This site is intended for UK Healthcare Professionals only

UK/FLY/2023/2636 V5| January 2025

Prescribing information and adverse event reporting statement can be found in the footer

This site is intended for UK Healthcare Professionals only

UK/FLY/2023/2636 V5| January 2025

Prescribing information and adverse event reporting statement can be found in the footer

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  • Vitamin D
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The ABC of Vitamin D

Now available on demand - This event outlines the role of vitamin D within the human body, along with the effects of vitamin D deficiency on health. It explores the evidence base for the pharmacological management of vitamin D deficiency and examines the clinical benefits of different treatment options for hypovitaminosis D.

H.pylori reference laboratory service paused in England

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Important Update Provided by Flynn Pharma Limited

Information Regarding MC&S (Microscopy, Culture and Sensitivity) Testing for H. pylori

 

There is currently a service pause of the national laboratory services performing H.pylori isolation and antimicrobial sensitivity testing (AST). This testing is currently recommended for patients with dyspepsia who meet any one of three criteria –

  1. Patients who have failed at least first- and second-line treatments
  2. Patients who have limited options due to drug hypersensitivity
  3. Patients who live in an area with high resistance rate

The UKHSA Gastrointestinal Bacteria Reference Unit (GBRU) undertakes culture for H.pylori biopsies. H.pylori-positive cultures are then tested for phenotypic susceptibility to clarithromycin, metronidazole, amoxicillin, tetracycline and levofloxacin. As of January 6th, 2025, this service has been suspended until March 31st, 2025.

Guidance for gastroenterologists and medical microbiologists has been published (17th January 2025) and can be read in full via Interim guidance for the management of Helicobacter pylori cases - GOV.UK

Information Regarding Flynn’s Product Pylera® 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride

Pylera is licensed for the treatment/eradication of Helicobacter Pylori (H.pylori), used in conjunction with omeprazole. Each capsule contains 140 mg of bismuth subcitrate potassium, 125 mg of metronidazole and 125 mg of tetracycline. Each dose of Pylera includes 3 identical hard capsules. Each dose should be taken 4 times a day, over a period of 10 days. One omeprazole 20 mg capsule/tablet should be taken twice a day.1

Historically, standard triple therapy (clarithromycin-amoxicillin-proton pump inhibitor, PPI, for 7 days) has been employed for H. pylori eradication. However, emerging antibiotic resistance is resulting in diminished success of these regimens that previously gave >90% eradication rates (note 90% is accepted as the arbitrary threshold for successful eradication therapy).

In a clinical trial aimed at assessing the efficacy and safety of bismuth-containing quadruple therapy (Pylera) for 10 days versus standard triple therapy for 7 days, Pylera achieved 93% H. pylori eradication (70% for standard triple therapy), 91% H. pylori eradication in patients harbouring clarithromycin-resistant H. pylori (8% for standard triple therapy) and 90% H. pylori eradication in patients harbouring metronidazole-resistant H. pylori (68% for standard triple therapy).

Use of Pylera may remove the need for routine antibiotic susceptibility testing since >90% H. pylori eradication is achieved in areas of high, low or unknown clarithromycin resistance and 90% eradication is maintained in patients harbouring metronidazole-resistant H. Pylori. Indeed, one of the recommendations from a recent publication from the European Registry on H. pylori (Hp-EuReg) was not to perform routine antibiotic resistance susceptibility testing to inform treatment selection; when using Pylera determining antibiotic resistance will not provide any advantage that might increase effectiveness.3

Used as first-line therapy Pylera has the potential to reduce unsuccessful/unnecessary antibiotic exposure and could consequently reduce antibiotic resistance. Pylera is also suitable for use in penicillin allergic and non-penicillin allergic patients.

In the context of current UK clinical guidance, Pylera use is positioned as a second-line treatment option in penicillin allergic patients and a third-line option in non-penicillin allergic patients. In wider, and more current European Guidelines, Pylera is positioned as a first-line treatment option.4

There are no routine monitoring requirements during treatment. A stool antigen test or urea breath test could be employed to determine treatment success, i.e. H. pylori eradication, if the prescriber considers it necessary.

The foreseeable demand/forecast for Pylera in the UK is subject to regular review of the rate of uptake, as well as taking full account of supply lead-times. Flynn does not envisage any supply constraints that will impact the availability of Pylera in the UK. The product is available through Alliance Healthcare.

 

  1. Pylera SmPC https://www.medicines.org.uk/emc/product/15622/smpc (Accessed Jan 2025)
  2. Malfertheiner et al., 2011 Malfertheiner Lancet 2011 - full article (Accessed Jan 2025)
  3. Olmedo et al., 2024 https://pubmed.ncbi.nlm.nih.gov/39461739/
  4. Malfertheiner et al., 2022 gut.bmj.com/content/gutjnl/71/9/1724.full.pdf