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Data from the Phase III UNIFI maintenance study announced at ECCO 2019

18th March 2019

Janssen has announced new data from the Phase III UNIFI maintenance study. 
 
The data showed that a significantly greater proportion of adults with moderate to severe ulcerative colitis (UC) receiving ustekinumab subcutaneous (SC) maintenance therapy were in clinical remission at Week 44, compared to patients receiving placebo – the study’s primary endpoint.1 Patients receiving ustekinumab SC maintenance therapy had a clinical response 8 weeks after receiving a single intravenous (IV) dose of ustekinumab.1
 
Results from the maintenance phase of the Phase III study demonstrated that 44% (90mg every 8 weeks [q8w]) and 38% (90mg every 12 weeks [q12w]) of patients with moderate to severe UC receiving ustekinumab SC injections achieved clinical remission, as defined by the Mayo score, at week 44 (52 weeks after IV induction) compared to 24% of patients who received placebo (p<0.001 and p=0.002, respectively).1 These data were included in submissions to the European Medicines Agency and the US Food and Drug Administration seeking approval of ustekinumab as a treatment for UC.
 
“Ulcerative colitis is a disruptive, lifelong and potentially debilitating inflammatory bowel disease; however, it is a condition where remission is possible,” said lead study investigator William Sandborn, MD, Chief, Division of Gastroenterology and Professor of Medicine, University of California, San Diego. “The data suggest the potential of ustekinumab as an effective therapy for helping people living with ulcerative colitis achieve remission, as well as providing other meaningful outcomes, including clinical response, histo-endoscopic improvement and corticosteroid-free remission.”
 
Major secondary endpoints, including maintenance of clinical response, endoscopic improvement, corticosteroid-free remission and maintenance of clinical remission from baseline, were also achieved in greater proportions of patients receiving ustekinumab q8w and q12w injections versus patients receiving placebo. At week 44:
  • 71% of patients receiving ustekinumab q8w and 68% of patients receiving ustekinumab q12w maintained clinical response, compared with 44% of patients receiving placebo (both p<0.001).1 Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a rectal bleeding sub-score of 0 or 1 or a decrease in the rectal bleeding sub-score ≥1.
  • 51% of patients receiving ustekinumab q8w and 44%of patients receiving ustekinumab q12w achieved endoscopic improvement, compared with 29% of patients receiving placebo (p<0.001 and p=0.002, respectively).1 Endoscopic improvement was defined as a Mayo endoscopy sub-score of 0 (normal mucosa or inactive disease) or 1 (mild disease activity)
  • 42% of patients receiving ustekinumab q8w and 38 percent of patients receiving ustekinumab q12w were in clinical remission and were corticosteroid-free, compared with 23% of patients receiving placebo (p<0.001 and p=0.002, respectively).1 The global remission definition was a Mayo score ≤2 points, with no individual sub-score >1.
Through to week 44, the proportions of patients with adverse events (AEs), serious AEs, infections and serious infections in the ustekinumab groups were generally comparable to the placebo group. The proportions of patients who discontinued the study agent were lower with ustekinumab q8w and q12w versus placebo. Among the primary population in the maintenance study, no deaths occurred. Two malignancies other than non-melanoma skin cancer (NMSC) (one colon cancer, q8w; one papillary renal cell carcinoma, q12w) were reported. One patient reported NMSC (two squamous cell carcinoma events, q12w).1 Overall, the safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab in Crohn’s disease.2
 
“The UNIFI maintenance data further build the case for ustekinumab as a potential new treatment option for ulcerative colitis and illustrate our ongoing commitment to researching and developing meaningful therapies for people living with inflammatory bowel diseases,” said Scott E Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. “Furthermore, we are proud that UNIFI is the first Phase III study to report a combined histo-endoscopic endpoint in patients with ulcerative colitis.”
 
References
  1. Sandborn W et al. Efficacy and safety of ustekinumab as maintenance therapy in ulcerative colitis: Week 44 results from UNIFI [Abstract OP37]. Presented at European Crohn’s and Colitis Organisation (ECCO 2019) 6-9 March, 2019; Copenhagen, Denmark.
  2. European Medicines Agency (2016) Ustekinumab Summary of Product Characteristics. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information…. Accessed March 2019.

How could high intensity interval training affect cardiovascular conditions?

15th March 2019

With high intensity interval training gaining in popularity, does the evidence suggest there are safe and effective cardiovascular health benefits for this type of exercise? Rod Tucker investigates.

The NHS has described exercise as a miracle cure that is able to reduce the risk of major illnesses such as heart disease, stroke, Type 2 diabetes and even cancer.

In order to achieve these benefits, the UK Government’s guidelines recommend that adults aged between 19 and 64 should undertake at least 150 minutes of moderate aerobic activities, such as cycling or brisk walking, every week, combined with strength training on two or more days per week. Sadly, this message is not filtering through to he general public.

A report by the British Heart Foundation suggested that physical inactivity and sedentary lifestyles cost the NHS as much as £1.2 billion a year and around 39% of adults (about 20 million people) fail to meet the Government’s physical activity targets. There are a range of possible reasons for this but one that is consistently reported among those who are not sufficiently active is lack of time.

The value of HIIT

One potential solution to achieving the same benefits of exercise in a much shorter space of time that is gaining in popularity is high intensity interval training (HIIT), which involves intermittent periods of intense exercise, i.e. going flat out, separated by periods of recovery.

In recent years, the value of HIIT as an exercise intervention has been extensively researched and compared to moderate intensity continuous training (MICT) such as jogging or cycling. The consensus appears to be that HIIT offers comparable health benefits to MICT. Furthermore, according to a new systematic review and meta-analysis of 786 studies, HIIT produced a 28.5% greater reduction in fat loss compared to MICT.

Many of the HIIT studies have been short-term and undertaken in laboratories using expensive exercise equipment. So, how transferable are these results to the real-world?

One recent ‘real-world’ 12-month study of adherence to HIIT in overweight adults sought to answer to this question. Participants could select HIIT or MICT as an exercise intervention and the results showed that adherence to HIIT reduced from 60% to 19% by 12 months. Nevertheless, for those who continued with HIIT, health outcomes were equivalent to those assigned to MICT.

Safe and effective?

But how safe or effective is HIIT for the majority of people who are likely to have a range of long-term health problems including cardiovascular disease, type 2 diabetes and are generally older. And should pharmacists be recommending this form of exercise?

This has been the subject of much scientific scrutiny with one review suggesting that HIIT may improve fitness and should be a component of the care for those with coronary artery disease. Similarly, HIIT improved glycaemic control, body composition, hypertension and dyslipidaemia in patients with type 2 diabetes and was beneficial in patients with heart failure and even older people.

While this research indicates the value of HIIT for patients with a range of health conditions, pharmacists should ensure that customers seek advice from their GP before embarking on HIIT.

Finally, HIIT is not without problems and exertional rhabdomyolysis (dissolution of muscle) has been reported in people who participate in vigorous and intense spinning classes. Nevertheless, the growth of HIIT gym classes is testament to the popularity of this form of exercise for achieving improvements in health and fitness but in the least amount of time.

Ireland to lead on €7 million Parkinson’s research project

Research led by the Royal College of Surgeons in Ireland (RCSI) has been awarded €7m to investigate new treatments for Parkinson’s over three years.

The grant from the Innovative Medicines Initiative (IMI) will help researchersincrease their understanding of how the mitochondria of cells in the brain become damaged in Parkinson’s.

There is growing evidence of the role that malfunctioning mitochondria play in Parkinson’s.

The researchers will focus on parts of the cell, known as mitochondria, that malfunction in people with Parkinson’s. Mitochondria contribute to cell death and neurodegeneration and there is growing evidence of their role in Parkinson’s, but no effective treatments have been developed based on this knowledge.

The EU public-private partnership funding health research and innovation chose the project as it recognises that new, more effective treatments are urgently needed. The most common drug to treat Parkinson’s used in Ireland is more than 50 years old, and no current treatment can stop, slow or reverse the condition.

The project’s coordinator Professor Jochen Prehn said: “This project will join forces with top scientists in academia and industry to bring a fresh look on how we identify and test novel drugs for the treatment of this devastating movement disorder.”

The project involves 14 partners from nine countries, including:

  • academic experts from: RCSI (Royal College of Surgeons in Ireland); Institut du Cerveau et de la Moelle Epinière;German Center for Neurodegenerative Diseases (DZNE); Neuroscience Institute of the National Research Council; University College London; Radboud University Nijmegen Medical Centre; the Centre National de la Recherche Scientifique
  • SMEs: GeneXplain GmbH; Mimetas B.V.; Pintail Limited
  • pharmaceutical companies from the EFPIA members: Teva Pharmaceutical Industries Ltd.;H. Lundbeck A/S and UCB S.A.
  • patient advocacy organisation: Parkinson’s UK

Depleting B-cells as a potential therapeutic option for lupus?

8th March 2019

Depleting the number of harmful B cells with a novel immunotherapy that employs modified T cells may offer an effective strategy to treat lupus, according to a study funded by the Lupus Research Alliance. 
 
These findings offer a renewed optimism for the elimination of B cells to provide a therapeutic option in lupus and pave the way for clinical research to test this new approach.
 
B cells are a critical component of the immune system and play an important role in lupus including the production of auto-antibodies which can lead to inflammation and organ damage. B cells can also directly activate other cells of the immune system – T cells – and can secrete cytokines that worsen the inflammatory immune response leading to disease flares. Given the central role and wide range of effects of B cells on lupus, it is not surprising that this cell type has been the subject of intense research in lupus for decades.
 
Depleting the number of B cells has been one approach that was tested in systemic lupus and lupus nephritis with rituximab: a humanised monoclonal antibody approved to treat blood cancers as well as several autoimmune diseases including rheumatoid arthritis and pemphigus vulgaris. Rituximab was not approved for lupus because the Phase III trials testing its use in lupus patients did not reach statistical significance. Yet the agent is still used off-label because it helps some lupus patients.
 
Marko Radic, PhD, of the University of Tennessee Health Science Center, Memphis, TN, and colleagues developed a novel approach to achieve B cell depletion in lupus. Specifically, the team created a new type of T cells by inserting into their DNA a genetic code for a chimeric molecule – the result of merging parts of three (entirely) different immune molecules to create a unique entity that does not exist naturally. The modified T cells recognise the CD19 molecule found on almost all B cells. When given to mice with lupus, these modified T cells, called chimeric antigen receptor (CAR) T cells, significantly lessened/improved disease symptoms and progression. Also, the lifespan of the animals treated with the special CAR T cells was significantly longer than the control-treated animals. In addition, the treatment lessened several manifestations of lupus including elevated protein in the urine, skin inflammation, and levels of proteins in the blood associated with chronic inflammation. The CAR T cells continued to be effective for up to a year.

Report exposes deficiencies in the cleanliness and working conditions of oncology units

7th March 2019

A report commissioned by the European Biosafety Network has shed light on conditions in hospitals across the EU which are endangering the lives of nurses and pharmacists, other hospital staff, carers and patients.
 
The report was launched on 7 March at a roundtable on preventing exposure to hazardous drugs in healthcare, held in the European Parliament in Brussels attended by MEPs, unions, employers, professional associations, representatives of Member States and the European Commission. 
 
The report exposes serious deficiencies in the cleanliness and working conditions of oncology outpatient units where hazardous cytotoxic drugs are used mainly by nurses to treat cancer: with 18% of the respondents having no policy for cleaning these areas, 45% failing to carry out standard routine contamination monitoring and 42% of staff not receiving regular medical testing. These basic measures are essential for protecting healthcare staff, carers and patients from exposure to hazardous drugs which can also cause them to contract cancer, particularly leukaemia, malignancy, birth defects and miscarriages. 
 
The report is based on a survey of hospital pharmacists and oncology nurses which focused particularly on exposure to cytotoxic drugs, vital in the treatment of cancers, but which are also carcinogenic and highly dangerous to staff, patients and their families. Exposure to cytotoxic drugs can cause acute skin and eye irritations, as well as nausea, headaches, and dizziness. Exposure has also been linked to complications during pregnancy, including higher incidences of spontaneous abortions, congenital malformations, low birth weight, and infertility. Studies show that nurses exposed to cytotoxic drugs are twice as likely to miscarry, and that hospital workers handling cytotoxic drugs are three times more likely to develop malignancy. 
 
The report found that: 
  • 23% of the oncology outpatient units failed to provide training policies for staff handling hazardous drugs. 
  • Regular medical testing is only carried out regularly in 58% of the units 
  • Regular monitoring of surface contamination is only carried out in 55% of oncology outpatient units 
  • 14% of the preparation of hazardous drugs and 59% of the spiking of medical bags does not take place in pharmacies, meaning that many nurses on wards are exposed to the risk of spillages and leakages 
The report, entitled “Observatory on current biosafety practice in European Oncology,” was commissioned by the European Biosafety Network, a European group set up by nurses and trade unionists in healthcare that promotes and campaigns for the health and safety of workers and patients. The survey was conducted by Ipsos MORI, the international survey research organisation, and covers 14 countries across the EU. 
 
The report also exposed failures in hospital pharmacies, where many of the hazardous drugs used in treatments are prepared and stored. 11% of pharmacies surveyed had no regular decontamination protocol for areas where hazardous drugs were handled, and nearly half of were failing to monitor surfaces for contamination. Further, it was revealed that medical devices such as syringes, needles and spikes were still in widespread use, despite the availability and recommendation of up-to-date devices, such as closed system drug transfer devices (CSTDs), that provide superior exposure prevention through closed systems. 
 
The report includes the following recommendations from the European Biosafety Network for healthcare regulators, policy makers and administrators: 
  • Increase the use of risk assessments and promote the active recording of incidents involving hazardous drugs. 
  • Regular monitoring of surface contamination should be universal, more frequent and more comprehensive. 
  • Ensure that decontamination and cleaning protocols are in place in all pharmacies and oncology nursing wards. 
  • Increase medical surveillance and regular medical testing for healthcare workers. 
  • Ensure that preparation of hazardous drugs and spiking of medication bags is carried out in the hospital pharmacy not on the wards. 
  • Ensure that sterile rooms used in the preparation of hazardous drugs are equipped with either a Biological Safety Cabinet (BSC) or an Aseptic Isolator (AI), and that closed systems drug transfer devices (CSTDs) are the primary device used to ensure a closed system in the preparation and administration of hazardous drugs. 
  • Hazardous drugs should be included in the Carcinogens and Mutagens Directive EU 2004/37, combined with mandatory European guidelines and a European list of hazardous drugs.

Alternative to anti-inflammatory therapies reduces IBD symptoms in mice

Researchers at Washington University School of Medicine in the USA have found a compound that may treat IBD without directly targeting inflammation. The compound tamps down the activity of a gene linked to blood clotting. They discovered that the gene, SERPINE-1, was turned on at sites of intestinal inflammation and damage, and blocking its activity reduces IBD symptoms in mice.1
 
Notably, the gene is especially active in people with severe disease and in those who do not respond to potent biologic drugs known as TNF blockers that are prescribed to treat severe IBD.
 
The findings may be a path to new therapeutic options for people whose IBD cannot be controlled effectively with current treatments.
 
“There’s a lot of interest in novel therapeutic approaches for IBD because inhibiting inflammatory molecules doesn’t work for all patients,” said senior author Thaddeus S Stappenbeck, MD, PhD, the Conan Professor of Laboratory and Genomic Medicine. “We found a unique target that’s not an inflammatory molecule, and yet blocking it reduces inflammation and signs of disease, at least in mice. If further research bears out our findings, we think this target could be helpful to a greater number of patients.”
 
When mice with IBD-like symptoms were treated with a compound called MDI-2268 that blocked the activity of the SERPINE-1 protein, they lost less weight, and their intestines showed less destruction and inflammation than mice that were treated with placebo. The compound was developed by Daniel A Lawrence, PhD, of the University of Michigan.
 
“What’s most exciting here is that SERPINE-1 and its protein seems to be most highly expressed in people with the most severe disease and those who don’t respond to immunosuppressive biologics,” Stappenbeck said. “No one’s ever thought of targeting something like this. But here we’ve found something that might help lots of people with IBD, especially the ones who aren’t benefiting much from current therapies.”
 
Reference
  1. Kaiko GE et al. PAI-1 augments mucosal damage in colitis. Science Translational Medicine 2019;March 6; DOI: 10.1126/scitranslmed.aat0852

Dupilumab label expanded for severe asthma indication

4th March 2019

The European Medicines Agency’s
Committee for
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab). 
The CHMP recommends its license in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO),who are inadequately controlled with high-dose inhaled corticosteroid plus another medicinal product for maintenance treatment.1
The UK has some of the highest asthma prevalence rates in Europe with asthma deaths increasing by 25% from 2007 to 2017 (1033 deaths in  2007, 1320 in 2017).2 Many patients with asthma have the severe form, which can be life-threatening if not controlled. Patients receiving standard-of-care therapy for severe asthma may often still have  uncontrolled, persistent  symptoms.3 Symptoms can include coughing, wheezing and difficulty breathing, and these patients are at risk of severe asthma attacks that may require emergency department visits or hospitalisations.4,5,6 Oral corticosteroids can provide relief for severe, short-term symptoms; however, current asthma guidelines suggest limiting their chronic use to the most severe  patients due to the potential for serious side effects.7 An Asthma UK survey found that people can  struggle to be diagnosed, with 55% taking a few years to be diagnosed with severe asthma following their initial asthma diagnosis.8
“Patients with severe asthma can face a daily struggle, not knowing whether they will face  an  unpredictable  exacerbation, which can be frightening, and  if  uncontrolled, may lead to death,” said  Dr Jasmin Hussein,  Head of Dermatology and Respiratory, Sanofi Genzyme. “Today’s CHMP positive opinion for dupilumab marks an important milestone for patients with severe asthma, moving us one step closer to bringing another treatment option for this potentially life-threatening disease to those in greatest need.”
The positive CHMP opinion is based on clinical data from 2888 adults and adolescents who participated in three pivotal trials from the global  LIBERTY ASTHMA  programme, including the Phase III QUEST and VENTURE trials.9,10 QUEST compared dupilumab vs.placebo in asthma patients inadequately controlled on a medium or high dose inhaled corticosteroid and a second controller medication. VENTURE compared dupilumab vs. placebo in oral corticosteroid-dependent asthma patients.
References
  1. European Medicines Agency. (2019). Summary of opinion (post authorisation). [Online]. www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dupixent-x-04-g_en.pdf(Last accessed March 2019).
  2. Asthma UK. (2018). Asthma deaths in England and Wales are the highest this century. [Online]. www.asthma.org.uk/about/media/news/statement-asthma-deaths-in-england-and-wales-are-the-highest-this-century/(Last accessed March 2019).
  3. Chung KF et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43:343–373.
  4. Haselkorn T et al. Consistently very poorly controlled asthma, as defined by the impairment domain of the Expert Panel Report 3 guidelines, increases risk for future severe asthma exacerbations in The Epidemiology and Natural History of Asthma:Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin. 2009;124(5):895-902.
  5. O’Byrne PM et al. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009;179(1):19-24.
  6. Suruki R et al. The Frequency of Asthma Exacerbations and Healthcare Utilization in Patients with Asthma from the UK and USA. BMC Pulmonary Medicine 2017;17:74.
  7. Global Initiative for Asthma. Global Strategy For Asthma Management and Prevention, 2017. www.ginasthma.org. Last accessed December 2018.
  8. Asthma UK. (2016). Tests for severe asthma. [Online]. www.asthma.org.uk/advice/severe-asthma/diagnosing-severe-asthma/tests-for-severe-asthma/(Last accessed March 2019).
  9. Castro M et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med 2018;378:2486-96.
  10. Rabe KF et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med 2018;378:2475-85.irator

Biosimilar pegfilgrastim launched in the UK

Napp Pharmaceuticals has announced the UK launch of Pelmeg®, a biosimilar of pegfilgrastim, following European Commission (EC) approval in November 2018.  
 
Pelmeg® is indicated for the reduction in the duration of neutropenia and incidence of febrile neutropenia (FN) in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by the Mundipharma network of independent associated companies in October 2018. 
 
Pelmeg® is a self-administered, single dose formulation and a lower drug cost alternative to the existing long-acting option Neulasta®. 
 
Although there have been improvements in the prognosis of FN, it is still responsible for considerable morbidity and mortality, with 20%-30% of patients requiring costly in hospital management and an overall mortality rate of approximately 10%. People who experience neutropenia and FN are at higher risk of infection, treatment dose reductions and dose delays. Failure to deliver planned chemotherapy can therefore be a major consequence of FN, that should be prevented as a clinical priority.
 
Biosimilar medicines are playing an increasingly important role in the oncology treatment pathway within the UK health system. Pelmeg® offers a patient-centric, effective alternative treatment option at a vital point in cancer care that can help address both the resource pressures on the health system, as well as patient needs.
 
Paul Clark, Director of Biosimilars at Napp Pharmaceuticals Ltd said “We are proud to be delivering treatments that address patient need in the oncology treatment pathway and that could potentially improve patient experience at such a critical time. We hope that Pelmeg® will not only help to alleviate some of the resource pressures on the NHS by providing a more affordable long-acting treatment option, but that it may also help improve patient access to these vital medicines.”

Phase IIIb trial with oral ferric maltol shows comparable efficacy to IV iron replacement therapy

Shield Therapeutics and Norgine have announced positive results from the AEGIS Head-to-Head (H2H) clinical trial, which compared Feraccru® (ferric maltol), a novel oral iron replacement therapy, to Ferinject® (ferric carboxymaltose (FCM)), a market-leading intravenously delivered iron replacement therapy.1
 
In the AEGIS-H2H study, ferric maltol demonstrated increases in the mean Hb levels that were comparable to IV FCM. Patients with iron deficiency anaemia (IDA), whose inflammatory  bowel disease (IBD) is inactive now have an important alternative treatment option, which is both effective over the long term and well tolerated, therefore reducing the need for time-consuming and expensive hospital administration. Current oral iron treatments can be poorly tolerated and do not always work,2 which leads to many unwell patients having to receive IV iron in hospital. 
 
The 52 week AEGIS–H2H Phase IIIb study compared the efficacy of oral ferric maltol to IVI FCM in the treatment and maintenance of IDA in subjects with inactive IBD in whom other oral iron therapies had failed.1
 
This was a multi-national Phase IIIb randomised, active-controlled trial in 242 patients across USA and Europe with haemoglobin (Hb) measurements as low as 8.0g/dl.  The objective of the study was to assess whether the effect of ferric maltol on Hb levels (defined by the protocol as normalisation of Hb or a >2g/dl rise in Hb from baseline) was comparable to the effect seen with IVI FCM treatment at 12 weeks.  This was followed by a 40-week extension phase, during which eligible subjects continued treatment with ferric maltol or received IVI FCM in line with clinical need as described in IVI FCM’s Summary of Product Characteristics in the EU and its Prescribing Information in the USA. 
 
Primary analysis of the AEGIS-H2H dataset has shown that the Hb response rate to ferric maltol was within 9% of the response rate seen with FCM, and comparable to the increase observed in the original AEGIS-IBD study.3  The primary endpoint of the study was defined as the Lower Confidence Limits being less than 20% different for ferric maltol versus IVI FCM and statistical analysis of this endpoint provides a positive p value of 0.0224.
 
“The results of this study provide an important opportunity to change clinical practice to improve patients’ lives. Patients with inactive IBD who are unwell as a result of IDA have often tried a number of oral iron treatments which didn’t work or they couldn’t tolerate” commented Dr Alastair Benbow, Chief Medical and Development Officer at Norgine. 
 
“Previously, they would have needed to go to hospital for time-consuming and expensive IV administration. Now many patients can be treated at home with an effective and well-tolerated oral iron alternative” he added.
 
References
  1. Shield Study ST10-01-304 Headline Results 4 March 2019. A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous ferric carboxymaltose, for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease.
  2. Lugg S et al. Iron treatment and inflammatory bowel disease: What happens in real practice? J Crohn’s Colitis 2014;8:876–880.
  3. Gasche C et al. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis 2015;21(3:579–588.

New scientific statement on blood pressure measurement published

The accurate measurement of blood pressure is essential for the diagnosis and management of hypertension, a major risk factor for heart disease and stroke, according to an updated American Heart Association scientific statement on blood pressure measurement in humans, published in the American Heart Association journal Hypertension.
 
The statement, which updates a previous statement on the topic published in 2005, provides an overview of what is currently known about blood pressure measurement. and supports recommendations in the 2017 American College of Cardiology/American Heart Association Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure
 
The auscultatory method – where a healthcare provider uses a blood pressure cuff, a stethoscope and a mercury sphygmomanometer (device that measures blood pressure) – has been the gold standard for office blood pressure measurement for several decades. The mercury sphygmomanometer has a simple design and is not subject to substantial variation across models made by different manufacturers. However, mercury devices are no longer being used due to environmental concerns about mercury.
 
“Many oscillometric devices, which use an electronic pressure sensor within the blood pressure cuff, have been validated (checked for accuracy) which allow for accurate blood pressure measurement in the healthcare office settings while reducing human errors associated with the auscultatory approach,” said Paul Muntner, PhD, chair of the writing group for the scientific statement.
 
“Additionally, newer automated oscillometric devices can obtain multiple measurements with the single push of a button, which can be averaged to better estimate blood pressure,” said Muntner, who is also a professor at the University of Alabama at Birmingham.
 
The statement also summarises current knowledge about ambulatory blood pressure monitoring, which is done when a patient wears a device which measures their blood pressure throughout the day to identify white coat hypertension and masked hypertension.
 
Substantial data have been published since the last scientific statement in 2005 showing the importance of measuring blood pressure outside of the clinic setting. 
 
As detailed in the scientific statement, patients with white coat hypertension may not have an increased risk for cardiovascular disease and may not benefit from initiating antihypertensive medication. In contrast, patients with masked hypertension have a substantial increased risk for cardiovascular disease.
 
The 2017 hypertension guideline also recommends conducting ambulatory blood pressure monitoring to screen for white coat hypertension and masked hypertension in clinical practice.
 
The American Heart Association continues to recommend patients measure their blood pressure at home using a blood pressure device with an upper arm cuff that has been checked for accuracy by a healthcare provider.

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