Monika Raut

Risk of Clinical Fractures After Gonadotropin-Releasing Hormone Agonist Therapy for Prostate Cancer

PURPOSE We assessed the relationship between GnRH agonists and the risk of clinical fractures in men with prostate cancer. MATERIALS AND METHODS Using a database of medical claims from 16 large American companies we identified a study group of 3,779 men with prostate cancer who received treatment with a GnRH agonist and a control group of 8,341 with prostate cancer who were not treated with a GnRH agonist. Men with 1 or more medical claims for bone metastases were excluded. The rates of any clinical fracture, hip fracture and vertebral fracture were compared between the groups. RESULTS The rate of any fracture was 7.91/100 vs 6.55/100 person-years at risk in men who received vs did not receive a GnRH agonist (relative risk 1.21, 95% CI 1.09 to 1.34). The rates of hip fracture (relative risk 1.76, 95% CI 1.33 to 2.33) and vertebral fracture (relative risk 1.18, 95% CI 0.94 to 1.48) were also higher in men who received a GnRH agonist. GnRH agonist treatment was independently associated with fracture risk on multivariate analyses. CONCLUSIONS GnRH agonists increase the risk of clinical fracture in men with prostate cancer.

The Cost of Treatment of Skeletal-Related Events in Patients with Bone Metastases from Lung Cancer

Purpose: Patients with bone metastases from lung cancer often experience skeletal-related events (SREs) including pathological fracture, spinal cord compression, hypercalcemia or pain requiring surgery, radiotherapy or opioid analgesics. These complications result in impaired mobility and reduced quality of life and have a significant negative impact on survival. The economic consequences of SREs in patients with lung cancer have not been examined. Methods: We conducted a retrospective analysis using a large US health insurance claims database to estimate the incidence and costs of treatment of SREs in patients with bone metastases of lung cancer treated in a naturalistic setting. Study subjects had ≧2 encounters with a diagnosis of primary lung cancer and ≧2 encounters with a diagnosis of metastases to bone. SREs were identified based on the occurrence on or after the date of first diagnosis of bone metastases, of (1) ≧1 encounter with a diagnosis of pathological fracture, spinal cord compression or hypercalcemia, (2) ≧1 bone surgery or radiotherapy procedure, or (3) the initiation of opioid analgesic therapy. Survival and costs of SRE-related care in patients with SREs were estimated using Kaplan-Meier methods. Results: We identified 534 patients with lung cancer and bone metastases, including 295 (55%) with ≧1 SRE. Radiotherapy (68%) and fracture (35%) were the most common SREs. Median survival after the first identified SRE was 4.1 months (95% confidence interval: 3.6–5.5 months). The estimated lifetime SRE-related cost per patient was USD 11,979 (95% confidence interval: USD 10,193–13,766). Radiotherapy accounted for the greatest proportion of cost (61%) by SRE type. Conclusion: The economic burden of SREs in patients with bone metastases of lung cancer is substantial. Intravenous bisphosphonates, such as zoledronic acid, which have been shown to prevent these events, may reduce these costs.

Red blood cell transfusions and the risk of acute respiratory distress syndrome among the critically ill: a cohort study

IntroductionRecent data indicate that transfusion of packed red blood cells (pRBCs) may increase the risk for the development of acute respiratory distress syndrome (ARDS) in critically ill patients. Uncertainty remains regarding the strength of this relationship.MethodsTo quantify the association between transfusions and intensive care unit (ICU)-onset ARDS, we performed a cohort study within Crit, a multicenter, prospective, observational study of transfusion practice in the ICU which enrolled 4,892 critically ill patients in 284 ICUs in the United States. Diagnostic criteria for ARDS were prospectively defined, and we focused on subjects without ARDS at admission. The development of ARDS in the ICU served as the primary endpoint.ResultsAmong the 4,730 patients without ARDS at admission, 246 (5.2%) developed ARDS in the ICU. At baseline, ARDS cases were younger, more likely to be in a surgical ICU, and more likely to be admitted with pneumonia or sepsis than controls without ARDS. Cases also were more likely to have a serum creatinine of greater than 2.0 mg/dl (23% versus 18%) and a serum albumin of less than or equal to 2.3 g/dl (54% versus 30%) and were more severely ill upon ICU admission as measured by either the APACHE II (Acute Physiology and Chronic Health Evaluation II) or SOFA (Sequential Organ Failure Assessment) score (p < 0.05 for all). Sixty-seven percent and 42% of cases and controls, respectively, had exposure to pRBC transfusions (p < 0.05), and the unadjusted odds ratio (OR) of developing ARDS in transfused patients was 2.74 (95% confidence interval [CI], 2.09 to 3.59; p < 0.0001) compared to those never transfused. After age, baseline severity of illness, admitting diagnosis, and process-of-care factors were adjusted for, the independent relationship between pRBC transfusions and ICU-onset ARDS remained significant (adjusted OR, 2.80; 95% CI, 1.90 to 4.12; p < 0.0001).ConclusionDevelopment of ARDS after ICU admission is common, occurring in approximately 5% of critically ill patients. Transfusion of pRBCs is independently associated with the development of ARDS in the ICU.

Impact of Skeletal Complications on Total Medical Care Costs among Patients with Bone Metastases of Lung Cancer

Introduction: Previous studies have estimated the costs of skeletal-related events (SREs) for patients with bone metastases of solid tumors by tallying costs for services specifically attributable to these events. This approach may underestimate costs if SREs indirectly increase use of other services. Methods: This is a retrospective observational study using a large health insurance claims database. Patients with bone metastases of lung cancer who experienced ≥1 SRE were matched to similar patients without SREs based on propensity scores. Kaplan-Meier estimated total medical care costs were compared for propensity-matched samples of patients with SREs and without SREs. Results: We identified 534 patients with lung cancer and bone metastases, including 295 (55%) with ≥1 SRE. After matching, there were 162 patients each in the SRE and no-SRE groups with mean follow-up of 5.3 and 3.9 months, respectively. In the SRE group, costs of treatment of SREs were

The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

9,480 (95% CI

The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis

7,625 to

COMPARISON OF RIVAROXABAN OR WARFARIN USE FOR VENOUS THROMBOEMBOLISM ON INPATIENT LENGTH OF STAY

11,374) per patient. Total medical care costs were

Retrospective study of the effect of skeletal complications on total medical care costs in patients with bone metastases of breast cancer seen in typical clinical practice.

27,982 (95% CI

Clinical Implications of Chemotherapy- induced Diarrhea in Patients With Cancer

15,921 to

Economic Burden of Atopic Manifestations in Patients With Atopic Dermatitis—Analysis of Administrative Claims

40,625) greater for SRE versus no-SRE patients (p < 0.001). Conclusions: The costs of SREs in patients with lung cancer and bone metastases are substantial and potentially greater than previously estimated.