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Holloway R.W.,Florida Hospital Cancer Institute | Grendys E.C.,Florida Gynecologic Oncology | Lefebvre P.,Groupe dAnalyse Ltee | Vekeman F.,Groupe dAnalyse Ltee | Mcmeekin S.,The University of Oklahoma Health Sciences Center
Oncologist | Year: 2010

Objective. To compare the tolerability, efficacy, and safety profiles of pegylated liposomal doxorubicin in combination with carboplatin (PLD-Carbo) with those of gemcitabine- carboplatin (Gem-Carbo) for the treatment of patients with platinum-sensitive recurrent ovarian cancer(PSROC)by reviewing the published literature. Methods. Using the PubMed database, a systematic review of peer-reviewed literature published between January 2000 and September 2009 was undertaken to identify studies related to the treatment of patients with PSROC with PLD-Carbo or Gem-Carbo. Studies reporting either response rate, progression-free survival (PFS), and/or overall survival (OS) were included. Treatment regimens, efficacy endpoints, and safety profiles were compared between the two combination therapies. Results. Ten studies evaluating 608 patients (PLD-Carbo: 5 studies, 278 patients; Gem-Carbo: 5 studies, 330 patients) were identified. The mean planned doses were: PLD, 34.8 mg/m2 and Gem, 993 mg/m2. The dose intensity reported in Gem trials was lower (75% of the planned dose) than the dose intensity reported inPLDtrials (93.7% of the planned dose), suggesting better tolerability for the PLD-Carbo regimen. Among patients receiving PLD- Carbo, 60.2% achieved a response (complete, 27.0%; partial, 33.2%), versus 51.4% of patients treated with Gem- Carbo (complete, 19.2%; partial, 32.2%). The median PFS times were 10.6 months and 8.9 months in the PLD- Carbo and the Gem-Carbo populations, respectively. The median OS was longer for the PLD-Carbo regimen (27.1 months) than for the Gem-Carbo regimen (19.7 months). The hematological safety profiles were comparable in the two groups, although grade III or IV anemia (PLD- Carbo, 13.6%; Gem-Carbo, 24.5%) and neutropenia (PLD-Carbo, 45.5%; Gem-Carbo, 62.9%) were more common in patients receiving Gem-Carbo. Conclusion. Results from this systematic analysis of peer-reviewed literature suggest that PLD-Carbo therapy is a rational alternative to Gem-Carbo for the treatment of patients with PSROC. © AlphaMed Press. Source


Vekeman F.,Groupe dAnalyse Ltee | Cloutier M.,Groupe dAnalyse Ltee | Yermakov S.,Analysis Group Inc. | Amonkar M.M.,Glaxosmithkline | And 2 more authors.
Melanoma Research | Year: 2014

Malignant melanoma patients frequently relapse with metastases in the brain, making it the third most common cancer-causing brain metastases in the USA. Management of brain metastases remains challenging because of the rapid progression of disease and ineffectiveness of conventional therapies. This retrospective study, with a 'pre/post' design, quantifies the economic burden of brain metastases among melanoma patients in the USA. A large managed-care insurance claims database (2000 Q1-2011 Q3) was used to identify patients with melanoma and brain metastases. The preperiod was defined as the 6 months before the index date (diagnosis of first observed brain metastases) and postperiod as the period following the index date up to 12 months. All-cause and brain metastasis-related healthcare resource utilization and healthcare costs were compared on a per-patient-per-month (PPPM) basis between preperiods and postperiods. The study included 6076 patients (mean age 63.4 years); 57.6% were men. Significant differences (P< 0.0001) were observed between the postperiods and preperiods in the mean all-cause and brain metastasis-related PPPM hospitalizations and emergency department and outpatient visits. Significant postperiod versus preperiod differences were also observed in the PPPM mean (standard error) all-cause healthcare costs [total: $14 489 ($231) vs. $7277 ($116); inpatient: $6330 ($195) vs. $1900 ($69); outpatient: $6609 ($102) vs. $4449 ($79); P<0.0001 for all] and brain metastasis-related costs [total: $6542 ($145) vs. $1933 ($62); inpatient: $2976 ($118) vs. $472 ($39); outpatient: $3451 ($76) vs. $1413 ($47); P<0.0001 for all]. Radiotherapy was the most common treatment. The economic burden associated with brain metastases in melanoma is significant and underscores the need for newer therapies to improve outcomes in these patients. Copyright © Lippincott Williams & Wilkins. Source


Laliberte F.,Groupe dAnalyse Ltee | Dea K.,Groupe dAnalyse Ltee | Duh M.S.,Analysis Group Inc. | Kahler K.H.,Novartis | And 2 more authors.
Menopause | Year: 2011

Objective: The aim of this study was to quantify the magnitude of risk reduction for venous thromboembolism events associated with an estradiol transdermal system relative to oral estrogen-only hormone therapy agents. Methods: A claims analysis was conducted using the Thomson Reuters MarketScan database from January 2002 to October 2009. Participants 35 years or older who were newly using an estradiol transdermal system or an oral estrogen-only hormone therapy with two or more dispensings were analyzed. Venous thromboembolism was defined as one or more diagnosis codes for deep vein thrombosis or pulmonary embolism. Cohorts of estradiol transdermal system and oral estrogen-only hormone therapy were matched 1:1 based on both exact factor and propensity score matching, and an incidence rate ratio was used to compare the rates of venous thromboembolism between the matched cohorts. Remaining baseline imbalances from matching were included as covariates in multivariate adjustments. Results: Among the matched estradiol transdermal system and oral estrogen-only hormone therapy users (27,018 women in each group), the mean age of the cohorts was 48.9 years; in each cohort, 6,044 (22.4%) and 1,788 (6.6%) participants had a hysterectomy and an oophorectomy at baseline, respectively. A total of 115 estradiol transdermal system users developed venous thromboembolism, compared with 164 women in the estrogen-only hormone therapy cohort (unadjusted incidence rate ratio, 0.72; 95% CI, 0.57-0.91; P = 0.006). After adjustment for confounding factors, the incidence of venous thromboembolism remained significantly lower for estradiol transdermal system users than for estrogen-only hormone therapy users. Conclusions: This large population-based study suggests that participants receiving an estradiol transdermal system have a significantly lower incidence of venous thromboembolism than do participants receiving oral estrogen-only hormone therapy. © 2011 by The North American Menopause Society. Source


Manjunath R.,Glaxosmithkline | Paradis P.E.,Groupe dAnalyse Ltee | Parise H.,Groupe dAnalyse Ltee | Lafeuille M.-H.,Groupe dAnalyse Ltee | And 4 more authors.
Neurology | Year: 2012

Objective: To quantify the clinical and economic burden of uncontrolled epilepsy in patients requiring emergency department (ED) visit or hospitalization. Methods: Health insurance claims from a 5-state Medicaid database (1997Q1-2009Q2) and 55 self-insured US companies ("employer," 1999Q1 and 2008Q4) were analyzed. Adult patients with epilepsy receiving antiepileptic drugs (AED) were selected. Using a retrospective matchedcohort design, patients were categorized into cohorts of "uncontrolled" (≥2 changes in AED therapy, then =1 epilepsy-related ED visit/hospitalization within 1 year) and "well-controlled" (no AED change, no epilepsy-related ED visit/hospitalization) epilepsy. Matched cohorts were compared for health care resource utilization and costs using multivariate conditional regression models and nonparametric methods. Results: From 110,312 (Medicaid) and 36,529 (employer) eligible patients, 3,454 and 602 with uncontrolled epilepsy were matched 1:1 to patients with well-controlled epilepsy, respectively. In both populations, uncontrolled epilepsy cohorts presented about 2 times more fractures and head injuries (all p values < 0.0001) and higher health care resource utilization (ranges of adjusted incidence rate ratios [IRRs] [all-cause utilization]: AEDs = 1.8-1.9, non-AEDs = 1.3-1.5, hospitalizations =5.4-6.7, length of hospital stays=7.3-7.7, ED visits=3.7-5.0, outpatient visits= 1.4-1.7, neurologist visits = 2.3-3.1; all p values < 0.0001) than well-controlled groups. Total direct health care costs were higher in patients with uncontrolled epilepsy (adjusted cost difference [95% confidence interval (CI)] Medicaid = $12,258 [$10,482- $14,083]; employer = $14,582 [$12,019-$17,097]) vs well-controlled patients. Privately insured employees with uncontrolled epilepsy lost 2.5 times more work days, with associated indirect costs of $2,857 (95% CI $1,042-$4,581). Conclusions: Uncontrolled epilepsy in patients requiring ED visit or hospitalization was associated with significantly greater health care resource utilization and increased direct and indirect costs compared to well-controlled epilepsy in both publicly and privately insured settings. © 2012 American Academy of Neurology. Source


Vekeman F.,Groupe dAnalyse Ltee | Lamori J.C.,Janssen Scientific Affairs LLC | Laliberte F.,Groupe dAnalyse Ltee | Nutescu E.,University of Illinois at Chicago | And 6 more authors.
Journal of Medical Economics | Year: 2012

Objective: Benefits of anti-coagulation for venous thromboembolism (VTE) prevention in total hip and knee arthroplasty (THA/TKA) may be offset by increased risk of bleeding. The aim was to assess in-hospital risk of VTE and bleeding after THA/TKA and quantify any increased costs. Methods: Healthcare claims from the Premier Perspective TM Comparative Hospital Database (January 2000September 2008) were selected for subjects 18 years with 1 diagnosis code for THA/TKA. VTE was defined as 1 code for deep vein thrombosis or pulmonary embolism. Bleeding was classified as major/non-major. Incremental in-hospital costs associated with VTE and bleeding were calculated as cost differences between inpatients with VTE or bleeding matched 1:1 with inpatients without VTE or bleeding. Results: A total of 820,197 inpatient stays were identified: 8042 had a VTE event and 7401 a bleeding event (2740 major bleeding). The risks of VTE, any bleeding, and major bleeding were 0.98, 0.90, and 0.33/100 inpatient stays, respectively. Mean incremental in-hospital costs per inpatient were $2663 for VTE, $2028 for bleeding, and $3198 for major bleeding. Limitations: These included possible inaccuracies or omissions in procedures, diagnoses, or costs of claims data; no information on the amount of blood transfused or decreases in the hemoglobin level to evaluate bleeding event severity; and potential biases due to the observational design of the study. Conclusions: In-hospital risk and incremental all-cause costs with THA/TKA were higher for VTE than for bleeding. Despite higher costs, major bleeding occurred less frequently than VTE, suggesting a favorable benefit/risk profile for VTE prophylaxis in THA/TKA. © 2012 Informa UK Ltd All rights reserved. Source

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