Heartburn and GERD:Primary Care Management

Wendy L. Wright, MS, RN, ARNP, FAANPFamily Nurse Practitioner

Wright & Associates Family HealthcareAmherst, New Hampshire

Objectives

Upon completion of this lecture, the participant will be able to:1. Identify the differences between heartburn and GERD2. Discuss the nonpharmacologic treatment options for the individual with heartburn and GERD3. Discuss the pharmacologic treatment options for the individual with heartburn and GERD

EE

52 year old female presents with anterior chest pain; non-radiating and not associated with any exertion. Occurs daily unless she avoids most foods. Has tried OTC antacids without much effect.Aggravating factors:Aggravating factors:

Foods – fatty meals, spicy mealsAlleviating factors:

NoneMedications:

Lexapro 5 mg one daily

EE (Continued)

PMHAnxiety disorderPostmenopausalOverweightL5-S1 disc surgeryL5 S1 disc surgery

No previous work-up for symptomsPhysical Examination

Unremarkable except for 1+ tenderness epigastric region12-lead ECG: No abnormalitiesHemocult: negative

What Does EE Have??

Episodic heartburnFrequent heartburnGERDChest pain of cardiac originCholecystitis/CholethiasisGastric/duodenal pathologyH. pylori induced pathology

Heartburn: What is it?

Heartburn has many namesIndigestionAcid regurgitationSour stomachOfficial name: pyrosis

Characterized byBurning in the chestBurning in the upper abdomenRises into the throatMost common symptom of GERD

Seems to be ubiquitous in the United States

Heartburn Population: Prevalence

In the United States, an estimated 65% of the total adult population experiences heartburn1

Frequent heartburn occurs in up to 46% of consumers with heartburn or approximately 50 pp ymillion people 1-3

Heartburn occurs daily in 7% to 10% of the adult population

This is approximately 25 million individuals 4,5

1. National Omnibus Study 2003 #US035247, data in Sponsors file.2. P&G MRD#US972782, data in Sponsor’s file. Yankelovich3. Oliveria SA, Christos PJ, Talley NJ, Dannenberg AJ. Heartburn risk factors, knowledge, and prevention strategies: a population-based survey of individuals with heartburn.

Arch Int Med. 1999;159:1592–1598.4. P&G MRD#US983190, data in Sponsor’s file.5. Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Dig Dis. 1976; 21(11):953–956.

The Frequent Heartburn Population: Demographics

Slightly more women (58%) than men report frequent heartburn 1,2

The mean age for FHB sufferers is 45 to 50 years1,9

Geographic location, marital status, family status (children), educational level, job type and level, and socioeconomic status all play a role in the tendency to develop heartburn 10

1. Oliveria SM, Christos PJ, Talley NJ, Dannenberg AJ. Heartburn risk factors, knowledge, and prevention strategies: a population-based survey of individuals with heartburn. Arch Int Med. 1999; 159: 1592-1598

2. Yankelovich Partners n= 507 FBH. Data in sponsor’s file3. P&G MRD #US983190, data in Sponsor’s file Yankelovich4. P&G MRD #US972782, data in Sponsor’s file5. P&G MRD #US996633, data in Sponsor’s file6. P&G MRD #US004463, data in Sponsor’s file7. NHBA Mail Survey Feb-Mar 2000, data in Sponsor’s file8. P&G MRD #US011624, data in Sponsor’s file9. American Gastroenterological Association and the Gallup Organization, Inc. A Gallup survey on heartburn across America, Princeton, NJ: 1988, 200010. AC Nielson/SmithKline Beecham Survey. Prog Groc. 1995;74(9):98-99

Heartburn: Frequency

Frequency of Heartburn in the US Population (1997)1 (Days per Week)

1. P&G MRD #US972782. Data in Sponsor’s file.

What is Episodic Heartburn?

Heartburn that occurs < 2 times weekly2 times weekly

What Is Frequent Heartburn?

Frequent heartburn (FHB) is described asas

“heartburn occurring 2 or more days per week.”

What is GERD?

Heartburn is one symptom of GERDThis is characterized by:

Reflux of food and acid from stomach into esophagusesophagus

Often associated with esophageal inflammation

May be associated with mucosal injury or even cancer

• Erosive esophagitis and/or Barrett’s

Frequency of Heartburn

Frequency and severity of heartburn does not necessarily correlate with development of esophageal damage or erosionsIndividuals with severe and frequent heartburn may have no esophagealheartburn may have no esophageal damage whereas individuals with little heartburn may have significant damageTherefore…response to standard OTC medications by the patient is likely to be a predictor of more serious or less serious pathology

Symptoms of GERD

Burning, substernal painRadiates up into the throatAcid taste in mouthChest painNauseaHoarseness of voiceWheezingCoughDysphagia

EE (Continued)

Most likely diagnosis is:GERD

Consider cardiac etiology given age; Negative nuclear stress testNegative nuclear stress test

Etiology of Heartburn and GERD

Heartburn and GERD occurs when:The lower esophageal sphincter (LES) temporarily relaxes

Allows reflux of stomach acid into the esophagus

Normally, gravity and peristalsis clear material from the esophagus and the saliva that we swallow neutralizes the remaining esophageal acid

Heartburn occurs when any one of these mechanisms are impaired

Draft 17Primary Cause of Heartburn and GERD

ACID

STOMACH LINING

SIGNALS

Cause of Lower Esophageal Sphincter Relaxation

Relaxation or weakening of the LES can be caused by:• Eating certain foods

Onions, garlic, black pepper

• Pressure on the stomach because of an individual’s weight

• Frequent bending and lifting particularly after eating• Frequent bending and lifting, particularly after eating

• Vigorous exercise

Cause of Lower Esophageal Sphincter Relaxation

Relaxation or weakening of the LES can be caused by:• Pregnancy

Progesterone relaxes LES; slows peristalsis and increases retention of partially digested food and acid

• Medications also can decrease LES pressurepCCB’s, hormone replacement therapy, muscle relaxants, beta blockers

Alpha-blockers

Nitrates

• Pathophysiologic mechanismsHiatal hernia and gastric acid hypersecretion

Zenker’s diverticulum

Etiology

Several other defects thought to contribute to heartburn and GERD

Abnormal esophageal epithelial resistanceAbnormalities of gastric emptyingG t i di t tiGastric distentionAbnormal acid production

Causes of Heartburn and GERD

www.heartburnalliance.com

Aggravating Conditions/Factors

Large mealsStressLying down after eatingCaffeineAcidic foods/juicesAcidic foods/juicesAlcoholTight clothingMint/chocolateExercise after eatingObesityHelicobacter pylori (controversial)

Physical Examination Findings

NoneAsthma

Wheezing

Cough

Hoarseness of voiceEpigastric/sub-xyphoid tenderness

Diagnosis of Heartburn

Diagnosis of heartburn is usually made with history and physical examinationUsually this is all that is neededUsually, this is all that is neededMany clinicians will try routine treatments first and assess for response prior to ordering a variety of tests

Diagnosis

Multiple tests available to make this diagnosis

Often times, patient is treated with medication 1st to see how he/she respondsIf i d t t ti f d ifIf inadequate response, testing performed or…if any worrisome signs present

• UGI: easiest, least expensive testHiatal hernia: present in 40-60% of populationMild reflux seen in 30% of general populationLooking for esophageal irregularities, ulcersNormal barium swallow may be seen in 40-60% of all individuals with GERD

Endoscopy

Endoscopy (Esophagoscopy)Best study for the evaluation and treatment of GERD

Allows for direct visualization of the mucosa of the esophagus and the lining of the stomach

Essential when suspecting Barrett’s esophagitis

If abnormalities are seen, biopsy is conducted

Intraesophageal Acid Perfusion

Also called Bernstein testThis is a test where the patients symptoms are reproduced or eliminated with this procedureNG t be placed 30 35 cm from the tip of the naresNG tube placed 30-35 cm from the tip of the nares into the esophagus

Saline is infused followed by HCL

Looking for reproduction of symptoms with HCL and relief of symptoms with saline infusion

24-hour pH Monitoring

2 mm flexible probe is placed transnasally to about 5 cm above the LESProbe is connected to a box similar to a Holter monitorPatient then returns home and eats a normal dietMonitoring of pH is conducted in addition to the patients symptoms

Esophageal Motility Studies

Conducted to measure the pressure of the LESThin, pressure sensitive tube is passed through mouth or nose and into stomachOnce in place, the tube is pulled back slowly into the esophagus while the patient is asked to swallowThe pressure of the muscle contractions is then measured along several sections of the tube

H. Pylori

Role of H. pylori in heartburn is subject of frequent debateH. pylori – water suppliesFirst identified in countries where water supply is poorpTransmitted via salivaBacteria may help erode protective layer of esophagusH. pylori breath test – most accurate test to be performed in primary care

Biopsy – gold standard

H. Pylori Breath Test

Sensitivity: 96.5%Specificity: 96%

Consequences of GERD

Most cases managed in primary care setting10% - 15% of individuals with GERD will develop complications

Barrett’s esophagitisCarcinoma of the esophagusCarcinoma of the esophagusHemorrhageAchalasia: absence of esophageal peristalsis and failure of lower esophageal sphincter (dysphagia)Esophageal constrictionsAsthmaPulmonary Fibrosis

Barrett’s Esophagitis

Occurs in < 1% of heartburn sufferersOccurs when the esophageal lining is replaced by tissue normally found in the intestines (metaplasia)the intestines (metaplasia)Increased risk of adenocarcinoma of the esophagus

30 – 125 times higher in the patient with Barrett’s

The Good News IS…

53 – 71% of all heartburn sufferers have endoscopically normal esophageal mucosa

Treatments

Lifestyle ModificationElimination of medicationsAntacids

If no improvement in 2 weeks, move to next group of p , g pmedications

H2 AntagonistsIf no improvement in 4-8 weeks, move to next group of medications

PPI (Proton pump inhibitors)Surgery

Red Flags

Weight loss accompanied by heartburnFailure to respond to traditional treatment regimensBlack or bloody stoolsAnemiaDifficulty swallowing/choking after eatingHoarse voiceChest pain with radiation or accompanying sob and diaphoresis

EE

History and physical examination were consistent with GERDNo additional testing performedC di th l l d tCardiac pathology ruled-outNo additional red flagsPatient started on lifestyle modification and a proton pump inhibitor given frequency and severity of symptoms

Treatment Options

Goals for Treatment

Because stomach acid is the main cause of heartburn and GERD, the goal is to mitigate its effects by:

1. Preventing the relaxation of the LES that allows1. Preventing the relaxation of the LES that allows stomach acid to reflux and/or

2. Reducing production of stomach acid, and/or

3. Neutralizing the acid

AND…eliminating the patient’s symptoms

Nonpharmacologic Treatment Options

Dietary ModificationBland dietSmaller mealsLess acidic foodsLess acidic foodsAvoidance of chocolate/mint

Nonpharmacologic Treatment Options

Dietary ModificationAvoidance of alcoholDecrease fat in dietWeight lossWeight lossLifestyle changes

• Elevate head of bed

M di tiMedications

Medication Habits and Practices of the Frequent Heartburn Population

More than 86% of frequent heartburn sufferers report using over-the-counter (OTC) medications 1

80% use antacids

48% use OTC H2 receptor antagonists

1. P&G MRD#US972782. Data in Sponsor’s file2. P&G MRD Number US 011624. Data in Sponsor’s file.

48% use OTC H2 receptor antagonists

47% medicate > 2 days in a row

55% take medication for heartburn prevention

58% have spoken with a healthcare provider about heartburn

34% use a prescription medication to manage heartburn

Volume of OTC Heartburn Product Use by Frequency of Heartburn (All OTC Users Past 12 Months)

Consumers Consumers who experiencewho experience

Medication Habits and Practices of the Frequent Heartburn Population

who experience who experience frequent frequent

heartburn heartburn account for the account for the majority of OTC majority of OTC

heartburn heartburn product usage.product usage.

Yet…

81% of heartburn sufferers are not completely satisfied with heartburn medication and the relief it affords them6

6. P&G MRD#US004463

AntacidsAntacids

Antacids

Examples:Maalox

• Aluminum hydroxide, magnesium hydroxide

Mylanta• Same as above• Same as above

Rolaids• Calcium carbonate, magnesium hydroxide

Surpass• Calcium carbonate

Tums• Calcium carbonate

Antacids

Although antacids have long been thought to work in the gastric lumen to decrease gastric acidity, they actually work in the esophageal lumenR idl i h l HRapidly increase esophageal pHNeutralize esophageal acid for 90 minutes after dosingLittle change in gastric pHIndication: intermittent or episodic heartburn

Antacids

AdvantagesMultiple products available

Many different preparations: liquid, swallowable tablets, chewable tablets, effervescent solutions and gumand gum

Gum and chewed tablet antacids seem to be more effective (per patients) than liquid products

Fast onset of action

Ease of dosing – take when patient has symptoms

Disadvantages of Antacids

Frequent dosing requiredShort duration of action

Few studies done with antacidsNo role with prevention

H2RA’H2RA’s

H2RA’s

Axid75 mg nizatidine

Pepcid AC10 mg famotidine

Maximum Strength Pepcid ACMaximum Strength Pepcid AC20 mg famotidine

Pepcid Complete10 mg famotidine, 800 mg of CaCO3 (Tums) and 165 mg of MG (OH)2

Tagamet HB200 mg cimetidine

Zantac 75/15075 mg ranitidine

Mechanism of Action

Drugs bind to histamine-2 receptors on parietal cells to decrease gastric acid secretionBegin to work by decreasing gastric acid secretion within 1 – 2 hours of dosingsecretion within 1 2 hours of dosingSeem to work best on nocturnal acid secretion vs. daytime (i.e. after meal secretion)Antacids vs. H2RA

Antacids: Onset: 30 minutes, Last: 60 minutesH2RA: Onset: 90 minutes, Last: 9 hours

H2RA’s

Numerous studies conducted at both OTC and prescription strength dosagesClearly surpass placebo in onset ofClearly surpass placebo in onset of action and sustained efficacy

H2RA’s

Indication: episodic heartburnAll products can be taken dailyNot indicated for frequent heartburn

Combination of Antacid and H2RA

Low Dose H2RA and Antacid

H2RA and antacid combinationSpeed of an antacid + duration of H2RAI di ti i t itt t i diIndication: intermittent or episodic heartburn

Not cost effective or indicated for individuals with frequent heartburn

Proton Pump InhibitorsProton Pump Inhibitors

Mechanism of Action

PPIsSuppress gastric acid production by blocking parietal cell hydrogen/potassium ion adenosine triphosphatase

Known as the proton pumpKnown as the proton pump

This is the final pathway involved in acid secretion

Remember…PPI’s affect only those pumps which are active

• Not all pumps are active at the same time

25% of new proton pumps are synthesized daily

Draft 60Mechanism of Action: Proton Pump Inhibitor

Proton Pump Inhibitors

Omeprazole (Prilosec)Lansoprazole (Prevacid)Esomeprazole (Nexium)Rabeprazole (AcipHex)Pantoprazole (Protonix)

Indications

Prilosec OTCFrequent heartburn

Prescription PPI’sGERD

Reduce risk of NSAID induced gastric ulceration

Erosive Esophagitis

Hypersecretory conditions• Zollinger-Ellison Syndrome

Proton Pump Inhibitors

Recent studies have shown an increased risk of:

Osteoporosis• Should take calcium citrate NOT carbonateShould take calcium citrate NOT carbonate

• Carbonate – i.e. Tums needs an acidic environment

Pneumonia• Diminished acid protection

Combination Therapy

Zegerid CapsulesOmeprazole

Sodium bicarbonate

I di tiIndications• Gastric and duodenal ulcer

• Erosive esophagitis

• Symptomatic GERD

Surgical Options

Nissen fundoplicationThe upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle

This surgery strengthens the LES between the esophagus and stomach

In one study, 62% of people who had surgery were still taking medications to control GERD symptoms.

• However, they were less likely to need to take medications regularly; and, when they did not take medications, their remaining symptoms were likely to be less severe.

Additional Surgical Option

EsophyXTransoral Incisionless Fundoplication

Treatment of GERDReconstruction of the antireflux barrier• Reconstruction of the antireflux barrier

• Restores GE junction back to normal anatomy

• Same concept as the Nissen without incisions

• Now FDA approved and cleared for US market

EE

Patient returns 1 month after initiating treatment with a PPI; no improvement in symptomsReferred for endoscopy given lack of response to traditional methods

Endoscopy shows mild esophagitis; negative biopsy

PPI – increased by GI to 2 dailyNo improvement at 1 month

What Now??

24 hour pH probeEsophageal motility studiesBernstein test

EE

24 hour probe shows NO significant correlation between pH and symptomsEsophageal motility studies showed decreased motilitydecreased motility

Started on metoclopramide (reglan) 5 mg 1 po tid – 30 minutes prior to meals with significant improvement in symptoms

Web Site Resources

www.heartburnalliance.orgwww.myheartburn.org

Thank You!Thank You! I Would Be Happy to Entertain

Any Questions

Wendy L. Wright, MS, RN, ARNP, FNP2 Rolling Woods Drive

Bedford New HampshireBedford, New Hampshire

Cell: 603-490-0154email: WendyARNP@aol.com