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OBJECTIVES:Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).METHODS:Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.RESULTS:DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: −1.56; 95% confidence interval (CI) −13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.CONCLUSIONS:BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups. [ABSTRACT FROM AUTHOR]

Introduction: The development of new pharmacological treatments for chronic obstructive pulmonary disease (COPD) has improved health‐related quality of life of patients. However, suboptimal adherence may limit its potential. Objective: The aim of the present study was to assess the adherence to free triple inhaled therapy and to investigate poor adherence determinants among primary care patients. Methods: Data were derived from a primary care database in Italy. Patients aged 40+ affected by COPD and prescribed with inhaled corticosteroids, long‐acting beta agonists and long‐acting muscarinic antagonists (N = 3177) were enrolled. Low adherence was defined as a proportion of days covered (PDC) by medications prescription lower than 80%. Predictors of low adherence were tested using logistic regression models. Results and conclusions: The 85% of enrolled patients showed poor adherence to free triple inhaled therapy. Comorbidities, such as heart failure (OR 1.78, 95%CI 1.19‐2.75), depression (OR 1.41, 95%CI 1.06‐1.88) and peripheral vascular disease (OR 1.32, 95%CI 1.01‐1.74) were associated with poor adherence. Former (OR 0.52, 95%CI 0.34‐0.78) or current smokers (OR 0.61, 95%CI 0.41‐0.93) and patients with more severe airways obstruction or history of severe exacerbations (OR 0.64, 95%CI 0.52‐0.79) were less likely to exhibit poor adherence. Real‐world adherence to triple inhaled therapy with different inhalers is generally low. Higher GOLD airways obstruction stage and current or former smoking status are associated with increased adherence to treatment. Reduced perceived benefit on symptoms control is probably linked to poorer adherence to free triple therapy. [ABSTRACT FROM AUTHOR]

A good understanding of the natural history of rare genetic lipid disorders is a pre-requisite for successful patient management. Disease registries have been helpful in this regard. Lipoprotein Lipase Deficiency (LPLD) is a rare, autosomal-recessive lipid disorder characterized by severe hypertriglyceridemia and a very high risk for recurrent acute pancreatitis, however, only limited data are available on its natural course. Alipogene tiparvovec (Glybera ® ) is the first gene therapy to receive Marketing Authorization in the European Union; GENIALL (GENetherapy In the MAnagement of Lipoprotein Lipase Deficiency), a 15-year registry focusing on LPLD was launched in 2014 as part of its Risk Management Plan. The aim of this publication is to introduce the GENIALL Registry within a structured literature review of registries in rare genetic lipid disorders. A total of 11 relevant initiatives/registries were identified (homozygous Familial Hypercholesterolemia (hoFH) [n = 5]; LPLD [n = 1]; Lysosomal Acid Lipase Deficiency [LALD, n = 1], detection of mutations in genetic lipid disorders [n = 4]). Besides one product registry in hoFH and the LALD registry, all other initiatives are local or country-specific. GENIALL is the first global prospective registry in LPLD that will collect physician and patient generated data on the natural course of LPLD, as well as long-term outcomes of gene therapy. Conclusion : There is a limited number of international initiatives focusing on the natural course of specific rare genetic lipid disorders. The GENIALL LPLD Registry could be the first step towards a future broader global initiative that collects data related to familial chylomicronemia syndrome and their underlying genetic causes. [ABSTRACT FROM AUTHOR]

A correction to the article "Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study" that was published in the journal in 2015 is presented.