Therapeutic Effects of Famotidine on Chronic Gastritis Symptoms

1. Therapeutic effects of Famotidine on Chronic Symptomatic Gastritis: subgroup analysis from future study Yoshikazu Kinoshita • Tsutomu Chiba Powerpoint by Stacy San Diego,MD

2. Introduction

3. Chronic Symptomatic Gastritis - patients with chronic upper abdominal symptoms without histologic or endoscopic evidence. • Functional Dyspepsia - patients reporting at least 1 of the following 4 typical symptoms: epigastralgia, epigastric burning, postprandial epigastric fullness, and early satiation, for over 6 months after the presence of organic disease has been ruled out • In Japan, patients with non-typical symptoms such as nausea and shorter symptom duration may be diagnosed symptomatically with chronic gastritis

4. Objective

5. To determine whether patients with chronic symptomatic gastritis will have a therapeutic response to famotidine similar to that in patients with functional dyspepsia

6. Patients and Methods

7. 10,311 patients with a diagnosis chronic symptomatic gastritis enrolled • patients with uninvestigated functional gastroduodenal disorders • no intake of histamine 2 receptor antagonists or proton pump inhibitors for 2 weeks • the presence of histological gastritis and the absence of organic abdominal diseases were not required for enrollment • A total of 8,640 have responded appropriately

8. Study Protocol

9. A multicenter, single arm, prospective, post marketing study • Daily administration of Famotidine 20mg • Face scale was used to assess the intensity of three symptoms (heartburn, epigastralgia, and epigastric fullness) • an Izumo questionnaire was used to asses the abdominal symptom-related QOL impairment before and 2 and 4 weeks after the beginning of famotidine administration • a symptom diary was also tasked

10. source: https://www.researchgate.net/figure/Five-face-scale-for-assessing-distress-in-children-modified-smiley-faces-scale-17_fig1_267039938

11. source: https://www.researchgate.net/figure/The-Izumo-Scale-Questionnaire-Respondents-Enter-the-Severity-Scores-After-Reflecting-on_tbl1_283685959

12. Patient Results

14. 2,750 (32.5%) patients out of 8,640 underwent endoscopy • 5,710 did not undergo endoscopy and continued to be diagnosed as chronic symptomatic gastritis • 155 patients showed evidence of organic disease and 2,595 were found to have no evidence • 2,402 only had at least 1 of the 4 abdominal symptoms required for the diagnosis of FD • 343 had experienced symptoms for more than 6 months and were finally diagnosed with FD according to the Rome III criteria

15. Effects of Famotidine on Patients with Chronic Symptomatic Gastritis

16. Upper gastrointestinal (GI) symptoms ranked in order: • epigastralgia (68.0%), epigastric fullness (67.5%), and heartburn (48.2%) • Initial intensity scores: epigastralgia: 1.8 ± 0.02, epigastric fullness: 1.7 ± 0.02, heartburn: 1.5 ± 0.02 • Initial symptom-related QOL impairment scores: epigastralgia: 6.3 ± 0.06 epigastric fullness: 5.8 ± 0.06, heartburn: 5.4 ± 0.07 • Intensity score for each symptom decreased rapidly and reached less than 0.3 after 4 weeks • Izumo scores were approximately 1.5 after 4 weeks. • Epigastric fullness tended to be relieved more slowly.

18. Effects of Famotidine on patients with FD-like symptoms and without organic disease

19. All patients in this subgroup underwent an endoscopic examination and were confirmed to have no organic disease • Symptoms are experienced for less that 6 months • Changes in Intensity scores: epigastralgia: 1.8 ± 0.03 epigastric fullness: 1.6 ± 0.03; both scores reduced to less than 0.03 • Changes in Symptom- specific QOL impairment scores: epigastralgia: 6.2 ± 0.11 to 1.3 ± 0.06, epigastric fullness: 5.8 ± 0.11 to 1.5 ± 0.07 • Therapeutic effect seemed to be stronger for epigastralgia

21. Effects of famotidine on patients with FD

22. 343 patients who had epigastralgia and/or epigastric fullness that had lasted for over 6 months with the absence of organic disease • 65.3% of these patients reported epigastralgia and 75.5% reported epigastric fullness, while 40.8% had both • Changes in intensity scores: epigastralgia: 1.8 ± 0.09 to 0.3 ± 0.05; epigastric fullness: 1.8 ± 0.08 to 0.4 ± 0.05. • Changes in Symptom specific QOL impairment scores: epigastralgia 6.5 ± 0.32 to 1.7 ± 0.2; epigastric fullness: 6.4 ± 0.30 to 2.0 ± 0.22 • Effect on epigastralgia was faster.

24. Famotidine induced remission

25. Symptomatic remission was defined as a score of 0 (asymptomatic) on the face scales. • Remission of QOL impairment required a score of less than 2 (slightly bothered) for each question, and a total score of 3 or less for the subscales • Symptomatic Remission is over 60% (figure A next slide) • Improved QOL to a remission state in over 90% (figure B next slide) • Remission rates evaluated by the Izumo scale • endoscopically examined: 76.5% • unexamined groups were: 75.7% • Remission rates for FD-like patients 76.72 and patients with organic disease: 72.83% • Depression, anxiety, stress, nonsteroidal anti-inflammatory drug (NSAID) use, and baseline Izumo scale scores were influential factors for the remission rates.

26. darker bars: 2nd week evaluations; lighter bars: 4th week evaluations

27. Discussion

28. In the present study, patients diagnosed with FD comprised only less than 5% of the population with chronic symptomatic gastritic • Helicobacter pylori infection has been proposed to be a cause of functional dyspepsia • Eradication of H. pylori did not markedly attenuate abdominal symptoms in patients with FD. • Gastric motor abnormality has been investigated as a cause • It is reported that administration of prokinetic drugs have promising results but majority of findings did not suggest a clinically relevant therapeutic effect • Intraduodenal pH was reported to be lower than in FD patients than in asymptomatic patients

29. Studies confirmed that the inhibition of gastric acid secretion relieved many types of dyspeptic symptoms • Acid inhibitors are considered to have therapeutic effects in at least some patients with FD, as well as having effects on abdominal symptoms reported by patients with other types of gastrointestinal diseases. • In this study, the therapeutic effects of the H2RA famotidine were compared in 3 types of symptomatic patients • 1.functional dyspepsia, 2.chronic symptomatic gastritis, 3. FD-like symptoms and without organic disease • Patient cohort included all dyspeptic patients irrespective of whether or not they had undergone endoscopic examinations.

30. The symptom intensity scores and abdominal symptom-specific impairment of QOL scores were markedly attenuated by famotidine administration. • Findings suggest that closer attention should be given to those patients experiencing lower QOL due to epigastralgia/epigastric fullness than other patients. • The rates of symptom remission and remission of QOL impairment in this study were over 60% and 90%

31. Famotidine

32. Famotidine comes in 20mg preparations • administered orally or parenterally. • H2 receptor blocker • Treatment for peptic ulcer, gastroesophageal reflux disease either as short term or maintenance therapy • It is also given as treatment to hypersecretory pathological conditions such. • Common side effects: diarrhea, constipation, dizziness and headache.

33. Limitations

34. No control group received a placebo • Patients with FD or dyspeptic symptoms tend to have high placebo responses • Various literature showed that remission on placebo was reported to be 15% after a 4-week treatment period on patients with FD or investigated dyspepsia. • Others have reported remission rates with a placebo were 44% at 2nd week of treatment and 23% at 4th week of treatment. • Placebo effect may be greater in patients with short symptom duration. • However in this study, the remission rates measured by the Izumo scale scores were similar in patients with short symptom duration and those with the longer duration, at 79.58 and 72.52%, respectively

35. Conclusion

36. Famotidine is effective to relieve abdominal symptoms and improve QOL, not only in patients with Rome III-defined FD, but also in those with chronic symptomatic gastritis.

37. Source J Gastroenterol (2012) 47:377–386