What‘s the science behind Fresubin® 2 kcal/ fibre DRINK? Wendy Martin Medical Scientific Affairs KIC BU Enteral Nutrition KIC BU EN, MSA, WMa, December 2007 1

Contents Malnutrition & oral nutritional supplements (ONS) How to make patients take ONS? General indications for Fresubin® 2 kcal/ fibre DRINK Special indications for Fresubin® 2 kcal/ fibre DRINK: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 2

Consequences of malnutrition KIC BU EN, MSA, WMa, December 2007 3

Consequences of malnutrition Physical functioning ⇩ Resistance to infection ⇩, wound healing ⇩, muscle atrophy … KIC BU EN, MSA, WMa, December 2007 4

Consequences of malnutrition Physical functioning ⇩ Resistance to infection ⇩, wound healing ⇩, muscle atrophy … Risk of complications ⇧ KIC BU EN, MSA, WMa, December 2007 5

Consequences of malnutrition Physical functioning ⇩ Resistance to infection ⇩, wound healing ⇩, muscle atrophy … Risk of complications ⇧ Time to recovery and hospital stay ⇧ KIC BU EN, MSA, WMa, December 2007 6

Consequences of malnutrition Physical functioning ⇩ Resistance to infection ⇩, wound healing ⇩, muscle atrophy … Risk of complications ⇧ Time to recovery and hospital stay ⇧ Therapeutic costs ⇧ Mortality ⇧ KIC BU EN, MSA, WMa, December 2007 7

Can we do something about it? Evidence for oral nutritional supplements KIC BU EN, MSA, WMa, December 2007 8

Evidence for ONS Preservation of appetite Overall higher intake of nutrients Improved functional outcomes Reduced hospital stay → potential cost benefit Decreased complication rates Decreased mortality KIC BU EN, MSA, WMa, December 2007 9

Evidence for ONS Preservation of appetite Overall higher intake of nutrients Improved functional outcomes Reduced hospital stay → potential cost benefit Decreased complication rates Decreased mortality Evidence-based ESPEN guidelines 2006 KIC BU EN, MSA, WMa, December 2007 10

Evidence doesn‘t help when the patient just won‘t take the sip! KIC BU EN, MSA, WMa, December 2007 11

How to make patients take ONS? KIC BU EN, MSA, WMa, December 2007 12

Most important feature of a successful product: Compliance Most important feature of a successful product: KIC BU EN, MSA, WMa, December 2007 13

Most important feature of a successful product: Compliance Most important feature of a successful product: GREAT TASTE!!! KIC BU EN, MSA, WMa, December 2007 14

Most important feature of a successful product: Compliance Most important feature of a successful product: GREAT TASTE!!! and a low volume KIC BU EN, MSA, WMa, December 2007 15

Compliance GREAT TASTE!!! Most important feature of a successful product: GREAT TASTE!!! and a low volume Patients do take about 400 ml ONS a day and not much more. (e.g. Roberts M et al., British Journal of Nutrition 2003) KIC BU EN, MSA, WMa, December 2007 16

Compliance GREAT TASTE!!! Most important feature of a successful product: GREAT TASTE!!! and a low volume Patients do take about 400 ml ONS a day and not much more. (e.g. Roberts M et al., British Journal of Nutrition 2003)  So we packed these 400 ml with nutrition KIC BU EN, MSA, WMa, December 2007 17

400 ml Fresubin® 2 kcal/ fibre DRINK KIC BU EN, MSA, WMa, December 2007 18

400 ml Fresubin® 2 kcal/ fibre DRINK 40 g protein KIC BU EN, MSA, WMa, December 2007 19

400 ml Fresubin® 2 kcal/ fibre DRINK 40 g protein All vitamins All minerals and trace elements KIC BU EN, MSA, WMa, December 2007 20

400 ml Fresubin® 2 kcal/ fibre DRINK 40 g protein With or without prebiotic fibre All vitamins All minerals and trace elements KIC BU EN, MSA, WMa, December 2007 21

400 ml Fresubin® 2 kcal/ fibre DRINK 40 g protein With or without prebiotic fibre All vitamins All minerals and trace elements Energy% of protein, fat, carbs 20 : 35 : 45 KIC BU EN, MSA, WMa, December 2007 22

High nutrient density – low volume KIC BU EN, MSA, WMa, December 2007 23

High nutrient density – low volume Low volume  better compliance for prescribed supplementation in all indications for standard ONS KIC BU EN, MSA, WMa, December 2007 24

High nutrient density – low volume Low volume  better compliance for prescribed supplementation in all indications for standard ONS ? But what about tolerance of Fresubin® 2 kcal/ fibre DRINK? KIC BU EN, MSA, WMa, December 2007 25

Tolerance test with Fresubin® 2 kcal DRINK KIC BU EN, MSA, WMa, December 2007 26

Tolerance test with Fresubin® 2 kcal DRINK Randomised, controlled, double-blind, multicentre study In 84 healthy elderly 400 ml/ day or KIC BU EN, MSA, WMa, December 2007 27

Tolerance test results in healthy elderly 2 kcal/ ml vs 1.5 kcal/ ml KIC BU EN, MSA, WMa, December 2007 28

Tolerance test results in healthy elderly 2 kcal/ ml vs 1.5 kcal/ ml equally well tolerated KIC BU EN, MSA, WMa, December 2007 29

General indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK KIC BU EN, MSA, WMa, December 2007 30

Scientific view on ONS 1 kcal Geriatric patients Cancer HIV Peri-operative patients Cardiac & circulatory failure COPD Liver diseases Dialysis 1 kcal 1.5 kcal 2 kcal KIC BU EN, MSA, WMa, December 2007 31

Indications for high energy ONS All general indications which go for standard ONS go for Fresubin® 2 kcal/ fibre DRINK PLUS conditions with fluid restriction KIC BU EN, MSA, WMa, December 2007 32

Indications for high energy ONS All general indications which go for standard ONS go for Fresubin® 2 kcal/ fibre DRINK PLUS conditions with fluid restriction KIC BU EN, MSA, WMa, December 2007 33

Indications for high energy ONS All general indications which go for standard ONS go for Fresubin® 2 kcal/ fibre DRINK PLUS conditions with fluid restriction …provided there is no need for protein restriction. KIC BU EN, MSA, WMa, December 2007 34

Additionally valuable: High protein 20 energy% of protein KIC BU EN, MSA, WMa, December 2007 35

Additionally valuable: High protein Proteins are needed for e.g. cell building, enzymes, antibodies, and hormones. Protein needs are increased in conditions like: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases Pressure ulcers, stress, ageing, …. 20 energy% of protein KIC BU EN, MSA, WMa, December 2007 36

Additionally valuable: High protein Proteins are needed for e.g. cell building, enzymes, antibodies, and hormones. Protein needs are increased in conditions like: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases Pressure ulcers, stress, ageing, …. 20 energy% of protein KIC BU EN, MSA, WMa, December 2007 37

Additionally valuable: High protein Proteins are needed for e.g. cell building, enzymes, antibodies, and hormones. Protein needs are increased in conditions like: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases . 20 energy% of protein KIC BU EN, MSA, WMa, December 2007 38

Special indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK: KIC BU EN, MSA, WMa, December 2007 39

Special indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 40

Dialysis induces catabolism Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS (e.g.Cano N et al., Clin Nutr 2006) KIC BU EN, MSA, WMa, December 2007 41

Dialysis induces catabolism Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS INTAKE Anorexia Fluid restriction Gastrointestinal impairments (e.g.Cano N et al., Clin Nutr 2006) KIC BU EN, MSA, WMa, December 2007 42

Dialysis induces catabolism Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS INTAKE Anorexia Fluid restriction Gastrointestinal impairments Malnutrition in up to 70% of dialysis patients! (e.g.Cano N et al., Clin Nutr 2006) KIC BU EN, MSA, WMa, December 2007 43

Satisfying increased needs KIC BU EN, MSA, WMa, December 2007 44

Satisfying increased needs Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS KIC BU EN, MSA, WMa, December 2007 45

Satisfying increased needs Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS INTAKE High energy and high protein in a small volume KIC BU EN, MSA, WMa, December 2007 46

Satisfying increased needs Hypermetabolism Body protein breakdown Nutrient loss with dialysis NEEDS INTAKE High energy and high protein in a small volume  ESPEN KIC BU EN, MSA, WMa, December 2007 47

Fresubin® 2 kcal DRINK in dialysis patients ESPEN guidelines 2006 (expert opinion): In dialysis patients, standard ONS can be used. KIC BU EN, MSA, WMa, December 2007 48

Fresubin® 2 kcal DRINK in dialysis patients ESPEN guidelines 2006 (expert opinion): In dialysis patients, standard ONS can be used. We had a first look at Fresubin® 2 kcal DRINK in dialysis patients: KIC BU EN, MSA, WMa, December 2007 49

Fresubin® 2 kcal DRINK in dialysis patients ESPEN guidelines 2006 (expert opinion): In dialysis patients, standard ONS can be used. We had a first look at Fresubin® 2 kcal DRINK in dialysis patients: Randomised, controlled study In 20 dialysis patients or Renilon 7.5 KIC BU EN, MSA, WMa, December 2007 50

Study results indicate: Renilon 7.5 Standard versus disease specific KIC BU EN, MSA, WMa, December 2007 51

Study results indicate: Renilon 7.5 Standard versus disease specific no relevant influences on serum electrolytes KIC BU EN, MSA, WMa, December 2007 52

Study results indicate: Renilon 7.5 Standard versus disease specific no relevant influences on serum electrolytes equally well tolerated KIC BU EN, MSA, WMa, December 2007 53

Special indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 54

Liver: Control unit of metabolism KIC BU EN, MSA, WMa, December 2007 55

Liver: Control unit of metabolism Fat metabolism Protein Carbohydrate Energy KIC BU EN, MSA, WMa, December 2007 56

Liver: Control unit of metabolism Fat metabolism Protein Vitamins and trace elements Carbohydrate Energy KIC BU EN, MSA, WMa, December 2007 57

Liver: Control unit of metabolism Fat metabolism Protein Vitamins and trace elements Carbohydrate Energy Hormone balance KIC BU EN, MSA, WMa, December 2007 58

Liver: Control unit of metabolism Fat metabolism Protein Vitamins and trace elements Carbohydrate Energy Hormone balance Digestion KIC BU EN, MSA, WMa, December 2007 59

Liver: Control unit of metabolism Fat metabolism Protein Vitamins and trace elements Carbohydrate Energy Hormone balance Digestion Detoxication, acid base balance, …. KIC BU EN, MSA, WMa, December 2007 60

Liver: Control unit of metabolism The development of malnutrition in liver diseases is complex Fat metabolism Protein Vitamins and trace elements Carbohydrate Energy Hormone balance Digestion Detoxication, acid base balance, …. KIC BU EN, MSA, WMa, December 2007 61

Liver diseases and malnutrition Up to 60% of liver patients are malnourished KIC BU EN, MSA, WMa, December 2007 62

Liver diseases and malnutrition Up to 60% of liver patients are malnourished with increased risk of complications like: Ascites Hepatic encephalopathy Severe infections Mortality (e.g. Cabré E et al., Gastroenterology 1990) KIC BU EN, MSA, WMa, December 2007 63

Liver diseases and malnutrition Up to 60% of liver patients are malnourished with increased risk of complications like: Ascites Hepatic encephalopathy Severe infections Mortality Tackle malnutrition with high energy, high protein oral nutritional supplements! (e.g. Cabré E et al., Gastroenterology 1990) KIC BU EN, MSA, WMa, December 2007 64

Liver diseases and malnutrition Up to 60% of liver patients are malnourished with increased risk of complications like: Ascites Hepatic encephalopathy Severe infections Mortality Tackle malnutrition with high energy, high protein oral nutritional supplements!  ESPEN (e.g. Cabré E et al., Gastroenterology 1990) KIC BU EN, MSA, WMa, December 2007 65

Special indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 66

COPD Chronic Obstructive Pulmonary Disease KIC BU EN, MSA, WMa, December 2007 67

COPD Chronic Obstructive Pulmonary Disease Altered enzyme/ cytokine activity KIC BU EN, MSA, WMa, December 2007 68

COPD Chronic Obstructive Pulmonary Disease Altered enzyme/ cytokine activity Altered substrate metabolism KIC BU EN, MSA, WMa, December 2007 69

COPD Chronic Obstructive Pulmonary Disease Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism KIC BU EN, MSA, WMa, December 2007 70

COPD Chronic Obstructive Pulmonary Disease Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition KIC BU EN, MSA, WMa, December 2007 71

COPD Chronic Obstructive Pulmonary Disease Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition KIC BU EN, MSA, WMa, December 2007 72

COPD Chronic Obstructive Pulmonary Disease Systemic inflammation Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition KIC BU EN, MSA, WMa, December 2007 73

COPD Chronic Obstructive Pulmonary Disease Systemic inflammation Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition Anorexia KIC BU EN, MSA, WMa, December 2007 74

COPD Chronic Obstructive Pulmonary Disease Systemic inflammation Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition Anorexia Muscle waisting KIC BU EN, MSA, WMa, December 2007 75

COPD Chronic Obstructive Pulmonary Disease Systemic inflammation Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Malnutrition Anorexia Muscle waisting Skeletal muscle weakness KIC BU EN, MSA, WMa, December 2007 76

COPD Chronic Obstructive Pulmonary Disease Malnutrition Systemic inflammation Anorexia Altered enzyme/ cytokine activity Altered substrate metabolism Hyper- metabolism Muscle waisting Skeletal muscle weakness Reduced breathing capacity KIC BU EN, MSA, WMa, December 2007 77

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. KIC BU EN, MSA, WMa, December 2007 78

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. Anorexia Hyper- metabolism Muscle waisting Malnutrition KIC BU EN, MSA, WMa, December 2007 79

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. Anorexia Hyper- metabolism Muscle waisting Malnutrition KIC BU EN, MSA, WMa, December 2007 80

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. High energy, high protein ONS KIC BU EN, MSA, WMa, December 2007 81

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. High energy, high protein ONS  ESPEN KIC BU EN, MSA, WMa, December 2007 82

COPD Chronic Obstructive Pulmonary Disease Up to 40% of COPD patients are malnourished. High energy, high protein ONS have been shown to improve nutritional status, physical functioning, and survival  ESPEN (e.g. Schols AM et al., Am J Respir Crit Care Med 1998. Steiner MC et al., Thorax 2003) KIC BU EN, MSA, WMa, December 2007 83

Special indications for the high energy, high protein Fresubin® 2 kcal/ fibre DRINK: Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 84

Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 85

Cardiovascular diseases Neurohormones KIC BU EN, MSA, WMa, December 2007 86

Cardiovascular diseases Neurohormones Renin-angiotensin system KIC BU EN, MSA, WMa, December 2007 87

Cardiovascular diseases Neurohormones Renin-angiotensin system Water retention KIC BU EN, MSA, WMa, December 2007 88

Cardiovascular diseases Neurohormones Renin-angiotensin system Water retention Cytokines KIC BU EN, MSA, WMa, December 2007 89

Cardiovascular diseases Neurohormones Renin-angiotensin system Water retention Cytokines Acute phase response KIC BU EN, MSA, WMa, December 2007 90

Cardiovascular diseases Neurohormones Renin-angiotensin system Water retention Catabolism Acute phase response Cytokines KIC BU EN, MSA, WMa, December 2007 91

Cardiovascular diseases About 15% of cardiac patients are malnourished. (e.g. Anker SD et al., Clin Nutr 2006. Von Haehling S et al., Cardiovas Res 2007) KIC BU EN, MSA, WMa, December 2007 92

Cardiovascular diseases About 15% of cardiac patients are malnourished. Water retention + catabolism (e.g. Anker SD et al., Clin Nutr 2006. Von Haehling S et al., Cardiovas Res 2007) KIC BU EN, MSA, WMa, December 2007 93

Cardiovascular diseases About 15% of cardiac patients are malnourished. Water retention + catabolism = need for high energy and high protein supplementation within a low volume (e.g. Anker SD et al., Clin Nutr 2006. Von Haehling S et al., Cardiovas Res 2007) KIC BU EN, MSA, WMa, December 2007 94

Cardiovascular diseases About 15% of cardiac patients are malnourished. Water retention + catabolism = need for high energy and high protein supplementation within a low volume  ESPEN (e.g. Anker SD et al., Clin Nutr 2006. Von Haehling S et al., Cardiovas Res 2007) KIC BU EN, MSA, WMa, December 2007 95

Take home messages ….great taste and good tolerance make Fresubin® 2 kcal/ fibre DRINK indicated for most patients with or at risk of malnutrition …low fluid load and high protein supply provide the rationale for the use of Fresubin® 2 kcal/ fibre DRINK in - Renal failure with dialysis treatment Liver diseases Chronic obstructive pulmonary disease Cardiovascular diseases KIC BU EN, MSA, WMa, December 2007 96

Thanks for your attention! KIC BU EN, MSA, WMa, December 2007 97