Injectable GLP 1 therapy: weight loss effects seen in obesity with and without diabetes
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1 Injectable GLP 1 therapy: weight loss effects seen in obesity with and without diabetes Dr Masud Haq Consultant Lead in Diabetes & Endocrinology Maidstone & Tunbridge Wells NHS Trust & The London Preventative Medicine Center (LPMC) Sat 22 nd Sep 2012
2 Outline Burden of obesity Role of gut hormones in appetite regulation Injectable GLP 1 therapy Weight loss effects in diabetes and obesity Future & Conclusions
3 The global obesity problem Obesity has become a worldwide health issue with a rapidly increasing prevalence
4
5 Global obesity forecast The World Health Organization In billion overweight adults 400 million were obese Prediction by billion overweight adults 700 million will be obese Source: World Health Organisation 2005
6 Obesity health risks Heart disease Strokes Type 2 diabetes Hypertension Raised lipids Premature death Chronic lower back pain Osteoarthritis Cancer Obstructive sleep apnoea Worsening asthma DVTs & venous disease Gall bladder disease Fatty liver Risks to expectant mothers and baby
7 Obesity Due to a state in which energy intake exceeds energy expenditure over a prolonged period of time Current pharmacological treatments result in initial weight loss but effects are often transient In contrast, gastric bypass surgery is an established and effective treatment for obesity, leading to sustained weight loss Mechanism not yet fully understood but several gut hormones have been implicated
8 Following gastric bypass surgery Ghrelin Peptide YY (PYY) Glucagon like peptide 1 (GLP 1) Ability to mimic gut hormone changes following gastric bypass surgery using pharmacological agents offers a novel way of treating obesity
9 Appetite and energy balance regulation between central nervous system (CNS), gastrointestinal tract (GIT), pancreas and adipose tissue (AT). Large box represents hypothalamic nuclei (PVN, paraventricular nucleus; HL, lateral hypothalamus; ARC, arcuate nucleus) with orexigenic neurons (NPY/AgRP, MCH and ORX), anorexigenic neurons (POMC/CART and CRH/TRH) and their connections. Vagus nerve, VG NPY, neuropeptide Y; AgRP, agouti related peptide; POMC, proopiomelanocortin; CART, cocaine and amphetamine regulated transcript; α MSH, melanocyte stimulating hormone (melanocortin); CRH, corticotropin releasing hormone; TRH, thyrotropin releasing hormone; MCH, melanin concentrating hormone; ORX, orexins CCK, cholecystokinin; GLP 1, glucagon like peptide; OXM, oxyntomodulin; PYY, peptide YY. Open circles locations of CB1 receptors of the endocannabinoid system. Adapted from Boguszewski et al, Pol J Endocrinol Vol , 61(2), 2010
10 Gastrointestinal and pancreatic peptides involved in appetite regulation Adapted from Boguszewski et al, Pol J Endocrinol Vol , 61(2), 2010
11 Glucagon like peptide 1 Food Glucagon like peptide 1 (GLP 1) is an incretin hormone GLP 1 is released from intestinal L cells in response to eating Native GLP 1 is rapidly degraded by dipeptidyl peptidase 4 (DPP 4) GLP-1 Drucker DJ, Nauck M. Lancet 2006;368:
12 GLP 1: Multiple physiological effects Increased glucose dependent insulin secretion* Increased insulin synthesis Decreased glucagon secretion Reduced hepatic glucose output *GLP 1 only stimulates insulin secretion when glucose is raised, thereby reducing the risk of hypoglycaemia Promotes satiety and reduces appetite Decreased gastric emptying Increased beta cell proliferation Decreased beta cell apoptosis In in vitro studies Drucker DJ, Nauck M. Lancet 2006;368: Baggio LL, Drucker DJ. Gastroenterol 2007;132:
13 The Incretin Effect is Reduced in Subjects with Type 2 Diabetes The Incretin Effect accounts for ~ 60% of total Insulin release following a meal Control subjects Subjects with type 2 diabetes Insulin (mu/l) * * * * * * * Insulin (mu/l) * * * Time (min) Oral Glucose Time (min) Intravenous Glucose Nauck MA, et al. Diabetologia 1986;29: *P.05 compared with respective value after oral load.
14 Plasma GLP-1 after ingestion of glucose in overnight fasted lean (n = 12) and obese (n = 13) healthy male volunteers Carr et al, JCEM 2010;95:
15 GLP 1 therapy in Type 2 Diabetes
16 Native GLP 1 Native GLP 1 is of little clinical value in the treatment of type 2 diabetes It is rapidly degraded by the enzyme DPP 4, giving it a very short half life ( min) 1 T ½ = min! It would therefore have to be continuously infused to have any clinical effect Vilsbøll T et al. J Clin Endocrinol Metab 2003;88:220 4
17 Incretin-based therapies used in Type 2 Diabetes Oral DPP-4 inhibitors Protect native GLP-1 from inactivation by DPP-4 Injectable GLP-1 receptor agonists Mimic native GLP-1 Sitagliptin Vildagliptin Saxagliptin Linagliptin Exenatide (Exendin 4- based therapy) Exenatide LAR Liraglutide (Human GLP-1 analogue)
18 1. Vilsbøll T et al. Int Diabetes Monit 2009;21: Wajcberg E, Tavaria A. Expert Opin Pharmacother 2009;10: Drucker DJ, Nauck M. Lancet 2006;368: Structure of native GLP 1, liraglutide and exenatide 97% amino acid homology to human GLP % amino acid homology to human GLP 1 2
19 Exenatide (Byetta) R Derived from exendin 4, a peptide isolated from the saliva of the Gila monster lizard native to S. America Exenatide is a synthetic form of exendin 4, approved in the EU in 2006 for type 2 diabetes treatment
20 Exenatide reduces HbA 1c in Type 2 Diabetes Change in HbA 1c (%) With MET With SU With MET + SU With MET + TZD With MET and/or SU MET, metformin SU, sulphonylurea TZD, thiazolidinedione week studies HbA 1c reduced by % with exenatide 2.0 Exenatide (up to 10 μg twice daily) Insulin glargine Placebo Adapted from: Drucker DJ, Nauck M. Lancet 2006;368:
21 Weight loss effects seen in Type 2 Diabetes patients treated with Exenatide Change in body weight (kg) With MET With SU With MET + SU With MET + TZD With MET and/or SU Exenatide (up to 10 μg twice daily) Insulin glargine Placebo MET, metformin SU, sulphonylurea TZD, thiazolidinedione week studies Weight reduced by kg with exenatide Adapted from: Drucker DJ, Nauck M. Lancet 2006;368:
22 Liraglutide (Victoza ) First human GLP 1 analogue Was approved for use in 2009 for treatment of adults with type 2 diabetes 97% homology to human native GLP 1
23 Liraglutide reduces HbA 1c in Type 2 Diabetes Change in HbA 1c (%) With MET 1 With glim 2 With MET + rosi With MET + glim 3 Phase 3 study results from the LEAD programme involving 3978 patients with type 2 diabetes MET, metformin glim, glimepiride rosi, rosiglitazone 26 week studies HbA 1c reduced by % with liraglutide Active comparators: Glimepiride 1 Rosiglitazone 2 Insulin glargine 3
24 Liraglutide often reduces weight With MET 1 With glim 2 With MET + rosi With MET + glim 3 Weight reduction of kg when used with: Metformin Change in weight (kg) Metformin + rosiglitazone Metformin + glimepiride Active comparators: Glimepiride 1 Rosiglitazone 2 Insulin glargine 3 Phase 3 study results from the LEAD programme involving 3978 patients with type 2 diabetes
25 Exenatide and Liraglutide: side effects Very common (10% of patients or more) Nausea Vomiting Diarrhoea Hypoglycaemia (in combination with sulphonylurea) Common (1 9% of patients) Abdominal pain Gastro oesophageal reflux disease Constipation Headache Dizziness
26 GLP 1 therapy in Obesity
27 Effects of Exenatide on Weight and Glucose tolerance in Obesity Subjects with and without Pre diabetes Primary end point results N= ± 0.5 kg N= ±0.5 kg p < N=152 randomised to receive Exenatide or Placebo Baseline weight ± 23, BMI 39.6 ±7, IGT or IFG 25% Rosenstock J Diabetes Care 2010;33(6):
28 Effects of Exenatide on Weight and Glucose tolerance in Obesity Subjects with and without Pre diabetes Secondary end points: Similar changes in blood pressure and lipids in both study groups Most subjects with pre diabetes (IFG or IGT) normalised glucose tolerance at 24 weeks (77% of Exenatide, 56% Placebo) Exenatide Placebo Nausea 25% 4% Diarrhoea 14% 3% Rosenstock J Diabetes Care 2010;33(6):
29 Effects of Liraglutide in the Treatment of Obesity: a randomised, double blind, placebo controlled study Astrup et al Lancet 2009; 374:
30 Changes in mean body weight from screening over 2 years Astrup et al Lancet 2009; 374:
31 Mean changes in body weight and waist circumference Astrup et al Lancet 2009; 374:
32 Percentage of individuals who lost more than 5% and 10% of baseline weight at 2yrs Astrup et al Lancet 2009; 374:
33 Safety and tolerability Most frequent side effects nausea and occasional vomiting Typically transient and at start of treatment > 90% mild to moderate Over 2 years, withdrawal rate from adverse events was 4% in liraglutide treated individuals Astrup et al Lancet 2009; 374:
34 Prevalence of pre diabetes and metabolic syndrome Astrup et al Lancet 2009; 374:
35 Changes in lipids Astrup et al Lancet 2009; 374:
36 Blood pressure and effects on pulse rate from randomisation to 2 yrs Astrup et al Lancet 2009; 374:
37 Future developments: GLP 1 receptor agonists Name (Brand) Developer Status Albiglutide (Syncria) GSK Phase 3; once weekly Lixisenatide (Lyxumia) Sanofi Phase 3; once daily Dulaglutide Eli Lilly Phase 3; once weekly LY Eli Lilly Phase 2; once weekly ITCA 650 Eli Lilly Phase 2; once yearly Exenatide QM Amylin Phase 2; once monthly
38 Conclusions Prevalence of obesity and its associated risks is rising rapidly Convincing evidence that GLP 1 agonists are beneficial in diabetes and leads to sustained weight loss in obese individuals over 2 years Well tolerated with commonest side effects of nausea and occasional vomiting typically being transient Additional benefits on lipids and blood pressure
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40 Thank you Thank you
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42 Audit of Exenatide Therapy in Tunbridge Wells DR RAHILA BHATTI, DR CYNTHIA MOHANDAS, DR LUQMAN SARDAR, DR DENNIS BARNES, DR MASUD HAQ SOUTH EAST THAMES PHYSICIANS DIABETES MEETING 11 TH MAY 2012
43 Methods Retrospective analysis. All T2DM patients who were started on Exe from were included in the audit. Demographic data, duration of known diabetes, diabetes medication list, HbA1c and weight (t= 0, 3, 6 and 12 months), side effects of Exe and reasons for discontinuation
44 Baseline Characteristics Total number of patients 117 Male 68% Female 32% Caucasians 100% Mean age (yrs) 58 (39-86) HbA1c (mean mmol/mol) 80 (46-133) HbA1c (mean %) 9.5 ( ) Weight (mean kg) 109 (73-169) BMI (mean kg/m 2 ) 36.9 (30-62)
45 Change in mean HbA1c over one year p < 0.01
46 Change in mean weight over one year
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