Determining Risk Factors for Successful PPI Weaning
| Status: | Terminated |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/6/2018 |
| Start Date: | September 1, 2016 |
| End Date: | October 1, 2018 |
Gastroesophageal Reflux Disease ("GERD") can happen when stomach acid flows backward into
your esophagus (tube from the mouth to the stomach), causing symptoms such as heartburn.
Proton pump inhibitors (called "PPIs") are a type of medication that reduce acid in the
stomach and are used to reduce the discomfort from GERD. Treatment for GERD with PPIs is
recommended to last up to eight weeks; however, many people take them for longer periods.
Some people are placed on PPIs (particularly in the hospital) to prevent ulcers and
inflammation of the stomach, but they do not need to be on the medication long term. Previous
research studies have shown that there are some risks with taking PPIs for a long time. These
risks include the inability of your body to absorb some vitamins and minerals, certain
infections such as pneumonia or the digestive tract infection called "C. diff," and possibly
bone fractures. Therefore, it is desirable to stop taking a PPI when possible.
The purpose of this study is to use a standard approach to help patients stop taking PPIs by
adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their
PPI dose. All medications used for this study are approved by the U.S. Food and Drug
Administration ("FDA"). You are being asked to take part in this study because you have been
taking a PPI for longer than the recommended time, and have either a diagnosis of GERD,
gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount
Carmel St. Ann's Family Medicine practice will participate in this research.
your esophagus (tube from the mouth to the stomach), causing symptoms such as heartburn.
Proton pump inhibitors (called "PPIs") are a type of medication that reduce acid in the
stomach and are used to reduce the discomfort from GERD. Treatment for GERD with PPIs is
recommended to last up to eight weeks; however, many people take them for longer periods.
Some people are placed on PPIs (particularly in the hospital) to prevent ulcers and
inflammation of the stomach, but they do not need to be on the medication long term. Previous
research studies have shown that there are some risks with taking PPIs for a long time. These
risks include the inability of your body to absorb some vitamins and minerals, certain
infections such as pneumonia or the digestive tract infection called "C. diff," and possibly
bone fractures. Therefore, it is desirable to stop taking a PPI when possible.
The purpose of this study is to use a standard approach to help patients stop taking PPIs by
adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their
PPI dose. All medications used for this study are approved by the U.S. Food and Drug
Administration ("FDA"). You are being asked to take part in this study because you have been
taking a PPI for longer than the recommended time, and have either a diagnosis of GERD,
gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount
Carmel St. Ann's Family Medicine practice will participate in this research.
Inclusion Criteria:
- > 18 years old
- Male or female
- PPI on home medication reconciliation
- GERD that is symptom controlled (per questionnaire), OR
- Gastritis that is symptom controlled (per questionnaire), OR
- An unclear indication for PPI use but free of GERD/gastritis/ulcer symptoms (includes
patients on GI prophylaxis from the hospital and continued medication)
- Desire or willingness to be off of PPI chronically
- On PPI chronically (> 2 months or 8 weeks, can be intermittent use)
- Initial PPI dose cannot exceed more than the equivalent of Omeprazole 40mg PO BID
- Comprehend English well (per provider's discretion; to understand questionnaires,
instructions, etc.)
Exclusion Criteria:
- On PPI for fewer than 2 months
- Co-morbid diagnosis of Peptic Ulcer Disease, H.pylori infection, Barrett's esophagus,
malignancy, Inflammatory Bowel Disease
- Diagnosis of moderate to severe renal impairment (defined as CrCl <50 mL/min;
reasoning due to caution of H2RB on renal failure)
- Diagnosis of prolonged QT interval with renal impairment (reasoning due to H2RB with
concomitant renal failure may increase QT interval if not renally dosed)
- True allergy to Proton Pump Inhibitor and / or H2 Receptor Blocker
- Patients with frequent cardiac angina symptoms (decreasing the dose of PPI may cause
rebound GERD and the patient may think they are having a heart attack)
- Pregnant women, fetuses, neonates or fetal material
- Females of reproductive potential at time of research that are not on a form on birth
control (OCPs, tubal ligation, etc) or lactating
- Adults with decisional impairment
- Prisoners
- Patients with uncontrolled Psychological illness
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