Class 161st Year

Introdução à Medicina IFMUP

Is Esomeprazole the most efficient Proton Pump Inhibitor to relief symptoms and to induce mucosal healing, in patients with Gastroesophageal Reflux Disease ?

19th December 2007

Class 161st Year

Doutor Mário Dinis Ribeiro

Introdução à Medicina IFMUP

Ana LopesAndreia PintoCatarina MeloDiogo DiasIsabel SaavedraJoão MatiasMariana FerreiraMariana Mangas Paula Neves Rita Sapage Rui CoelhoTeresa Caridade Teresa Tavares

• Introduction to GERD• Research Question and Aim• Methods

• Study Design• Papers Selection:

• Queries• Number of Abstracts• Inclusion/Exclusion Criteria• Fluxogram

• Data to be extracted: • Variables• Quality assessment• Statistical treatment

Summary

Gastroesophageal Reflux Disease (GERD)• Prevalent and chronic condition

• Reflux of the stomach contents into the oesophagus

Troublesome symptoms- heartburn- acid regurgitation

Complications- haemorrhage, stricture, - Barrett’s oesophagus - adenocarcinoma of the distal

oesophagus

35% of Portuguese adults

refer GERD

symptoms

Adapted from: Maria João Branco, Paulo Nogueira, Teresa Contreiras. Uma observação sobre estimativas da prevalência de algumas

doenças crónicas, em Portugal Continental. Julho 2005, Observatório Nacional de Saúde, Instituto Dr. Ricardo Jorge.

• mainstay of medical therapy in GERD;• heals esophageal mucosal injury; • highly selective and effective in their action and have few short- or long-term adverse effects.

Omeprazole, Lanzoprazole Pantoprazole, Raberprazole

Proton Pump Inhibitors (PPIs)

Pettit M (2005). Treatment of gastroesophageal reflux disease. Pharm World Sci. 27 (6):432-5.

• New - generation PPI;

ESOMEprazole (40 mg)

• efficacy and safety were reviewed and causes of failure were discussed;

• Several studies have shown marginal differences in efficacy between various PPIs regimens.

Glatzel D et al (2006). Pantoprazole 40 mg is as effective as esomeprazole 40 mg to relieve symptoms of gastroesophageal reflux disease after 4 weeks of treatment and superior regarding the prevention of symptomatic relapse. Digestion. 74(3-4):145-54.

• Introduction to GERD• Research Question and Aim• Methods

• Study Design• Papers Selection:

• Queries• Number of Abstracts• Inclusion/Exclusion Criteria• Fluxogram

• Data to be extracted: • Variables• Quality assessment• Statistical treatment

Summary

Is esomeprazole more effective in enduring symptom relief and in healing

mucosal injury, relatively to omeprazole, lansoprazole, rabeprazole, pantoprazole,

in GERD patients?

Question of the study

Aim To compare efficacy of esomeprazole relatively to the other PPIs, in GERD patients, in

symptoms relief inducing mucosal healing

• Introduction to GERD• Research Question and Aim• Methods

• Study Design• Papers Selection:

• Queries• Number of Abstracts• Inclusion/Exclusion Criteria• Fluxogram

• Data to be extracted: • Variables• Quality assessment• Statistical treatment

Summary

Synthesis’ studies: Sistematic review Metanalysis

study

Bibliographic databases:• Medline (http://www.nlm.nih.gov/medlineplus/)• Scopus (http://www.scopus.com)• ISI Web of Knowledge

(http://isiwebofknowledge.com/)

Methods: Study design

• (gastroesophageal reflux OR "Gastroesophageal Reflux"[Mesh] OR GERD OR NERD OR non-esophagitis reflux disease OR esophagitis) AND (regurgitation OR heartburn) AND (randomized controlled trial[Publication Type] OR (randomized[Title/Abstract] AND controlled[Title/Abstract] AND trial[Title/Abstract])) AND (omeprazole OR "Omeprazole"[Mesh] OR pantoprazole OR "pantoprazole"[Substance Name] OR rabeprazole OR "rabeprazole"[Substance Name] OR lansoprazole OR "lansoprazole"[Substance Name]) AND (esomeprazole OR "Omeprazole"[Mesh]) NOT (”Barrett esophagus” [Mesh])

158 articles

Methods: Paper Selection - Queries

- Pubmed -

• ((gastroesophageal reflux OR GERD OR NERD OR non-esophagitis reflux disease OR esophagitis)

AND (regurgitation OR heartburn)

AND (omeprazole OR pantoprazole OR rabeprazole OR lansoprazole) AND (esomeprazole) NOT (Barrett Syndrome))

35 articles

Methods: Paper Selection - Queries

- ISI Web of Knowledge -

• ((gastroesophageal reflux OR gerd OR nerd OR non-esophagitis reflux disease OR esophagitis)

AND (regurgitation OR heartbun) AND NOT (barrett syndrome))

AND (omeprazole OR pantoprazole OR rabeprazole OR lansoprazole) AND (esomeprazole)

AND (EXCLUDE(DOCTYPE, "re") OR EXCLUDE(DOCTYPE, "cp"))

57 articles

Methods: Paper Selection - Queries - Scopus -

ISI

PUBMED

SCOPUS12

7815

30

143

Methods: Paper Selection - Number of Abstracts

N=215

• Studies in Humans;• Studies in adults (19 - 75 years old);• Clinical trials; • Original articles; • Treatment of patients only with

PPIs;

Methods: Paper Selection - Inclusion criteria

• Inaccessibility of data;• Articles published from December

of 2007; • Studies in pregnant; • Studies in people with other

illnesses beyond GERD;

Methods: Paper Selection - Exclusion criteria

Paper Selection: FluxogramStart

Define a focused review

questionDefine a query

250 articles found

Run search on MedLine

35 articles excluded

Are the articles repeated?

No Yes

215 articles included

Do the two reviewers includ

the article?NoYes

100 articles included

Select articles according to inclusion and exclusion criteria

Do the two reviewers exclud

the article?

115 articles excluded

Yes

No The two reviewer

s discussEnd

• Data to collect:• number of participants; number of

participants who had abandoned the study• Intention to treat

• age and gender;• ethnia;• GERD (NERD vs Esophagitis)

• which PPI was esomeprazole compared against;

• dose of esomeprazole (20 or 40mg) and other;

Methods: Data to be Extracted - Variables

• time of intervention (in weeks)• time to outcome• primary aim (esomeprazole vs

other)• mucosal healing (assessment)• symptoms relief

• habits of the participants (ex. smoking)

• physiological state (ex. menopause)

Methods: Data to be Extracted - Variables

Methods: Data to be Extracted - Quality assessment

• CONSORT - Consolidated Standards of Reporting Trials

• QUOROM - Guidelines for Meta-Analyses and Systematic Reviews of RCTs

• SPSS and specific software for metanalysis (eg.: RevMan)

Methods: Data to be Extracted - Statistical treatment

• If Esomeprazole is:• more effective in symptom

relief;• healing and prevention of

mucosal injury;than old PPIs.

Outcome

Class 161st Year

Introdução à Medicina IFMUP

Feliz Natal!