Relieving Frequent Heartburn Day Through Night
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1 Page 1 Relieving Frequent Heartburn Day Through Night Relieving Frequent Heartburn Day Through Night David Metz, MD Professor of Medicine University of Pennsylvania School of Medicine Philadelphia, PA This program has been supported by an educational grant from Novartis Consumer Healthcare PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. Accreditation: Pharmacists: L01-P CE Credits: 1.0 contact hour Target Audience: Pharmacists Program Overview: 50 million Americans are estimated to have frequent heartburn, defined as symptoms occurring at least 2 days / week. Many of these sufferers experience nighttime symptoms, which are often associated with a higher rate of complications. Most episodes of nighttime reflux occur during the first few hours of sleep and lead to a broken sleep pattern. This can result in daytime fatigue, affecting quality of life and work productivity. Many heartburn sufferers seek the advice of their pharmacist on how they should best relieve their symptoms. Frequent heartburn can be treated effectively over the 24 hour dosing interval with a once daily PPI given OTC. This knowledge based webinar aims to provide pointers on who is at risk of frequent heartburn, what questions to ask to diagnose heartburn and recognize nighttime symptoms, and how to decide who is appropriate for OTC PPI treatment and who should be recommended to see their physician. The webinar includes a case scenario to provide an opportunity to discuss many of the key issues relating to the management of frequent heartburn with nighttime breakthrough. Objectives: Identify individuals with frequent heartburn and night time breakthrough Explain the impact of night time symptoms on health-related quality of life and work productivity Discuss strategies for identifying and managing those individuals who are appropriate for OTC PPI treatment within the pharmacy setting This activity is co-sponsored by Strategic Consultants International, PharmCon and Postgraduate Institute for Medicine Relieving Frequent Heartburn Day Through Night Speaker: Dr David Metz earned his MBBCh from the University of the Witwatersrand in Johannesburg, South Africa. He moved to the United States in 1986 and pursued a residency in internal medicine at Albert Einstein Medical Center in Philadelphia. He completed a fellowship in gastroenterology in Washington, DC, in the combined Georgetown/Veterans Affairs Medical Center/National Institutes of Health (NIH) program. In 1993, Dr Metz moved to Philadelphia in the role of Assistant Professor in the clinician educator track at the University of Pennsylvania. He was promoted to Associate Professor in 1998 and Full Professor in Speaker disclosure: Dr. David Metz has consulted for Novartis, Takeda and AstraZeneca; and has received grant / research support from Teraca, XenoPort and Artann. This activity is supported by an educational grant from Novartis Consumer Healthcare PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education Objectives By participating in this activity, learners will be better able to: Identify individuals with frequent heartburn and nighttime breakthrough symptoms Recognize the impact of nighttime symptoms on health-related quality-of-life and work productivity Discuss strategies for identifying and managing those individuals who are appropriate for OTC PPI treatment within the pharmacy setting Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.
2 Page 2 Summary of Webinar 1 - The role of the pharmacist as gatekeeper to the appropriate use of OTC PPI therapy in frequent heartburn OTC PPI treatment is appropriate and FDA-approved for self-management of frequent heartburn (i.e., occurring 2 days/week) Important to identify potential consumers who may not be appropriate for this and who may require medical assessment OTC PPI treatment is generally safe in appropriate users Pharmacists will be asked for advice about OTC PPIs and potential interactions with other medicines Defining the problem Definition of daytime GERD A disorder that occurs when the reflux of gastric contents into the esophagus causes troublesome symptoms and/or complications 1 Definition of nocturnal GERD Reflux that takes place during the night when the patient is recumbent 2,3 Definition of heartburn A burning retrosternal discomfort that radiates upwards toward the neck 1 Vakil et al, Am J Gastroenterol 2006; 101: Frazzun et al, Aliment Pharmacol Ther 2003; 18: Orr et al, Am J Gastroenterol 1994; 89: Factors contributing to GERD Increase in prevalence of GERD (USA) Prevalence (%) Foods Peppermint Coffee Chocolate Cola Citrus fruit juices Tomato juice Fat Drugs Anticholinergics Ca+ 2 blockers Barbiturates Benzodiazepines ß-blockers Narcotics Less secretion of salivary bicarbonate Impaired esophageal clearance Impaired mucosal resistance Hiatal hernia Disturbed LES function No association with H. pylori infection Delayed gastric emptying El-Serag, Clin Gastroenterol Hepatol 2007; 5: 17 26
3 Page 3 Economic impact of GERD is significant $9.3 billion spent annually on direct costs 1 Consultation, testing and treatment $75 billion in indirect costs estimated annually 2 Productivity losses due to GERD h/wk due to absenteeism 6 7 hr/wk due to presenteeism 15 h/wk due to presenteeism in patients with sleep disturbance from nocturnal GERD GERD symptoms Symptoms highly specific for GERD include heartburn, regurgitation, or both 1 Often occur after meals (esp. large and/or fatty meals) Often aggravated by recumbency or bending over May be relieved by antacids A Gallup survey of patients with at least weekly GERD revealed that most report both nighttime and daytime heartburn 2 Severity of heartburn may not reliably predict the severity of esophagitis in elderly patients 3 1 American Gastroenterological Association (AGA). The Burden of Gastrointestinal Diseases. Bethesda, Md: AGA Wahlqvist et al, Aliment Pharmacol Ther 2006; 24: DeVault & Castell, Am J Gastroenterol 2005; 100: Shaker et al, Am J Gastroenterol 2003; 98: Johnson & Fennerty, Gastroenterology 2004; 126: Pathophysiology of GERD: Summary Prevalence of nocturnal GERD symptoms GERD occurs when protective mechanisms are overwhelmed and / or esophageal acid exposure increases to pathologic levels 1 Symptoms highly specific for GERD include heartburn, regurgitation, or both 2 Some patients diagnosed with GERD will have erosive esophagitis; however, the majority of patients diagnosed with GERD will have a normal endoscopy (NERD) 1 n=791 Adults with weekly heartburn 1 Nocturnal heartburn only Daytime heartburn only Both Among 78% who reported nocturnal heartburn, 40% reported impact on ability to function the next day 1 Richter, Gastroesophageal reflux disease and its complications In: Feldman et al, eds. Gastrointestinal and Liver Disease. 8th ed. Philadelphia, Pa: Saunders; 2006: DeVault & Castell, Am J Gastroenterol 2005; 100: Shaker et al, Am J Gastroenterol 2003; 98:
4 Page 4 Heartburn: Underlying causes 1. Acid exposure 2. Activation of nociceptive fibres Luminal acid H + H + H + H + H + H+ H + H + Stratified squamous Brain epithelium Heartburn symptoms H+ H +H+ 4. Afferent brain signals Spinal cord To cortex Reflex arc To muscle Chemosensitive nocioceptors Nerve plexus Muscularis propria 3. Activation of muscles Overweight / obesity Eating large meals Eating late in the evening Specific dietary factors high fat foods carbonated beverages alcohol mint / citrus / tomatoes vary among patients Smoking Medicines (anticholinergics, ß-blockers, Ca +2 blockers, benzodiazepines) Stress (?) Risk factors for heartburn Hiatus hernia not a prerequisite for GERD but, when present, may worsen tendency to reflux Barlow & Orlando, Gastroenterology 2005; 128: 771 Foods that affect GERD Carminative (e.g., peppermint, spearmint) Chocolate Citrus fruit juices Coffee (caffeinated) Cola beverages Fat Onion Tomato juice Orlando et al, Textbook of Gastroenterology, JB Lippincott Co 1996: 1214 Weinberg et al, Med Clin North Am 1996; 80: 411 QoL score Vitality Impact of GERD on quality-of-life Bodily pain General health Mental health Emotional role functioning Physical role functioning Social Physical role functioning functioning Patients with GERD have similar QoL impairment to patients with heart failure and greater QoL impairment than hypertension and Type 2 diabetes Endoscopynegative reflux disease (n=256) Erosive esophagitis (n=198) Healthy population Wiklund, Am J Gastroenterol 2001; 96: S46 Glise et al, Scan J Gastroenterol 1996; 31: 14
5 Page 5 Impact of GERD on productivity Satisfaction of patients on current PPI with breakthrough heartburn Patients (%) Patients with breakthrough heartburn* (%) Absence from work due to GERD Reduced productivity while at work (%) None Mild heartburn Moderate heartburn Severe heartburn (n=136) Breakthrough heartburn No breakthrough heartburn Work productivity score (WPS) (%) n=1064 In the morning In the middle of the day At night Only 23% of patients were completely satisfied with their PPI therapy * Proportion have heartburn at multiple times points During sleep Wahlquorist et al, Am J Gastroenterol 2001; 96(Suppl.): S57 American Gastroenterological Association. GERD Patient Study Patients and Their Medications Harris Interactive Inc; 2008 Nocturnal heartburn Almost 80% of patients with frequent heartburn report nocturnal symptoms 1 71% with nighttime HB reported taking OTC medicine for the symptoms, but <1/3 rated them extremely effective Patients with nighttime heartburn indicate that this is more bothersome than daytime heartburn 1 Nocturnal GERD is potentially more damaging to the esophageal mucosa than daytime GERD Suspect nocturnal GERD in every patient who presents with GERD symptoms 2,3 Intensity rating Intensity rating (cm) * Sleep deprivation causes visceral hypersensitivity Healthy controls (n=10) GERD patients (n=10) Acid perfusion sensitivity Acid perfusion sensitivity score Subjects randomized to sleep deprivation (1 night with 3 hours of sleep) or sufficient sleep 1 (3 days with 7 hours sleep) Shaker et al, Am J Gastroenterol 2003; 98: Johnson et al, Gastroenterology 2005; 129: Fass et al, Journal of Clinical Outcomes Management 2004; 11: 791 Schey et al, Gastroenterology 2007; 133: *p=0.02 *
6 Page 6 Impact of nocturnal GERD on health-related quality-of-life (SF-36 Scale) Internet-based survey of full-time working adults in the US 1002 had symptomatic GERD SF-36 scores Work productivity loss associated with nighttime GERD Internet-based survey conducted among 65,000 full-time working adults in the US 13,231 responded, of whom 1002 were symptomatic GERD cases Worker Productivity and Activity Impairment Scale (WPAI) Nighttime GERD (n=475*) Mean % reduction Daytime GERD (n=525*) Difference P Absenteeism Presenteeism < Worker Productivity Score (WPS) < Note: Differences for each score statistically significant (p<.01) vs DG or controls. *NG = nighttime GERD; DG = daytime GERD; MCS = mental component summary; PCS = physical component summary. *2 cases with missing data excluded Dubois et al, Gastroenterology 2005; 128: A286 Dubois et al, Gastroenterology 2005; 128: A286 Dubois et al, Gastroenterology 2005; 128: 1445 Night-time reflux increases risks of GERD complications Esophageal disease progression Erosive esophagitis 1 Complicated erosive esophagitis 2 ulceration strictures Barrett s esophagus Adenocarcinoma 3 Atypical manifestations Asthma 4 Aspiration pneumonia Chronic cough Other symptoms Sleep deprivation 4 Please answer the Poll Question Frequent heartburn can be defined as: 1. Occurs on a weekly basis 2. Occurs once a month 3. Occurs on 2 or more days of the week 4. Occurs on 2 or more days of the month 1Orr et al, Am J Gastroenterol 1994; 89: Robertson et al, Gut 1987; 28: Lagergren et al, N Engl J Med 1999; 340: Gislason et al, Chest 2002; 121:
7 Page 7 Case study Today s case in point A 42-year-old male, average height and weight presented with heartburn several times a week both during the day and at night, when he also experiences episodes of regurgitation Past medical history: Mild hypertension takes Ca +2 antagonist Suffer HB for past 10 years made worse by certain foods and stress controlled with H 2 receptor antagonists then a PPI Negative endoscopy 4 years ago The nighttime GERD symptoms and regurgitation are disrupting his sleep, affecting his ability to concentrate at work He would like advice on how he should control these symptoms / improve his sleep pattern Pharmacist s role Pharmacists play an important role in ensuring best use of OTC PPIs provide most effective therapy for those with typical heartburn and nighttime symptoms identify those who are not currently receiving medical care identify subjects not suitable for OTC therapy who should be referred for medical assessment Identifying frequent heartburn: Some questions to consider How would you describe your symptom? How long have you experienced this problem? Have you consulted a doctor about this problem? How often and when does the symptom occur? Are there any trigger factors? Do antacids relieve the symptom? Have you previously taken a course of (OTC) H 2 RA / PPI? If so, when? Do you take any other medicines? Describe your typical diet
8 Page 8 How to identify nighttime acid sufferers Factors indicating referral to a doctor Coughing or choking caused by fluid / acid / bitter taste / food in the throat during the night Heartburn or reflux when lying down Alarm symptoms Weight loss, unintentional Vomiting of blood Atypical symptoms Chest pain Predominant epigastric pain Risk factors for complex disease Age 55 or above New onset of symptoms in subjects >45 years Wakening in the morning with heartburn or a sour or bitter taste in the mouth Taking additional medication during the evening or night to prevent heartburn Melena (black feces / blood in stool) Difficulty swallowing Painful swallowing Severe symptoms Hoarseness Sore throat Cough FH gastric / esophageal cancer Co-morbidities Does not respond to 2 weeks of OTC PPI therapy McColl et al, Am J Gastroenterol 2005; 100: Haag et al, Digestion 2009: 80; Please answer the Poll Question Which of the following would be an indication to refer the patient to a doctor? 1. Burning sensation in the chest, worse after a large meal 2. Mild regurgitation at night 3. Certain foods / drinks triggering an attack 4. Difficulty / painful swallowing What to recommend for heartburn Life-style Elevate the head of the bed 4 8 inches Reduce the size of meals Lose weight (if overweight) Lifestyle changes Avoid eating for a minimum of 3 hours before retiring Avoid foods / agents that decrease LES pressure Avoid smoking and alcohol ingestion Genval conference and Reference from PSAP IV
9 Page 9 What to recommend for nighttime symptoms Life-style Elevation of head elevation of the head end of bed by 11 lead to: fewer and shorter reflux episodes fewer nocturnal symptoms more rapid acid clearance 1 sleeping on a foam wedge showed decreased reflux in controlled studies 2 timing of evening meal reflux > in patients who eat 2hrs before bed compared to 6hrs before bed 3 Life-style measures adopted by patients experiencing nocturnal heartburn Patients with nocturnal heartburn (%) (n=791) consumption of carbonated drinks at bedtime may also contribute 4 1 Stanciu C et al, Digestion 1977;15: Hamilton JW et al, Dig Dis Sci 1988;33: Piesman M et al, Am J Gastroenterol 2007;102: Fass R et al, Chest 2005;127: Adapted from Shaker et al, Am J Gastroenterol 2003; 98: Goal of treatment: Achieve acid control OTC treatment choices Goals of acid suppressive therapy for GERD 1 3 eliminate symptoms of heartburn maintain gastric ph>4, day prevent mucosal injury Antacids Alginates H 2 RA Alginate Proton pump PPI promote healing of erosive esophagitis prevent complications PPI H + K + Gastrin Acetylcholine H 2 blockers Histamine 1 Modlin et al, Acid Related Diseases: Biology and Treatment. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins 2004; Hunt, Arch Intern Med 1999; 159: Castell et al, Aliment Pharmacol Ther 2005; 21:
10 Page 10 Types of Medication Indication Antacids and alginates Mild moderate heartburn Examples Alka-Seltzer Gaviscon Bromo-Seltzer Algicon Tums Milk of Magnesia Maalox How they act Formulation Duration of action Available as Side effects Antacids and alginates Antacids neutralize acid in the stomach Alginates form a foam barrier on top of the gastric acid Tablet or liquid Effect will last 2 3 hours, so more than 1 dose might be required. Always follow the instructions on the pack. Best taken with food or directly after food OTC Mild side effects include: Diarrhea Constipation Types of Medication Indication H 2 -receptor antagonists H 2 -receptor antagonists Mild moderate heartburn Examples Ranitidine (Zantac ) Cimetidine (Tagamet ) Famotidine (Pepcid ) Nizatidine (Axid ) How they act Blocks H 2 receptor on parietal cells and reduces gastric acid secretion Formulation Tablet or liquid Duration of action Available as Side effects 6 12 hours. Tachyphylexis occurs with prolonged use OTC and prescription strength Uncommon but include: Diarrhea Dizziness Headaches Skin rashes Tiredness Types of medication Indication Examples How they act Proton Pump Inhibitors (PPI) Prescription PPIs Moderate-severe heartburn that occurs on 2 or more days of the week OTC PPIs Moderate-severe heartburn that occurs on 2 or more days of the week Prevacid (lansoprazole) (15 mg and 30 mg) Prevacid 24hr (15 mg) Prilosec (omeprazole) (20 mg and 40 mg) Prilosec OTC (20 mg) Pantoprazole (Protonix) (20 mg and 40 mg) Zegerid OTC (20 mg) Rabeprazole (Aciphex) (20 mg) Esomeprazole (Nexium) (20 mg and 40 mg) Zegerid (omeprazole/sodium bicarbonate (20 mg and 40 mg) Blocks acid production in the stomach cells Formulation Tablet Tablet Duration of action Side effects 24 hour, best taken minutes before breakfast Mild side effects include: Diarrhea Headaches Constipation Skin rashes Blocks acid production in the stomach cells 24 hour, best taken minutes before breakfast Mild side effects include: Diarrhea Headaches Constipation Skin rashes n=40 Development of tolerance to H 2 RA during twice-daily dosing with DR-PPI Time intragastric ph<4 (supine) (%) OME 20 mg bid (2 weeks) *p<0.05 vs other time periods * 0.7 OME 20 mg bid + ranitidine 300 mg qhs (1 day) 29.4 OME 20 mg bid + ranitidine 300 mg qhs (4 weeks) Fackler et al, Gastroenterology 2002; 122: 625
11 Page 11 PPI treatment is the most effective therapy for esophagitis and heartburn relief Who is / is not suitable for OTC PPI treatment 134 trials; n=35,978 1 Relative risk of esophagitis (RR) Prokinetics H 2RAs Standard dose PPI All vs placebo 31 trials; n=9,457 2 Relative risk for heartburn remission (RR) Prokinetics H 2RAs Standarddose PPI All vs placebo I M P R O V E M E N T Patients appropriate for OTC PPIs Those over 18 years of age Those experiencing heartburn 2 or more days / week Those who have experienced some but incomplete relief of heartburn with antacids or H 2 -receptor antagonists Patients NOT appropriate for OTC PPIs Those under 18 years (unless advised by a physician) Those experiencing heartburn less than 2 days / week Those with predominant abdominal discomfort rather than true heartburn Those with a previous diagnosis of erosive esophagitis or GERD that has required continuous treatment with a prescription PPI Heartburn accompanied by: Dysphagia (difficulty swallowing) Vomiting Pain or discomfort when swallowing Gastrointestinal bleeding Unexplained or unintentional weight loss New symptoms in patients (>55) 1 Khan et al, Cochrane Database Syst Rev 2007; 2: CD van Pinxteren et al, Cochrane Database Syst Rev 2006; 3: CD Omeprazole 20 mg vs placebo in patients with frequent heartburn Randomized, controlled trial comparing omeprazole 20 mg and placebo once daily for 14 days in patients with frequent heartburn Patients heartburn-free for 24 hours (%) 100 Lansoprazole 15 mg vs lansoprazole 30 mg vs placebo in self-treating patients with frequent nighttime heartburn Randomized, controlled trial comparing lansoprazole 15 mg, lansoprazole 30 mg, and placebo once daily for 14 days in self-treating patients with frequent nighttime heartburn Nights with no heartburn (%) 24-hour days with no heartburn (%) ** 49.7 ** 46.8 Placebo Omeprazole 20 mg *** *** *** *** Study 1 Study 2 **p<0.001 vs placebo Allgood et al, J Clin Pharm Therap 2005; 30: n = n = Placebo Lansoprazole 15 mg Lansoprazole 30 mg ***p< vs placebo Peura et al, Aliment Pharmacol Therap 2009; 30:
12 Page 12 Lansoprazole 15 mg vs placebo in patients with frequent heartburn Two randomized, controlled trials comparing lansoprazole 15 mg, and placebo once daily for 14 days in patients with frequent heartburn 24-hour days with no heartburn (%) *** *** Nights with no heartburn (%) ** *** Number of arousals 20 ** 11.6 GERD and sleep alteration after acid suppression 16 patients; 8 with GERD, 8 controls Patients were studied before and after omeprazole treatment Number of awakenings 20 Pre-treatment Post-treatment 1.5 * n = n = **p< vs placebo Placebo Lansoprazole 15 mg ***p< vs placebo Kushner et al, Postgrad Med 2009; 121: **p<0.01 vs post-treatment *p<0.05 vs post-treatment 0 Reflux-related arousals and awakenings decreased by acid suppression Dimarino Jr et al, Aliment Pharmacol Ther 2005; 22: Algorithm for pharmacy-based management of typical reflux symptoms Atypical symptoms or alarm features Referral to PCP Heartburn / regurgitation Symptoms persist Typical reflux symptoms OTC PPI for 14 days Relapse within 4 months Complete symptom relief Stop OTC PPI Relapse in >4 months Summary and conclusions OTC PPI treatment is appropriate and FDA-approved for self-management of frequent day and nighttime heartburn (i.e., occurring 2 days/week) Important to identify potential consumers who may not be appropriate for this and who may require medical assessment OTC PPI treatment is generally safe in appropriate users Pharmacists will be asked for advice about OTC PPIs and potential interactions with other medicines Repeat 14 day OTC PPI
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