R. Ryder, K. Thong, M. Cull, AP Mills, C. Walton, P. Winocour
{"title":"英国临床糖尿病学家协会(ABCD)在全国范围内审核艾塞那肽","authors":"R. Ryder, K. Thong, M. Cull, AP Mills, C. Walton, P. Winocour","doi":"10.1002/PDI.1522","DOIUrl":null,"url":null,"abstract":"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. Copyright © 2010 John Wiley & Sons. Practical Diabetes Int 2010; 27(8): 352–357","PeriodicalId":92116,"journal":{"name":"Practical diabetes international : the journal for diabetes care teams worldwide","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2010-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/PDI.1522","citationCount":"37","resultStr":"{\"title\":\"The Association of British Clinical Diabetologists (ABCD) nationwide exenatide audit\",\"authors\":\"R. Ryder, K. Thong, M. Cull, AP Mills, C. Walton, P. Winocour\",\"doi\":\"10.1002/PDI.1522\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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. Copyright © 2010 John Wiley & Sons. 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引用次数: 37
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. Copyright © 2010 John Wiley & Sons. Practical Diabetes Int 2010; 27(8): 352–357