Safety Of. long-term PPI. Layli Eslami, MD Tehran, 1393

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1 Safety Of long-term PPI Layli Eslami, MD Tehran, 1393

2 n The introduction of PPIs in the late 1980s optimized the medical treatment of acidrelated disorders n In some cases such as GERD patients given the propensity of esophagitis to relapse, maintenance acid suppressive therapy is often necessary.

3

4 What is the Long term PPI use?

5 Daily use More than 4-6 months

6 Pneumonia Enteric infections Vitamin B12 malabsorption Iron malabsorption Hip fracture and calcium malabsorption Magnesium absorption Gastric Premalignant Lesions Use in pregnancy Use in cirrhotic patients

7 Pneumonia

8 Reduction of gastric acid More easily colonization of pathogens in the upper GI

9 SR of 8 Observational [OR]=1.2, 95% CI= Increase in PPI users Increase risk in H2RA users SR of 23 RCTs RR=1.22, 95% CI= Increase risk of hospitalacquired pneumonia in H2RA

10 Pneumonia Might be associated with Use of PPI and or H2RA Clinicians should use caution in prescribing acid-suppressive drugs for patients at risk.

11 Enteric Infections

12 Gastric acidity normally protects against these infections Gastric acid inhibition might increase the risk of enteric infections

13 Observational studies 12 studies (2,948 patients) 6 studies (11,280 patients) Clostridium difficile Salmonella, Campylobacter, Increased risk of taking antacids Increased risk of taking acid suppression OR: 1.94, 95% CI OR : 2.55, 95% CI

14 Enteric Infections Studies observational significant heterogeneity between Might be associated with Use of PPI and or H2RA Further prospective studies are needed to establish whether this association is causal

15 Vitamin B12 malabsorption

16 Gastric acidity Necessary to activate pepsinogen to pepsin Release vitamin B12 from foods

17 PPIs Reduce Gastric acidity Necessary to activate pepsinogen to pepsin Release vitamin B12 from foods

18 B12 malabsorption in Short-term use of PPI n 1994 assessment of vitamin B12 absorption before and after omeprazole therapy in healthy male volunteers n Each participant had a gastric analysis, as well as measurements of serum vitamin B12, gastrin, and folate levels.

19 n Five patients were then randomly assigned to take either 20 mg or 40 mg of omeprazole daily. n After 2 weeks of omeprazole therapy, these tests were repeated. n Omeprazole therapy acutely decreased cyanocobalamin absorption in a dosedependent manner.

20 B12 malabsorption in long-term use of PPI n Five out of six studies have shown that PPIs used long-term in non-elderly patients do not reduce serum vitamin B12 concentrations, and therefore body B12 stores. n In elderly patients who may already have gastric atrophy (possibly from H. pylori infection), PPIs used long-term may reduce serum vitamin B12 concentrations.

21 B12 malabsorption Does not occurred in Longterm PPI use Except possible in the elderly or in persons with ZES who are on high doses of PPI for prolonged periods of treatment.

22 Iron malabsorption

23 long term with high dose PPIs Reduce gastric acidity Possible decrease in duodenal absorption of organic and non-organic iron

24 This effect is small PPIs are not associated with an increased risk of iron deficiency.

25 Osteoporosis AND Fractures

26 Long term PPI use Observational studies prospective cohort study Increased risk of clinical fractures Not associated with low BMD or, over a two-year interval, the rate of BMD decline Not associated with osteoporosis or accelerated BMD loss

27 How big was the risk of fractures? - 7 years of PPI exposure OR: % CI,

28 Are PPIs associated with osteoporosis and fractures?

29 Are PPIs associated with osteoporosis and fractures? YES, but in the observational studies These studies do not prove causality

30 What should we do? Patients taking long-term PPI or H2 blocker therapy increase dietary calcium and, when necessary, use calcium supplements.

31 Magnesium malabsorption

32 Reduced intestinal absorption of magnesium March 2011 FDA issued a safety alert warning providers of the risk of hypomagnesemia in longer than one year use of PPIs Hypomagnesaemia can result in muscle spasms, cardiac arrhythmias, and seizures.

33 SR of symptomatic case reports (2012) Occurred : after 5.5 years (median) Onset : ranged from 14 days to 13 years Discontinuation of PPIs: recovery from in 4 days Re-challenge led to reoccurrence within 4 days H2RA: were the preferable replacement therapy

34 Case control study (2013) The effect was seen only in those Concomitantly receiving diuretics

35 FDA suggestions: Check serum magnesium levels prior to starting a PPI and periodically in : Patients who are expected to be on the medication for long periods of time Patients who take PPIs in conjunction with other medications associated with hypomagnesemia (digoxin or diuretics).

36 PPI use in cirrhotic patients

37 Magnesium Mean serum magnesium concentrations in patients with cirrhosis were significantly lower in PPI users than nonusers. Serious Infection In patients with decompensated cirrhosis, PPIs but not H2 RA increase the rate of serious infections.

38 n With regard to the prevention and treatment of oesophageal complications after banding or sclerotherapy of oesophageal varices, there is little evidence for a protective role of PPI. n With regard to Helicobacter pylori infection, it seems that H pylori eradication does not prevent gastro-duodenal ulcer formation and bleeding. n Moreover, due to liver metabolism of PPI, the dose of most available PPIs should be reduced in cirrhotics.

39 In cirrhotic patients: The use of this class of drugs seems more habit related than evidence based eventually leading to an increase in health costs.

40 PPI use and gastric pre/malignant lesions

41 The main concerns regarding the long-term safety of PPIs: n Possible association of PPIs with Gastric Atrophy n Induction of Hypergastrinemia and gastric carcinoid tumors

42 What is Gastric Premalignant Lesions? Chronic gastritis Atrophic gastritis Intestinal metaplasia Dysplasia Adenocarcinoma

43 Studies in Rats Study PPI (dose, type) Results Freston, 1996 High dose Omeprazole Plasma level: 100 fold Hypergastrinemia Carcinoid tumor Vista, 2004 Wetschers, y. Lansoprazole (Duodenogastric reflux) 1 y. Omeprazole, SC (Intragastric ph=ph in human receiving po. omeprazole) Gastric cancer Gastric cancer

44 Case Reports in Human Attila, 2005 Haga, years old man with Pernicious Anemia - 2 month Lansoprazole -Omeprazole, Lansoprazole & H2 Blocker Alternatively - 38 month - Hypergastrinemia - Carcinoid tumor - Decrease in Gastrin level when D/C Lansoprazole - Carcinoid Tumor

45 Clinical Trials in Humans Study PPI (type, duration and dose) Results Association with HP infection Uemura, 2000 Omeprazole,3 y. 20 mg/day No increase in atrophy, IM Not estimated Solica, 1992 Omeprazole, 6-36 mo mg/day Increase in ATROPHIC GASTRITIS, micro nodular ECL hyperplasia Not estimated Regina, 2001 Omeprazole, 10 y mg/day Schank, 1999 Omeprazole, 61 month 40 mg/day Increase in single or mixed type ECL cell hyperplasia Increased ATROPHIC GASTRITIS Decrease in B12 level Increased Atrophy & Intestinal Metaplasia Increased Atrophic gastritis Gabe's, 2001 Lansoprazole, 5 years 30 mg/day No change in HP negative patients Increase in corpus Atrophy

46 Clinical Trials in Humans Study PPI (type, duration and dose) Results Association with HP infection Diebold, 1998 Omeprazole, >5mo. in the past 6mo, 20 mg/d No significant change No increase in atrophy, Decreased ECL cell H.plasia Schank, 2000 Omeprazole, 12 month 40 mg/day Increased active corpus gastritis Increased Kuipers, 1999 Omeprazole, 5 y mg/day Increased ATROPHIC GASTRITIS Increased Maton, 2001 Esomeprazole, 12 mo mg/day No significant change in chronic gastritis, increased ECL abnormality Not estimated Klinkenberg Knol, 2000 Omeprazole, 11 y mg/ day Some Corpus gastritis and argyrophil cell hyperplasia Increased but NOT significant

47 PPIs seem to be safe with no increase in malignant lesions A Systematic Review of RCTs Simple ECL hyperplasia happens which apparently is not a pre-malignant lesion H Pylori appears to increase the rate of chronic inflammation and ECL hyperplasia Further well Controlled studies are necessary

48 How long PPIs can be used safely?

49 How long PPIs can be used safely?

50 Systematic Review At least 3 yr. Nasseri-Moghaddam, 2011 RCT Up to 7 yr. Lundell 2007 Cohort (non interventional) Up to 10 yr. Regina, 2001

51 PPI use in Pregnancy

52 Large Cohort Study n Among 840,968 live births, 5082 involved exposure to PPIs between 4 weeks before conception and the end of the first trimester of pregnancy n No significant association between the use of PPIs during the first trimester of pregnancy and the risk of major birth defects.

53 n Modestly increased risk during the period before conception that was observed with PPIs as a group was not seen with omeprazole. (OR= 1.51 (95% CI= )

54 Is PPI use safe during pregnancy? YES

55 Thank you Questions and Comments?

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