Nexium 24HR®

Pharmacy Training

Your pharmacist's advice is required. Always read the label. Use only as directed. If symptoms persist, consult your doctor/ healthcare professional. Pfizer Consumer Healthcare 38-42 Wharf Rd West Ryde NSW 2114

Agenda

• Basics of Anatomy

– Quick Revision

• What is Heartburn?

– Causes & Symptoms

• Heartburn Sufferers

– Impact on life

• OTC Treatments Available

• Why Nexium 24HR®?

– A new solution

• Nexium 24HR®

– An appropriate first line treatment

Your pharmacist's advice is required. Always read the label. Use only as directed. If symptoms persist, consult your doctor/ healthcare professional. Pfizer Australia PTY Limited 38-42 Wharf Rd West Ryde NSW 2114 ©Pfizer 2015

Basics of Anatomy

Quick Revision

The Digestive System

• Ingestion

– Food enters the body

• Digestion

– Food is broken down into nutrients by

physical and chemical processes so it

can be used by cells of the body

• Absorption

– Nutrients pass from gastrointestinal

tract into bloodstream

• Elimination

– Excretion of indigestible parts of food

that cannot be absorbed into the

bloodstream

Large Intestine

Stomach

Lower Oesophageal

Sphincter

Small Intestine

Oesophagus

What is Heartburn

Heartburn

• Heartburn is caused by the REFLUX,

or back flow, of GASTRIC ACID into

the OESOPHAGUS

• It occurs when the lower

oesophageal sphincter (LOS) does

not close tightly, allowing acid

escape out of the stomach

http://www.gesa.org.au/files/editor_upload/file/consumer%20Brochures/2014/heartburn.pdf

Oesophagus

Gastric Acid

Stomach

Heartburn

• Typical Symptoms include;

– a painful, burning feeling behind the

breastbone

– an acidic taste in the back of the throat

(acid regurgitation)1

• Some of the Triggers are;

– spicy foods, caffeine, tobacco,

pregnancy, stress, and hiatal hernia1

1. http://www.gesa.org.au/files/editor_upload/file/consumer%20Brochures/2014/heartburn.pdf

Oesophagus

Gastric Acid

Stomach

Heartburn Sufferers

Occasional or Frequent

Occasional Heartburn

• Occurs sporadically

– the cause is usually obvious

– often overeating, spicy foods, rich desserts or

alcohol

Frequent Heartburn

• Occurs 2 or more times a week

– more common after meals and at night

– stress and foods may be triggers but not

always cause

PSA Protocol GORD. – guidance for provision of PPI’s.

Prevalence

• It is estimated that 30% of Australian adults suffer from Heartburn

That’s 4M Australian adults

• 40% of these people have frequent heartburn

Source: Forbes Consulting Group Australian U&A Study Dec 2014

Unmet Need

• Frequent heartburn has a SIGNIFICANT IMPACT on the

physical, mental and social well being of sufferers

– causes severe pain

– affects food and drink choices

– impacts sleep

Source: Forbes Consulting Group Australian U&A Study Dec 2014

Real Impact on Life

• Regardless of severity, frequent heartburn impacts

quality of life

Farup C et al. Arch Intern Med. 2001;161:45-52

What Patients Want

More effective treatment

Not have to treat through-out the day

Treat the cause rather than the symptoms

Prevent heartburn / reflux in first place

To be in control - target complete relief

To be symptom free even lying down.

Above all they want normality

Not having to watch out for triggers in diet

Not having sleep affected

Source: Forbes Consulting Group Australian U&A Study Dec 2014

OTC Treatments

OTC Treatment Options

• PPIs are an effective way of treating frequent

heartburn

– They treat the root cause rather than symptoms

Antacids

Neutralise stomach acid

Alginates

Put a barrier over stomach

contents

H2 blockers

Block 1 of the 3 signals that stimulate acid

production

PPI’s

Block all 3 signals that

stimulate acid production

Sporadic Frequent

Why Nexium 24HR®

Nexium is #1Worldwide

IMS OTC global data 2015

• The #1 selling Acid Blocker Brand Worldwide is now available without a

prescription for Heartburn and Acid Reflux

Not all PPI’s are the same

• Esomeprazole is the first PPI developed as a single optical

isomer1

• Esomeprazole and omeprazole contain the same compound

but with a different composition of isomers (geometric

configurations, called S or R)1,2

1. Tonini M et al. Dig Liver Dis. 2001;33:600-6.

2. Summary of Product Characteristics.

50%

S form

50%

R form 100%

S form

Omeprazole Esomeprazole

50-50 mixture of S and R isomers Pure S isomer

With Nexium 24HR®, 70% more active drug reaches the source of acid production1,2

• Nexium 24HR® is less extensively metabolised by the liver than

omeprazole, leaving more drug available to act on proton

pumps with longer-lasting acid-control1,2

Omeprazole Nexium 24HR®

100% 100%

S isomer

R isomer

64% 38%

Metabolism

by the liver

1.Tonini M et al. Dig Liver Dis. 2001;33:600-6; 2. Lind T et al. Aliment Pharmacol Ther. 2000;14:861-7

Nexium 24HR® Posology

• Nexium 24HR® is taken:

– Once daily until complete relief is achieved

• Complete relief is defined, in clinical trials, as zero

heartburn for seven consecutive days

– It can be taken for up to 14 consecutive days

– If symptoms persist or recur within 2 weeks of

completing of the course, customer should be

advised to consult their doctor

Refer to Product Information for full details

• Your pharmacist's advice is required. Always read the label. Use only as directed. If symptoms persist, consult your doctor/ healthcare professional. Pfizer Consumer Healthcare 38-42 Wharf Rd West Ryde NSW 2114

The Nexium 24HR® benefit

• Continuous 24-hour protection from heartburn1

• Significant resolution of night-time heartburn2

• Restores quality of life

1. Data of File | Clinical study report Next I and Next II 2. Johnson 2015 Curr Med Res Opin p243

The 24HR® benefit

• 8 out of 10 people reported first resolution of their

heartburn within the first week of treatment

• 4 out of 5 nights were heartburn free with the

median time to first night being heartburn free after

1 day

Source: Johnson 2015 Curr Med Res Opin p243

Nexium 24HR® – an appropriate first line treatment

PSA GORD protocol supports PPI’s as

first-line treatment for heartburn

• Initial treatment with a PPI is the current first line

treatment for treating frequent heartburn1

• Response to treatment with a PPI demonstrates

whether or not symptoms are acid related, and

provides an opportunity for heartburn to be ruled

out2

1. PSA Protocol GORD. – guidance for provision of PPI’s. 2. 2. Haag S et al. Digestion. 2009;80:226-34.

PPI’s are first-line treatment for frequent heartburn

• Not treating with a PPI falls short of providing the

protection frequent heartburn sufferers want

Could treatment with Nexium 24HR®

mask a serious condition?

• Heartburn symptoms may accompany more serious

problems – for example: oesophageal adenocarcinoma (cancer) or Barrett’s

oesophagus1,2

• Such conditions are very rare, particularly when

compared with the high occurrence of heartburn1,2

– of individuals with reflux symptoms referred for endoscopy

(10% of newly diagnosed patients), <1% had Barrett’s oesophagus

and <0.5% had oesophageal adenocarcinoma3

1. Haag S et al. Digestion. 2009;80:226-34.

2. Holtmann G et al. Int J Clin Pharm. 2011;33:493-500.

3. Ruigomez A et al. Dis Esophagus. 2008;21:251-6.

The likelihood of Nexium 24HR® covering up a

serious condition is extremely low, in fact, it is the

same as with antacids or alginates

Symptoms of serious conditions

• Nexium 24H® is appropriate for people whose main

symptoms are heartburn or acid reflux, at least

twice a week

The following signs may indicate a more serious problem and the customer should be advised to see their GP

Serious Symptoms • Unintentional weight loss

• Vomiting of blood

• Black faeces / blood in stool

• Difficulty swallowing

• Painful swallowing

• Severe symptoms

Atypical and/or Unspecific Symptoms

• Chest pain

• Predominant epigastric pain

• Belching

• Hoarseness

• Sore throat

• Cough

PSA Protocol GORD. – guidance for provision of PPI’s.

Summary

Summary

• Heartburn is a common condition which can have a

significant, negative impact on sufferers’ quality of life

• PPI’s are the most effective OTC solution for treating

frequent heartburn

• New Nexium 24HR® is indicated for the short-term

treatment of reflux symptoms (heartburn and acid

regurgitation) in adults

• PSA guidelines support PPI’s as a first-line treatment for

frequent heartburn

Summary

• The active in Nexium 24HR®, esomeprazole, is lessextensively metabolised by the liver than omeprazoleresulting in

– a more efficient delivery of the drug to the parietal cells

– which also gives longer-lasting acid-control

• Nexium 24HR® has a well established safety profile andis associated with mostly minor adverse reactions.

• The likelihood of Nexium 24HR® masking a seriouscondition is extremely low, and in fact, it is the same aswith antacids or alginates