Edoardo Vincenzo Savarino.pdf

Prof. Edoardo Vincenzo Savarino is mainly interested in:

- Neurogastroenterology and Motility,
- Esophageal Diseases (i.e.gastroesophageal reflux disease, motor disorders, achalasia, eosinophilic esophagitis
- Functional and Inflammatory Bowel Disorders (i.e. Crohn’s disease and ulcerative colitis, diverticulitis, irritable bowel syndrome,),
- Gut microbiota

He has published extensively on gastroesophageal reflux disease (GERD), esophageal motility disorders, swallowing disorders, Barrett’s Esophagus, functional disorders (functional dyspepsia, irritable bowel syndrome), achalasia, eosinophilic esophagitis, new methodologies of esophageal function testing, and inflammatory bowel diseases (Crohn’s disease and ulcerative colitis). He received various prizes for his work from United European Gastroenterology Federation, OESO foundation, ISDE, Società Italiana di Gastroenterologia ed Endoscopia (SIGE). In particular, he was awarded by the United European Gastroenterology Federations as Rising Star in 2016 (Major Award from the European Societies of Gastroenterology for young Researchers) and he was invited to give state-of-the-art lectures at University of Washington University, Cambridge University, Stanford University, UEGW and DDW. Prof. Edoardo Vincenzo Savarino is an ISDE, AGA, OESO, SIGE, SIED, GISMAD, ESDO, IG-IBD, ESNM and ECCO member. He is an Associate Editor of BMC Gastroenterology, Digestive and Liver Disease, World Journal of Gastroenterology and Diseases of The Esophagus. He is a Steering Committee Member of the ESNM, SIGE and ISDE. He is Reviewer for several journals, including New England Journal of Medicine, American Journal Respiratory and Critical Care Medicine (AJRCCM), Gastroenterology, Gut, Alimentary Pharmacology And Therapeutics (APT), Clinical Gastroenterology and Hepatology (CGH), American Journal of Gastroenterology, UEG Journal, Journal of Gastroenterology and Hepatology (JGH) and Neurogastroenterology and Motility (NMO).

1. Savarino E, Pohl D, Zentilin P, Dulbecco P, Sammito G, Sconfienza L, Vigneri S, Camerini G, Tutuian R, Savarino V. Functional heartburn has more in common with functional dyspepsia than with non-erosive reflux disease. Gut. 2009 Sep;58(9):1185-91. doi: 10.1136/gut.2008.175810.

2. Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362

3. Savarino E, Bazzica M, Zentilin P, Pohl D, Parodi A, Cittadini G, Negrini S, Indiveri F, Tutuian R, Savarino V, Ghio M. Gastroesophageal reflux and pulmonary fibrosis in scleroderma: a study using pH-impedance monitoring. Am J Respir Crit Care Med. 2009 Mar 1;179(5):408-13. doi: 10.1164/rccm.200808-1359OC.

4. Savarino E, Zentilin P, Savarino V. NERD: an umbrella term including heterogeneous subpopulations. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):371-80. doi: 10.1038/nrgastro.2013.50.

5. Savarino E, Bredenoord AJ, Fox M, Pandolfino JE, Roman S, Gyawali CP; International Working Group for Disorders of Gastrointestinal Motility and Function. Advances in the physiological assessment and diagnosis of GERD. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):323.

6. Molina-Infante J, Arias Á, Alcedo J, Garcia-Romero R, Casabona-Frances S, Prieto-Garcia A, Modolell I, Gonzalez-Cordero PL, Perez-Martinez I, Martin-Lorente JL, Guarner-Argente C, Masiques ML, Vila-Miravet V, Garcia-Puig R, Savarino E, Sanchez-Vegazo CT, Santander C, Lucendo AJ. Step-up empiric elimination diet for pediatric and adult eosinophilic esophagitis: The 2-4-6 study. J Allergy Clin Immunol. 2018 Apr;141(4):1365-1372.

7. Savarino E, Carbone R, Marabotto E, Furnari M, Sconfienza L, Ghio M, Zentilin P, Savarino V. Gastro-oesophageal reflux and gastric aspiration in idiopathic pulmonary fibrosis patients. Eur Respir J. 2013 Nov;42(5):1322-31. doi: 10.1183/09031936.00101212.

8. Savarino E, Zentilin P, Tutuian R, Pohl D, Casa DD, Frazzoni M, Cestari R, Savarino V. The role of nonacid reflux in NERD: lessons learned from impedance-pH monitoring in 150 patients off therapy. Am J Gastroenterol. 2008 Nov;103(11):2685-93

9. Savarino E, Bodini G, Dulbecco P, Assandri L, Bruzzone L, Mazza F, Frigo AC, Fazio V, Marabotto E, Savarino V. Adalimumab is more effective than azathioprine and mesalamine at preventing postoperative recurrence of Crohn's disease: a randomized controlled trial. Am J Gastroenterol. 2013 Nov;108(11):1731-42.

10. Savarino E, Tutuian R, Zentilin P, Dulbecco P, Pohl D, Marabotto E, Parodi A, Sammito G, Gemignani L, Bodini G, Savarino V. Characteristics of reflux episodes and symptom association in patients with erosive esophagitis and nonerosive reflux disease: study using combined impedance-pH off therapy. Am J Gastroenterol. 2010 May;105(5):1053-61.

Public and Competitive Funding

a) 2008 - Title of The Research Project “Pathogenic Mechanisms And Common Therapeutic Strategies In the Immune-Related Dermatopathies Associated To Chronic Enteropathies” Funded by Italian Ministry of Instruction, Research and University – PRIN 2008

b) 2009 - Title of The Research Project “Evaluation Of Small Bowel Distension After Ingestion of Oral Lactulose By Means Of Magnetic Resonance Imaging In Healthy Volunteers And A Group Of Patients With Irritable Bowel Syndrome” Funded by Italian Society of Gastroenterology (SIGE)

c) 2010 - Title of The Research Project “Relationship Between Gastro-oesophageal Reflux And Idiopathic Pulmonary Fibrosis – A Study Using Impedance-pH And High Resolution Computed Tomography” Funded by Italian Society of Gastroenterology (SIGE)

d) 2016 - Title of The Research Project “Impact of Chronicity on Disability State and Quality of Life in Patients with Ulcerative Colitis” Funded by the Italian Group of Inflammatory Bowel Disease (IG-IBD)

Commercial Funding (Clinical Trials)

Number of Clinical Trials: IBD (n=30), IBS (n=5), GERD (n=30)

Clinical Trials Phases: IIa, IIb, III and IV (post marketing)

Role: Principal Investigator or Secondary Investigator

Date of last GCP Training: 19/JUL/2017

Among them:

1)    Phase IIB Study: Rifaximin delayed release (400 mg tablet) for the prevention of recurrent acute diverticulitis and diverticular complications. A phase II, multicenter, double-blind, placebo-controlled, randomized clinical trial (The ROAD trial).

2)    Phase IV Study (Funded by AIFA): Appropriatezza d’uso di Mesalazina e/o di Rifaximina nel trattamento della malattia diverticolare sintomatica non complicata del colon: studio multicentrico, randomizzato, doppio cieco, doppio dummy, controllato verso placebo (studio MERISUDD)

3)    Phase III Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Followed by an Open-Label Treatment Period to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)

4)    Phase III Study: Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis

5)    Phase III Study: RLM-MD-01 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

6)    Phase III Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

7)    Phase II Study: A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence (STOP-Postoperative Endoscopic Recurrence Study)

8)    Phase II/III Study: A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

9)    Phase II/III Study: RPC01-3201 / RPC01-3202; Phase III Ozanimod induction study for moderately to severely active Crohn’s disease, RPC01-3203 Ozanimod Maintenance Study and RPC01-3204 Ozanimod Open-Label Extension Study

10)  Phase III Study: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease