Facilitated by Partners In Healthcare Education, LLC and...

6/22/2008

Partners in Healthcare Education, LLC 1

Identification and Managementof Heartburn and GERD: 2008

Wendy L Wright MS RN ARNP FNP FAANP

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Wendy L. Wright, MS, RN, ARNP, FNP, FAANPAdult/Family Nurse Practitioner

Owner – Wright & Associates Family HealthcarePartner – Partners in Healthcare Education, LLC

Facilitated by Partners In Healthcare Education, LLC and supported by aneducational grant from the National Heartburn Alliance

Objectives• Upon completion, the participant will be

able to:1. Discuss the impact of heartburn and GERD

on individuals in the United Stateson individuals in the United States2. Outline the nonpharmacologic treatment

options for the individual with heartburn and GERD

3. Differentiate the pharmacologic treatment options (OTC and prescription) available for the individual with heartburn and GERD

Case StudyElizabeth

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Elizabeth• 52 year-old female presents with a burning in her anterior

chest; non-radiating and not associated with exertion or shortness of breath. Occurs 4 days per week unless she avoids many foods. Has tried OTC antacids without much effect.A ti f t• Aggravating factors:– Foods – fatty meals, spicy meals, spearmint, caffeine

• Alleviating factors:– None

• Medications:– Escitalopram (LexaproTM) 5 mg one po daily– Amlodipine (NorvascTM) 5 mg one po daily– Cyclobenzaprine (FlexerilTM) 5 mg one po daily at bedtime prn

Elizabeth (Continued)• PMH

– Anxiety disorder– Hypertension– Postmenopausal– Overweightg– L5-S1 disc surgery

• No previous evaluation for this complaint• Physical Examination

– Unremarkable except for 1+ tenderness epigastric region

– 12-lead ECG: No abnormalities– Stool for guaiac: negative

Differentials to Consider…

• Episodic heartburn• Frequent heartburn• GERD• Chest pain of cardiac origin• Cholecystitis / Cholelithiasis• Gastric/duodenal ulcerations• H. pylori induced pathology• Gastroparesis / Gastric dysmotility

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Heartburn: What is it?• Heartburn has many names:

– Indigestion– Acid regurgitation– Sour stomach– Official name: pyrosis py

• Characterized by– Burning in the chest– Burning in the upper abdomen– Rises into the throat– Most common symptom of GERD

• Seems to be ubiquitous in the United Stateshttp://digestive.niddk.nih.gov/ddiseases/pubs/gerd/#1 accessed 5-6-08

Prevalence: Heartburn Population

Approximately two-thirds of individuals in the United States experience heartburn1

Frequent heartburn occurs in up to 46% of consumers with heartburn or approximately 50 million people1,2,3with heartburn or approximately 50 million people , ,

Even worse, daily heartburn occurs in 7% to 10% of the adult population or approximately 25 million individuals4,5

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.

Frequency of Heartburn Prescriptions

• In 1999, 90 million prescriptions were written for antisecretive medications

• Cost of therapy - $8.5 billion annually

9

Corley DA, Katz P, Wo JM, et al. Improvement of gastroesophageal reflux symptomsAfter radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology.2003;125:668-676.

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Population Based Study:Frequency of Heartburn

• Population based study of 25 -75 year-old patients (n = 1511):– 42% experienced heartburn

45% had heartburn in last year– 45% had heartburn in last year– 18% had heartburn at least weekly– 12% of those with symptoms weekly reported it

as severe or very severe

10

Rao, Goutham. Management of GERD: Current Primary Care Approaches.The Journal of Family Practice. 2005 ( Suppl):Dec 3-8.

Heartburn Frequency

11 8%

5.9%4 – 6 per week

62.8%< 1 per week

7.9%Daily

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

11.8%1 per week

11.8%2 – 3 per week

What is Episodic Heartburn?

Heartburn that occurs 2 ti kl< 2 times weekly

http://digestive.niddk.nih.gov/ddiseases/pubs/gerd/#1 accessed 5-6-08

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What Is Frequent Heartburn?

Frequent heartburn (FHB) is described as

“heartb rn occ rring 2 or“heartburn occurring 2 or more days per week.”


Demographics: Frequent Heartburn Population

Slightly more women (58%) than men report frequent heartburn1,2

The mean age for FHB sufferers is 45 to 50 years1,3

Many factors contribute to the development of heartburn and may be influenced by geographicheartburn and may be influenced by geographic location, marital status, family status (children), educational level, job type and level, and socioeconomic status4

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: 1592-15982. Yankelovich Partners n= 507 FBH. Data in sponsor’s file3.. American Gastroenterological Association and the Gallup Organization, Inc. A Gallup survey on heartburn across America, Princeton, NJ: 1988, 20004. AC Nielson/SmithKline Beecham Survey. Prog Groc. 1995;74(9):98-99

What is GERD?

• Constellation of symptoms which affects about 5 – 7% of the population

• Most common symptom of GERD is heartburn• Frequently accompanied by

– EructationEructation– Recurrent sore throat– Dysphagia– Chest pain– Hoarseness of voice– Waterbrash (sudden production of excess saliva)– Halitosis– Erosion of tooth enamel

http://www.webmd.com/heartburn-gerd/guide/reflux-disease accessed 05-25-2008

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Etiology of Heartburn and GERD

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

relaxes– Allows reflux of stomach acid into the esophagusp g– 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


Lower Esophageal Sphincter

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www.med-ars.it/main.htm accessed 05-10-2008

Causes of Lower Esophageal Sphincter Relaxation

• Relaxation or weakening of the LES can be caused by:– Eating certain foods– Pressure on the stomach because of an

individual’s weight– Frequent bending and lifting, particularly

after eating– Vigorous exercise


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Aggravating Conditions/Factors

• Large meals• Stress• Lying down after eating• Tight clothing

– Especially a tight waistband or belt

Heartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. Accessed May 5, 2007.

Foods That Worsen Heartburn

• Acidic citrus fruits and juices• Chocolate• Drinks with caffeine, carbonation, or alcohol

F d f i d f d• Fatty and fried foods• Garlic and onions• Mint flavoring• Black pepper and vinegar• Tomato-based foods

20Heartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. Accessed May 5, 2007.

Causes of Heartburn and GERD

www.heartburnalliance.com accessed 01-25-2005

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Causes of Lower Esophageal Sphincter Relaxation

• Pregnancy– Progesterone relaxes LES; slows peristalsis and

increases retention of partially digested food and acidacid

• Medications also can decrease LES pressure– CCB’s, hormone replacement therapy, muscle

relaxants, and beta blockers– Alpha-blockers and nitrates

Rao, Goutham. Management of GERD: Current Primary Care Approaches.The Journal of Family Practice. 2005 ( Suppl):Dec . 3-8.

Causes of Heartburn / GERD

• Pathophysiologic mechanisms– Hiatal hernia– Zollinger Ellison syndromeg y– Zenker’s diverticulum

Rao, Goutham. Management of GERD: Current Primary Care Approaches.The Journal of Family Practice. 2005 ( Suppl):Dec . 3-8.

Etiology

• Several other defects thought to contribute to heartburn and GERD– Abnormal esophageal epithelial resistance– Abnormalities of gastric emptying– Gastric distention– Abnormal acid production

Scott M, Gelhot AR. Gastroesophageal Reflux Disease: Diagnosis and Management. American Family Physician. 1999; 59:87-94.

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H. Pylori and GERD

• Forty percent of patients with GERD are infected with Helicobacter Pylori

• Cause and effect have not been clearly t bli h destablished

• Much of the discomfort associated with H. pylori is related to gastritis and/or ulcerations

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O’Connor HJ. Helicobacter pylori and GERD: clinical implications and Treatment. Aliment Pharmacol Ther. 1999:Feb; 13(2):117-27.

Symptoms of Heartburn / GERD• Burning, substernal pain• Radiates up into the throat• Acid taste in mouth• Chest painp• Nausea• Hoarseness of voice• Wheezing• Cough• Dysphagia


Physical Examination Findings

• None• Asthma

– WheezingC h– Cough

• Hoarseness of voice• Epigastric/subxyphoid tenderness

Wright, WL. Strategies for GERD and Heartburn. Advance for Nurse Practitioners2007;15:(9) 49 -50.

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Diagnosis of Heartburn

• Diagnosis of heartburn is usually made with history and physical examination

• Usually, this is all that is neededM li i i ill t ti t t t• Many clinicians will try routine treatments first and assess for response prior to ordering a variety of tests

Response to PPI -Does It Help Diagnose GERD?

• Omeprazole 40 mg given daily for 14 days• Thought to be as specific and sensitive for

diagnosis of GERD as the results of 24 hour pH monitoringmonitoring

• Conclusion: Due to efficacy of omeprazole in relieving reflux symptoms, failure to respond to this intervention would warrant investigation for other causes of reflux

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Schenk BE, Kuipers EJ, et al. Omeprazole as a diagnostic tool in gastroesophagealReflux disease. Am J Gastroenterol 1997;92:1997-2000.

Elizabeth

• Most likely diagnosis is:–Frequent heartburn / GERD–Consider cardiac etiology given ageConsider cardiac etiology given age

• Negative nuclear stress test

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What Might Be Contributing To Heartburn in Elizabeth?

• Calcium channel blocker (amlodipine)• Muscle relaxant (cyclobenzaprine)• Weight• Fatty foods• Caffeine• Spearmint

31http://digestive.niddk.nih.gov/ddiseases/pubs/gerd/#1 accessed 5-6-08

Diagnostic Testing

Upper GI

• UGI: easiest, least expensive test– Hiatal hernia: present in 40-60% of

populationMild reflux seen in 30% of general population– Mild reflux seen in 30% of general population

– Looking for esophageal irregularities, ulcers– Normal barium swallow may be seen in 40-

60% of all individuals with GERD– Not sensitive nor specific

Heartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. Accessed May 5, 2008

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Esophageal Stricture

34www.cdc.gov/nchs/ppt/icd9/att3_Furuta_Sep07.ppt accessed 05-25-2008

Endoscopy

• Best study for the evaluation of recalcitrant or recurrent GERD– Allows for biopsy if abnormalities seen

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

• Essential when suspecting Barrett’s esophagitis


• Endoscopy should be considered for 2 groups for patients1 Those with alarm symptoms

ACG Guidelines - GERD

1. Those with alarm symptoms• Dysphagia, bleeding, weight loss,

anemia1

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1. Rao, Goutham. Management of GERD: Current Primary Care Approaches.The Journal of Family Practice. 2005 ( Suppl):Dec . 3-8.

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Endoscopy

2. Those at risk for Barrett’s esophagitis– 6%-12% of patients who undergo endoscopy

for GERD are found to have Barrett’s1

– Odds ratio for Barrett’s GERD 1-5 years = 3 0Odds ratio for Barrett s GERD 1-5 years = 3.0– Odds ratio for Barrett’s – GERD for 5-10 years

= 52

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1. Falk GW. Barrett’s esophagus. Gastroenterology. 2002;122:1569-1591.2. Sampliner RE, The Practice Parameters Committee of the American

College of Gastroenterology. Updated guidelines for the diagnosis surveillance, and therapy of Barrett’s esophagus. Am J Gastrol. 2002;97:1888-1895.

Intraesophageal Acid Perfusion

• Also called Bernstein test• This is a test where the patients symptoms are

reproduced or relieved temporarily with this procedure• NG tube placed 30-35 cm from the tip of the nares intoNG 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

Heartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. accessed May 5, 2008

24-hour pH Monitoring

• 2 mm flexible probe is placed transnasally to about 5 cm above the LES– Can be placed by endoscopy

• Attached to the appropriate place above LES

• Probe is connected to a box similar to a Holter monitor• Patient then returns home and eats a normal diet• Monitoring of pH is conducted in addition to

documentation of patients symptoms


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Esophageal Motility Studies

• Conducted to measure the pressure of the LES• Thin, pressure sensitive tube is passed through

mouth or nose and into stomach• Once in place, the tube is pulled back slowly intoOnce in place, the tube is pulled back slowly into

the esophagus while the patient is asked to swallow

• The pressure of the muscle contractions is then measured along several sections of the tube


H. Pylori • 2/3rds of world population is infected• In the U.S, it is more prevalent in the

following individualsOlder adults– Older adults

– African Americans– Hispanics– Lower socioeconomic groups

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Helicobacter pylori and Peptic Ulcer Disease accessed 5-30-08www.cdc.gov/ulcer/keytocure.htm

Who Should Be Tested for H. Pylori?

• Active gastric ulcers• Active duodenal ulcers• Documented history of ulcers• FYI: To date there has been no

conclusive evidence that treatment of H. pylori infections in patients with non-ulcer dyspepsia is warranted

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Helicobacter pylori and Peptic Ulcer Disease accessed 5-30-08www.cdc.gov/ulcer/keytocure.htm

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H. Pylori Breath Test

• Gold standard: – Stomach Biopsy (Steiner’s Stain)– Sensitivity 95%; Specificity 99-100%1

H l i b th t t t t t t• H. pylori breath test – most accurate test to be performed in primary care– Sensitivity: 96.5%– Specificity: 96%

Seth AK, Kakkar S, Manchanda GS. Role of Biopsy from Gastric Corpus in diagnosis of Helicobacter Pylori infection in patients on acid suppression

therapy. MJAFI 2003;59:216-217 .

H Pylori Testing

• Stool antigen Test (HpSA test)–Sensitivity >97.8%–Specificity >94.9%Specificity 94.9%

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Altindis M, Delik ON, Usefulness of the Helicobacter pylori stool antigenTest for detection of Helicobacter pylori . Acta Gastroenterol Belg. 2002;65:74-76.

H Pylori Testing

• C-Urea blood test– Sensitivity of 89%– Specificity of 96%1

• Blood Antibody Test – Sensitivity 75% – Specificity of 67%2-5

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1. Chey WE. Et al. The 13C-urea Blood test accurately detects the active HelicobacterPylori infection: a United States, multicenter trial. Am Gastroenterol June 1999;94:1522-4.2.Quartero AO, Numans ME et.al In practice evaluation of whole blood Helicobacter3.Pylori test: its usefulness in detecting peptic ulcer. British Journal of GeneralPractice, Jan 2000: 13-16.4.Mauro M, Radovic V, et.al. 13C Urea breath test for Helicobacter Pylori : evaluation of5.10 minute breath collection. Can J Gastroenterol.2006 Dec;20(12):755-8.

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Long term Impact of Heartburn/GERD

• Untreated heartburn / GERD can cause serious complications– Inflammation of the esophagus from refluxed

id d li i / bl di / iacid damage lining / cause bleeding /anemia– Scars from tissue damage lead to strictures

and narrowing of esophagus– Barrett’s esophagus, esophageal cancer

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Consequences of Heartburn / GERD

• 10% - 15% of individuals with GERD will develop complications– Barrett’s esophagitis– Carcinoma of the esophagusg– Hemorrhage– Achalasia: absence of esophageal peristalsis and

failure of lower esophageal sphincter (dysphagia)– Esophageal strictures

Heartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. Accessed May 5, 2007.

Barrett’s Esophagitis

• Occurs in < 1% of heartburn sufferers• Occurs when the esophageal lining is

replaced by tissue normally found in the intestines (metaplasia)intestines (metaplasia)

• Increased risk of adenocarcinoma of the esophagus– 30 – 125 times higher in the patient with

Barrett’sBarrett’s Esophagus. National Institute of Diabetes and Digestive and KidneyDiseases. Available at www.digestive.niddk.nih.gov/ddiseases/pubs/barrettsIndex.htm. Accessed June 21, 2007 .

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Barrett’s Esophagitis

49www.med-ars.it/main.htm accessed 05-30-2008

Complications of Heartburn / GERD

• Exacerbation of several pulmonary conditions:– Asthma

Pneumonia– Pneumonia– Chronic cough– Pulmonary fibrosis

50

Gastroesophageal reflux disease. MedlinePlus Medical Encyclopedia. Available at:www.nlm.nih.gov/medlineplus/ency/article/000265.htm accessed May 6, 2008

Risk Factors for Adenocarcinoma

• Uncontrolled GERD– Esophagitis– Esophageal bleeding and ulcers– Barrett’s Esophagus– Strictures– Increased risk of esophageal cancer

• Barrett’s Esophagus– Premalignant condition– Up to 0.5% of people with Barrett’s esophagus will

develop esophageal cancer each year

Heartburn/GERD Guide accessed 5-30-08 atwww.webmd.con/heartburn-gerd/guide/complications-untreated-gerd

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Red Flags• Weight loss accompanied by heartburn• Failure to respond to traditional treatment regimens• Black or bloody stools• Anemia• Difficulty swallowing/choking after eating• Hoarse voice• Difficulty breathing• Chest pain with radiation or accompanying

shortness of breath and diaphoresisHeartburn, hiatal hernia and gastroesophageal reflux disease (GERD)National Institute of Diabetes and Digestive and Kidney Diseases. Available At www.digestive.niddk.nih.gov/ddiseases/pubs/gerd. Accessed May 5, 2007.

What Signals Increased Risk of Complications?

• Frequency and severity of heartburn does not necessarily correlate with the development of esophageal damage or erosions

• Individuals with severe and frequent heartburn may h h l d h i di id lhave no esophageal damage whereas individuals with little heartburn may have significant damage

• Therefore…response to standard OTC medications by the patient is likely to be a predictor of more serious or less serious pathology

Heartburn’s hidden effects. National Heartburn Alliance Web site. AvailableAt: www.heartburnalliance.org/section3/consequences.jsp accessed 5-5-08.

Management Stages for GERDStage Treatment

Stage 1 : Lifestyle Changes Head of bed elevationsDecreased fat intakeSmoking cessation, weight reduction

Stage 2 : As needed pharmacologic therapy

Antacid and or antacid product OTC histamine H2 receptor blocker

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py p

Stage 3 : Scheduled Pharmacologic therapy

H2 blocker for 8-12 weeksFor persistent symptoms, high dose H2 blocker or PPI for another 8-12 weeksWith documented erosive esophagitis, may use a PPI first line


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Stages TreatmentStage 4: Maintenance Therapy Appropriate for patient with

symptomatic relapse or complicated diseaseLowest effective dosage of H2 blocker

Management Stages for GERD

Lowest effective dosage of H2 blocker or PPI

Stage 5: Surgical Intervention Severe symptoms or erosive esophagitis or disease complicationsLaparoscopic Nissen fundoplication procedure

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Elizabeth• History and physical examination were

consistent with frequent heartburn• No cardiac pathology identified• No additional red flags• No additional testing conducted• Patient started on lifestyle modification and

a proton pump inhibitor given frequency and severity of symptoms

Treatment Options

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Goals for Treatment

• Because stomach acid is the main cause of heartburn and GERD, the goal is to mitigate its effects by:1 P ti th l ti f th LES th t ll1. Preventing the relaxation of the LES that allows

stomach acid to reflux and/or 2. Reducing production of stomach acid,

and/or3. Neutralizing the acid

AND…eliminating the patient’s symptoms

Nonpharmacologic Treatment Options

• Dietary Modification– Avoidance of beverages containing

alcohol caffeine and carbonationalcohol, caffeine, and carbonation– Decrease fats, spearmint, peppermint,

tomato based products, raw onions etc– Avoid large meals

Marks, JW. Gastroesophageal Reflux Disease (GERD, Acid Reflux, Heartburn)http://www.medicinenet.com/gastroesophageal_reflux_disease_gerd/article.htmAccessed 5-12-08 .

Lifestyle Modification for Heartburn / GERD

• Smoking cessation• Weight reduction• Small frequent meals • Loose fitting clothing• Avoid lying down for 2 - 3 hours after a

meal

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• Elevate head of the bed 6 - 8 inches• Wedge pillow may be a good option

– Does not bother the sleep partnerC i ll il bl f b t $30

Lifestyle Modification for Heartburn / GERD

– Commercially available for about $30

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ACG Treatment Guidelines• Lifestyle Modification

– May benefit many patients with GERD– Lifestyle changes alone are unlikely to control

symptoms in the majority of patientssymptoms in the majority of patients• Patient Directed Therapy

– OTC acid suppressants are options for patient directed therapy

62

DeVault KR, Castell DO. Updated Guidelines for the Diagnosis and TreatmentOf Gastroesophageal Reflux Disease. Am J Gastroenterol 2005;100:190-200.

• Acid Suppression– Mainstay of therapy for GERD– PPI provide most rapid symptom relief and

healing

ACG Treatment Guidelines

healing– Although less effective – H2RA given in

divided doses may be effective in some patients

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• Maintenance Therapy– Because GERD is a chronic condition, chronic

therapy to control symptoms is appropriate


• Refractory GERD– Is rare– Diagnosis should be carefully confirmed

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• Surgery– Antireflux surgery is a maintenance option for

the patient with well documented GERD who is responsive to treatment yet not adequately


responsive to treatment yet not adequately controlled

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Medications

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Classes of Medications

• Antacids• Histamine 2 Receptor Antagonists• Proton Pump Inhibitors• Combination Therapy

ACG GuidelinesHeartburn and GERD

• Empiric therapy is appropriate for uncomplicated heartburn and GERD– If a patient has symptoms of heartburn or

GERD and responds to an initial trial of acidGERD and responds to an initial trial of acid suppressive therapy, an assumed diagnosis of GERD is reasonable

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DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatmentOf gastroesophageal reflux disease. Am J Gastroenterol. 2005; 100:190-200

Antacids

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Antacids• Maalox™

– Aluminum hydroxide, magnesium hydroxide• Mylanta™

– Aluminum hydroxide, magnesium hydroxide and simethicone

• 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 lumen

• Rapidly increase esophageal pH• Rapidly increase esophageal pH• Neutralize esophageal acid for 90 minutes after

dosing• Little change in gastric pH• Indication: intermittent or episodic heartburn


Antacids

• Advantages– Multiple products available– Many different preparations:

• Liquids, tablets, chewable tablets, effervescent solutions and gum

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

– Fast onset of action– Ease of dosing – take when patient has symptoms


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Disadvantages of Antacids

• Frequent dosing required– Short duration of action

• Few studies done with antacids• No role with prevention


H2RA’sH2RA’s

H2RA’s

• Nizatidine - Axid™– 75 mg nizatidine

• Famotidine - Pepcid AC™ – 10 mg famotidine, 40 mg

• Maximum Strength Pepcid AC™Maximum Strength Pepcid AC– 20 mg famotidine

• Cimetidine - Tagamet HB™ – 200 mg cimetidine

• Ranitidine - Zantac™75/150 – 75 mg and 150 mg ranitidine, by Rx 300 mg


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Mechanism of Action• Drugs bind to histamine-2 receptors on parietal

cells to decrease gastric acid secretion• Begin to work by decreasing gastric acid

secretion within 1 – 2 hours of dosingS t k b t t l id ti• Seem to work best on nocturnal acid secretion vs. daytime

• Antacids vs. H2RA– Antacids: Onset: 30 minutes, Last: 60 minutes– H2RA: Onset: 90 minutes, Last: 9 hours


H2RA’s

• Indication: episodic heartburn• All products can be taken daily• Not indicated for frequent heartburn


Combination of Antacid and H2RA

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Low Dose H2RA and Antacid

• Pepcid Complete™– 10 mg famotidine, 800 mg of CaCO3 (TumsTM) and

165 mg of MG (OH)2 H2RA and antacid combination

• Speed of an antacid + duration of H2RA• Indication: intermittent or episodic heartburn

– Not cost effective or indicated for individuals with frequent heartburn


Proton Pump InhibitorsProton Pump Inhibitors

Mechanism of Action• PPIs

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

– Known 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 dailyMarks, JW. Gastroesophageal Reflux Disease (GERD, Acid Reflux, Heartburn)http://www.medicinenet.com/gastroesophageal_reflux_disease_gerd/article.htmAccessed 5-12-08 .

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Draft 82

Mechanism of Action: Proton Pump Inhibitor

Proton Pump Inhibitors

• Omeprazole magnesium (Prilosec OTC™)• Omeprazole (Prilosec™)• Lansoprazole (Prevacid™)• Esomeprazole (Nexium™)• Rabeprazole (AcipHex™)• Pantoprazole (Protonix™)

Indications

• Omeprazole magnesium (Prilosec OTC™) and omeprazole (Prilosec™)– Frequent heartburn

P i ti PPI’• Prescription PPI’s– GERD– Reduce risk of NSAID induced gastric ulceration– Erosive esophagitis– Hypersecretory conditions

• Zollinger-Ellison Syndrome

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• Discontinuation of treatment with a PPI may be followed by return of symptoms

• Continuous therapy to control symptoms and prevent complications may be

ACG Guidelines - GERD

and prevent complications may be appropriate for some patients

85

DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatmentOf gastroesophageal reflux disease. Am J Gastroenterol. 2005; 100:190-200

Efficacy of PPI vs. H2RA

• 3 PPI’s (omeprazole, lansoprazole, pantoprazole) relieved heartburn and healed esophagitis at significantly faster rates than did H2RA’s (cimetidine, (nizatidine, ranitidine, famotidine)– 2 weeks of PPI treatment relieved symptoms

that took 8 weeks for H2RA’s– PPI healed esophagitis in same number of

patients as did 12 weeks of treatment with H2RA’s

Chiba N, De Gara CJ, et. al. Speed of healing and symptom relief in Grade IITo IV gastroesophageal reflux disease: a meta-analysis. Gastroenterology1997;112:1798-1810.

PPI’s vs. ranitidine

• Endoscopically confirmed GERD• Meta-analysis of 26 randomized, placebo

controlled trialsP l d d t h d• Pooled data showed:– Rate of heartburn resolution after 4 weeks of

treatment was 1.53 times higher with PPI’s– 4 week and 8 week healing rate rates for PPI’s

compared with ranitidine were also higher

87

Caro JJ, Salas M, Ward A. Healing and relapse rate in GERD treated with newerProton pump inhibitors lansoprazole, rabeprazole, pantoprazole compared withomeprazole, ranitidine, and placebo: evidence from randomized clinical trials.Clin Ther. 2001;23:998-1017.

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Proton Pump Inhibitors

• Recent studies have shown there may be an increased risk of:– Osteoporosis

• Should take calcium citrate NOT carbonate• Should take calcium citrate NOT carbonate• Carbonate – i.e. TumsTM needs an acidic

environment– Pneumonia

• Diminished acid protection


Combination Therapy

• Zegerid™ Capsules– Omeprazole– Sodium bicarbonate– Indications

• Gastric and duodenal ulcer• Erosive esophagitis• Symptomatic GERD

Source: Product Insert 2007


Surgical Options

• Nissen fundoplication– The 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

l f h ltunnel 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.Bammer T, Hinder RA, Klaus A, Klinger PJ. Five to eight year outcomeof the first laparoscopic Nissen fundoplications.. J Gastrointerst Surg.2001;5:42-48.

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Fundoplication has drawbacks

• Majority of patients continue to require PPI or other disabling symptoms– 20% abdominal bloating

6% had persistent heartburn– 6% had persistent heartburn– 7% developed dysphagia requiring esophageal

dilatation– Difficulty with burping or vomiting in some

patients (may be technique specific outcome)

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Bammer T, Hinder RA, Klaus A, Klinger PJ. Five to eight year outcomeof the first laparoscopic Nissen fundoplications. J Gastrointerst Surg.2001;5:42-48.

EsophyX

• Transoral Incisionless Fundoplication– Treatment of GERD

• Reconstruction of the antireflux barrier• Restores GE junction back to normal anatomyRestores GE junction back to normal anatomy• Same concept as the Nissen without incisions• Now FDA approved and available

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Cadiere GB, Rajan A, Rqibate M, et al. Endoluminal fundoplication ELFEvolution of EsophyX, a new surgical device for transoral surgery. Min InvasiveTher Allied Technol. 2006;15:348-355.

Elizabeth

• Patient returns 1 month later after completing a 2 week regimen with omeprazole magnesium (Prilosec OTCTM)

• Reports that all of her symptoms have• Reports that all of her symptoms have resolved

• Patient is encouraged to follow-up if symptoms return

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But…What if the Case Study WereWhat if the Case Study Were

Different?

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Thomas…

• Patient returns 1 month after initiating treatment with a prescription PPI; no improvement in symptoms

• Referred for endoscopy given lack of py gresponse to traditional methods– Endoscopy shows mild esophagitis– Negative H. pylori biopsy

• PPI – increased by GI to 2 daily– No improvement at 1 month

What Now??

• 24 hour pH probe• Esophageal motility studies• Bernstein test

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Thomas

• 24 hour probe showed NO significant correlation between pH and symptoms

• Esophageal 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

– Follow up monthly due to potential for extrapyramidal effects

Purpose of Additional Case Study

• Investigate failure to respond to traditional therapy

• Not all that sounds like heartburn or GERD is actually heartburn or GERDis actually heartburn or GERD

• Evaluate for the presence of any red flags

Web-Based Resources for Providers and Patients

• www.heartburnalliance.org• www.myheartburn.org• National Digestive Diseases Information

Cl i h (NDDIC)Clearinghouse (NDDIC)– www.digestive.niddk.nih.diseases

• Medline Plus– http://www.nlm.nih.gov/medlineplus/tutorials/g

erd/htm/index.htm

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Stop and Select Guide

www.heartburnalliance.orgg

Available in English and Spanish

www.heartburnalliance.org

Resources • American College of Gastroenterology

P.O. Box 342260Bethesda, MD 20827–2260Phone: 301–263–9000Internet: www.acg.gi.orgInternet: www.acg.gi.org

• American Gastroenterological AssociationNational Office4930 Del Ray AvenueBethesda, MD 20814Phone: 301–654–2055Fax: 301–654–5920Email: [email protected]: www.gastro.org 102

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Resources

• International Foundation for Functional Gastrointestinal DisordersP.O. Box 170864Milwaukee WI 53217–8076Milwaukee, WI 53217 8076Phone: 1–888–964–2001 or 414–964–1799Fax: 414–964–7176Email: [email protected]: www.aboutgerd.org

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Resources

• North American Society for Pediatric Gastroenterology, Hepatology, and NutritionP O Box 6P.O. Box 6Flourtown, PA 19031Phone: 215–233–0808Fax: 215–233–3918Email: [email protected]: www.naspghan.org

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Resources

• Pediatric/Adolescent Gastroesophageal Reflux Association, Inc.P.O. Box 486Buckeystown MD 21717–0486Buckeystown, MD 21717 0486Phone: 301–601–9541Email: [email protected]: www.reflux.org

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Conclusions

• Millions of individuals are affected by heartburn and GERD

• For many individuals, these symptoms significantly affect quality of lifesignificantly affect quality of life

• Nurse practitioners and physician assistants are in a perfect position to identify individuals with these symptoms and initiate treatments

• Red flags and failure to respond to traditional therapy necessitates further evaluation

Thank You for YourThank You for Your Time and Attention!!!

Please visit us at:Partners in Healthcare Education, LLC

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www.4healtheducation.com

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