Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis

Authors: Sanyal, Arun J., Ratziu, Vlad, Loomba, Rohit, Anstee, Quentin M., Kowdley, Kris V., Rinella, Mary E., Sheikh, Muhammad Y., Trotter, James F., Knapple, Whitfield, Lawitz, Eric J., Abdelmalek, Manal F., Newsome, Philip N., Boursier, Jérôme, Mathurin, Philippe, Dufour, Jean-François, Berrey, M. Michelle, Shiff, Steven J., Sawhney, Sangeeta, Capozza, Thomas, Leyva, Rina, Harrison, Stephen A., Younossi, Zobair M.

Source: In Journal of Hepatology November 2023 79(5):1110-1120

Sa1603 OBETICHOLIC ACID TREATMENT OF FIBROSIS DUE TO NONALCOHOLIC STEATOHEPATITIS REDUCES INCIDENCE OF DIARRHEA BUT INCREASES CONSTIPATION: AN ANALYSIS BASED ON ADVERSE EVENTS FROM THE REGENERATE TRIAL

Authors: Walters, Julian R., Erickson, Mary, Capozza, Thomas, White, Christopher, Shiff, Steven J.

Source: Gastroenterology. 164(6):S-1310-S-1310

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100194452709.0x000001&indx=1&recIds=ETOCvdc_100194452709.0x000001

Sulindac Inhibits Neointimal Formation after Arterial Injury in Wild-Type and Apolipoprotein E-Deficient Mice

Authors: Reis, Ernane D., Roque, Merce, Dansky, Hayes, Fallon, John T., Badimon, Juan J., Cordon-Cardo, Carlos, Shiff, Steven J., Fisher, Edward A.

Source: Proceedings of the National Academy of Sciences of the United States of America, 2000 Nov 01. 97(23), 12764-12769.

Access URL: https://www.jstor.org/stable/123924

451 NEW SAFETY AND EFFICACY ANALYSES FROM THE REGENERATE TRIAL OF OBETICHOLIC ACID FOR THE TREATMENT OF NONALCOHOLIC STEATOHEPATITIS

Authors: Rinella, Mary, Sanyal, Arun J., Loomba, Rohit, Anstee, Quentin M., Ratziu, Vlad, Kowdley, Kris V., Lawitz, Eric, Abdelmalek, Manal F., Berrey, M. Michelle, White, Christopher, Shiff, Steven J., Sawhney, Sangeeta, Capozza, Thomas, Leyva, Rina, Harrison, Stephen A., Younossi, Zobair M.

Source: Gastroenterology. 164(6):S-1250-S-1251

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100194454667.0x000001&indx=1&recIds=ETOCvdc_100194454667.0x000001

Effect of Linaclotide on Severe Abdominal Symptoms in Patients With Irritable Bowel Syndrome With Constipation

Authors: Rao, Satish S.C., Quigley, Eamonn M.M., Shiff, Steven J., Lavins, Bernard J., Kurtz, Caroline B., MacDougall, James E., Currie, Mark G., Johnston, Jeffrey M.

Source: In Clinical Gastroenterology and Hepatology April 2014 12(4):616-623

Comparison of adequate relief with symptom, global, and responder endpoints in linaclotide phase 3 trials in IBS‐C

Authors: Camilleri, Michael, Lembo, Anthony J, Lavins, Bernard J, MacDougall, James E, Carson, Robyn T, Williams, Valerie SL, Nelson, Lauren M, Shiff, Steven J, Currie, Mark G, Kurtz, Caroline B, Johnston, Jeffrey M

Source: United European Gastroenterology journal. 3(1):53-62

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100112782040.0x000001&indx=1&recIds=ETOCvdc_100112782040.0x000001

A review of the clinical efficacy of linaclotide in irritable bowel syndrome with constipation

Authors: Johnston, Jeffrey M., Shiff, Steven J., Quigley, Eamonn M.M.

Source: Current medical research and opinion. 29(2):149-160

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100103119341.0x000001&indx=1&recIds=ETOCvdc_100103119341.0x000001

Two Randomized Trials of Linaclotide for Chronic Constipation.

Authors: Lembo, Anthony J., Schneier, Harvey A., Shiff, Steven J., Kurtz, Caroline B., MacDougall, James E., Jia, Xinwei D., Shao, James Z., Lavins, Bernard J., Currie, Mark G., Fitch, Donald A., Jeglinski, Brenda I., Eng, Paul

Source: New England Journal of Medicine; August 11 2011, Vol. 365 Issue 6, p527-536, 10p

Selection of topically applied non-steroidal anti-inflammatory drugs for oral cancer chemoprevention

Authors: Sood, Sandeep, Shiff, Steven J., Yang, Chung S., Chen, Xiaoxin

Source: In Oral Oncology 2005 41(6):562-567

Method for identifying individuals at risk for colorectal neoplasia by quantifying normal colonic mucosal epithelial cell apoptosis

Cyclooxygenase inhibitors: drugs for cancer prevention

Authors: Shiff, Steven J, Shivaprasad, Punitha, Santini, Diana L

Source: In Current Opinion in Pharmacology 2003 3(4):352-361

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Aspirin for cancer.

Authors: Shiff, Steven J., Rigas, Basil

Source: Nature Medicine; December 1999, Vol. 5 Issue 12, p1348-1349, 2p

Sa2008 Efficacy and Safety of Linaclotide in Chronic Idiopathic Constipation Patients With Abdominal Bloating: Phase 3b Trial Results

Authors: Lacy, Brian E., Lembo, Anthony, Schey, Ron, Lavins, Bernard J., Eng, Paul F., Fox, Susan M., Jia, Xinwei D., Hao, Xinming, Currie, Mark G., Kurtz, Caroline B., Johnston, Jeffrey, Shiff, Steven J.

Source: In Gastroenterology May 2014 146(5) Supplement 1:S

Colon adenomatous polyps—do they grow inward?

Authors: Shiff, Steven J., Rigas, Basil

Source: Lancet; June 28 1997, Vol. 349, p1853-1854, 2p

A ssessment of treatment response in chronic constipation clinical trials.

Authors: Ervin, Claire M., Fehnel, Sheri E., Baird, Mollie J., Carson, Robyn T., Johnston, Jeffrey M., Shiff, Steven J., Kurtz, Caroline B., Mangel, Allen W.

Source: Clinical & Experimental Gastroenterology; 2014, Vol. 7, p191-198, 8p, 5 Charts, 1 Graph

Subject Terms: CONSTIPATION, THERAPEUTICS, CLINICAL trials, HEALTH outcome assessment, DIAGNOSIS of abdominal pain, ABDOMINAL bloating

Company/Entity: UNITED States. Food & Drug Administration