Drug and Therapeutics Bulletin recent issues

Prescribing in pregnancy--therapeutic discrimination?

2013-06-13T00:30:43-07:00

It is estimated that 10% of pregnant women have a chronic medical disorder that requires regular use of medicines. In addition, some women develop health problems during pregnancy, and at least 40% take a prescription drug at some point.1,2 The impact of the increasing age and body mass index of the population has contributed to the proportion of women who require medication during pregnancy. For example, 4% of women delivering in England and Wales in 2011 were aged 40 years or over (compared with 1% in the 1990s) and 19% of women of child-bearing age in England in 2008 were obese.3,4 The relative lack of information on the use of medicines during pregnancy remains an area of concern for healthcare professionals.

Indirect maternal deaths in the UK, where a new or pre-existing medical or mental health problem is aggravated...

DTB Select: 6 | June 2013

2013-06-13T00:30:43-07:00

Every month, DTB scans sources of information on treatments, disease management and other healthcare topics for key items to bring to our readers’ attention and help them keep up to date. To do this, we produce succinct, contextualised summaries of the information concerned. We also include comments on, for example, the strengths of the information, whether it contains anomalies, ambiguities, apparent error or omissions, or whether or how it affects current practice.

{blacktriangledown}Glycopyrronium for COPD

2013-06-13T00:30:43-07:00

Glycopyrronium powder for inhalation (Seebri Breezhaler—Novartis) is a long-acting muscarinic receptor antagonist (LAMA), licensed as a maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD).¹ This is the third long-acting agent that has recently been licensed in the UK for use in people with COPD (see Indacaterol for COPD² and Aclidinium for COPD?³). The company's promotional material claims that ‘Seebri is a once daily LAMA which supports cost effective prescribing at all stages of COPD’.⁴ In this article we review the evidence for glycopyrronium and assess its place in the management of COPD.

Prevention of recurrent urinary tract infections in women

2013-06-13T00:30:43-07:00

Around 40–50% of women experience at least one urinary tract infection (UTI) during their lifetime and 20–30% of these have a recurrence within 3–4 months of the initial infection.¹ Recurrent UTI (usually defined as three episodes in the last 12 months or two episodes in the last 6 months) can have a considerable impact on a woman's quality of life. Each episode of acute UTI in young women is typically associated with about 6 days of symptoms, 2.4 days of restricted activities and 0.4 days of bed rest.¹ Antibacterial prophylaxis is effective in preventing recurrent episodes, but at the expense of unwanted effects and a risk of promoting bacterial resistance. Here we assess the efficacy of different antibacterial regimens and non-antibacterial alternatives (cranberry, probiotics, oestrogens, immunostimulation, hyaluronic acid and chondroitin, acupuncture and herbs) in the prevention of recurrent uncomplicated UTIs in women.

Time to say goodbye to minocycline?

2013-05-08T00:30:41-07:00

Minocycline has been licensed for over 35 years for a wide range of bacterial infections (a Summary of Product Characteristics [SPC] lists 16 indications) including respiratory, genitourinary and skin conditions.1,2 However, much of its popularity has been for its use in treating acne. Minocycline was associated with claims that it was "more effective, less likely to cause bacterial resistance and easier to take than other tetracyclines".3 In addition, the availability of an adherence-friendly, once-daily, modified-release preparation and a lack of restriction when taken with food or ‘moderate amounts of milk’, quickly made it a favourite with general practitioners and patients. It became particularly popular for use for teenagers with acne, a group notorious for non-adherence and for whom a single daily dose was seen as an advantage. Between 1997 and 2006 about 500,000 prescriptions for minocycline were dispensed each year in...

DTB Select: 5 | May 2013

2013-05-08T00:30:42-07:00

Every month, DTB scans sources of information on treatments, disease management and other healthcare topics for key items to bring to our readers' attention and help them keep up to date. To do this, we produce succinct, contextualised summaries of the information concerned. We also include comments on, for example, the strengths of the information, whether it contains anomalies, ambiguities, apparent error or omissions, or whether or how it affects current practice.

What place for {blacktriangledown}racecadotril?

2013-05-08T00:30:42-07:00

Worldwide, there are about two billion cases of diarrhoeal disease every year and it is the second leading cause of death in children under 5 years of age, killing 1.5 million children annually.¹ The most severe threat posed by diarrhoea is dehydration. In the UK, the incidence of diarrhoea is about one episode per person per year,² and approximately 10% of children younger than 5 years old present to healthcare services with gastroenteritis each year.³ Racecadotril (Hidrasec) is the first in a new class of antidiarrhoeal drug (‘enkephalinase inhibitor’) that has an antisecretory mechanism and is licensed in adults, children and infants (over 3 months of age) for symptomatic treatment of acute diarrhoea or as complementary treatment when causal treatment is possible.^4–6 Here we review the evidence for racecadotril and its place in the management of acute diarrhoea.

What are biosimilars and are they important?

2013-05-08T00:30:42-07:00

All prescribers will be familiar with the issues associated with the use of branded and generic ‘chemical’ medicines.¹ For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the biological reference medicine).² Six biosimilar medicinal products are currently marketed in the UK—three versions of filgrastim (Nivestim, Tevagrastim and Zarzio),^3–5 two versions of epoetin (Binocrit and Retacrit)^6,7 and one version of somatropin (Omnitrope).⁸ Applications for biosimilar versions of follitropin alfa and infliximab are under evaluation by the European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use.⁹ In the future there may also be biosimilar versions of insulins, recombinant vaccines, interferons and monoclonal antibodies such as rituximab and trastuzumab.¹⁰ It is estimated that about 50% of the current UK market for biological medicines by spend may be subject to biosimilar competition by 2019. In this article, we will consider the background to developing biosimilar medicines, how and why they differ from traditional generic medicines in their licensing requirements and the issues that may arise as they are introduced to clinical practice.

Optimising medicines management?

2013-04-10T00:30:46-07:00

Improving the use of medicines has been a recurring challenge in healthcare for several decades and terms such as ‘quality prescribing’, ‘rational prescribing’, ‘cost-effective prescribing’, ‘compliance’ ‘adherence’ and ‘concordance’ have been applied to elements of the process.1,2 More recently, attempts have been made to capture all aspects of medicines use under the heading of ‘medicines management’, which has now been replaced by ‘medicines optimisation’.3 Unfortunately, providing credible, reliable definitions and explanations for these expressions is fraught with difficulty. Frequently the terms become empty catchphrases and expressions that are meaningless to the majority of healthcare professionals. ‘Medicines optimisation’ is intended to focus attention on outcomes rather than process in relation to improving quality, benefits and value for patients from their use of medicines, and to highlight the role that all parts of the health service must play. It will require greater engagement...

DTB Select: 4 | April 2013

2013-04-10T00:30:46-07:00

HbA1c targets in type 2 diabetes: guidelines and evidence

2013-04-10T00:30:46-07:00

Type 2 diabetes is defined by chronic hyperglycaemia, decreased insulin secretion and increased insulin resistance and is often associated with overweight or obesity, hypertension and dyslipidaemia.¹ Aims of treatment include minimising long-term complications (e.g. cardiovascular disease, blindness, chronic kidney disease, premature mortality) and avoiding unwanted effects of treatment (e.g. severe hypoglycaemia, weight gain).¹ Publication of the United Kingdom Prospective Diabetes Study (UKPDS) 33 study in 1998 suggested that ‘intensive blood glucose control’ to lower the glycated haemoglobin (HbA_1c) in people with type 2 diabetes reduced microvascular disease but not macrovascular complications.² The UKPDS 34 study in overweight patients found that metformin produced less of a reduction in HbA_1c but reduced cardiovascular complications and death.³ More recently, further trials have examined the impact of intensive glycaemic control and have produced conflicting results.^1,4–11 Here we examine the evidence and guideline recommendations for HbA_1c targets; glycaemic control for acutely unwell patients and targets in pregnancy will not be covered.

{blacktriangledown}Aclidinium for COPD?

2013-04-10T00:30:46-07:00

Chronic obstructive pulmonary disease (COPD) affects around 64 million people worldwide and is the fourth leading cause of death.¹ In Europe, COPD is thought to be responsible for the deaths of 200,000 to 300,000 people each year and its economic burden estimated to be EUR102 billion/year.¹ In 2011, over 1.5 million people (3.6% of the population ≥16 years) in England had COPD, which included 720,000 people aged over 65.² Drug management of COPD includes treatments to relieve respiratory symptoms, and prevent or manage acute exacerbations. Short-acting inhaled bronchodilators (either a beta₂ agonist [SABA] or muscarinic antagonist [SAMA]) are used as initial empirical treatment to relieve breathlessness and reduce exercise limitation. Long-acting bronchodilators with or without an inhaled corticosteroid (ICS) are added for people who remain breathless or have exacerbations.³ Aclidinium bromide powder for inhalation (Eklira Genuair—Almirall) is a long-acting muscarinic antagonist (LAMA), licensed to be used twice a day as a maintenance bronchodilator to relieve symptoms in adults with COPD.⁴ In this article, we consider the evidence for aclidinium and how its use fits with current management strategies for COPD.

Subprime research?

2013-03-12T17:30:42-07:00

The development of modern drugs and their therapeutic use is entirely due to the tireless work of medical researchers. It would be no exaggeration to suggest that the giants upon whose shoulders today's prescribers stand are themselves resting on the bedrock of randomised controlled trials. While some studies have been pivotal in changing the way that medicines are used (e.g. the Medical Research Council trial of treating mild hypertension,1 the Scandinavian Simvastatin Survival Study2 and the United Kingdom Prospective Diabetes Study 343), most trials incrementally add to our knowledge and nudge changes in the way medicine is practised. Despite the best endeavours of some researchers and public relations companies very few trials can, or should, produce an instant change in disease management, unless they raise concerns relating to patient safety (e.g. resulting in regulatory action or product labelling changes). Nevertheless, all...

DTB Select: 3 | March 2013

2013-03-12T17:30:42-07:00

An update on the management of hay fever in adults

2013-03-12T17:30:42-07:00

Allergic rhinitis is a common disorder occurring in about one in four people in Britain with a peak onset during adolescence.1–3 Although not necessarily a serious illness, it can adversely affect quality of life and disrupt normal activities, and is a risk factor for asthma.2,3 The symptoms of seasonal allergic rhinitis/rhino-conjunctivitis caused by an IgE-mediated type 1 hypersensitivity reaction to airborne allergens, particularly pollens, and which typically occur between spring and autumn are commonly referred to as hay fever.3 There are a number of management options available including drug therapy. Several drugs can be bought over the counter in the UK, and so people with allergic rhinitis may commonly present to the pharmacy or to general practice. The choice of treatment will be influenced by the spectrum, intensity and frequency of symptoms, and should take into account safety, efficacy, cost and patient preferences. Some of the treatments now available have been developed since our previous review was published and include the newer antihistamines, oral leukotriene receptor antagonists (LTRA),ⁱ and sublingual allergen desensitisation immunotherapy.4

Hypomagnesaemia

2013-03-12T17:30:42-07:00

Magnesium plays an important role in the body as a cofactor for DNA and protein synthesis, oxidative phosphorylation, neuromuscular excitability, enzyme activity and regulation of parathyroid hormone (PTH) secretion.1 The regulation of plasma magnesium concentration is balanced by intestinal absorption and renal excretion. Hypomagnesaemia (variously defined but taken here as plasma magnesium <0.7mmol/L) may result from inadequate magnesium intake, increased gastrointestinal or renal loss or redistribution from extracellular to intracellular space. In addition, hypomagnesaemia has been associated with the use of a number of drugs and, in 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) drew attention to the risk associated with prolonged use of proton pump inhibitors (PPIs).2 Here we review the causes and management of hypomagnesaemia.