We bring you the latest news from the healthcare about the health care in the United Kingdom.

zondag 18 februari 2018

DTB: Correction: Dimethyl fumarate for psoriasis

Correction: Dimethyl fumarate for psoriasis

Our article Dimethyl fumarate for psoriasis (DTB 2017; 55: 141�C4) contained three numerical errors. In the Cost section, the maximum dose should have read "720mg daily". In the Conclusion, the first sentence of the second paragraph should have read "Dimethyl fumarate produces a clinically significant improvement in psoriasis in around 38% of patients who take it (compared with 15% with placebo) after 16 weeks." These changes do not alter our overall conclusion.

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Cladribine for multiple sclerosis

In the UK, there are twelve disease-modifying drugs licensed for various forms of multiple sclerosis (MS), of which three are oral therapies. An oral formulation of cladribine (Mavenclad - Merck Serono Europe Limited) was recently licensed by the European Medicines Agency (EMA) for the treatment of adult patients with highly active relapsing MS.1,2 It is claimed to be "an innovatively simple approach" for treating this form of MS and "the only disease modifying therapy that can deliver and sustain 4 years of disease control with a maximum of 20 days oral treatment in the first 2 years."3 Here, we consider the evidence for its use in the treatment of highly active relapsing MS.

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Kyleena - another levonorgestrel IUS

A levonorgestrel (LNG) intrauterine system (IUS) known as Kyleena (Bayer PLC) received marketing authorisation from the European Medicines Agency in 2016.1 The device contains 19.5mg LNG and is licensed for contraception for up to 5 years. This is the fourth LNG IUS product to be licensed for use in the UK. The company states that Kyleena offers advantages over Mirena and Jaydess LNG IUS devices.2 Here we consider the evidence for Kyleena.

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Intensive weight management for remission of type 2 diabetes

Intensive weight management delivered within a primary care setting as an intervention for achieving remission of type 2 diabetes has been assessed in a randomised trial.1 The premise of the intervention was that people with type 2 diabetes can be returned to normal glucose control by calorie restriction.

The open-label, cluster-randomised trial was conducted at 49 primary care practices in Scotland and northern England. Practices were randomly assigned to provide either a weight management programme (intervention) or best-practice care by guidelines (control). The co-primary outcomes were a reduction in weight of ≥15kg and remission of diabetes, defined as HbA1c <6.5% (<48mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to month 12.

A nurse or dietitian in each intervention practice was given a total of 8 hours structured training. Participants in the intervention group were asked to follow a weight management programme with the...

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Testosterone therapy in hypogonadal men

The use of testosterone replacement therapy (TRT) has been subject to much debate over its safety and effectiveness, particularly related to its use in older men.1,2 It is thought that the difficulty with assessing the effects of TRT may result from variation in formulations and doses, leading to contradictory study findings. A systematic review has used a network meta-analysis to assess the relative effects of individual testosterone products in adult men with low testosterone levels.3

The reviewers found 70 randomised placebo- and activecontrolled trials and 19 non-randomised studies that included an outcome of interest. Studies involved adult men (≥18 years) with low testosterone (total testosterone ≤12nmol/L or free testosterone ≤225pmol/L) who were administered a testosterone product. However, most studies were at high or unclear risk of bias, with short treatment duration and follow-up. The mean age of men in the studies ranged from...

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MHRA: quinine QT-prolonging effects and drug interactions

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a reminder about the QT-interval-prolonging effect of quinine.1 The MHRA has also provided advice on prescribing quinine alongside other medicines that prolong the QT interval. Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.

Prolongation of QT can be caused by several rare inherited long QT syndromes but is more commonly caused by drugs, typically in the presence of additional risk factors for QT prolongation. A 2017 routine EU-wide review, conducted by the European Medicines Agency, recommended that warnings for dose-dependent QT-prolonging effects should be present in the product information for all quinine-containing medicines.2

Clinicians are advised:

  • to be aware of dose-dependent effects on the QT interval and use caution if prescribing quinine in patients:

  • with conditions...

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    Adverse effects of opioids for non-cancer pain

    Despite a lack of evidence that opioids are more effective than other drugs used for chronic non-cancer pain (CNCP) there has been a large increase in the use of opioids for CNCP and concerns expressed over the risks associated with long-term use.1 An overview of Cochrane systematic reviews has assessed the occurrence and nature of adverse events associated with opioids.2 The review assessed any opioid agent (any dose, frequency or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults. The overview included 16 reviews (61 studies, 18,679 participants), of which 14 presented unique quantitative data on 14 different opioid agents that were administered for periods of 2 weeks or longer. The longest study lasted 13 months, with most in the 6- to 16-week range. The reviews included 61 studies with a total of 18,679 randomised participants.

    In...

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    CVS effects of {blacktriangledown} canagliflozin

    Canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been reported to reduce macrovascular complications in people with type 2 diabetes and elevated cardiovascular risk.1 Using data from the same study programme, the authors have assessed the effect of canagliflozin among patients with and without a history of cardiovascular disease (secondary versus primary prevention).2

    The study involved two trials that randomly assigned 10,142 participants with type 2 diabetes to canagliflozin or placebo.1, 2 Mean follow-up was 188 weeks. The primary prevention cohort (individuals aged ≥50 years) had at least two risk factors for cardiovascular events but no prior cardiovascular event, while the secondary prevention cohort (individuals aged ≥30 years) had a history of a prior cardiovascular event.

    The primary outcome (composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) event rate was higher in the secondary prevention group compared with the...

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    FMT: colonoscopy or capsule?

    A study has assessed the efficacy of fecal microbiota transplantation (FMT) by oral capsule compared with the same treatment delivered via colonoscopy in preventing recurrent Clostridium difficile infection (CDI).1 Following a course of antibiotic therapy for CDI, between 10% and 30% of patients will have a recurrence, with the risk approaching 60% after the third episode. While FMT has a reported efficacy of between 60% and 90% after a single treatment, it is still a relatively new treatment with evidence lacking on many aspects of its use, including the optimum route of delivery.

    The study, a non-inferiority unblinded randomised trial, was conducted in three academic centres in Canada between 2014 and 2016 and included 116 adult patients with recurrent CDI. The primary outcome was the proportion of patients without recurrent CDI 12 weeks after FMT. In per-protocol analysis, prevention of recurrent CDI after a single treatment was...

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    Revised advice on switching between antiepileptic products

    The Medicines and Healthcare products Regulatory Agency (MHRA) has revisited advice it issued in 2013 on switching between oral antiepileptic drugs from different manufacturers.1 The new advice, published in the MHRA's Drug Safety Update, follows a review by the Commission of Human Medicines in 2016, which was prompted by feedback and requests for clarification on the 2013 advice from patients and healthcare professionals.

    The core advice from 2013 has been updated with some refinements and revisions.1,2 For example, the 2016 review concluded that, although the reported loss of seizure control and/or worsening of adverse effects that occur around the time of switching between products could be explained as chance associations, the effect of switching could not be ruled out in all cases.

    The main message of the updated advice is that, in addition to the three risk-based categories of antiepileptic drugs, patient-related factors...

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    Clinical guidelines - more PDAs please

    In September 2017, the National Institute for Health and Care Excellence (NICE) published a clinical guideline for the diagnosis and management of endometriosis.1 Accompanying the guideline for this complex and variable condition is a patient decision aid (PDA) that was developed by a group of clinicians, patients and a representative from Endometriosis UK. The PDA has been designed for patients to work through with a healthcare professional and covers symptom relief, contraceptive reliability, practicalities of treatment, effect on periods, as well as providing advice on stopping treatment, information about planning pregnancy and details of the risk of deep vein thrombosis and breast cancer. There is an accompanying guide for clinicians that expands upon the evidence behind the decision aid and advises on its use.

    The NICE guideline on the management of sinusitis, published in October 2017, is supported by information for the public on the harms and...

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