Association of British Clinical Diabetologists

Liraglutide Nationwide Audit

 
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Above - centres contributing to the ABCD nationwide exenatide (left) and liraglutide (right) audits as it was in 2011 – click to enlarge

 

Above: In real clinic practice in the UK, patients treated with exenatide or liraglutide had far worse glycaemic control and were much heavier than patients treated in clinical trials  – click to enlarge

 

Above: Key messages from the paper on pancreatitis in the ABCD nationwide liraglutide audit. They illustrate the extent to which the ABCD audits can contribute to debates on important clinical issues – click to enlarge

 

Above: Though the combination of exenatide and insulin was not licensed at the time of the ABCD nationwide exenatide audit, many contributors to the audit found benefits from the combination  – click to enlarge

 

Above: In both the ABCD nationwide exenatide and liraglutide audits, it was found that whilst about 60% patients achieved improvement in both HbA1c and weight, less than half of these achieved this to the criteria levels set by NICE. Many patients achieved considerable HbA1c reduction but not much weight reduction, whilst many others achieved considerable weight reduction but not much HBA1c reductions - click to enlarge

 

Above: Liraglutide – coming off insulin, improving control, losing weight and “never felt so good” – click to enlarge

 

 

 

 

The ABCD nationwide liraglutide audit

About the ABCD nationwide liraglutide audit
This audit was established in the wake of the success of the original ABCD nationwide exenatide audit. Learning from the exenatide audit a considerably improved tool for the audit was created and the audit was launched in the Autumn of 2009. The audit had a number of objectives. Though data collection has ceased during 2018, analysis of the data continues.

Over 10 years of audit
2019 marked the 10th anniversary of the launch of the audit and saw the publication of the 9th paper. In 2020 a 10th paper is in press. As well as 10 published papers, there have also been 17 published abstracts, eight oral presentations and 17 poster presentations.

What we learned from the exenatide and liraglutide audits
After the audit had been active for 5 years, at the ABCD autumn meeting in 2014, Dr Ryder summarised the main findings from the ABCD nationwide exenatide and liraglutide audits and the slides from that presentation are available for viewing. In summary, the findings over the 10 years since the audit was launched have been:
• The patients treated with exenatide or liraglutide in real clinical practice are much heavier and with much poorer glycaemic control than in clinical trials of these agents; nevertheless, the agents have proven to be very effective.1
• Exenatide and liraglutide were used outside NICE guidelines in substantial numbers of patients and were found to be effective in outside NICE guidelines. In particular, the agents were used with insulin (40% in the nationwide liraglutide audit) with good effect in many patient.2
• Off licence use of exenatide with insulin was found to be safe and effective in real clinical practice, a reduction in insulin dose frequently occurred, weight fell and 1 in 6 patients were able to come off insulin.3,4
• An important safety issue was uncovered in that some clinicians attempted to stop insulin when starting exenatide in order to stay within license. This led to harm to the patient in some instances - for example there are 11 reported cases of ketosis or diabetic ketoacidosis - 7 of these occurred to patients who stopped insulin at the time of exenatide initiation. Analysis of audit data allowed us to recommend that when starting exenatide in an insulin-treated patient, not to stop the insulin but rather to tail the insulin off during treatment if response to treatment allowed.5,6
• When concerns were raised in 2013 in a TV documentary and in the British Medical Journal that incretin therapies might cause pancreatic damage, we were able to publish data suggesting that in the ABCD audits there is no evidence of such a side effect and that most cases of acute pancreatitis in the ABCD exenatide and liraglutide audits had other causes for acute pancreatitis, in particular gall bladder disease.7,8,9,10,11
• Many patients with a professional driver’s licence who would lose their jobs if they went onto insulin, were able to avoid insulin, and maintain similar glycaemic outcomes and keep their jobs by using exenatide or liraglutide.12,13
• Liraglutide was found to be safe and effective among patients with moderate renal impairment, even though that was an exclusion for use at the time.14,15
• Liraglutide use was found to be associated with a reduction in alanine aminotransferase levels (an index of fat in the liver) when they are elevated.16
• Though initially liraglutide was not licensed for use with insulin and in due course it was licensed only for use with insulin determir, it was found in the audit to be effective with all the common insulin regimes, whether basal, basal-bolus or biphasic.17
• Exenatide and liraglutide may be less effective at improving glycaemic control amongst non-insulin treated South Asians.18
• Long duration of diabetes and insulin use both predict reduced response to liraglutide, with insulin use being the strongest predictor.19
• Improvements in HbA1c and weight were seen when switching from exenatide and DPP4 inhibitors to liraglutide.20
• Older age and non-metformin use were associated with more significant gastro-intestinal side effects leading to discontinuation of liraglutide treatment.21,22
• In occasional patients the nausea, vomiting or diarrhoea was so severe that they developed transient acute kidney injury. No other new safety issues were uncovered.23,24
• Starting liraglutide was found to reduce 10-year cardiovascular risk as assessed by the UKPDS risk-engine.25,26

Further information
Further enquiries may be made to the ABCD nationwide audits database administrator of the project, Melissa Cull

Liraglutide audit objectives - 2009

First visit data entry form used in the audit

Follow up visit data entry form used in the audit

Nationwide exenatide audit

Papers, abstracts, presentations, posters from the audit

Further information- contact us

Main ABCD homepage

     

The ABCD nationwide exanatide QW audit is an independent audit supported by an unrestricted grant from Astra Zeneca

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