management of gerd
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Management of GERD:A patient outcome/education-
driven session
Dalia A. Hamdy, BPSc, MSc, PhD, RP(ACP), MRSC
Nahla H. KandilBPSc, MSc, BCPS
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Putting issues in perspective: why are we here?
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Learning Objectives• Define GERD and recognize its triggers and
pathophysiology• Identify GERD symptoms and red flags• Describe the non pharmacological treatment options for
your patient• Choose the most appropriate therapeutic agent for your
patient• Identify the possible drug-drug interactions• Set the appropriate monitoring plan for your patient
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Session outline• GERD pathophysiology, triggers and exacerbating
factors• GERD goals of therapy• GERD symptoms and red flags• GERD non pharmacological treatment• GERD therapy algorithms and drug interactions
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References1. Thomson P., Pham Q.D. Patient Self-Care. 2nd Edition. Canadian Pharmacists
Association; 2010. Chapter
2. Shaffer E.A. Therapeutic Choices. 6th Edition. Canadian Pharmacists Association; 2011. Chapter 60
3. Kinnear M. Clinical Pharmacy and Therapeutics, 5th Edition. Elservier; 2012. Chapter 12.
4. Kaiser T.E. Gastrointestinal disorders. ACCP Updates in Therapeutics; 2014.
5. rxPassport. Antacids, H2RA or PPI? Am I Choosing the Best Option for my Patient? Heartburn series; 2015
http://www.rxbriefcase.com/passportdefault.aspx
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GERD: pathopysiology• Gastroesophageal Reflux Disease
“Refers to troublesome symptoms (heart burn & regurgitation) and/or complications that result from an excessive reflux of stomach contents into esophagus”
Therapeutic Choices 2011NERD
non erosive
reflux disease
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GERD: pathophysiology , triggers ad Exacerbating factors1.Physiologic: -Transient relaxation of the lower esophageal sphincter (LES),
-hypotensive LES -anatomic disruption of the junction; often caused by hiatal hernia
2. Drugs inducing LES relaxation : anticholinergics, aminophyllines, β-adrenergic agonists, benzodiazepines, and nitroglycerines, B-blockers, -blockers, calcium channel blockers, narcotics, nicotine, theophylline.
3. Life style: obesity, smoking, diet (fatty food, chocolate, coffee, alcohol, carbonated drinks)4. Pregnancy5. Stress and anxiety6. Age >65 years
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GERD: goals of therapy• Relief symptoms & improve quality of life
• Promote healing of esophagitis
• Prevent complications
• Prevent recurrences
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GERD: Visit your patient• Mrs Hoda, a 75-year-old woman, showed up in your pharmacy. She is
suffering from heart burn and acidic taste. Two days ago, she had a coffee ground color vomit. Her past medical history included osteoarthritis, gout, hypertension, and resting tremor secondary to anxiety. She had no known drug allergies and was taking the following prescription drugs: Propranolol 40 mg tid prn
Indometacin 25 mg tidDiclofenac 50 mg qdAllopurinol 100 mg qdRamipril 10 mg qdSimvastatin 40 mg qn
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GERD: Questions for your patient
Rxpassport, Heartburn series, 2015
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GERD: Red Flags!Alarming symptoms
Description
Chest pain Resembling cardiac pain
Chocking Sensation of acid refluxing into the windpipe causing shortness of breath, coughing or hoarsness
Dysphagia Difficulty swallowing
GIT bleeding Vomiting blood or having tarry or black bowl movement
odynophagia Pain upon swallowingUnintentional weight loss (>3kg in past 6 months)
Anemia
Persistent vomiting
Severe abdominal pain
Refer to a
Doctor!
Therapeutic Choices . 2011Patient Self-Care, 2010
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GERD: non-pharmacological treatmentLife style modification:Avoid foods that ppts eventsAvoid lying down right after mealsObtain ideal body weightReduce alcohol intake!Reduce caffeine intake (2-3 cups/day)Smaller more frequent meals
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GERD: non-pharmacological treatmentII. Patient recommendations
Reassure patient about the benign nature of diseaseStress reductionAvoid exercising or bending on full stomachAvoid exacerbating foodsAvoid lying down after mealsAvoid tight fitting cloths around the waistRaise head of bed around 10 cmLimit nicotine consumptionObtain ideal body weight
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GERD: revisit your patientPatient information:Question is:Guidelines and references states…………….Patient recommendation is………………..Monitoring plan is……………………
Assessment
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GERD: therapeutic algorithmsThe choice of agent should be based on:• Severity of GERD symptoms• Impact of symptoms on the patient’s daily life• Previous experience with GERD pharmacotherapy• Current medications, adverse effects and potential drug
interactions• Cost
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GERD: therapeutic algorithmsA 43-year-old man with type 2 diabetes mellitus and hypertension presents with a 6-week history of intermittent regurgitation occurring about every other day and an acidic taste in his mouth. He takes metoprolol 100 mg once daily and states that his diabetes is controlled by diet. He avoids chocolate and spicy foods, sleeps with his head elevated on a wedge pillow, and uses OTC famotidine 10 mg when symptoms intensify and when he remembers. He admits that he rarely takes it before eating; instead, he usually takes it only once the symptoms are present and do not dissipate. The symptoms have been so significant that he has not slept and has missed 2 days of work recently. Which is the best course of action to address his symptoms?
A. Administer metoclopramide 10 mg four times daily.B. Administer esomeprazole 20 mg/day.C. Continue famotidine 10 mg, but take on a scheduled frequency of three or four times daily.D. Continue famotidine, but increase dose to 20 mg, scheduled three or four times daily.
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GERD: therapeutic algorithms
Pharmacological Group Choice
Rxpassport, Heartburn series, 2015
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GERD: therapeutic algorithms
GERD (DH/NK-April 2015) 19
GERD: therapeutic algorithms
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GERD: therapeutic algorithmsA 43-year-old man with type 2 diabetes mellitus and hypertension presents with a 6-week history of intermittent regurgitation occurring about every other day and an acidic taste in his mouth. He takes metoprolol 100 mg once daily and states that his diabetes is controlled by diet. He avoids chocolate and spicy foods, sleeps with his head elevated on a wedge pillow, and uses OTC famotidine 10 mg when symptoms intensify and when he remembers. He admits that he rarely takes it before eating; instead, he usually takes it only once the symptoms are present and do not dissipate. The symptoms have been so significant that he has not slept and has missed 2 days of work recently. Which is the best course of action to address his symptoms?
A. Administer metoclopramide 10 mg four times daily.B. Administer esomeprazole 20 mg/day.C. Continue famotidine 10 mg, but take on a scheduled frequency of three or four times daily.D. Continue famotidine, but increase dose to 20 mg, scheduled three or four times daily.
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GERD: therapeutic algorithmsProkinetics
• Prokinetics are not widely used to treat GERD because they are not as effective as other treatments and are associated with numerous side effects (sedation, anxiety, extrapyramidal symptoms, etc.).
• Prokinetics are reserved for patients who are refractory to other available treatment options or who have delayed gastric emptying
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Which of the following is inappropriate monotherapy for mild, intermittent GERD?
1. Omeprazole2. Metoclopramide3. Famotidine4. Calcium carbonate
GERD: therapeutic algorithms
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GERD: therapeutic algorithms
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• L.F. is a 48-year-old woman who presents to her primary-care provider complaining of recurrent heartburn occurring daily for the past 6 weeks. She states that the heartburn occurs frequently after meals and often wakens her at night. Lately, she has been experiencing difficulty swallowing solid foods. L.F. currently smokes two packs of cigarettes per day and likes to have two glasses of wine each night with her dinner. She states that she occasionally uses OTC ranitidine 150 mg orally up to twice daily, which temporarily relieves her symptoms. Which medication do you suggest?
GERD: therapeutic algorithms
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GERD: therapeutic algorithms
a) It should be taken 30 minutes prior to a mealb) It takes 1-3 days for a clinical responsec) It is associated with a therapeutic effect that last for more than the 14 days of treatmentd) All of the above
Which of the following statements should be used when counselling a patient taking non-prescription PPI therapy?
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Maintenance Therapy
L.F.’s symptoms resolved in about 2 weeks after starting PPI therapy, and she remained asymptomatic after 8 weeks. She then underwent endoscopy, which revealed that the esophagus had healed completely.Her primary-care physician then stopped the PPI.• Now, 2 weeks later, she is experiencing mild heartburn. Is
L.F. a candidate for long-term maintenance therapy?
GERD: therapeutic algorithms
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Stepping down treatment if patient responds adequately
It includes:1- Discontinuing PPI Therapy 2- Switching To Symptom-driven Therapy3- Reducing dose of daily PPI
GERD: therapeutic algorithms
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GERD: therapeutic algorithms
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GERD: therapeutic algorithmsKey Points on Non-Prescription PPI
• Most patients will respond to PPI therapy within 1-3 days of treatment. Maximum acid suppression with PPIs is seen after 3-5 days of treatment.
• Patients should be instructed to take their full course of therapy and to not discontinue it when the symptoms start to improve.
• This medication is NOT recommended for PRN use like antacids or H2-receptor antagonists.
• It should not be taken more frequently than every 4 months
Bottom Line: A 14-day course of non-prescription omeprazole is the first-line treatment of choice for patients with heartburn symptoms occurring on 2 or more days per week. This course will most often resolve the condition.
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GERD: therapeutic algorithmsRebound Acid Secretion
• Antacids can be prescribed as “rescue” medication for rebound acid secretion
• Medicines that contain both an antacid and an anti-foaming agent are likely to be the most effective treatment for rebound acid secretion.
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• Rapidly neutralize esophageal acid within 15-30 minutes and will typically provide modest relief for up to 90 minutes.
• Alginic acid does not neutralize acid but acts as a physical barrier. Currently combined with an antacid, as it offers limited benefit when administered alone.
• Generally well tolerated but can lead to constipation (calcium, aluminum) or diarrhea (magnesium).
• Interact with many medications• Caution in older patients and those with renal disease • Alginic acid contains a large amount of sodium and could be an issue in
patients with congestive heart failure or renal disease
Bottom Line: Inexpensive and rapid relief. The major limitation is the short duration of action. Guidelines
recommend considering it for episodic (≤1 day/week) and/or mild symptoms.
GERD: therapeutic algorithmsKey Points on Antacids
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Which of the following disorders is an adverse event associated with aluminum hydroxide?
1.Tinnitus2.Diarrhea3.Constipation 4.Hyperkalemia
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Antacid component
Adverse effects Drug interactions
Notes
•Calcium salts•Magnesium salts•Aluminum salts•Magnesium/aluminum antacids•Alginic acid
•Aluminum: Constipation•Accumulation in patients with renal failure•Hypophosphatemia•Calcium: Constipation•Rebound hyperacidity•Magnesium: Diarrhea•Accumulation in patients with renal impairment•Magnesium/aluminum comboMinor changes in bowel habits•Alginic AcidFlatulence, belching
•Allopurinol•Bisphosphonates•Iron salts•Quinolones•Tetracyclines•Digoxin•RosuvastatinTo minimize the interaction with these products patients should separate antacid dosing by 1-2 hours
•Dosing should be taken within 20-60 minutes and/or after a meal at bedtime as needed•Relieves symptoms but unlikely to heal inflamed esophagus•Dosing for magnesium/aluminum antacids is 10-30 mL PC and HS
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W.J. is a 39-year-old, 130-kg, 170-cm-tall man who presents with complaints of indigestion. He describes a burning sensation behind his breastbone and some belching that is often associated with an acid taste in the back of his mouth. He indicates that his symptoms began a few months ago, and they only occur a few times a month, especially after eating large or spicy meals. Also, if he eats too close to his bedtime, the burning keeps him up at night. He has used liquid antacids in the past for these symptoms and states they work fairly well, but he has to take frequent doses, as the symptoms return quickly. He does not take any other medications. Which medication do you suggest?
GERD: therapeutic algorithms
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• Mild symptoms and occur infrequently, and no alarm symptoms.
• To specifically “prevent” meal-related symptoms, he should take an H2RA 30 to 60 minutes before eating or drinking.
• If symptoms remain infrequent but are unrelated to meals, the use of an OTC H2RA as needed for symptoms may be required.
GERD: therapeutic algorithms
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a) Famotidine is usually superior to ranitidine at equivalent dosesb) Tachyphylaxis commonly develops with these medicationsc) They provide symptom relief in approximately 50% of patientsd) Most drug interactions with these medications are clinically significant
You start to discuss H2-receptor antagonists with the patient. Which one of the following statements is TRUE?
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The H2RA associated with the most significant drug interactions due to inhibition of CYP450 enzymes is
a)ranitidine b) cimetidine c) Nizatidined) famotidin
GERD: therapeutic algorithms
Drug Metabolism!! Stay Tuned!
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• Bind to the H2-receptors on the gastric parietal cells to reduce gastric acid secretion.
• They start to reduce gastric acid within 1 to 2 hours of dosing and the effects last up to 9 hours.
• In equivalent doses, ranitidine and famotidine are equally effective for mild symptoms but are generally not effective for more frequent or severe symptoms.
• Provide complete symptom relief in only 15% of GERD patients. • Tachyphylaxis (decrease in acid-lowering response over time) commonly develops and has
been reported within a few doses with these medications; this can limit their use beyond the on-demand treatment of mild heartburn.
• H2RAs are generally very well tolerated and adverse effects are infrequent.
Bottom Line: Slower onset but longer duration of action compared to antacids. Guidelines recommend their use for mild
and episodic (≤1 episode per week) heartburn or occasional meal-provoked heartburn.
GERD: therapeutic algorithmsKey Points on H2 Receptor Antagonists
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BACK TO PPIs!
The pharmacology of proton pump inhibitors
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• The gastrointestinal adverse effects of PPIs can be mistaken for symptoms of GORD, sometimes resulting in increased doses of PPI being prescribed.
PPIs Adverse Effects
GERD: therapeutic algorithms
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Which adverse event can occur in a patient receiving chronic PPI therapy?
1. Gynecomastia2. Increased infection risk3. Extrapyramidal side effects4. Altered calcium and vitamin D levels
GERD: therapeutic algorithms
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Adverse effects due to chronic use• May 2010 - Decreased calcium absorption, leading to
increased risk of fracture• March 2011- may cause low hypomagnesium if taken
for prolonged periods (in most cases, greater than 1 year).
• Gastric acid suppression with PPIs increases the risk of infection with gastrointestinal (C.difficile) or respiratory pathogens, although the absolute risk to most patients remains low.
GERD: therapeutic algorithms
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GERD: therapeutic algorithmsPPI-Drug interactions
Drug Metabolism
Phase 1: Functionalization reactions (introduction of a functional group)
Phase 2: Conjugative reactions(Conjugation with endogenous compounds)
Drug
AND /OR
PPI-Drug interactionsPhase 1 metabolismBy introducing or unmasking more polar a functional group
more readily eliminated
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Chemical reactionsOxidationReductionHydrolysisHydrationIsomerizationDethioacetylation
GERD: therapeutic algorithms
PPI-Drug interactionsPhase 2 metabolismBy conjugation with an more polar and water soluble endogenous substance
more readily excretable in
urine or bile
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Chemical reactionsGlucuronidation/glycosidationSulfationMethylationAcetylationAmino acid conjugationFatty acid conjugation
GERD: therapeutic algorithms
PPI-Drug interactions
PPI’sOmeprazoleEsomeprazoleLansoprazolePantoprazole (Na or Mg)Rabeprazole
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GERD: therapeutic algorithms
All metabolized by CYP P450, 2C19 and 3APossibility of drug-drug interactions
Pantoprazole lower affinity to CYP P450 enzyme system + mostly sulfation
Rabeprazole metabolized through non enzymatic pathways
Less drug interactions possibilities
Clinical Pharmacy and Therapeutics 2012
PPI-Drug interactions
PPI’sOmeprazoleEsomeprazoleLansoprazolePantoprazole (Na or Mg)Rabeprazole
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GERD: therapeutic algorithms
Inhibition of CYP2C9 and CYP2C19D-D interactions possibility with (Monitoring, sp. With >20 mg/day dose)Phenytoin (2C9) diazepam (2C19)S-Warfarin (2C9) R-Warfarin (2C19)Weak Induction of CYP1A2
D-D interactions possibility with (Monitoring) Theophylline
Clinical Pharmacy and Therapeutics 2012
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Interaction with clopidogrel • While there was evidence that PPIs may affect clopidogrel
activity ex vivo, the available evidence suggested that this would not translate to clinically significant adverse outcomes.
• However, if considering prescribing a PPI at the same time as clopidogrel then pantoprazole is the recommended choice. Pantoprazole is known to have less of an inhibitory effect on the CYP2C19 enzyme compared with omeprazole or lansoprazole.
GERD: therapeutic algorithms
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GERD: Visit your patient• Mr. Hassan, a 45-year-old man, showed up in your pharmacy. His past
medical history included hypertension and . One week ago, he suffered from heart burn and acidic taste and was prescribed omeprazole to alleviate this symptom and was asked to decrease smoking and coffee intake. Yesterday he noticed bruising in his leg and arm. He is coming to ask for heamoclare and wondering if there is better suggested brand. He had no known drug allergies and was taking the following prescription drugs:
Omeprazole 40 mg qdIbuprofen 400 mg prn
Warfarin Ramipril 10 mg qd
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GERD: revisit your patientPatient information:Question is:Guidelines and references states…………….Patient recommendation is………………..Monitoring plan is……………………
Assessment
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PPIs dose adjustment GERD: therapeutic algorithms
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Formulations
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Calcium carbonate
Aluminium hydroxide
Magnesium hydroxide
Sodium bicarbonate
Which of these antacids is available as a combination product with a proton pump inhibitor (PPI)?
GERD: therapeutic algorithms
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Use a combination or not?
GERD: therapeutic algorithms
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What is the drug of choice for GERD during pregnancy?
• Between 30 – 50% of pregnant women experience symptoms of GORD and this is considered a normal part of pregnancy
• Antacids > ranitidine >PPIs
GERD: therapeutic algorithms
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Gastroprotective Therapy A 67-year-old woman with rheumatoid arthritis is taking naproxen 500 mg by mouth daily, metoprolol 25 mg by mouth twice daily, aspirin 81 mg by mouth once daily, and alendronate 70 mcg by mouth weekly.• Which gastroprotective therapy is best to recommend?
A. Lansoprazole 30 mg daily.B. No gastroprotective therapy necessary.C. Misoprostol 200 mcg twice daily.D. Esomeprazole 40 mg twice daily.
GERD: therapeutic algorithms
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Gastroprotective Therapy
GERD: therapeutic algorithms
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SUMMARY! Monitoring Plans!Your symptoms should not require more than 2 weeks of continuous medication every 6 months
See your doctor if- Red Flags- symptoms persist after treatment- any side effects of the monitored drugs
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Educ
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Man
agem
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f Dia
betic
s (DH
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NK/Z
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June
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Thank You
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