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- 1. 01/12/2014 1 FOOD FOR HEALTH, CARE FOR COSTS: MEDICAL NUTRITION PRODUCTS INTEGRATED IN HEALTH CARE HANNN November 26th, 2014 Ardy van Helvoort Dir. Research Nutrition & Metabolism in Elderly & Disease 4 DIVISIONS WITHIN DANONE Fresh Dairy Bottled Water Medical Nutrition Baby Nutrition NUTRITION, HEALTH & DISEASE ACROSS OUR LIFESPAN Nutrition supports the body in every phase of life Development and decline Early phases of growth Adulthood and healthy ageing Disease WHAT IS MALNUTRITION? No universally accepted definition of malnutrition, but following definition widely acknowledged (also by ESPEN)1-2: “A state of nutrition in which a deficiency, excess or imbalance of energy, protein, and other nutrients causes measurable adverse effects on tissue/body form (body shape, size, and composition) and function, and clinical outcome.” ‘Malnutrition’ includes both over-nutrition (overweight and obesity) as well as under-nutrition In most cases, ‘malnutrition’ is used synonymously with under-nutrition and nutritional risk 1.Elia M. Maidenhead, BAPEN. 2000 2. Lochs H et al. Clin Nutr 2006; 25(2):180-186. OUR PURPOSE: TO PIONEER NUTRITIONAL DISCOVERIES THAT HELP PEOPLE LIVE LONGER, HEALTHIER LIVES OUR MISSION: TO ESTABLISH ADVANCED NUTRITION AS AN INTEGRAL PART OF HEALTHCARE
- 2. 01/12/2014 2 What is Medical Nutrition? What is s Medical Medica al Nutrition? Nutritio Nutrition on? MEDICAL NUTRITION: TO TREAT (AND PREVENT) PATIENTS SUFFERING FROM MALNUTRITION AS PART OF INTEGRATED MEDICAL CARE For patients of different ages Medical Nutrition Proven safety and efficacy with research Used under medical supervision Always taken via the gastrointestinal tract Composition tailored for specific needs of the patients Taken for 2 weeks or even lifelong Medical nutrition products are regulated in Europe by Commission Directive 1999/21/EC on dietary foods for special medical purposes PREVALENCE OF MALNUTRITION 1 in 3 adults on admission to hospitals were at risk of malnutrition 1 in 3 adults on admission to care homes were at risk of malnutrition Malnutrition seen at admission to institutions indicates the high prevalence in the community BAPEN NSW, 2011 PREVALENCE OF DISEASE RELATED MALNUTRITION Dementia Lung transplantation Elderly Oncology Renal failure Stratton RJ et al. 2003 0% 10% 20% 30% 40% 50% 60% Stroke % Disease Related Malnutrition 1 IN 6 CHILDREN IN HOSPITALS IN THE NETHERLANDS IS MANOURISHED Persberichten op 26 januari 2010 hebben geleid tot Kamervragen over het hoge percentage ondervoeding aan de Minister van Volksgezondheid, Welzijn en Sport A CHILD IS NOT A SMALL ADULT From Koletzko B, Kinder und Jugendmedizin Berlin Springer 13th ed 2007 Body composition Physiological immaturity Brain immaturity Immune immaturity Metabolism Nutritional requirements Food sensitivity
- 3. 01/12/2014 3 EXAMPLES OF PAEDIATRIC RANGE FOR FALTERING GROWTH 0 0 – 1.5 years (<8 kg) 1 – 6 years (8 - 20 kg) 7 – 12 years (21 – 45 kg) Full product range adjusted to age specific needs DISEASE-RELATED MALNUTRITION (DRM) HAS FAR-REACHING CONSEQUENCES Impaired wound healing Stratton et al, 2003 Impaired ability to fight infection Apathy, depression, reduced QOL Reduced muscle strength, fatigue, mobility Increased morbidity and mortality More GP visits and hospital admissions Reduced ability to work, shop, cook, self-care MALNUTRITION IS A HUGE FINANCIAL BURDEN In Europe 33 million people are estimated to be at risk of malnutrition Managing malnourished patients was twice as expensive as non-malnourished: Related costs in Europe: €170 billion per year What is the situation in Globally? Ljungqvist and de Man, 2009 Ljungqvist et al, 2010 (extrapolation from UK K data) PREFERRED ROUTE OF FEEDING Healthy meal Oral Enteral gastric Enteral duodenal/jejunal Small amount Enteral rest Parenteral Total parenteral MEDICAL NUTRITION: WHY Food: large quantities to treat nutritional deficiencies often not tolerated by patients Medical Nutrition Nutritional complete Medical Nutrition: small quantities that are tolerated to treat nutritional deficiencies in a convenient and safe way EVIDENCE BASED REDUCED MORTALITY: ONS VS STANDARD DIETARY CARE Stratton et al Clin Nutr 2007
- 4. 01/12/2014 4 ORAL NUTRITIONAL SUPPLEMENTS (ONS) REDUCE MORTALITY IN HOSPITAL PATIENTS 24% reduction in mortality Hospitalised liver disease, orthopaedic, surgical patients, older people; meta-analysis of 11 trials, n = 1965; no significant heterogeneity between individual studies Stratton et al, 2003 P<0.001; Odds Ratio 0.61 (95% CI, 0.48 to 0.78), ONS REDUCE COMPLICATIONS IN HOSPITAL PATIENTS 56% reduction in complication rates Surgical, orthopaedic, elderly and neurology hospital patients; meta-analysis of 7 trials, n = 384; no significant heterogeneity between studies Stratton et al, 2003 P<0.001; Odds Ratio 0.31 (95% CI, 0.17 to 0.56), CLINICAL OUTCOMES OF ORAL NUTRITIONAL SUPPLEMENTS (ONS) IN THE HOSPITAL Retrospective study 2000-2010 • Ca. 20% all US hospital admissions • 44 million adult in-patient episodes • 724,027 hospital episodes with ONS • ONS: Nutritional complete Oral Supplement Compared to matched controls ONS use associated with: • 21% decrease in LOS (2.3 days) • 21.6% decrease in episode cost ($4734) • 6.7% decrease in readmissions Philipson et al., AJMC, 2013 BENEFITS OF ORAL NUTRITIONAL SUPPLEMENTS (ONS) Proven nutritional benefits ONS increase total energy intake without decreasing food intake and lead to weight gain and prevention of weight loss in patients who are malnourished or ‘at-risk’ of malnutrition in hospital and in community settings1-4 Proven functional benefits ONS have proven functional benefits such as improvements in activity, quality of life and independence measures, particularly in older malnourished patients in the community5-11 1. Stratton, 2003; 2. NICE, 2006; 3. Milne, 2009; 4. Cawood, 2012; 5. McMurdo, 2009; 6. Norman, 2008; 7. Rabadi MH, 2008; 8. Gariballa, 2007; 9. Persson, 2007; 10. Parsons, 2011; 11. Stange, 2011 DO WE RECOGNIZE THE SIZE OF THE PROBLEM? Do we routinely determine the nutritional status of our patients? MEASURING MALNUTRITION MNI report, 2012 About 1 in 4 patients in hospital are at risk of malnutrition
- 5. 01/12/2014 5 IMPACT OF AWARENESS, SCREENING, INTERVENTION AND PERFORMANCE INDICATORS Prevalence of malnutrition 2004-2012 (%) Halfsen et al, LPZ zorgreport 2012 Screening 2009-2012 (%) General hospital Nursing and care homes MEDICAL NUTRITION AS INTEGRAL PART OF HEALTH CARE: THE NEED FOR DISEASE TARGETED SOLLUTIONS MEDICAL NUTRITION IS UNIQUELY POSITIONED BETWEEN FOOD AND PHARMA Consumer goods focus Pharmaceutical focus Parenteral Pharma clinical nutrition Our playing field Food Disease Targeted Nutrition Infant allergy Metabolic control Oral nutrition Frail & elderly Tube feeds & Medical devises Paediatric nutirion COPD, dysphagia, diabetes, oncology, Alzheimer’s ,… Vitamins, minerals and supplements Medical Nutrition INBORN ERRORS OF METABOLISM (IEM) Amino acid metabolism • e.g. Phenylketonuria, Tyrosinemia, Maple Syrup Urine Disease, … Carbohydrate metabolism • e.g. Galactosemia, … Fatty acid metabolism • e.g. VLCAD and many more. Untreated PKU Patients Treated PKU Patients INBORN ERRORS OF METABOLISM (IEM) Amino acid metabolism • e.g. Phenylketonuria, Tyrosinemia, Maple Syrup Urine Disease, …. Carbohydrate metabolism • e.g. Galactosemia, … Fatty acid metabolism • e.g. VLCAD and many more. Diagnosis + diet MALNOURISHED PATIENTS WITH RENAL FAILURE REQUIRE SPECIALIZED NUTRITION Up to 70% of hemodialysis patients are malnourished (Stratton et al. 2005) <20% patients meet recommended energy and protein intakes Malnourishment is a powerful predictor of mortality in these patients Nutritional status is compromised due to: •Dietary restrictions, nausea, anorexia, chronic inflammation, effect of hemodialysis Dietary recommendations for renal patients: • Increase kcal intake (35 kcal/kg BW/day) • Increase protein intake (1.2 g/kg BW/day) • Restrict fluid intake (urine volume + 1000 ml) • Restrict intakes of P, K, Na, Ca
- 6. 01/12/2014 6 RENILON 7.5 IMPROVES ENERGY AND PROTEIN INTAKES IN PATIENTS WITH RENAL FAILURE Three months supplementation with Renilon 7.5 resulted in: • Significant increase in total energy and protein intakes D. Fouque et al. Nephrol Dial Transplant (2008) • Improvement of Quality of Life • No increased use of phosphate binders MULTIMORBIDITY INCREASES WITH AGE Number of chronic disorders by age group Barnett et al. Lancet 2012 THE FACE OF HEALTHCARE TODAY TOWARDS AN INTEGRATED APPROACH IN HEALTHCARE INNOVATION Current focus: Patient care and treating disease Diagnosis Pharma Life style interventions Food Medical nutrition Future focus: patient value, prevention, participation and empowerment Diagnosis Life style interventions Patient Pharma Food Medical nutrition Opportunities for new solutions with focus on patients and integrated approaches in prevention and care OUR MISSION: TO ESTABLISH ADVANCED NUTRITION AS AN INTEGRAL PART OF HEALTHCARE INTEGRATED MULTIDISCIPLINARY CARE AROUND SURGERY
- 7. 01/12/2014 7 ENHANCED RECOVERY AFTER SURGERY (ERAS): AN EXAMPLE OF MULTIDISCIPLINARY APPROACH Fearon et al., Clin. Nutr.2005 Main elements of the ERAS protocol ERAS PROTOCOL META-ANALYSIS ERAS vs traditional care reduces length of hospital stay ERAS vs traditional care reduces complications Varadhan et al., Clin Nutr. 2010 NUTRITIONAL CARE AS INTEGRATED PART OF PRESSURE ULCER MANAGEMENT TO IMPROVE OUTCOME Successful wound healing requires a multi-disciplinary approach Positioning Nutrition Wound dressings WOUND CARE: CUBITAN FORMULATION Cubitan: high-protein, arginine-enriched nutritional supplement for patients with pressure ulcers Ready-to-use formula with per 200-ml serving: • high in protein, 20 g • high in arginine, 3 g • high in vitamin C, 250 mg • high in vitamin E, 38 mg • high in zinc, 9 mg • 250 kcal To promote wound healing and formation of new tissue WOUND CARE: CLINICAL EVIDENCE Medical Nutrition use enhances recovery by increased speed of wound healing: Specific Medical Nutrition vs. Control P≤0.016 The Medical Nutrition group required fewer dressing-changes per week: Specific Medical Nutrition vs. Control: P≤0.045 In the Medical Nutrition group significantly less time was needed to change the ulcer dressings (cumulative per week): Specific Medical Nutrition vs. Control: P≤0.022 Baseline week 4 week 8 16 14 12 10 8 6 4 2 7 6 5 4 75 60 45 15 0 Control Control Control Control Cubitan 30 Time/wound/week (min) Baseline Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 7 Wk 8 0 Cubitan 3 # dressings per week 0 7 14 21 28 35 42 49 56 0 Cubitan Days Ulcer size (cm2) Cubitan Van Anholt et al., Nutrition. 2010 OEST (OLIGO ELEMENT SORE TRIAL) STUDY. CUBITAN IMPROVES PRESSURE ULCER HEALING. Parallel RCT Malnourished PU patients (n=157) Intervenition • Cubitan vs isocaloric, isonitrogenous control 4X100ml/day for 8 weeks Reduction in PU area 0 -10 -20 -30 -40 -50 -60 -70 after 8 weeks Control Disease-specific Difference: 19.5% [9.6, 29.4] (P<0.001) Cereda et al, Ann Int Med, accepted for publication
- 8. 01/12/2014 8 AT LOWER COST 1000 900 800 700 600 500 400 300 200 100 0 P=0.091 P=0.015 P<0.001 Control formula Disease-specific formula ONS costs Ulcer care costs Total costs 639 689 445 531 158 194 NUTRITIONAL CARE AS INTERGRATED PART OF DISEASE MANAGEMENT TO IMPROVE OUTCOME Example INTERCOM study in COPD: Exercise capacity in depleted v.s. non-depleted patients Exercise Stop smoking Medication Nutrition P<0.001 Most pronounced effect on 6MWD in nutritionally depleted patients receiving disease targeted nutrition & counseling COST EFFICACY IN PREDEFINED INTERCOM SUBGROUP: 16000 14000 12000 10000 8000 6000 4000 2000 0 Hospital Dietician Nutrition INTERCOM Medication Other costs * Specific MN Usual Care Costs (€) Subgroup analysis of patients receiving COPD Specific Medical Nutrition: cost effective due to reduction in hospitalization costs! Van Wetering CR, J Am Med Dir Assoc 2010; 11: 179–187 Any food that is not consumed is never nutritious! Prof Jeya Henri ANY FOOD THAT IS NOT CONSUMED IS NEVER NUTRITIOUS Compliance is key in nutritional care • Motivational: − benefit, medical endorsement, care giver, … • Circumstantial: − cultural food habits; meal frequency and timing, product availability, age, gender, BMI, anorexia, tumor type, disease stage, treatment type, … • Convenience: − packaging and appearance, variety, texture, satiation, volume, masked off-flavors, flavors and taste preference MEDICAL NUTRITION: NUTRITION FOR PEOPLE WHO ARE SICK OR NEED SPECIAL CARE: Key innovation objective to improve patient compliance • Enhanced convenience • Improved taste • Increased variety • Compressed volume dosages
- 9. 01/12/2014 9 COMPACT: COMPRESSED VOLUME TO INCREASE NUTRITIONAL INTAKE Research suggests that often only 30-65% of the prescribed supplement volume is actually consumed Kayser-Jones et al., 1998; Joosten & Vander Elst, 2001; Stratton et al., 2003; Miller et al., 2005 Satiety and food intake are strongly influenced by volume Rolls et al., 1998; Rolls et al., 2000; de Castro, 2006 A single 125 ml bottle contains… s… • 2.4 kCal/ml => 300 kCal per r serving • 12 gr protein • Complete nutrition ….all in 40% less volume CLINICAL STUDIES HAVE SHOWN INCREASED INTAKE OF ENERGY-DENSE ONS VS STANDARD Fortimel Compact in daily practice Higher product intake Higher product intake after 1 week2 after 10 weeks1 1. Hubbard GP, et al., Proc Nutr Soc 2010;69;E164 2. Freeman R, et al, Aging Clin Exp Res 2011; Vol 23; Suppl to No1; 159 HOW TO MEASURE IN CLINICAL PRACTICE? Study setup: • Patients are not informed before intervention about study participation • Consent to permit use of the data will be obtained after observational phase • Nursing staff is not informed about exact objective of study • Study does not interfere with normal clinical practice (incl. nutritional intervention) • Hospital setting allows to measure accurately compliance without informing the patient 2 wards A SIGNIFICANT INCREASE IN COMPLIANCE WITH FORTIMEL COMPACT Lombard et al, 2014 DIFFERENCE IN INTAKE SEEMS TO BECOME MORE APPARENT IN TIME (P=0.078) Lombard et al, 2014 ANY FOOD THAT IS NOT CONSUMED IS NEVER NUTRITIOUS Compliance is key in nutritional care • Motivational: − benefit, medical endorsement, care giver, … • Circumstantial: − cultural food habits; meal frequency and timing, product availability, age, gender, BMI, anorexia, tumor type, disease stage, treatment type, … • Convenience: − packaging and appearance, variety, texture, satiation, volume, masked off-flavors, flavors and taste preference
- 10. 01/12/2014 10 NUTRITIONAL INTERVENTION HELPS TO REDUCE COMPLICATIONS AND ILLNESS Specific Nutritional Interventions ILLNESS DISEASE-RELATED UNDER-NUTRITION Decreased intake increased losses of nutrients Complications O "Let medicine be thy food, and food be thy medicine.“ Hippocrates of Cos, Greece 460-377 B.C.