The Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit

In December 2008, to accelerate understanding of a new agent, the Association of British Clinical Diabetologists (ABCD) launched a nationwide audit on the use of exenatide in clinical practice. A password‐protected online questionnaire for collection of anonymised patient data was established and diabetes specialists in the UK were given persistent encouragement to submit data on their exenatide‐treated patients. Baseline and latest HbA1c, weight, body mass index (BMI), waist circumference, blood pressure and lipids were compared and adverse events related to exenatide were quantified. A total of 315 contributors from 126 centres submitted data on 6717 patients (54.9% male) – mean baseline age was 54.9 years, HbA1c 9.47% (80mmol/mol), weight 113.8kg, BMI 39.8kg/m2. Of these, 4551 and 4385 had dated baseline and latest HbA1c and weight respectively. Mean (±SE) HbA1c fell by 0.73±0.03% (p<0.001) and weight by 5.9±0.1kg (p<0.001) at a median (range) of 26.1(6.6–164.1) and 26.0(6.6–159.0) weeks respectively. The following parameters also showed significant falls (p<0.001): BMI 2.2±0.1kg/m2, waist circumference 5.1±0.3cm, systolic blood pressure 3.6±0.6mmHg, total cholesterol 0.16±0.03mmol/L and HDL cholesterol 0.03±0.01mmol/L. Triglycerides decreased by 0.14±0.06mmol/L (p=0.009). The change in diastolic blood pressure was not statistically significant. In all, 23.7% of patients reported gastrointestinal side effects with 7.2% having to stop exenatide permanently. Hypoglycaemia rates were 3.3% before and 5.6% after exenatide use (p<0.001). After scrutiny, one case of pancreatitis and four cases of renal failure occurring in patients on exenatide had no obvious alternate cause. All other reported side effects had <1% incidence. The rate of exenatide discontinuation was 19.9% throughout the span of the audit, most commonly due to gastrointestinal side effects (36.1%) and lack of glycaemic or weight benefit (33.8%). This large scale audit confirmed the effectiveness of exenatide in clinical use and highlighted rare associated adverse events. Importantly, we have successfully demonstrated a novel approach by a national specialist society to independently monitor the efficacy and safety of a new treatment.