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1 Things we knew, things we did… Things we have learnt, things we should do GASTROPROTECTIVE DRUGS Dr Elia SAMAHA Pr Christophe Cellier Hôpital Européen.

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Presentation on theme: "1 Things we knew, things we did… Things we have learnt, things we should do GASTROPROTECTIVE DRUGS Dr Elia SAMAHA Pr Christophe Cellier Hôpital Européen."— Presentation transcript:

1 1 Things we knew, things we did… Things we have learnt, things we should do GASTROPROTECTIVE DRUGS Dr Elia SAMAHA Pr Christophe Cellier Hôpital Européen Georges Pompidou, Paris

2 2 Things we knew, things we did… Things we have learnt, things we should do Gastroprotector: a drug that protects the gastric mucosa to prevent ulcers and bleeding

3 Drugs available Anti-H 2 Anti-acides, Protecteurs IPP Drug discovery vol2 fevrier 2003

4 4 Pedagogic goals Situation of the issue: prescription of PPIs in France What risk factors have been identified? Does treatment with PPIs reduce the risk of bleeding? Does eradication of Hélicobacter pylori reduce the risk of bleeding?

5 Prescription of ulcer drugs in France Prevalence: 12% (PPI= 85%) Prescribers: General Practitioners = 80% Main reasons: – GERD 58% – Gastroprotection 50% – Dyspepsia24.7% – Ulcer disease 9.5% Ile de France Urcamif - assurance-maladie

6 Non-compliance rate in PPI treatment GPs in Grenoble region in 2004:46% Patients admitted to an internal medicine unit in Rouen: 67% Main differences from references: – Upper GI endoscopy – Respect for indications Marie I. et al. Rev Med Int 2007 Levy-Neumand O et al. Gastroenterol Clin Biol 2007

7 Non-compliance rate in PPI treatment Reports to the Social Security accounting committee – October Million

8 Growth of use by volume from 2004 to 2008 (number of UCD / inhabitant) National Health Insurance – 19 October 2007 Cost > 1 billion in 2006 (3 rd ranked)

9 Pedagogic goals Situation of the issue: prescription of PPIs in France What risk factors have been identified? Does treatment with PPIs reduce the risk of bleeding? Does eradication of Hélicobacter pylori reduce the risk of bleeding?

10 10 Upper digestive tract lesions with low-dose aspirin EROSIONS: 50% ULCERS: 10% Incidence (%) in patients receiving low-dose aspirin ( mg/d)

11 11 The risk of bleeding ulcer with aspirin is dose-dependent Weil et al. BMJ 1995

12 12 Complications of GD bleeding in relation to aspirin dose Number of patients to treat to observe an additional severe bleeding episode / year as compared to the group without aspirin ASPIRIN mg > 325 mg Laine Aliment Pharmacol Ther 2006; 24:

13 Demonstrated risk factors for gastroduodenal bleeding with low-dose aspirin ( 325 mg/d) History of bleeding ulcer6.5 History of ulcer2 Co-prescription AVK2 NSAIDs 2-4 Steroids 3-7 Coxib2 Clopidogrel7 Relative Risk

14 Is age a risk factor? AGE: The risk of lesions in the digestive tract increases, especially ulcers. SUBJECT > 65 years: Subject at risk for GI complications with NSAIDs

15 Pedagogic goals Situation of the issue: prescription of PPIs in France What risk factors have been identified? Does treatment with PPIs reduce the risk of bleeding? Does eradication of Hélicobacter pylori reduce the risk of bleeding?

16 Survival without recurrence of a major GI event in high-risk patients with aspirin vs. clopidogrel ± PPIs Hsiao et al. Clinical Therapeutics/Volume 31, Number 9, ,627 patients Aspirin + PPI > Aspirin Clopidogrel = Clopidogrel + PPI NS Asp + PPI > clopidogrel

17 Risk of recurring GDU Chan et al. N Engl J Med. 2005;352: 238–244. P = 0.001P = Lai et al. Clin Gastroenterol Hepatol. 2006; 4:860–865.

18 Cumulative incidence of GD ulcers after 26 weeks of treatment with low-dose aspirin 991 patients > age 60 Yeomans ND et al. Am J Gastroenterology 2008 Risk of ulcer reduced by 70% with PPI

19 Should Helicobacter pylori be taken into account?

20 Prevalence of GDU with NSAIDs or aspririn in relation to H. pylori status Meta-analysis 16 controlled studies RR: 2.12 (95% CI: ) Huang et al. Lancet 2002

21 Rate of recurrent bleeding after 6 months with low-dose aspirin or NSAIDs (PPI vs Eradication) Chan et al. NEJM 2001 Randomized prospective study 400 patients Hp+: -250 Aspirin -150 Naproxen NS P=0.005

22 Recommendations for the use of PPIs - Approval 1.GERD and its complications 2.Gastric and duodenal ulcers and their complications 3.Eradication of Hélicobacter pylori 4.Zollinger-Ellison Syndrome 5.Prevention of GI ulcer with NSAIDs in presence of risk factors 6.Prevention of GI stress ulcers in resuscitation HAS – December 2009 AFSSAPS – November 2007

23 PREVENTION OF GI LESIONS INDUCED BY NSAIDs Risk situations: – Age > 65 years – History of gastroduodenal ulcer (look for and treat Helicobacter pylori infection) – Association with platelet antiaggregant (low-dose aspirin or clopidogrel), an anticoagulant or steroids Half-dose PPI (except omeprazole) (Grade A) Stop PPI at same time as NSAIDs HAS – December 2009

24 PREVENTION OF GI LESIONS INDUCED BY LOW- DOSE ASPIRIN ( 325 MG/DAY) No systematic gastroprotection (little evidence) In patients with GI bleeding on low-dose aspirin. If continued, it is advisable to associate a PPI (Grade A) systematically. Always look for and treat Helicobacter pylori infection in cases of ulcer history. AFSSAPS – November 2007

25 25 PREVENTION OF ACUTE STRESS LESIONS (RESUSCITATION) Two main risk factors: Intubation with mechanical ventilation > 48h Coagulation disorders No drug not approved PPI or anti-H 2 (Grade A) No justification for prescribing an antisecretory agent if no RF (Grade A) Cook et al. N Engl J Med Am J Health-Syst Pharm. 1999

26 PRESCRIPTION OF PPI WITHOUT ENDOSCOPY IN 2 SITUATIONS 1.Typical GERD, in a patient < age 55 with no warning signs 2.Prevention of NSAID-induced lesions in patients > age 65 or with risk factors In other circumstances, endoscopy is necessary before ANY treatment. AFSSAPS – November 2007

27 TAKE-HOME MESSAGE Key role of general practitioners Valid indications for PPIs as protection: 1.Prevention with NSAIDs in presence of RF Age > 65 years History of GI ulcer Co-prescription (antiaggregants, AVK, steroids) 2.Secondary prevention with low-dose aspirin 3.Prevention of stress ulcer in resuscitation

28 Dyspepsia = NO Low-dose aspirin = NO Efficacy = PPIs TAKE-HOME MESSAGE

29 Things we knew, things we did… Things we have learnt, things we should do International Congress of Medicine for Everyday Practice Thank you for your attention Questions? ~ Answers!


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