Comparative effectiveness of nivolumab versus standard of care for third-line patients with small-cell lung cancer.

Aim: To estimate the comparative effectiveness of nivolumab versus standard of care (SOC) in terms of overall survival (OS) for small-cell lung cancer patients treated with two prior lines of chemotherapy, in other words, third line in the USA. Materials & methods: Data were from CheckMate 032, a single-arm trial of nivolumab, and real-world electronic patient records. Comparisons of OS were conducted using three different methods to adjust for differences (regression, weighting and doubly robust) between the populations. Results: Nivolumab was associated with longer survival compared with SOC (hazard ratio for OS: 0.58-0.70) across all methods for adjustment. Conclusion: Nivolumab was more efficacious in terms of OS as third-line treatment for small-cell lung cancer compared with current SOC in the USA.

Resource use among patients with diabetes, diabetic neuropathy, or diabetes with depression.

BACKGROUND: Diabetes is often associated with complications and comorbidities. The purpose of this research is to compare medical resources used by patients with the following diagnoses: diabetes mellitus (DM), diabetic neuropathy (DN), and diabetes mellitus combined with comorbid depression (DD). METHODS: Adult patients who were diagnosed with DM, DN, or DD were included in the study. There were 55,972 patients in the DM cohort, 2,146 in the DN, and 2,379 in the DD. P values for comparisons between the three mutually exclusive cohorts were conducted using the Tukey-Kramer method. Cost comparisons among the cohorts were conducted using a stepwise multivariate regression that controlled for patient characteristics and comorbid conditions. RESULTS: Individuals in the DM or DN cohorts were generally more likely to use antidiabetic medications than patients in the DD group. Those diagnosed with DN or DD generally used more pain medications than individuals in the DM cohort. The DM cohort had significantly lower diabetes-related total medical costs ($1,297 v $5,125, p < 0.0001) and lower total medical costs ($4,819 v $24,765, p < 0.0001) than the DN cohort. The DM cohort also had significantly lower diabetes-related total medical costs ($1,297 v $3,264, p < 0.0001) as well as significantly lower total medical costs ($4,819 v $19,298, p < 0.0001) than the DD cohort. CONCLUSION: Results from this study indicated significant differences in demographic characteristics, comorbidities, and medication use among individuals diagnosed with DM, DN, or DD. These differences translated into significant cost differences. Patients diagnosed with DN or DD had higher diabetes-related costs than patients diagnosed with DM.

Duloxetine in the long-term management of diabetic peripheral neuropathic pain: An open-label, 52-week extension of a randomized controlled clinical trial.

BACKGROUND: Duloxetine hydrochloride, a selective serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor, is relatively balanced in its affinity for both 5-HT and NE reuptake inhibition and is the first US Food and Drug Administration-approved prescription drug for the management of diabetic peripheral neuropathic pain (DPNP). OBJECTIVES: The aim of this study was to determine whether management of DPNP with duloxetine interferes with the treatment of diabetes. It also examined the tolerability of long-term exposure to duloxetine with regard to the progression of diabetic complications, and assessed the impact of DPNP management with duloxetine versus routine care. METHODS: This was a 52-week, multicenter, re-randomized, open-label extension of a parallel, double-blind, randomized, placebo-controlled, acute (12-week) study. Patients who completed the duloxetine or placebo acute treatment period were randomly reassigned in a 2:1 ratio to treatment with duloxetine 60 mg BID or routine care for an additional 52 weeks. The study included male and female outpatients aged ≥18 years with a diagnosis of DPNP caused by type 1 or type 2 diabetes. Over the course of the 52-week study, visits were scheduled on the following weeks (of the extension phase of the study): 1 (via phone only), 2, 4, 8, 12, 20, 28, 40, and 52. Tolerability was assessed by review and analyses of discontinuation rates, adverse events (AEs), laboratory data, vital signs, electrocardiographic results, concomitant medications, and diabetic complications. Treatment-emergent AEs (TEAEs) were defined as AEs that appeared during therapy (were not present at baseline) or were exacerbated during treatment. Data on AEs and concomitant medications were collected at every visit. Data on blood pressure, heart rate, and significant hypoglycemic events were collected at every visit starting from week 2. Fasting clinical chemistry and electrolyte group laboratory assessments were done at every visit, starting from week 4. Electrocardiographic data was collected at weeks 4 and 52, and glycosylated hemoglobin and lipid profile data were collected at weeks 20 and 52. Hematology and urinalysis laboratory assessments and diabetic complication assessments were done at week 52. All safety data was assessed in cases of early discontinuation. Treatment differences on quality of life (QOL) were compared using the Short Form-36 Health Status Survey (SF-36) and the EQ-5D instrument of the European Health-Related Quality of Life Measures. This was assessed at the last visit or at early discontinuation. RESULTS: The open-label extension-phase study included 337 patients (duloxetine, n = 222; routine care, n = 115). For the duloxetine group, mean age was 60.2 years, 61.3% were male, and 78.4% were white. For the routine-care group, mean age was 58.9 years, 60.0% were male, and 74.8% were white. Mean weight was 95.3 kg for both groups. None of the TEAEs occurred significantly more often in the duloxetine-treated group than in the routine-care-treated group. No TEAEs were reported by >10% of patients in the duloxetine group. The TEAEs reported by >10% of patients in the routine-care group included dizziness (11.3%), somnolence (13.0%), headache (10.4%), and vomiting (10.4%). No significant differences were found between treatment groups in the occurrence of serious AEs or in the number of patients discontinuing because of AEs. Duloxetine was significantly better than routine care on the bodily pain subscale of the SF-36 (mean change: 1.5 vs -4.1; P= 0.021) and on the EQ-5D (mean change: -0.00 vs -0.09; P = 0.001). CONCLUSIONS: Over 52 weeks of follow-up, treatment of these diabetic patients with duloxetine for peripheral neuropathic pain was associated with outcomes similar to, or significantly better than, that of routine care on most measures of tolerability, diabetic complications, and QOL.

Patient characteristics, comorbidities, and medication use for children with ADHD with and without a co-occurring reading disorder: A retrospective cohort study.

BACKGROUND: Children and adolescents with attention-deficit/hyperactivity disorder (ADHD) often have a co-occurring reading disorder (RD). The purpose of this research was to assess differences between children with ADHD without RD (ADHD-only) and those with ADHD and co-occurring RD (ADHD+RD). METHODS: Using data from the U.S. Thomson Reuter Marketscan® Databases for the years 2005 through 2007, this analysis compared the medical records--including patient demographics, comorbidities, and medication use--of children (age < 18) with ADHD-only to those with ADHD+RD. RESULTS: Patients with ADHD+RD were significantly younger, more likely to have received a procedure code associated with formal psychological or non-psychological testing, and more likely to have been diagnosed with comorbid bipolar disorder, conduct disorder, or depression. They were no more likely to have received an antidepressant, anti-manic (bipolar), or antipsychotic, and were significantly less likely to have received a prescription for a stimulant medication. CONCLUSIONS: Relying on a claims database, there appear to be differences in the patient characteristics, comorbidities, and medication use when comparing children with ADHD-only to those with ADHD+RD.

Comparing clinical and economic characteristics between commercially-insured patients with diabetic neuropathy and demographically-matched diabetic controls.

OBJECTIVE: To examine medical conditions associated with diabetic neuropathy (DN) and to identify drivers of healthcare charges and utilization using administrative claims. METHODS: The study examined commercially-insured under-age-65 individuals with 24 months continuous enrollment in a large US national health plan. DN patients were identified by having at least one claim with a DN diagnosis between July 2004 and June 2005. A demographically-matched control cohort of patients with diabetes but no DN (10: 1 ratio) was constructed using propensity scoring. Overall illness burden via a comprehensive disease classification, year 2 (July 2005 through June 2006) distribution of charges, and reasons for inpatient admissions and emergency room (ER) visits were compared between DN patients and diabetic controls. Multivariate regressions were used to assess the marginal contribution of DN to healthcare charges and utilization, and the most common reasons for ER and inpatient admissions, controlling for differences in overall illness burden. RESULTS: Both DN patients (n = 8655) and diabetic controls (n = 86 550) had a mean age of 51 years, and 46% were female. Compared with controls, DN patients had more comorbid medical conditions (9.7 vs. 6.8, p < 0.05) and higher total healthcare charges. Controlling for differences in overall illness burden, DN patients had significantly more hospital days (0.67), more ER (0.09), physician office (0.62), and outpatient hospital visits (2.87), and higher total healthcare charges ($5696) than controls (all p < 0.05), with majority of the difference in charges from inpatient service ($3975, p < 0.05). Patients with DN were also far more likely to be hospitalized (ketoacidosis, neurological manifestation, heart disease, skin infection) or have an ER encounter (amputation) for diabetes-related complications. Due to the use of a retrospective claims database, limitations of this analysis include a lack of formal diagnostic testing of patients, inability to measure factors such as disease duration and severity that are not captured in such databases, and the possible lack of generalization from this group of patients with diabetes to other populations. CONCLUSIONS: DN patients had significantly more comorbid medical conditions and higher healthcare charges and utilization than age- and sex-matched diabetic controls. Controlling for differences in overall illness burden, DN patients incurred more ER visits and inpatient admissions.

Duloxetine for the management of diabetic peripheral neuropathic pain: evaluation of functional outcomes.

OBJECTIVE: To assess the effectiveness of duloxetine, compared with placebo, on patient-reported health outcomes over a 12-week period, in the management of diabetic peripheral neuropathic pain (DPNP). METHODS: The results were pooled from three 12-week multicenter, double-blind studies. In study 1 (N = 457), patients with DPNP were randomly assigned to treatment with duloxetine 20 mg once daily (QD), 60 mg QD, 60 mg twice daily (BID), or placebo. In studies 2 (N = 334) and 3 (N = 348), patients with DPNP were randomly assigned to treatment with duloxetine 60 mg QD, 60 mg BID, or placebo. Patient-reported functional outcomes were measured by the Short Form 36 (SF-36), the interference portion of the Brief Pain Inventory (BPI), and EuroQol 5D Health Questionnaire (EQ-5D). Results for all functional outcomes from the intent-to-treat and completer populations are discussed. RESULTS: In the SF-36 health survey and the BPI interference, duloxetine 60 mg QD and 60 mg BID were significantly superior to placebo in all the domains (P