Exenatide Use in diabetes OPD at the RD&E Clinical Audit Dr Pamela Bowman (FY2) Dr Angus Jones (ACF/ST3)
Background <ul><li>Incretin effect </li></ul><ul><ul><li>Augmentation of glucose-stimulated insulin secretion by intestina...
Exenatide <ul><li>Incretin mimetic approved by FDA 2005 </li></ul><ul><li>GLP-1 receptor analogue </li></ul><ul><li>Resist...
 
Actions of Exenatide <ul><li>Stimulates endogenous insulin secretion in a glucose-dependent manner </li></ul><ul><li>Suppr...
NICE guidelines 2008 Type 2 Diabetes Starting Exenatide <ul><li>BMI >35 in those of European descent (adjusted accordingly...
NICE guidelines 2008 Type 2 Diabetes Continuation of Exenatide <ul><li>Greater than or equal to 1% reduction in HbA1c at 6...
Criteria <ul><li>1.  Prescribing of Exenatide within NICE guidelines (and if prescribed outwith guidelines comparison of o...
Standards (1) <ul><li>1. Patients will be started on Exenatide in line with current NICE guidelines (80%).  </li></ul><ul>...
Standards (2) <ul><li>2.   Patients prescribed Exenatide will be entered into the diabetes Diamond database so that they m...
Standards (3) <ul><li>4. Patients on Exenatide will achieve an improvement in glycaemic control as evidenced by a reductio...
Methods  Data Collection & Analysis <ul><li>List of patients started on Exenatide obtained from DSN who used list on X-dri...
Duration of treatment
Results (1) <ul><li>‘ Patients will be started on Exenatide in line with current </li></ul><ul><li>NICE guidelines (target...
Results (1) cont... <ul><ul><li>(c) inadequate blood glucose control (HbA1c equal to or greater than 7.5%) with convention...
Results (1) cont... <ul><li>Total number of patients meeting all 4 criteria for starting Exenatide in accordance with rece...
Starting Exenatide
<ul><li>‘ Patients prescribed Exenatide will be entered into the diabetes Diamond database so that they may be easily trac...
Results (3) <ul><li>‘ Patients on Exenatide will lose at least 5% body weight at 1 year for the drug to be continued, in l...
Results (3) cont..... <ul><li>Of these patients 13 were on insulin + Exenatide; therefore </li></ul><ul><ul><li>Insulin + ...
Results (4) <ul><li>‘ Patients on Exenatide will achieve an improvement in glycaemic control as evidenced by a reduction i...
Results (4) cont.... <ul><li>Of these 7 patients were on insulin + Exenatide; therefore </li></ul><ul><ul><li>Insulin + Ex...
Changes in weight & HbA1c
Results (3&4) <ul><li>Number of patients meeting both criteria for continuation of Exenatide = 7 </li></ul><ul><li>Number ...
Changes in weight (kg) over time
Changes in HbA1c over time
Results (5) <ul><li>‘ Patients prescribed Exenatide will receive education about the need for self blood glucose monitorin...
Results (6) <ul><li>‘ Patients on Exenatide will be followed up in the outpatient department at 3 months, 6 months and 1 y...
<ul><li>Characteristics of specific patient groups </li></ul>
Exenatide stopped <ul><li>Number of patients = 8/33 = 24% </li></ul><ul><li>Of these, 4/8 were on OHA and 4/8 were on insu...
Duration of treatment
Reasons for stopping Exenatide
Doing particularly well on Exenatide <ul><li>Number of patients = 8 / 33 = 24% </li></ul><ul><li>Of these, 3/8 were on OHA...
Conclusions (1) <ul><li>Most criteria (A-C) for starting patients on Exenatide are being met in line with NICE guidance </...
Conclusions (2) <ul><li>There is inconsistent use of the diabetes Diamond database between prescribing clinicians </li></u...
Discussion <ul><li>Difficult to set standards against NICE guidance as most patients on drug for less than 1 year. </li></...
Suggestions for change <ul><li>Improve documentation </li></ul><ul><ul><li>Very variable between clinicians  </li></ul></u...
Future considerations <ul><li>Development of generic hospital guidelines on prescribing/monitoring any new pharmacological...
References <ul><li>NICE clinical guideline 66. The management of type 2 diabetes;  www.nice.org.uk . </li></ul><ul><li>Dav...
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Transcript of "Exenatide Presentation"

  1. 1. Exenatide Use in diabetes OPD at the RD&E Clinical Audit Dr Pamela Bowman (FY2) Dr Angus Jones (ACF/ST3)
  2. 2. Background <ul><li>Incretin effect </li></ul><ul><ul><li>Augmentation of glucose-stimulated insulin secretion by intestinally derived peptides released in the presence of glucose or nutrients in the gut </li></ul></ul><ul><ul><li>GIP and GLP-1 (rapidly inactivated by DPP4) </li></ul></ul><ul><li>Loss of incretin effect in T2DM </li></ul><ul><ul><li>Pathway target for development of new agents </li></ul></ul>
  3. 3. Exenatide <ul><li>Incretin mimetic approved by FDA 2005 </li></ul><ul><li>GLP-1 receptor analogue </li></ul><ul><li>Resistant to DPP4 degradation </li></ul><ul><li>Injectable therapy </li></ul><ul><li>Adjunctive therapy in Type 2 Diabetes </li></ul>
  4. 5. Actions of Exenatide <ul><li>Stimulates endogenous insulin secretion in a glucose-dependent manner </li></ul><ul><li>Suppresses glucagon </li></ul><ul><li>Slows gastric emptying </li></ul><ul><li>Reduces food intake </li></ul><ul><li>Importantly, associated with a reduction in body weight vs. insulin </li></ul>
  5. 6. NICE guidelines 2008 Type 2 Diabetes Starting Exenatide <ul><li>BMI >35 in those of European descent (adjusted accordingly for other ethnic groups) </li></ul><ul><li>Specific psychological, biochemical or physical problems arising from high body weight </li></ul><ul><li>HbA1c greater than or equal to 7.5% with conventional oral agents after a trial of metformin and sulphonylurea </li></ul><ul><li>Would otherwise be starting other high cost medication e.g. thiazolidinedione or insulin </li></ul>
  6. 7. NICE guidelines 2008 Type 2 Diabetes Continuation of Exenatide <ul><li>Greater than or equal to 1% reduction in HbA1c at 6 months </li></ul><ul><li>Weight loss greater that 5% at one year </li></ul><ul><li>Problem! Most of our patients have been on Exenatide for less than one year (and many less than 6 months) </li></ul>
  7. 8. Criteria <ul><li>1. Prescribing of Exenatide within NICE guidelines (and if prescribed outwith guidelines comparison of outcomes to those patients prescribed the drug within the guidelines). </li></ul><ul><li>2. Entry of patients on Exenatide into electronic databases (Diamond database / X-drive). </li></ul><ul><li>3. Change in weight after being started on Exenatide. </li></ul><ul><li>4. Change in HbA1c after being started on Exenatide. </li></ul><ul><li>5. Delivery and documentation of patient education regarding (a) blood glucose monitoring (b) potential for hypoglycaemia and (c) driving. </li></ul><ul><li>6. Follow-up arrangements after starting patients on Exenatide and documentation of these. </li></ul>
  8. 9. Standards (1) <ul><li>1. Patients will be started on Exenatide in line with current NICE guidelines (80%). </li></ul><ul><ul><li>(a) BMI > 35 kg/m2 in those of European descent (adjust as appropriate for other ethnic groups) </li></ul></ul><ul><ul><li>(b) have specific psychological, biochemical or physical problems arising from a high body weight </li></ul></ul><ul><ul><li>(c) inadequate blood glucose control (HbA1c equal to or greater than 7.5%) with conventional agents after a trial of metformin and sulphonylurea </li></ul></ul><ul><ul><li>(d) would otherwise be starting other high-cost medication, such as a thiazolidinedione or insulin. </li></ul></ul>
  9. 10. Standards (2) <ul><li>2. Patients prescribed Exenatide will be entered into the diabetes Diamond database so that they may be easily traceable for the purposes of audit / follow-up (90%). </li></ul><ul><li>3. Patients on Exenatide will lose at least 5% body weight at 1 year for the drug to be continued, in line with NICE guidance (75%). If the patient has been on the drug for less than one year the degree of weight loss should be in proportion to the time the patient has been taking Exenatide e.g. 2.5% weight loss at 6 months and 1.25% weight loss at 3 months. </li></ul>
  10. 11. Standards (3) <ul><li>4. Patients on Exenatide will achieve an improvement in glycaemic control as evidenced by a reduction in HbA1c of at least 1.0% at 6 months for drug to be continued, in line with NICE guidance (75%). If the patient has been on the drug for less than 6 months the improvement in glycaemic control should be in proportion to the time the patient has been taking Exenatide e.g. 0.5% reduction in HbA1c at 3 months and 0.25% reduction in HbA1c at 6 weeks. </li></ul><ul><li>5. Patients prescribed Exenatide will receive education about the need for self blood glucose monitoring, potential for hypoglycaemia and issues related to driving and this will be documented in the clinical notes (80%). </li></ul><ul><li>6. Patients on Exenatide will be followed up in the outpatient department at 3 months, 6 months and 1 year and follow up arrangements will be clearly documented in the patients' notes (90%). </li></ul>
  11. 12. Methods Data Collection & Analysis <ul><li>List of patients started on Exenatide obtained from DSN who used list on X-drive (41 in total) </li></ul><ul><ul><ul><li>Notes available for 33 patients (80% of total) </li></ul></ul></ul><ul><li>Data collected retrospectively </li></ul><ul><ul><li>Clinical notes (paper) </li></ul></ul><ul><ul><ul><li>For criteria 2-6 </li></ul></ul></ul><ul><ul><li>Diamond database </li></ul></ul><ul><ul><ul><li>For criteria 1 </li></ul></ul></ul><ul><li>Time on Exenatide calculated from start date to date of last clinic appointment </li></ul>
  12. 13. Duration of treatment
  13. 14. Results (1) <ul><li>‘ Patients will be started on Exenatide in line with current </li></ul><ul><li>NICE guidelines (target 80%).’ </li></ul><ul><ul><li>(a) BMI > 35 kg/m2 in those of European descent </li></ul></ul><ul><ul><li>N= 26 / 33 78% </li></ul></ul><ul><ul><li>(b) have specific psychological, biochemical or physical problems arising from a high body weight </li></ul></ul><ul><ul><li>N= 33 / 33 100% </li></ul></ul><ul><ul><li>As 100% patients’ BMI > 30 </li></ul></ul>
  14. 15. Results (1) cont... <ul><ul><li>(c) inadequate blood glucose control (HbA1c equal to or greater than 7.5%) with conventional agents after a trial of metformin and sulphonylurea </li></ul></ul><ul><ul><li>N = 30 / 32 94% </li></ul></ul><ul><ul><li>1 patient had no HbA1c recorded on starting Exenatide </li></ul></ul><ul><ul><li>(d) would otherwise be starting other high-cost medication, such as a thiazolidinedione or insulin </li></ul></ul><ul><ul><li>N = 15 / 33 45% </li></ul></ul><ul><ul><li>55% patients already on insulin +/- metformin / sulphonylurea when started on Exenatide. </li></ul></ul>
  15. 16. Results (1) cont... <ul><li>Total number of patients meeting all 4 criteria for starting Exenatide in accordance with recent NICE guidelines; </li></ul><ul><li>N = 12 / 33 36% </li></ul><ul><li>Mostly accounted for by the large number of patients already on insulin who started Exenatide (criteria 4). </li></ul>
  16. 17. Starting Exenatide
  17. 18. <ul><li>‘ Patients prescribed Exenatide will be entered into the diabetes Diamond database so that they may be easily traceable for the purposes of audit / follow-up (90%).’ </li></ul><ul><li>Of 41 patients on list obtained from X-drive; </li></ul><ul><li>15 had Exenatide recorded on medications list (37%) </li></ul><ul><li>14 had Exenatide treatment recorded as a comment either in an individual consultation episode or a comment attached to the medications list (34%) </li></ul><ul><li>12 had no record of Exenatide on Diamond (29%) </li></ul>Results (2)
  18. 19. Results (3) <ul><li>‘ Patients on Exenatide will lose at least 5% body weight at 1 year for the drug to be continued, in line with NICE guidance. If the patient has been on the drug for less than one year the degree of weight loss should be in proportion to the time the patient has been taking Exenatide e.g. 2.5% weight loss at 6 months and 1.25% weight loss at 3 months (target 75%).’ </li></ul><ul><li>N = 21/31 68% </li></ul><ul><li>1 patient no recent weight recorded in clinic notes / letter </li></ul><ul><li>1 patient on Exenatide for only 1 month (awaiting f/u) </li></ul>
  19. 20. Results (3) cont..... <ul><li>Of these patients 13 were on insulin + Exenatide; therefore </li></ul><ul><ul><li>Insulin + Exenatide </li></ul></ul><ul><ul><ul><li>13/21 met target weight loss = 62% </li></ul></ul></ul><ul><ul><li>Oral hypoglycaemic + Exenatide </li></ul></ul><ul><ul><ul><li>8/21 met target weight loss = 38% </li></ul></ul></ul>
  20. 21. Results (4) <ul><li>‘ Patients on Exenatide will achieve an improvement in glycaemic control as evidenced by a reduction in HbA1c of at least 1.0% at 6 months for drug to be continued, in line with NICE guidance. If the patient has been on the drug for less than 6 months the improvement in glycaemic control should be in proportion to the time the patient has been taking Exenatide e.g. 0.5% reduction in HbA1c at 3 months and 0.25% reduction in HbA1c at 6 weeks (target 75%).’ </li></ul><ul><li>N = 13/27 48% </li></ul><ul><li>4 patients had no HbA1c recorded from most recent clinic visit (mx decisions made on recorded BMs/other info) </li></ul><ul><li>1 patient only on Exenatide for 1 month (awaiting f/u) </li></ul><ul><li>1 patient hereditary haemochromatosis therefore HbA1c n/a </li></ul>
  21. 22. Results (4) cont.... <ul><li>Of these 7 patients were on insulin + Exenatide; therefore </li></ul><ul><ul><li>Insulin + Exenatide </li></ul></ul><ul><ul><ul><li>7/13 met target HbA1c reduction = 54% </li></ul></ul></ul><ul><ul><li>Oral hypoglycaemic + Exenatide </li></ul></ul><ul><ul><ul><li>6/13 met target HbA1c reduction = 46% </li></ul></ul></ul>
  22. 23. Changes in weight & HbA1c
  23. 24. Results (3&4) <ul><li>Number of patients meeting both criteria for continuation of Exenatide = 7 </li></ul><ul><li>Number of patients in whom Exenatide was continued = 25 </li></ul><ul><li>Therefore of the patients in whom the drug was continued, 72% did not meet the criteria for continuation of Exenatide (NICE) </li></ul><ul><li>This may be explained by the fact that the majority of patients have been on the drug for less than one year (32/33 = 97%) </li></ul>
  24. 25. Changes in weight (kg) over time
  25. 26. Changes in HbA1c over time
  26. 27. Results (5) <ul><li>‘ Patients prescribed Exenatide will receive education about the need for self blood glucose monitoring, potential for hypoglycaemia and issues related to driving and this will be documented in the clinical notes (80%).’ </li></ul><ul><li>Number educated /documented re: blood glucose monitoring and potential for hypoglycaemia = 16/33 = 48% </li></ul><ul><li>Number educated / documented re: issues related to driving = 2/33 = 6% </li></ul><ul><li>Number educated re: all of the above = 1/33 = 3% </li></ul>
  27. 28. Results (6) <ul><li>‘ Patients on Exenatide will be followed up in the outpatient department at 3 months, 6 months and 1 year and follow up arrangements will be clearly documented in the patients' notes (90%).’ </li></ul><ul><li>Number of patients with follow-up documented appropriate to length of time on Exenatide; </li></ul><ul><li>N = 32 / 33 97% </li></ul><ul><li>Variable as to whether all f/u with doctor or some nurse led intermediate appointments with doctor involvement if deemed necessary. </li></ul>
  28. 29. <ul><li>Characteristics of specific patient groups </li></ul>
  29. 30. Exenatide stopped <ul><li>Number of patients = 8/33 = 24% </li></ul><ul><li>Of these, 4/8 were on OHA and 4/8 were on insulin when Exenatide was started </li></ul><ul><li>25% had BMI < 35 and 25% had BMI just >35 (35.3 and 35.6) when started on Exenatide </li></ul><ul><li>Start HbA1c values ranged from 7.6-11.8 (mean 9.9) </li></ul><ul><li>50% of patients have been back to clinic since stopping Exenatide and all have had an improvement in HbA1c and/or weight on alternative therapies (mostly insulin) </li></ul>
  30. 31. Duration of treatment
  31. 32. Reasons for stopping Exenatide
  32. 33. Doing particularly well on Exenatide <ul><li>Number of patients = 8 / 33 = 24% </li></ul><ul><li>Of these, 3/8 were on OHA and 5/8 were on insulin when Exenatide was started </li></ul><ul><li>25% had BMI < 35 and 50% had BMI >45 </li></ul><ul><li>Start HbA1c values ranged from 7.2%–11.4% (mean 10.2) </li></ul>
  33. 34. Conclusions (1) <ul><li>Most criteria (A-C) for starting patients on Exenatide are being met in line with NICE guidance </li></ul><ul><ul><li>A large proportion of patients are being started on the drug outwith NICE guidance (i.e. already on insulin when Exenatide is introduced – criteria D) </li></ul></ul><ul><li>Outcomes in patients started on Exenatide are variable and difficult to predict </li></ul><ul><ul><li>Better results with weight loss (2/3 of patients meeting target, more likely to meet target if on insulin already) </li></ul></ul><ul><ul><li>HbA1c more variable (around half meeting target, no difference relating to initial therapy) </li></ul></ul><ul><ul><li>There does not appear to be a significant difference in outcomes between those patients prescribed Exenatide in line with NICE guidance vs. those prescribed it outwith NICE guidance (i.e. already on insulin) </li></ul></ul><ul><li>There does not appear to be significant correlations between initial weight / HbA1c/ treatment regime and whether patients will do particularly well or badly on Exenatide </li></ul>
  34. 35. Conclusions (2) <ul><li>There is inconsistent use of the diabetes Diamond database between prescribing clinicians </li></ul><ul><ul><li>Information recorded was variable and nearly one third had no record of being started on Exenatide </li></ul></ul><ul><li>Patient education is not consistently documented in the notes </li></ul><ul><ul><li>in particular regarding issues related to driving </li></ul></ul><ul><ul><li>potential for hypoglycaemia / need for self blood glucose monitoring discussed & documented more often </li></ul></ul><ul><li>Follow-up (at 3,6 and 12 months or thereabouts) is being arranged and documented clearly in the notes for those patients on Exenatide. </li></ul>
  35. 36. Discussion <ul><li>Difficult to set standards against NICE guidance as most patients on drug for less than 1 year. </li></ul><ul><ul><li>However if positive response, usually seen at first f/u appointment </li></ul></ul><ul><li>Documentation may not be representative of everything discussed during consultation e.g. relating to patient education. </li></ul><ul><ul><li>Figures obtained for patient education unlikely to be truly representative of what is happening in reality </li></ul></ul><ul><li>Patients on Insulin and Exenatide (not currently licensed) </li></ul><ul><ul><li>Seem to have the potential to do just as well / better than those patients on OHA and Exenatide </li></ul></ul><ul><ul><li>Some have stopped insulin altogether after being started on Exenatide </li></ul></ul>
  36. 37. Suggestions for change <ul><li>Improve documentation </li></ul><ul><ul><li>Very variable between clinicians </li></ul></ul><ul><ul><li>Difficult in busy OPD setting </li></ul></ul><ul><ul><li>General point across all areas of medicine </li></ul></ul><ul><li>More consistent use of electronic databases </li></ul><ul><ul><li>Most effective for purposes of audit / follow-up if everyone involved in patient care uses central database </li></ul></ul><ul><ul><li>Will not be so useful if use is inconsistent between clinicians </li></ul></ul>
  37. 38. Future considerations <ul><li>Development of generic hospital guidelines on prescribing/monitoring any new pharmacological agent. </li></ul><ul><li>C-peptide and collection of urine samples from clinic patients on Exenatide. </li></ul><ul><ul><li>Potentially important clinical application particularly in view of the fact that this audit has shown that outcomes are difficult to predict </li></ul></ul><ul><ul><li>Would be very useful to be able to identify those patients who are likely to do well on Exenatide before it is started </li></ul></ul><ul><li>Comparison of our results with other centres </li></ul><ul><ul><li>National ABCD audit </li></ul></ul><ul><li>Reaudit when more patients have been on the drug for over 1 year. </li></ul>
  38. 39. References <ul><li>NICE clinical guideline 66. The management of type 2 diabetes; www.nice.org.uk . </li></ul><ul><li>Davis SN et al. Exploring the substitution of Exenatide for Insulin in patients with Type 2 Diabetes treated with insulin in combination with oral antidiabetes agents. November 2007, Diabetes Care ; Vol 30:11 p2767-2772. </li></ul><ul><li>Ramori RE et al. Efficacy and safety of incretin therapy in Type 2 Diabetes. July 2007, JAMA ; 298:2 p194-205. </li></ul>
  39. 40. Thank-you!

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