RCT: Effect of daily chlorhexidine bathing on hospital-acquired infection
Source: N Engl J Med Area: News Single-centre, observational studies have suggested that daily bathing of patients with chlorhexidine may prevent hospital-acquired bloodstream infections and the acquisition of multidrug-resistant organisms (MDROs).   This multicentre, randomised trial evaluated the usefulness of bathing with chlorhexidine to reduce the risks of MDRO acquisition and hospital-acquired bloodstream infection among patients at high risk for health care-associated infections. It was conducted at nine intensive care and bone marrow transplantation units in six hospitals and involved 7727 patients. The ...
Source: NeLM - News - February 7, 2013 Category: Drugs & Pharmacology Source Type: news

Direct Healthcare Professional communication: Two strengths of Insulin degludec (Tresiba) on UK market
Source: Novo Nordisk Area: News Insulin degludec (Tresiba) has recently been launched in the UK in two strengths: 100 units/mL and 200 units/mL. The latter strength is higher than that of other existing insulin products available in the UK. Tresiba comes in the form of two distinct pen devices which have been designed to clearly differentiate between the two strengths.   Novo Nordisk has issued this letter to minimise the risk of medication errors when prescribing Tresiba. It contains the following recommendations:   . Ensure that the strength of Tresiba is included on the prescription.   ...
Source: NeLM - News - February 7, 2013 Category: Drugs & Pharmacology Source Type: news

Direct Healthcare Professional Communication: Refined guidance on when first dose monitoring procedures should be repeated for Gilenya (fingolimod)
Source: Novartis Area: News It is known that the effects of fingolimod on heart rate and atrioventricular conduction may recur on reintroduction of fingolimod (Gilenya) treatment following interruption. Further analyses of clinical pharmacology and dose titration data indicate that the risk of occurrence of these effects depends upon the duration of the interruption and time since initiation of treatment. In April 2012, Novartis issued notification about enhanced first dose monitoring procedures in relation to the transient decrease in heart rate and atrioventricular conduction delay upon treatment initiation with fingol...
Source: NeLM - News - February 7, 2013 Category: Drugs & Pharmacology Source Type: news

Neostigmine Bromide 15 mg Tablets are now available within UK
Source: Personal communication, Alliance Pharmaceuticals Area: News According to Alliance Pharmaceuticals supplies of neostigmine bromide 15 mg tablets (licensed formulation) are now available again in the UK. (Source: NeLM - News)
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

BMJ review: Ulcerative colitis
Source: BMJ Area: News The BMJ has featured an evidence based review on the diagnosis and management of ulcerative colitis. The following questions are addressed:   . What is ulcerative colitis and who gets it? . What are the clinical features and associated conditions? . What is the underlying pathophysiology of ulcerative colitis? . How is ulcerative colitis diagnosed? . What is the prognosis? . What are the treatment options? . Monitoring of drug therapy in ulcerative colitis . Colorectal cancer screening in ulcerative colitis . Osteoporosis ...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices 'Behind the Headline' assessment of BMJ dietary linoleic acid study
This study has several strengths. It was a randomised controlled trial, using just one type of oil to increase consumption of polyunsaturated fatty acids.   . The study also has its limitations. The dietary data collected during the original trial does not contain enough information to rule out the possibility that changes in other nutrients could have caused the effect seen.   . In this trial, participants were advised to increase their intake of polyunsaturated fatty acids, mainly from omega 6-linoleic acid, ... (Source: NeLM - News)
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Phase II study to evaluate an antidote to Factor Xa inhibitors
Source: PharmaLive Area: News Portola Pharmaceuticals has announced a clinical collaboration agreement with Bayer HealthCare and Janssen Pharmaceuticals for a phase II study which will evaluate the potential of the novel recombinant protein PRT4445 as a universal  antidote to Factor Xa inhibitor blood thinners.   Results of a Phase 1 single ascending dose safety and tolerability study, conducted in 32 healthy volunteers in the United States, showed that PRT4445 was generally well tolerated with no apparent safety signals.   The phase II study will report on the safety and efficacy of PRT445 in healt...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

FDA rejects rintatolimod (AmpligenT) for chronic fatigue syndrome
Source: BioSpace Area: News The US Food and Drug Administration has rejected the New Drug Application for rintatolimod (AmpligenT), an injectable immunomodulator being investigated for chronic fatigue syndrome (CFS).   The Agency considered that the evidence provided by the company did  not provide sufficient information to determine whether the product is safe and effective for CFS.   It will require the company to conduct at least one addition clinical trial of the medicine, complete various nonclinical studies and perform further data analysis. (Source: NeLM - News)
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

EMA grants marketing authorisation of aflibercept (ZaltrapT) for previously treated metastatic colorectal cancer
Source: BioSpace Area: News The European Commission (EC) has granted marketing authorisation for aflibercept (ZaltrapT) for use in combination with irinotecan/ 5-fluorouracil/ folinic acid (FOLFIRI) chemotherapy for the treatment of adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.   This decision was based on the efficacy and safety results of the multinational, phase III randomised controlled VELOUR trial (n=1,226). The study showed that in patients previously treated with an oxaliplatin containing regimen, adding aflibercept to FOLF...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

RCT: Effect of ramipril on walking times and QoL in patients with peripheral artery disease and intermittent claudication:
Source: JAMA Area: News Approximately one-third of patients with peripheral artery disease (PAD) experience intermittent claudication, with consequent loss of quality of life (QoL).   This multicentre randomised, double-blind, placebo-controlled trial evaluated the efficacy of ramipril for improving walking ability, patient-perceived walking performance, and QoL in 212 Australian patients with PAD (mean age 65.5 years).   Patients were randomised to receive ramipril (10mg/day; n = 106) or matching placebo (n = 106) for 24 weeks. Patients were observed for two prespecified primary outcomes, maximum and p...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

RCT: Effect of corticosteroid injection, physiotherapy, or both in patients with unilateral lateral epicondylalgia
Source: JAMA Area: News Both corticosteroid injection and physiotherapy are common treatments for lateral epicondylalgia (commonly known as tennis elbow). They are frequently combined in clinical practice although evidence on their combined efficacy is lacking.   This randomised, injection-blinded, placebo-controlled study investigated the effectiveness of corticosteroid injection (n=43), placebo injection (n = 41),multimodal physiotherapy (n=41), or both (n=40) in Australian adult patients with unilateral lateral epicondylalgia of longer than 6 weeks' duration.   The 2 primary outcomes were 1-year globa...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

Phase III study: Twelve-Month comparison of 0.5 mg or 2.0 mg ranibizumab in patients with wet age-related macular degeneration (HARBOR)
Source: Ophthalmology Area: News Several small studies have suggested the potential of enhanced efficacy with higher 2mg dosing of ranibizumab. The HARBOR study was a 24-month, phase III, randomised, multicentre, double-masked study which evaluated the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients (n=1,098) aged over 50 years with subfoveal neovascular age-related macular degeneration (wet AMD).   Noninferiority (NI) tests with a prespecified NI margin of 4 letters comparing the 0.5 mg PRN with the 0.5 ...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

Meta-Analysis: Beta-Blockers and outcome in heart failure and atrial fibrillation
Source: J Am Coll Cardiol Heart Failure Area: News Although beta-blockers are widely used for the treatment of heart failure (HF), little is known about their efficacy in patients with co-existing atrial fibrillation (AF).   To investigate, researchers conducted a meta-analysis of placebo-controlled, randomised beta-blocker therapy in patients with AF at baseline and HF with reduced systolic left ventricular ejection fraction (LVEF) <40%.   Overall, four studies enrolling 8,680 patients with HF met the inclusion criteria. Of these, 1,677 (19%) had AF (mean 68 years of age; 30% women), where 842 pati...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

Francis report: Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry
Source: Mid Staffordshire NHS Foundation Trust Public Inquiry website Area: News The final Francis report of the Mid Staffordshire NHS Foundation Trust Public Inquiry has been published. The report examines the commissioning, supervisory and regulatory organisations in relation to their monitoring role at Mid Staffordshire NHS Foundation Trust between January 2005 and March 2009.  It considers why the serious problems at the Trust were not identified and acted on sooner, and identifies important lessons to be learnt for the future of patient care.   There are 290 recommendations in the report. At the highes...
Source: NeLM - News - February 6, 2013 Category: Drugs & Pharmacology Source Type: news

2013/14 NHS Standard Contract published
Source: NHS Commissioning Board Area: News The NHS Commissioning Board has published the 2013/14 NHS Standard Contract, for use by commissioners when commissioning healthcare services (other than those commissioned under primary care contracts). Please see the link below for further details. (Source: NeLM - News)
Source: NeLM - News - February 5, 2013 Category: Drugs & Pharmacology Source Type: news