Objectives Tirzepatide Audit

ABCD is setting up a nationwide audit of tirzepatide (Mounjaro) in real clinical use in the UK. The aim will be to ascertain whether the experience in real clinical use matches the data from phase 3 clinical trials.

Clinicians using tirzepatide will be invited to submit the data that they routinely collect as they monitor the progress of their patients (HbA1c, weight etc) to the nationwide audit. Based on technologies used in previous such registries, a secure, on-line, encrypted, IT tool will be developed to make this process as easy and user friendly as possible. It will also facilitate easy analysis of locally collected data by the local clinicians. ABCD hopes to gain insight into both the safety and efficacy of tirzepatide. ABCD hopes that the data from analyses of the data in the nationwide audit will inform future practice and guidelines.

From the data submitted in the nationwide audit ABCD hopes it might be able to quantify and analyse in detail:

• How much weight loss occurs with tirzepatide in real clinical use. Is weight loss durable over time?
• How much HbA1c reduction occurs with tirzepatide in real clinical use. Is this reduction durable over time in the real world?
• What percentage of patients achieve both HbA1c reduction and weight loss with tirzepatide as opposed to just one or neither of these parameters.
• In our analysis of the nationwide audit of liraglutide in real clinical use the efficacy appeared to be less with longer duration of diabetes – does this also apply to tirzepatide?
• What is the real-world experience of progression to insulin treatment in patients treated with tirzepatide?
• What is the impact on lipids of tirzepatide in real clinical use?
• What is the impact on alanine aminotransferase (ALT) of tirzepatide – through weight loss and impact on lipids might tirzepatide improve metabolic dysfunction-associated steatotic liver disease (MASLD).
• Who are the patients who respond especially well to tirzepatide in real clinical use – does it relate to initial HbA1c, weight, body mass index, duration of diabetes, initial age or sex, ethnicity or particular other medications being used etc. Is it possible to predict the patients who are more likely to respond to tirzepatide?
• Similarly, who are the patients who don’t respond to tirzepatide?
• What percentage of patients using tirzepatide have a history of cardiovascular disease? How much cardiovascular benefit are we likely to bring to our patients if we assess their risk using the UKPDS risk engine?
• What are the side effects? Tirzepatide seems to be more effective than the GLP1 receptor agonists – are the side effects worse as a result of a more potent medication?
• If there are safety issues with tirzepatide which may come out in due course, we hope to get some forewarning of these now through pooling the national real-world experience.
• To what extent does tirzepatide allow avoidance of insulin and continuation in their jobs for professional drivers, or regaining of their jobs for such workers who have lost them through insulin?
• What is the size of the problem of hypoglycaemia with tirzepatide and insulin, or tirzepatide and sulphonylureas. Is there a problem of worsening hyperglycaemia if insulin is stopped and tirzepatide started? Are there guidelines that can be deduced from the nationwide experience with regard to how to add tirzepatide to insulin and how to add tirzepatide to sulphonylureas without inducing hypoglycaemia or hyperglycaemia.
• What percentage of patients cannot tolerate tirzepatide in real clinical use?
• Is the clinical efficacy of tirzepatide sustained in real clinical use? Does the weight loss continue with time or does it plateau off?
• Are there benefits, or otherwise, in combining other medications such as SGLT2 inhibitors and/or thiazolidinediones and tirzepatide?