93/2486) in 2016. Combination immunotherapy (OR: 2.44, p&lt;0.001) was associated with increased odds of developing irAEs requiring hospitalization, whereas older patients (OR 0.98 per additional year, p&lt;0.001) and those with non-lung cancer were associated with decreased odds of irAEs requiring hospitalization (melanoma OR: 0.70, p=0.01, renal cell carcinoma OR: 0.71, p=0.03, other cancers OR: 0.50, p&lt;0.001). Sex, region, zip-code-imputed income, and zip-code unemployment were not associated with incidence of irAE requiring hospitalization. Prednisone (72%) and methylprednisolone (25%) were the most common immunosuppressive treatments identified in irAE hospitalizations. <h3>Conclusions</h3> We found that 3.5% of patients initiating ICI therapy experienced irAEs requiring hospitalization and immunosuppression. The odds of irAEs requiring hospitalization were higher with younger age, treatment with combination ICI therapy (cytotoxic T lymphocyte-associated 4 and programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1)), and lower for other cancers compared with patients on PD-1 or PD-L1 inhibitors with lung cancer. This evidence from the first nationwide study of irAEs requiring hospitalization in the USA identified the real-world epidemiology, risk factors, and treatment patterns of these irAEs which may guide treatment and management decisions.

Tegaserod and the Risk of Cardiovascular Ischemic Events: An Observational Cohort Study

Tegaserod, a partial 5-HT(4) agonist previously approved for treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, was suspended from US marketing in 2007, based on pooled clinical trial results which contained a signal suggesting increased risk of cardiovascular ischemic events (CVIEs). We sought to evaluate whether there was an association between tegaserod and CVIE in a setting of routine clinical practice. This was a matched cohort study conducted within a large US health insurance database, involving 52 229 patients who initiated tegaserod and 52 229 patients with similar characteristics who did not initiate tegaserod. Participants were followed for up to 6 months for the occurrence of CVIE (myocardial infarction, acute coronary syndrome, coronary revascularization, and stroke). Outcomes were identified using insurance claims and were confirmed by review of medical records. We conducted as-matched analyses providing hazard ratios (HRs) along with 95% confidence intervals (95% CI) and as-treated analyses accounting for changes in dispensed therapy. There was no increased risk of CVIE associated with tegaserod treatment. The as-matched association between tegaserod and ischemic cardiovascular outcomes (HR = 0.95, 95% CI 0.73-1.23) and stroke (HR = 0.90, 95% CI 0.46-1.77) did not change substantially in the as-treated analyses (cardiovascular relative risk [RR] = 1.14, 95% CI 0.83-1.56; stroke: RR = 1.09, 95% CI = 0.49-2.02). The results were largely unaffected by adjustment for characteristics or subgroup analyses. In this observational study of tegaserod use, we found no evidence for an increased risk of CVIE in tegaserod users.

The thiazolidinediones rosiglitazone and pioglitazone and the risk of coronary heart disease: A retrospective cohort study using a US health insurance database

Background: The thiazolidinediones (TZDs), including rosiglitazone maleate and pioglitazone hydrochloride, are commonly prescribed in patients with type 2 diabetes mellitus. Although recent meta-analyses suggest there is an increased risk of myocardial infarction (MI) among rosiglitazone users, these findings were not supported by data from other studies. Objective: The goal of this research was to compare the risk of MI, coronary revascularization (CR), and sudden death in patients who began rosiglitazone therapy versus those who began pioglitazone therapy. Methods: This was a retrospective cohort study using information from a large health care database (with data available on ~14 million individuals). All initiators of rosiglitazone or pioglitazone from July 1, 2000, through March 31, 2007, for whom the first dispensing followed ≥6 months of health plan membership and the member's 18th birthday were identified. The propensity score method was used to create matched cohorts of patients in 3 treatment groups: TZD monotherapy, dual therapy (a TZD plus another antidiabetic agent), and TZD therapy with concomitant insulin. Follow-up continued to a change in treatment regimen, defined as regimen switch (ie, the addition of any antidiabetic agent to an existing regimen) or regimen stop (ie, the discontinuation of any component of the therapeutic regimen). Three outcomes that represent coronary heart disease were assessed for this analysis: MI, CR, and sudden death. The proportional hazards model, stratified by therapeutic regimen, was used to estimate hazard ratios (HRs) and 95% CIs of coronary heart disease risk associated with use of rosiglitazone relative to pioglitazone. Results: Among 47,501 matched pairs of rosiglitazone and pioglitazone users, 72,104 (75.9%) were receiving TZD monotherapy, 17,822 (18.8%) were receiving dual therapy, and 5076 (5.3%) were receiving TZD therapy with insulin. Mean follow-up was 9.6 months with regimen switch as the censoring event and 8.4 months with regimen stop as the censoring event. For MI, the HR was 1.35 (95% CI, 1.12–1.62) through regimen switch and 1.41 (95% CI, 1.13–1.75) through regimen stop. For the composite outcome of MI, CR, and/or sudden death, the HR was 1.09 (95% CI, 0.97–1.22) through regimen switch and 1.12 (95% CI, 0.98–1.27) through regimen stop. Conclusions: In this retrospective cohort analysis, MI was more common in users of rosiglitazone than in users of pioglitazone. The incidence of a combined end point of MI, CR, and/or sudden death in patients receiving rosiglitazone was not significantly different from that in patients receiving pioglitazone.

Risk of hospitalization for neutropenic complications of chemotherapy in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis: A retrospective cohort study

Background: In a meta-analysis of data from randomized trials, the risk of febrile neutropenia during myelosuppressive chemotherapy was reported to be lower with pegfilgrastim prophylaxis than filgrastim prophylaxis. However, there is limited information on the comparative effectiveness of these agents in clinical practice. Objective: This study was undertaken to compare the risks of hospitalization for neutropenic complications of chemotherapy in US clinical practice in patients with primary solid tumors receiving pegfilgras-tim or filgrastim prophylaxis. Methods: This was a retrospective cohort study employing a US health insurance database. The source population included all patients who received chemotherapy for a primary solid tumor between January 2003 and December 2005 and who received filgrastim or pegfilgrastim during their first course of chemotherapy. All unique chemotherapy cycles were identified for each patient, and cycles in which pegfilgrastim or filgrastim was administered by cycle day 5 (considered to represent prophylaxis) were selected and pooled for analysis. The risks of hospitalization for neutro-penic complications (using both narrow and broad criteria) and for any reason were then compared between cycles in which filgrastim or pegfilgrastim prophylaxis was administered. Generalized estimating equations were used to control for potential confounding variables. Results: Filgrastim prophylaxis was used in 1193 unique chemotherapy cycles (mean [SD] number of days per cycle, 4.5 [3.3]); for pegfilgrastim prophylaxis, the number of unique chemotherapy cycles was 14,570. First-cycle use represented 16% of all cycles analyzed. The mean ages of patients receiving filgrastim and pegfilgrastim prophylaxis were 61 and 60 years, respectively. Breast cancer was the most common tumor type (52% and 51%), followed by non-Hodgkin's lymphoma (21% and 18%) and lung cancer (11% and 15%). Hospitalization for neutro-penic complications (narrow criterion) occurred during 2.1% of filgrastim cycles and 1.2% of pegfilgrastim cycles; hospitalization for neutropenic complications (broad criterion) occurred in a respective 4.8% and 3.1% of cycles; and hospitalization for all causes occurred in 8.7% and 6.3% of cycles (all, P < 0.01). The risks of hospitalization were consistently lower for chemotherapy cycles that involved pegfilgrastim prophylaxis compared with filgrastim prophylaxis (odds ratios = 0.64–0.73; P < 0.05). Conclusion: The risk of hospitalization for neutro-penic complications during cancer chemotherapy in clinical practice was approximately one third higher among patients who received filgrastim prophylaxis than among those who received pegfilgrastim prophylaxis.

Characteristics and healthcare costs of patients with fibromyalgia syndrome

SummaryPurpose:To examine the characteristics and healthcare costs of fibromyalgia syndrome (FMS) patients in clinical practice.Materials and methods:Using a US health-insurance database, we identified all patients, aged ≥ 18 years, with any healthcare encounters for FMS (ICD-9-CM diagnosis code 729.1) in each year of the 3-year period, 1 July 2002 to 30 June 2005. A comparison group was then constituted, consisting of randomly selected patients without any healthcare encounters for FMS during this 3-year period. Comparison group patients were matched to FMS patients based on age and sex. Characteristics and healthcare costs of FMS patients and comparison group patients were then examined over the 1-year period, 1 July 2004 to 30 June 2005 (the most recent year for which data were available at the time of the study).Results:The study sample consisted of 33,176 FMS patients and an identical number in the comparison group. Mean age was 46 years, and 75% were women. FMS patients were more likely to have various comorbidities, including painful neuropathies (23% vs. 3% for comparison group), anxiety (5% vs. 1%), and depression (12% vs. 3%) (all p < 0.001); they also were more likely to have used pain-related pharmacotherapy (65% vs. 34% for comparison group; p < 0.001). Mean (SD) total healthcare costs over 12 months were about three times higher among FMS patients [$9573 ($20,135) vs. $3291 ($13,643); p < 0.001]; median costs were fivefold higher ($4247 vs. $822; p < 0.001).Conclusions:Patients with FMS have comparatively high levels of comorbidities and high levels of healthcare utilization and cost.

Risk of diabetes in a real-world setting among patients initiating antihypertensive therapy with valsartan or amlodipine

In the Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial, the risk of new-onset diabetes was reported to be 23% lower among patients initiating therapy with valsartan versus amlodipine. The objective of our study was to examine whether this finding is generalizable to 'real-world' clinical practice. A retrospective cohort design and a large US health insurance database were employed for analyses. Study subjects included all hypertensive patients, aged >or=35 years, who were free from diabetes and who initiated treatment with valsartan (n=9999) or amlodipine (n=18 698) between January 1999 and March 2005. Unadjusted absolute risks of diabetes were 21.4 (95% confidence interval (CI) 18.9-24.3) and 26.3 (95% CI 24.3-28.3) per 1000 patient-years for valsartan and amlodipine, respectively; the corresponding relative risk (RR) for valsartan was 0.82 (95% CI 0.70-0.94). Multivariate analyses - controlling for age, sex, presence of hypercholesterolemia, cardiovascular disease and kidney disease, and pretreatment medical care expenditures - yielded similar results (RR=0.79, 95% CI 0.68-0.92). Our study thus corroborates the finding from VALUE that diabetes risk is lower for patients who receive valsartan versus amlodipine, and extends this finding to a 'real-world' setting.