Real-world burden of comorbidities in US patients with psoriasis.

BACKGROUND: Understanding background comorbidity rates in psoriasis can provide perspective for adverse events associated with new therapies. OBJECTIVE: We sought to assess the extent of comorbidities in psoriasis patients by use of the Truven Health Analytics MarketScan database. METHODS: MarketScan, comprising commercial claims representative of a large US-insured population, had 1.22 million patients with ≥1 claim with a psoriasis diagnosis between January 1, 2008, and December 31, 2014. Patients ≥18 years of age who had ≥2 health claims in any diagnosis field for psoriasis (International Classification of Diseases, 9th Revision, Clinical Modification 696.1) with a psoriasis diagnosis (index) date between July 1, 2008, and June 30, 2014, were included to allow follow-up observation time. RESULTS: Prevalence and incidence of 24 comorbidities were assessed in 469,097 psoriasis patients; the most common comorbidities were hyperlipidemia (45.64% and 30.83%, respectively), hypertension (42.19% and 24.19%), depression (17.91% and 12.68%), type 2 diabetes mellitus (17.45% and 8.44%), and obesity (14.38% and 11.57%). LIMITATIONS: A limitation of the study was that only a certain insured population was represented. CONCLUSIONS: Comorbidity rates align with those described in the literature and support the concept that psoriasis patients have high rates of cardiometabolic comorbidities. This analysis highlights the potential utility of very large insurance databases for determining comorbidity prevalence in psoriasis, which may aid health care providers in managing psoriasis.

Real-world burden of comorbidities in US patients with psoriatic arthritis.

OBJECTIVES: We assessed comorbidities associated with psoriatic arthritis in a broad cohort of US-insured adult patients using the Truven Health Analytics MarketScan Database. METHODS: Prevalence and incidence rates were assessed for 28 comorbid conditions among adult patients in the MarketScan database with a diagnosis of psoriatic arthritis and having two or more health claims for psoriatic arthritis between 1 July 2008 and 31 July 2015. Findings were compared with those of a similar, previously published analysis of patients with psoriasis. RESULTS: Among a total of 186 552 patients with a diagnosis of psoriatic arthritis, 94 302 had two or more health claims for psoriatic arthritis during the study period and were included in the comorbidity analysis. The prevalence and incidence rates of the most common comorbidities were 47.5% and 35.0% for hyperlipidaemia, respectively; 47.3% and 31.3% for hypertension; 21.2% and 15.4% for depression; 20.2% and 13.5% for type 2 diabetes mellitus; and 16.6% and 12.4% for fibromyalgia. Patients with psoriatic arthritis had notably higher incidence rates of uveitis, fibromyalgia, osteoporosis, Crohn's disease and non-alcoholic liver disease than patients with psoriasis. CONCLUSION: This observational retrospective analysis using the MarketScan database provides real-world health claims data on the prevalence and incidence of comorbidities in a large US patient population with psoriatic arthritis. The observed high cardiometabolic comorbidity rates align with those reported in the literature and may help healthcare providers in the comprehensive management of patients with psoriatic arthritis.

Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer.

PURPOSE: To compare the efficacy of pegylated liposomal doxorubicin (PLD) with that of a common salvage regimen (comparator) in patients with taxane-refractory advanced breast cancer. PATIENTS AND METHODS: Following failure of a first- or second-line taxane-containing regimen for metastatic disease, 301 women were randomly assigned to receive PLD (50 mg/m(2) every 28 days); or comparator-vinorelbine (30 mg/m(2) weekly) or mitomycin C (10 mg/m(2) day 1 and every 28 days) plus vinblastine (5 mg/m(2) day 1, day 14, day 28, and day 42) every 6 to 8 weeks. Patients were stratified before random assignment based on number of previous chemotherapy regimens for metastatic disease and presence of bone metastases only. RESULTS: Progression-free survival (PFS) and overall survival (OS) were similar for PLD and comparator (PFS: hazard ratio [HR], 1.26; 95% CI, 0.98 to 1.62; P =.11; median, 2.9 months [PLD] and 2.5 months [comparator]; OS: HR, 1.05; 95% CI, 0.82 to 1.33; P =.71; median, 11.0 months [PLD] and 9.0 months [comparator]). In anthracycline-naïve patients, PFS was somewhat longer with PLD, relative to the comparator (n = 44; median PFS, 5.8 v 2.1 months; HR, 2.40; 95% CI, 1.16 to 4.95; P =.01). Most frequently reported adverse events were nausea (23% to 31%), vomiting (17% to 20%), and fatigue (9% to 20%) and were similar among treatment groups. PLD-treated patients experienced more palmar-plantar erythrodysesthesia (37%; 18% grade 3, 1 patient grade 4) and stomatitis (22%; 5% grades 3/4). Neuropathy (11%), constipation (16%), and neutropenia (14%) were more common with vinorelbine. Alopecia was low in both the PLD and vinorelbine groups (3% and 5%). CONCLUSION: PLD has efficacy comparable to that of common salvage regimens in patients with taxane-refractory metastatic breast cancer, thereby representing a useful therapeutic option.

Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and simvastatin.

AIMS: The primary aims of these two single-centre, randomized, evaluator-blind, placebo/positive-controlled, parallel-group studies were to evaluate the potential for pharmacodynamic and pharmacokinetic interaction between ezetimibe 0.25, 1, or 10 mg and simvastatin 10 mg (Study 1), and a pharmacodynamic interaction between ezetimibe 10 mg and simvastatin 20 mg (Study 2). Evaluation of the tolerance of the coadministration of ezetimibe and simvastatin was a secondary objective. METHODS: Eighty-two healthy men with low-density lipoprotein cholesterol (LDL-C) >or=130 mg dl-1 received study drug once daily in the morning for 14 days. In Study 1 (n=58), five groups of 11-12 subjects received simvastatin 10 mg alone, or with ezetimibe 0.25, 1, or 10 mg or placebo. In Study 2 (n=24), three groups of eight subjects received simvastatin 20 mg alone, ezetimibe 10 mg alone, or the combination. Blood samples were collected to measure serum lipids in both studies. Steady-state pharmacokinetics of simvastatin and its beta-hydroxy metabolite were evaluated in Study 1 only. RESULTS: In both studies, reported side-effects were generally mild, nonspecific, and similar among treatment groups. In Study 1, there were no indications of pharmacokinetic interactions between simvastatin and ezetimibe. All active treatments caused statistically significant (P<0.01) decreases in LDL-C concentration vs placebo from baseline to day 14. The coadministration of ezetimibe and simvastatin caused a dose-dependent reduction in LDL-C and total cholesterol, with no apparent effect on high-density lipoprotein cholesterol (HDL-C) or triglycerides. The coadministration of ezetimibe 10 mg and simvastatin 10 mg or 20 mg caused a statistically (P<0.01) greater percentage reduction (mean -17%, 95% CI -27.7, -6.2, and -18%, -28.4, -7.4, respectively) in LDL-C than simvastatin alone. CONCLUSIONS: The coadministration of ezetimibe at doses up to 10 mg with simvastatin 10 or 20 mg daily was well tolerated and caused a significant additive reduction in LDL-C compared with simvastatin alone. Additional clinical studies to assess the efficacy and safety of coadministration of ezetimibe and simvastatin are warranted.