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

Efficacy and safety of adding sotagliflozin, a dual sodium‐glucose co‐transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m2

Authors: Danne, Thomas, Edelman, Steven, Frias, Juan Pablo, Ampudia‐Blasco, Francisco Javier, Banks, Philip, Jiang, Wenjun, Davies, Michael J., Sawhney, Sangeeta

Source: Diabetes, obesity & metabolism. 23(3):854-860

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100121426319.0x000001&indx=1&recIds=ETOCvdc_100121426319.0x000001

Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone

Authors: Danne, Thomas, Joish, Vijay N., Afonso, Marion, Banks, Phillip, Sawhney, Sangeeta, Lapuerta, Pablo, Davies, Michael J., Buse, John B., Lin, Dee, Reaney, Matthew, Guillonneau, Sophie, Snoek, Frank J., Bailey, Timothy S., Polonsky, William H.

Source: Diabetes technology & therapeutics. 23(1):70-77

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100151019884.0x000001&indx=1&recIds=ETOCvdc_100151019884.0x000001

Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study

Authors: Bode, Bruce W., Cengiz, Eda, Wadwa, R. Paul, Banks, Phillip, Danne, Thomas, Kushner, Jake A., McGuire, Darren K., Peters, Anne L., Strumph, Paul, Sawhney, Sangeeta

Source: Diabetes technology & therapeutics. 23(1):59-69

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100151019877.0x000001&indx=1&recIds=ETOCvdc_100151019877.0x000001

Incidence and risk of dyslipidemia and hyperglycemia in a phase 3 study of obeticholic acid for the treatment of non-alcoholic steatohepatitis

Authors: Abdelmalek, Manal, Capozza, Thomas, Davis, Pamela, Randhawa, Amarita, Sawhney, Sangeeta

Source: Journal of hepatology. 78(S1):S809-S810

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100194687362.0x000001&indx=1&recIds=ETOCvdc_100194687362.0x000001

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

Dose‐dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial

Authors: Baker, Claire, Wason, Suman, Banks, Phillip, Sawhney, Sangeeta, Chang, Anna, Danne, Thomas, Gesty‐Palmer, Diane, Kushner, Jake A., McGuire, Darren K., Mikell, Frank, O'Neill, Mark, Peters, Anne L., Strumph, Paul

Source: Diabetes, obesity & metabolism. 21(11):2440-2449

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100090977905.0x000001&indx=1&recIds=ETOCvdc_100090977905.0x000001

Sotagliflozin Added to Optimized Insulin Therapy Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c at 52 Weeks in Adults with Type 1 Diabetes

Authors: Danne, Thomas, Pettus, Jeremy, Giaccari, Andrea, Cariou, Bertrand, Rodbard, Helena, Weinzimer, Stuart A., Bonnemaire, Mireille, Sawhney, Sangeeta, Stewart, John, Wang, Stella, Castro, Rita de Cassia, Garg, Satish K.

Source: Diabetes technology & therapeutics. 21(9):471-477

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100087278672.0x000001&indx=1&recIds=ETOCvdc_100087278672.0x000001

Safety, pharmacokinetics and pharmacodynamics of obeticholic acid in subjects with fibrosis or cirrhosis from NASH.

Authors: Alkhouri, Naim, LaCerte, Carl, Edwards, Jeffrey, Poordad, Fred, Lawitz, Eric, Lee, Lois, Karan, Sharon, Sawhney, Sangeeta, Erickson, Mary, MacConell, Leigh, Zaru, Luna, Chen, Jianfen, Campagna, Jason

Source: Liver International; Apr2024, Vol. 44 Issue 4, p966-978, 13p

Subject Terms: FARNESOID X receptor, CIRRHOSIS of the liver, FIBROSIS, LIVER histology, PHARMACODYNAMICS, ALANINE aminotransferase

Utility of pathologist panels for achieving consensus in NASH histologic scoring in clinical trials: Data from a phase 3 study.

Authors: Sanyal, Arun J., Loomba, Rohit, Anstee, Quentin M., Ratziu, Vlad, Kowdley, Kris V., Rinella, Mary E., Harrison, Stephen A., Resnick, Murray B., Capozza, Thomas, Sawhney, Sangeeta, Shelat, Nirav, Younossi, Zobair M.

Source: Hepatology Communications; Jan2024, Vol. 8 Issue 1, p1-9, 9p

Incidence and median times to onset and resolution of pruritus adverse events in a phase 3 study of obeticholic acid in patients with non-alcoholic steatohepatitis

Authors: Younossi, Zobair, Feinman, Leighland, Randhawa, Amarita, Leyva, Rina, Stepanova, Maria, Sawhney, Sangeeta

Source: Journal of hepatology. 78(S1):S823-S823

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100195502263.0x000001&indx=1&recIds=ETOCvdc_100195502263.0x000001

LBP-036 Final results from the phase 3 REGENERATE trial evaluating the effects of obeticholic acid in patients with pre-cirrhotic fibrosis due to metabolic dysfunction-associated steatohepatitis

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

Source: In Journal of Hepatology June 2024 80 Supplement 1:S95-S95

FINAL RESULTS FROM THE PHASE 3 REGENERATE TRIAL EVALUATING THE EFFECTS OF OBETICHOLIC ACID IN PATIENTS WITH PRE-CIRRHOTIC FIBROSIS DUE TO NONALCOHOLIC STEATOHEPATITIS

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

Source: In Gastroenterology 18-21 May 2024 166(5) Supplement:1057e-1057e

Mo1582 SAFETY ANALYSIS OF THE CURRENT US PRESCRIBING INFORMATION–INDICATED POPULATION FROM THE HEROES STUDY OF OBETICHOLIC ACID IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS

Authors: Hirschfield, Gideon, Brookhart, Maurice A., Fried, Michael W., Bessonova, Leona, Chu, Yucheng J., Wheeler, Darren, Hansen, Bettina, Seeger, John D., Sawhney, Sangeeta, Jones, Dave E.

Source: In Gastroenterology 18-21 May 2024 166(5) Supplement:S

FRI-516 - Incidence and median times to onset and resolution of pruritus adverse events in a phase 3 study of obeticholic acid in patients with non-alcoholic steatohepatitis

Authors: Younossi, Zobair, Feinman, Leighland, Randhawa, Amarita, Leyva, Rina, Stepanova, Maria, Sawhney, Sangeeta

Source: In Journal of Hepatology June 2023 78 Supplement 1:S823-S823

FRI-467 - Incidence and risk of dyslipidemia and hyperglycemia in a phase 3 study of obeticholic acid for the treatment of non-alcoholic steatohepatitis

Authors: Abdelmalek, Manal, Capozza, Thomas, Davis, Pamela, Randhawa, Amarita, Sawhney, Sangeeta

Source: In Journal of Hepatology June 2023 78 Supplement 1:S809-S810

Efficacy and safety of adding sotagliflozin, a dual sodium‐glucose co‐transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m².

Authors: Danne, Thomas, Edelman, Steven, Frias, Juan Pablo, Ampudia‐Blasco, Francisco Javier, Banks, Philip, Jiang, Wenjun, Davies, Michael J., Sawhney, Sangeeta

Source: Diabetes, Obesity & Metabolism; Mar2021, Vol. 23 Issue 3, p854-860, 7p

Subject Terms: SODIUM-glucose cotransporters, TYPE 1 diabetes, BODY mass index, DRUG efficacy, SODIUM-glucose cotransporter 2 inhibitors, INSULIN

Geographic Terms: EUROPE

Effect of sotagliflozin as an adjunct to insulin therapy on blood pressure and arterial stiffness in adults with type 1 diabetes: A post hoc pooled analysis of inTandem1 and inTandem2.

Authors: Rodbard, Helena W, Giaccari, Andrea, Cariou, Bertrand, Garg, Satish, Davies, Michael J, Seth, Kiernan, Sawhney, Sangeeta

Source: Diabetes & Vascular Disease Research; Jan/Feb2021, Vol. 18 Issue 1, p1-4, 4p

Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.

Authors: Peters, Anne L., McGuire, Darren K., Danne, Thomas, Kushner, Jake A., Rodbard, Helena W., Dhatariya, Ketan, Sawhney, Sangeeta, Banks, Phillip, Jiang, Wenjun, Davies, Michael J., Lapuerta, Pablo

Source: Diabetes Care; Nov2020, Vol. 43 Issue 11, p2713-2720, 8p

Subject Terms: TYPE 1 diabetes, DIABETIC acidosis, INSULIN pumps, INSULIN, PATIENT education, ADULTS

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