Background Hypovitaminosis D is common in obesity and insulin resistant states. Increased fat mass in patients with non-alcoholic fatty liver disease (NAFLD) may contribute to hypovitaminosis D. Aims To determine the relation between plasma vitamin D concentration, severity of disease and body composition in NAFLD. Methods Plasma vitamin D concentration was quantified in 148 consecutive biopsy proven patients with NAFLD (non alcoholic steatohepatitis-NASH: n=81; and hepatic steatosis n=67) and healthy controls (n=39). NAFLD was scored using the NASH CRN criteria. Body composition was quantified by bioelectrical impedance analysis and abdominal CT image analysis. Results Plasma vitamin D concentration was significantly lower in NAFLD (21.2±10.4 ng/ml) compared to healthy controls (35.7±6.0 ng/ml). Higher NAFLD activity scores were associated with lower plasma concentration of vitamin D (r2=0.29; p<0.001). Subgroup analysis among patients with NAFLD showed that patients with NASH had significantly lower (p<0.01) vitamin D levels than those with steatosis alone (18.1±8.4 vs. 25.0±11.3 ng/ml). Low concentrations of vitamin D were associated with greater severity of steatosis, hepatocyte ballooning and fibrosis (p<0.05). On multivariate regression analysis, only severity of hepatocyte ballooning was independently associated (p=0.02) with low vitamin D concentrations. Plasma vitamin D (p=0.004) and insulin concentrations (p=0.03) were independent predictors of the NAFLD activity score on biopsy. Patients with NAFLD had higher fat mass that correlated with low vitamin D (r2=0.26; p=0.008). Conclusions Low plasma vitamin D concentration is an independent predictor of the severity of NAFLD. Further prospective studies demonstrating the impact of vitamin D replacement in NAFLD patients are required.

Novartis, East Hanover, NJ As oral cancer therapies are developed, a high degree of persistence and adherence is necessary for optimal outcomes. Ensuring persistence, continuing treatment for the prescribed duration, and adherence-taking medication as prescribedhas been a challenge to patient management and health care cost containment in real-world settings. 1 It may appear as though persistence and adherence to oral cancer therapies is superior to that observed with oral noncancer therapies. 2 Indeed, patients with cancer tend to be highly motivated, to prefer oral therapies, and to exhibit high persistence and adherence in clinical trials. 3 However, emerging real-world data indicate otherwise.Persistency rates for oral cancer medications are generally lower in real-world settings compared with in clinical trials (Table 1), 4-20 especially for chronically administered medications. Persistence with tamoxifen at 3.9 years was 71.7% in the Arimidex, Tamoxifen Alone or in Combination (ATAC) trial, 6 but persistence was only 64.8% at 3.5 years among women identified in a pharmacy database. 5 The difference may be more pronounced in the elderly. 9,12 Similarly, persistence with letrozole was 84% at 4.25 years in the Breast International Group 1-98 trial, 5 but it was only 77% at 1 year in an analysis of two large-claims databases (data on file, Novartis, East Hanover, NJ). This difference remains despite inclusion of 23% of patients with a Ն 30-day treatment gap (Figure 1). Differences were not limited to patients with breast cancer. In the IRIS (International Randomized Study of Interferon Versus ST1571) trial, patients with chronic myelogenous leukemia (CML) persisted with imatinib at a rate of 91% at 19 months. 4 By contrast, real-world persistence at 12 and 24 months among patients with CML and GI stromal tumors was 56% and 41%, respectively, when dosing gaps Ն 30 days were disallowed (data on file, Novartis, East Hanover, NJ). In addition, pharmacy records from 4,043 patients demonstrated a decrease in imatinib persistence from 100% to 23% between months 4 and 14 of treatment. 21 There is less information on adherence compared with persistence in clinical trials. In the adherence companion study 60104 to Cancer and Leukemia Group B 49907, adherence to capecitabine in elderly patients with breast cancer was 78% during the prescribed six cycles of therapy. 18 In the real world, a 96.7% adherence was observed. 20 However, capecitabine is not a chronic therapy, and in this study, adherence was measured for only 44.3 days (two cycles). The majority of adherence data is from the real-world setting, and these have shown variability (Table 1). Analysis of claims data demonstrated 89% adherence to imatinib among patients with CML at 1 year when unlimited dosing gaps were allowed (data on file, Novartis, East Hanover, NJ). It was 78% at 2 years according to pharmacy records. 21 Among patients with breast cancer, 54% to 80% of patients receiving hormonal therapy have been shown to adhere to treatment (data on fil...

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