Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03980899
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2019-06-07
Brief Title:
Evaluation of the Long-term Tolerance of Proton Pump Inhibitor PPI Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Valuation of the Long-term Tolerance of Proton Pump Inhibitor PPI Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGERIPP 2
Brief Summary:
Proton pump inhibitors PPIs are widely prescribed in France as anti-ulcer drugs The indications currently approved in France with variations according to molecules are as follows eradication of Helicobacter pylori active peptic ulcer disease maintenance treatment of duodenal ulcer disease treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs NSAIDs prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects symptomatic treatment of gastroesophageal reflux disease GERD esophagitis by GERD maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome
Several misuse situations had been identified by the High Authority of Health HAS in its reassessment in 2009
Although these molecules are very well tolerated in the short term studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections Clostridium difficile infections and an increased risk of fractures
Several misuse situations had been identified by the High Authority of Health HAS in its reassessment in 2009
Although these molecules are very well tolerated in the short term studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections Clostridium difficile infections and an increased risk of fractures
Detailed Description:
Professor Sylvie Legrain in a 2005 HAS report described that Better prescribing in the elderly is thus a public health issue Indeed although multi-medication in the elderly is often justified it increases the risk of drug iatrogeny reduces compliance and has a significant cost to society In this report it is specified that digestive tract drugs including PPIs represent the 3rd most prescribed class of drugs for people over 65 years of age 17 of patients use them regularly PPIs are also mentioned in this report as overuse overtreatment
The first study conducted in 2017 at our centre EGERIPP sought to assess whether a rebound effect was observed in patients who stopped PPI therapy if not indicated In this study 30 patients were included and no rebound effects were observed Five patients resumed PPIs out of the 30 patients included unexplored anemia - n1 epigastric pain - n1 gastroesophageal reflux disease - n1 no justification found - n2 For all patients during reassessment on D14 and D21 during hospitalization patients did not report more symptoms after discontinuation In this context the investigators now wish to study whether the short-term tolerance is prolonged in the long term for the discontinuation of PPIs
This first study also allowed us to assess the prevalence of PPI use in the elderly and the prevalence of patients on PPI for a recognized indication During the study 270 patients were screened and 76 patients had a PPI at admission 28 Of these 76 patients no indication recognized by the HAS was found in the medical file for 63 patients 83
The discontinuation of PPI treatments in case of use outside the recommendations is usually carried out in the department where the study is being conducted There is therefore no change in practices On the other hand it is good practice to discontinue a treatment that is prescribed outside the recommendations
Following the EGERIPP study the systematic reassessment of PPI treatments has become a service practice with discontinuation when no recognized indication is found and prescription of antacids on demand
The first study conducted in 2017 at our centre EGERIPP sought to assess whether a rebound effect was observed in patients who stopped PPI therapy if not indicated In this study 30 patients were included and no rebound effects were observed Five patients resumed PPIs out of the 30 patients included unexplored anemia - n1 epigastric pain - n1 gastroesophageal reflux disease - n1 no justification found - n2 For all patients during reassessment on D14 and D21 during hospitalization patients did not report more symptoms after discontinuation In this context the investigators now wish to study whether the short-term tolerance is prolonged in the long term for the discontinuation of PPIs
This first study also allowed us to assess the prevalence of PPI use in the elderly and the prevalence of patients on PPI for a recognized indication During the study 270 patients were screened and 76 patients had a PPI at admission 28 Of these 76 patients no indication recognized by the HAS was found in the medical file for 63 patients 83
The discontinuation of PPI treatments in case of use outside the recommendations is usually carried out in the department where the study is being conducted There is therefore no change in practices On the other hand it is good practice to discontinue a treatment that is prescribed outside the recommendations
Following the EGERIPP study the systematic reassessment of PPI treatments has become a service practice with discontinuation when no recognized indication is found and prescription of antacids on demand
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None