Management of GERD

Management of GERD:
A patient outcome/education-driven
session
Dalia A. Hamdy,
BPSc, MSc, PhD,
RP(ACP), MRSC
Nahla H. Kandil
BPSc, MSc, BCPS

Putting issues in perspective: why
are we here?
GERD (DH/NK-April 2015) 2

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

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

References
1. 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

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 2011

GERD: pathophysiology , triggers ad Exacerbating factors
1.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. Pregnancy
5. Stress and anxiety
6. Age >65 years

GERD: goals of therapy
• Relief symptoms & improve quality of life
• Promote healing of esophagitis
• Prevent complications
• Prevent recurrences

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 tid
Diclofenac 50 mg qd
Allopurinol 100 mg qd
Ramipril 10 mg qd
Simvastatin 40 mg qn

GERD: Questions for your patient
GERD (DH/NK-April 2015) 10Rxpassport, Heartburn series, 2015

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 swallowing
Unintentional weight
loss (>3kg in past 6
months)
Anemia
Persistent vomiting
Severe abdominal pain GERD (DH/NK-April 2015) 11
Therapeutic Choices . 2011
Patient Self-Care, 2010

GERD: non-pharmacological treatment
Life style modification:
Avoid foods that ppts events
Avoid lying down right after meals
Obtain ideal body weight
Reduce alcohol intake!
Reduce caffeine intake (2-3 cups/day)
Smaller more frequent meals

GERD: non-pharmacological treatment
II. Patient recommendations
Reassure patient about the benign nature of disease
Stress reduction
Avoid exercising or bending on full stomach
Avoid exacerbating foods
Avoid lying down after meals
Avoid tight fitting cloths around the waist
Raise head of bed around 10 cm
Limit nicotine consumption
Obtain ideal body weight

GERD: revisit your patient
Patient information:
Question is:
Guidelines and references states…………….
Patient recommendation is………………..
Monitoring plan is……………………
Assessment
Care Plan
Follow-up
evaluation

GERD: therapeutic algorithms
The 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

A 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.

Pharmacological
Group Choice
Rxpassport, Heartburn series, 2015

A 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.

Prokinetics
• 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

Which of the following is inappropriate monotherapy
for mild, intermittent GERD?
1. Omeprazole
2. Metoclopramide
3. Famotidine
4. Calcium carbonate

• 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?

a) It should be taken 30 minutes prior to a meal
b) It takes 1-3 days for a clinical response
c) It is associated with a therapeutic effect that last for more than the
14 days of treatment
d) All of the above
Which of the following statements should be used when
counselling a patient taking non-prescription PPI therapy?

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?

Stepping down treatment if patient responds
adequately
It includes:
1- Discontinuing PPI Therapy
2- Switching To Symptom-driven Therapy
3- Reducing dose of daily PPI

Key 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.

Rebound 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.

• 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 (DH/NK-April 2015) 31
Key Points on Antacids

Which of the following disorders is an adverse
event associated with aluminum hydroxide?
1. Tinnitus
2. Diarrhea
3. Constipation
4. Hyperkalemia

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
•Rosuvastatin
To 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

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?

• 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.

a) Famotidine is usually superior to ranitidine at equivalent doses
b) Tachyphylaxis commonly develops with these medications
c) They provide symptom relief in approximately 50% of patients
d) 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?

The H2RA associated with the most significant drug
interactions due to inhibition of CYP450 enzymes is
a) ranitidine
b) cimetidine
c) Nizatidine
d) famotidin
Drug Metabolism!!
Stay Tuned!

• 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 (DH/NK-April 2015) 38
Key Points on H2 Receptor Antagonists

BACK TO PPIs!
The pharmacology of
proton pump inhibitors

• 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

Which adverse event can occur in a patient receiving
chronic PPI therapy?
1. Gynecomastia
2. Increased infection risk
3. Extrapyramidal side effects
4. Altered calcium and vitamin D levels

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.

PPI-Drug interactions
Drug Metabolism
Phase 1: Functionalization reactions
(introduction of a functional group)
Phase 2: Conjugative reactions
(Conjugation with endogenous compounds)
Drug
AND /OR

Phase 1 metabolism
By introducing or unmasking more polar
a functional group
more readily eliminated
Chemical reactions
Oxidation
Reduction
Hydrolysis
Hydration
Isomerization
Dethioacetylation

Phase 2 metabolism
By conjugation with an more polar and water soluble
endogenous substance
more readily excretable in
urine or bile
Chemical reactions
Glucuronidation/glycosidation
Sulfation
Methylation
Acetylation
Amino acid conjugation
Fatty acid conjugation

PPI’s
Omeprazole
Esomeprazole
Lansoprazole
Pantoprazole (Na or Mg)
Rabeprazole
All metabolized by CYP P450, 2C19 and 3A
Possibility 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’s
Omeprazole
Esomeprazole
Lansoprazole
Pantoprazole (Na or Mg)
Rabeprazole
Inhibition of CYP2C9 and CYP2C19
D-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

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: 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 qd
Ibuprofen 400 mg prn
Warfarin
Ramipril 10 mg qd

GERD: revisit your patient
Patient information:
Question is:
Guidelines and references states…………….
Patient recommendation is………………..
Monitoring plan is……………………
Assessment
Care Plan
Follow-up
evaluation

PPIs dose adjustment

Formulations

 Calcium carbonate
 Aluminium hydroxide
 Magnesium hydroxide
 Sodium bicarbonate
Which of these antacids is available as a combination
product with a proton pump inhibitor (PPI)?

Use a combination or not?

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

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.

Gastroprotective Therapy

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

Education&ManagementofDiabetics(DH/AY/NK/ZGJune6,2014)
60

Management of GERD

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