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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

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Early phases of growth

Adulthood and healthy ageing

Disease

‘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

WHAT IS MALNUTRITION?

1.Elia M. Maidenhead, BAPEN. 2000 2. Lochs H et al. Clin Nutr 2006; 25(2):180-186.

“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.”

No universally accepted definition of malnutrition, but following definition widely acknowledged (also by ESPEN)1-2:

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

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What is

Medical

Nutrition?

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What is

Medical

Nutrition?

MEDICAL NUTRITION: TO TREAT (AND PREVENT) PATIENTS SUFFERING FROM MALNUTRITION AS PART OF INTEGRATED MEDICAL CARE

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

For patients of different ages

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

BAPEN NSW, 2011

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

PREVALENCE OF DISEASE RELATED MALNUTRITION

Stratton RJ et al. 2003

0% 10% 20% 30% 40% 50% 60%

Stroke

Renal failure

Oncology

Elderly

Lung transplantation

Dementia

% 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

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EXAMPLES OF PAEDIATRIC RANGE FOR FALTERING GROWTH

Full product range adjusted to age specific needs

0 – 1.5 years (<8 kg)

1 – 6 years (8 - 20 kg)

7 – 12 years (21 – 45 kg)

DISEASE-RELATED MALNUTRITION (DRM) HAS FAR-REACHING CONSEQUENCES

Stratton et al, 2003

Impaired ability to fight infection

Apathy, depression, reduced QOL

Impaired wound healing

Increased morbidity

and mortality

More GP visits and hospital admissions

Reduced ability to work, shop, cook, self-care

Reduced muscle strength, fatigue, mobility

MALNUTRITION IS A HUGE FINANCIAL BURDEN

Ljungqvist and de Man, 2009 Ljungqvist et al, 2010 (extrapolation from UK data)

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?

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: small quantities that are tolerated to

treat nutritional deficiencies in a convenient and safe way

Nutritional complete

Medical Nutrition

EVIDENCE BASED REDUCED MORTALITY: ONS VS STANDARD DIETARY CARE

Stratton et al Clin Nutr 2007

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ORAL NUTRITIONAL SUPPLEMENTS (ONS) REDUCE MORTALITY IN HOSPITAL PATIENTS

Hospitalised liver disease, orthopaedic, surgical patients, older people; meta-analysis of 11 trials, n = 1965; no significant heterogeneity between individual studies

24% reduction in

mortality

Stratton et al, 2003

P<0.001; Odds Ratio 0.61 (95% CI, 0.48 to 0.78),

mortality

ONS REDUCE COMPLICATIONS IN HOSPITAL PATIENTS

Surgical, orthopaedic, elderly and neurology hospital patients; meta-analysis of 7 trials, n = 384; no significant heterogeneity between studies

56% reduction in

complication rates

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

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IMPACT OF AWARENESS, SCREENING, INTERVENTION AND PERFORMANCE INDICATORS

Halfsen et al, LPZ zorgreport 2012

Prevalence of malnutrition 2004-2012 (%)

General hospital

Nursing and care homes

Screening 2009-2012 (%)

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

Pharma Parenteral clinical

nutrition

Our playing field

Food

Infant allergy

Metabolic control

Oral nutrition Frail & elderly

Tube feeds & Medical devises

Paediatric nutirion

COPD, dysphagia, diabetes, oncology, Alzheimer’s ,…

Disease Targeted Nutrition

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

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RENILON 7.5 IMPROVES ENERGY AND PROTEIN INTAKES IN PATIENTS WITH RENAL FAILURE

D. Fouque et al. Nephrol Dial Transplant (2008)

Three months supplementation with Renilon 7.5 resulted in:

• Significant increase in total energy and protein intakes

• Improvement of Quality of Life

• No increased use of phosphate binders

MULTIMORBIDITY INCREASES WITH AGE

Barnett et al. Lancet 2012

Number of chronic disorders by age group

THE FACE OF HEALTHCARE TODAY

TOWARDS AN INTEGRATED APPROACH IN HEALTHCARE INNOVATION

Opportunities for new solutions with focus on patients and

integrated approaches in prevention and care

Diagnosis

Pharma

Life style interventions

Food

Medical nutrition

Patient

Diagnosis

Pharma

Food

Life style interventions

Medical nutrition

Current focus: Patient

care and treating disease

Future focus: patient value, prevention,

participation and empowerment

OUR MISSION:

TO ESTABLISH ADVANCED NUTRITION AS AN INTEGRAL PART OF HEALTHCARE

INTEGRATED MULTIDISCIPLINARY CARE AROUND SURGERY

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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

Varadhan et al., Clin Nutr. 2010

ERAS vs traditional care reduces length of hospital stay

ERAS vs traditional care reduces complications

NUTRITIONAL CARE AS INTEGRATED PART OF PRESSURE ULCER MANAGEMENT TO IMPROVE OUTCOME

Successful wound healing requires a multi-disciplinary approach

Positioning

Wound dressings

Nutrition

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 80

15

Cubitan

Control

30

45

60

75

Tim

e/w

ou

nd

/week (

min

)

Ba

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Wk

1

Wk

2

Wk

3

Wk

4

Wk

5

Wk

6

Wk

7

Wk

8

0

Cubitan

Control

3

4

5

6

7

# d

ressin

gs p

er

week

0 7 14 21 28 35 42 49 560

2

4

6

8

10

12

14

16

Cubitan

Control

Days

Ulc

er

siz

e (

cm

2)

Cubitan

Control

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

-70

-60

-50

-40

-30

-20

-10

0

Control Disease-specific

Reduction in PU area after 8 weeks

Difference: 19.5% [9.6, 29.4] (P<0.001)

Cereda et al, Ann Int Med, accepted for publication

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AT LOWER COST

0

100

200

300

400

500

600

700

800

900

1000

Control formula Disease-specific formula

ONS costs

Ulcer care costs

Total costs

639

689

445 531

194 158

P<0.001

P=0.015

P=0.091

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

patientspatients

Exercise

Nutrition Medication

Stop smoking

P<0.001

Most pronounced effect on 6MWD in nutritionally depleted patients receiving disease targeted nutrition & counseling

COST EFFICACY IN PREDEFINED INTERCOM SUBGROUP:

Subgroup analysis of patients receiving COPD Specific Medical Nutrition: cost effective due to reduction in hospitalization costs!

0

2000

4000

6000

8000

10000

12000

14000

16000

Hospital

Dietic ian

Nutrition

INTERCOM

Medication

Other costs

Specific MN Usual Care

Co

sts

(€

) *

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

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COMPACT: COMPRESSED VOLUME TO INCREASE NUTRITIONAL INTAKE

Research suggests that often only 30-65% of the prescribed supplement volume is actually consumed

Satiety and food intake are strongly influenced by volume

Kayser-Jones et al., 1998; Joosten & Vander Elst, 2001; Stratton et al., 2003; Miller et al., 2005

Rolls et al., 1998; Rolls et al., 2000; de Castro, 2006

A single 125 ml bottle contains…

• 2.4 kCal/ml => 300 kCal per serving • 12 gr protein • Complete nutrition

….all in 40% less volume

s…

r serving

Higher product intake after 10 weeks1 Higher product intake after 1 week2

Fortimel Compact in daily practice

CLINICAL STUDIES HAVE SHOWN INCREASED INTAKE OF ENERGY-DENSE ONS VS STANDARD

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

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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.