Global healthcare company Viatris has organised a series of important promotional workshops for healthcare professionals to raise awareness about PEI and the impact it can have on patients with diabetes.

PEI is characterised by the secretion of insufficient pancreatic enzymes ­– consisting of amylase, proteases, and lipase – into the duodenum following a meal to maintain normal digestive processes. ¹,². This results in abnormal food breakdown, leading to nutrient malabsorption and malnutrition. ¹,².

Viatris’ series of two-day workshops – called “Gastrointestinal disorders in diabetes workshop: Could this be Pancreatic Exocrine Insufficiency (PEI)?” – will be led by Su Down and Professor Mike Cummings who are both leading experts in diabetes with an interest in PEI.        

                                                                                                                             

The workshops will explore:

• The management of patients with diabetes and gastrointestinal (GI) symptoms,
• An overview of PEI and its role and prevalence in diabetes,
• A review of latest management guidance,
• How unmanaged PEI can impact glycaemic control and treatment of PEI with Creon® (Pancreatin).

Chris Hall, Gastroenterology therapy area lead, Viatris said: “Through these workshops we hope to raise awareness among healthcare professionals about the role PEI can play in diabetes.

“Gastroinestinal symptoms are commonly attributed to the side effects of diabetes medication, particularly metformin, glucagon like polypeptide GLP-1 receptor agonists and DPP4 inhibitors.”

“If symptoms persist, despite stopping the medication or reducing the dose, healthcare professionals can sometimes struggle to come up with an alternative diagnosis.”

“We hope these workshops will encourage healthcare professionals to consider PEI as a diagnosis in these situations.”

“Almost a quarter of diabetic patients may be suffering gastrointestinal symptoms. Data suggests 42% of these patients could have underlying PEI and untreated PEI can cause metabolic instability and impact glycaemic control.³”

The two distinct roles of the pancreas — the endocrine and exocrine roles — are functionally and anatomically closely related.⁴

Type 3c diabetes is diabetes due to pancreatic disease or injury, in which both endocrine and exocrine hormone production are affected. Type 3c diabetes is said to account for just under 10% of cases in people with diabetes in Western populations, and its most common cause is chronic pancreatitis. ⁵

The aetiology of PEI differs between type 1 and type 2 diabetes, and several possible mechanisms have been described.⁶ These include diabetic neuropathy, lack of insulin as a trophic factor for exocrine tissue, dysregulation due to changes in the secretion and, or action of other islet hormones including glucagon and somatostatin, and autoimmunity against endocrine and exocrine antigens specific to type 1 diabetes.⁶

Once PEI is diagnosed, the goal of treatment is to normalise digestion and alleviate symptoms in addition to managing the underlying cause.⁷ Normalising digestion may be achieved by using PERT — this oral preparation is taken at mealtimes and with snacks. The current guidelines recommend a starting dose of 25,000 units of pancreatin with snacks and 40,000 to 50,000 units with meals.

There are 2 opportunities to attend the two-day workshops which will take place between 7 and 9pm; 31st October; 1st November, 22nd and 23rd November.

These are promotional workshops, initiated, funded and reviewed by Viatris. Brand names will be mentioned. These workshops are intended for UK healthcare professionals only.

To book a place on one of the workshops:

click here

 

1. Guts UK. Pancreatic exocrine insufficiency (PEI) and pancreatic enzyme replacement therapy (PERT). gutscharity.org.uk/advice-and-information/conditions/pancreatic-exocrine-insufficiency-pei-and-pancreatic-enzyme-replacement-therapy-pert/ (accessed 2 June 2020).
2. Struyvenberg M, Martin C, Freedman S. Practical guide to exocrine pancreatic insufficiency—breaking the myths. BMC Med 2017; 15 (1): 29.
3. Cummings M et al. Practical diabetes 2015; 32(2): 54-58
4. Czako L et al. Pancreatology 2009;9:351-359
5. Ewald N, Kaufmann C, Raspe A et al. Prevalence of diabetes mellitus secondary to pancreatic diseases (type 3c). Diabetes Metab Res Rev 2012; 28 (4): 338–342.
6. Hardt P, Ewald N. Exocrine pancreatic insufficiency in diabetes mellitus: a complication of diabetic neuropathy or a different type of diabetes? Exp Diabetes Res 2011; 2011: 761950.
7. British National Formulary. Exocrine pancreatic insufficiency. bnf.nice.org.uk/ treatment-summary/exocrine-pancreatic-insufficiency.html (accessed 2 June 2020).

PRESCRIBING INFORMATION

Creon Micro Pancreatin 60.12 mg Gastro-resistant Granules, Creon 10000 Capsules, Creon 25000 Capsules 
Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation:

Creon Micro:                                  Gastro-resistant granules of pancreatin, containing in 100mg: 5,000 PhEur units of lipase; 3,600 PhEur units of amylase; 200 PhEur units of protease.                                                    
Creon 10000:                                  Each capsule contains pancreatin equivalent to: 10,000 PhEur units of lipase; 8,000 PhEur units of amylase; 600 PhEur units of protease. 
Creon 25000:              Each capsule contains pancreatin equivalent to: 25,000 PhEur units of lipase; 18,000 PhEur units of amylase; 1,000 PhEur units of protease.

Indication: Pancreatic exocrine insufficiency.
Dosage and Administration: Creon Micro: Initially 100mg (5000 lipase units) taken with each feed or meal or immediately after.  The required quantity of granules should be dispensed using the measuring scoop provided which holds 100mg.  In young infants, mix with a small amount of (undiluted) apple juice and give from a spoon directly before the feed.  In weaned infants, mix with acidic liquids or soft foods (e.g. undiluted apple juice or apple puree) and take directly before the meal without chewing. Alternatively, mix the granules with a small amount of milk on a spoon and administer to the infant immediately. The granules should not be added to the baby’s bottle.
Creon 10000 and 25000: Initially one or two capsules during or immediately after meals, then adjust according to response. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice.
Creon Micro, 10000 and 25000: Dose increases, if required, should be added slowly with careful monitoring of response and symptomatology.  Maximum daily dosage of Creon Micro should not exceed 10,000 units lipase/kg/day.  Ensure adequate hydration. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result.  In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth. Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see below).
Contraindications, Warnings and Precautions: Hypersensitivity to pancreatin of porcine origin or any excipients. Fibrosing colonopathy has been reported in CF patients taking high dose pancreatin preparations.  As a precaution, medically assess unusual or changes in abdominal symptoms, especially for doses above 10000 units of lipase/kg/day.
Pregnancy and Lactation: There is inadequate evidence of safety in use during pregnancy. Pancreatic enzymes can be used during breast-feeding.
Effects on Ability to Drive and Operate Machinery: No or negligible influence on ability.
Undesirable Effects: Most commonly, gastrointestinal disorders.  Common: nausea, vomiting, constipation, diarrhoea and abdominal distension.  Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain (very common, ≥1/10).  Uncommon: rash.  Frequency unknown:  Hypersensitivity (anaphylaxis), pruritus and urticaria, strictures of the ileo-caecum and large bowel (fibrosing colonopathy). See SPC for further information. 
Interactions: no studies performed.
Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL
Marketing Authorisation Number: Creon Micro: PL 46302/0031, Creon 10000: PL 46302/0028, Creon 25000: PL 46302/0029,
NHS price: Creon Micro (20g): £31.50, Creon 10000 (100 capsules): £12.93, Creon 25000 (100 capsules): £28.25
Legal Category: Creon Micro and Creon 10000: P, Creon 25000: POM
Date of Last Revision: 14/08/2020

The SmPC for this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:  http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm and from Mylan Medical Information, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, phone no. 01707 853000, Email: info@mylan.co.uk

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should be reported to UK Pharmacovigilance, Mylan, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, on phone no. +44 (0) 800 121 8267, Email: ukpharmacovigilance@mylan.com