Cardiovascular and Metabolic Disorders

Postprandial triglyceride reduction following acute treatment of a selective 5-hydroxytryptamine-2c agonist and characterization using a semi-physiological model.

Leohr J, Heathman M, Kjellsson MC. Diabetes Obes Metab. 2021 Apr;23(4):1001-1010. doi: 10.1111/dom.14306.

A Model-Informed Drug Development (MIDD) Approach for a Low Dose of Empagliflozin in Patients with Type 1 Diabetes

Johnston CK, Eudy-Byrne RJ, Elmokadem A, Nock V, Marquard J, Soleymanlou N, Riggs MM, Liesenfeld K-H. Pharmaceutics. 2021; 13(4):485.

Low-Dose Empagliflozin as Adjunct-to-Insulin Therapy in Type 1 Diabetes: A Valid Modeling and Simulation Analysis to Confirm Efficacy

Perkins BA, Soleymanlou N, Rosenstock J, Skyler JS, Laffel LM, Liesenfeld KH, Neubacher D, Riggs MM, Johnston CK, Eudy-Byrne RJ, Elmokadem A, George JT, Marquard J, Nock V.  Diabetes, Obesity & Metabolism, 2019 Dec 19. Available from:

The confluence of Statistical and Pharmacometric Approaches for Benefit Risk Analysis: a case study using Bayesian joint models for safety and efficacy

Presented by Jonathan French, Sc.D., at the American Conference on Pharmacometrics (ACoP10) during the tutorial: The Role of Pharmacometrics in Advancing Quantitative Benefit-Risk Assessments for Drug Review and Approval. 24 Oct 2019

Real world evidence and model-informed drug development – an antidiabetic drug cardiovascular outcome case study

Meng Z, Rogers JA, Sidi J, Tang Q, Patel D, Gaudel-Dedieu N, and Delvart D. Presented at the Annual Meeting of the Population Approach Group in Europe (PAGE) Montreux, Switzerland, May 2018. Abstract I-76.

Population pharmacokinetic – pharmacodynamic analysis to characterize the effect of empagliflozin on renal glucose threshold in patients with type 1 diabetes mellitus

Mondick J, Riggs M, Kaspers S, Soleymanlou N, Marquard J, Nock V. J Clin Pharmacol. 58 (5): 640-649; May 2018

Quantitative disease progression model of α-1 proteinase inhibitor therapy on computed tomography lung density in patients with α-1 antitrypsin deficiency

Tortorici MA, Rogers JA, Vit O, Bexon M, Sandhaus R A, Burdon J, Chorostowska-Wynimko J, Thompson P, Stocks J, McElvaney NG, Chapman KR, and Edelman JM. Br J Clin Pharmacol, June 2017.  doi: 10.1111/bcp.13358.

Population pharmacokinetics and exposure-response (efficacy and safety/tolerability) of empagliflozin in patients with type 2 diabetes

Baron KT, Macha S, Broedl UC, Nock V, Retlich S, Riggs M.  Diabetes Ther. 2016 Sep;7(3):455-71.

Mixed-effects modelling to quantify the effect of empagliflozin on renal glucose reabsorption in patients with type 2 diabetes

Mondick J, Riggs M, Sasaki T, Sarashina A, Broedl UC, Retlich S. Diabetes Obes Metab. 2016 Mar;18(3):241-8.

Facilitating cardiovascular safety exposure-response modeling in early-phase clinical studies with the cardioModel package for R

Conrado DJ, Hather GJ, Chen D, Denney WS. Facilitating Cardiovascular Safety Exposure-Response Modeling in Early-Phase Clinical Studies with the cardioModel Package for R.  Presented at the 6th American Conference on Pharmacometrics (ACoP), Arlington, VA, October 2015

Altered morphine glucuronide and bile acid disposition in patients with nonalcoholic steatohepatitis

Ferslew B, Johnston C, Tsakalozou E, Bridges A, Paine M, Jia W, Stewart P, Barritt A and Brouwer K. Clinical Pharmacology and Therapeutics, 97: 419–427. doi:10.1002/cpt.66

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study

Jin Y, Bies R, Gastonguay MR, Wang Y, Stockbridge N, Gobburu J, Madabushi R. J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):693-704. doi: 10.1007/s10928-014-9394-9

Exposure−response modelling for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes

Riggs MM, Seman LJ, Staab A, MacGregor TR, Gillespie W, Gastonguay MR, Woerle HJ, Macha S.  Br J Clin Pharmacol. 2014 Dec;78(6):1407-18. doi: 10.1111/bcp.12453.

Altered fasting and postprandial serum bile acids in patients with non-alcoholic steatohepatitis (NASH)

Ferslew BC, Johnston CK, Tsakalozou EF, Su MI, Xie GU, Jia WE, Brouwer KLR and Barritt AS. Presented at the American Association for the Study Of Liver Diseases Annual Meeting, Boston, MA, November 2014; Abstract 831.

Pharmacokinetic modeling of the relationship between sustained virological response and plasma concentrations of faldaprevir or bi-207127 in hcv gt1-infected patients in sound-c2

Olson S, Baron K, Riggs M, Bocher WO, Mensa FJ.  Journal of Hepatology, 58:S492–S493.

Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes

Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S.  The Journal of Clinical Pharmacology. 2013 Oct;53(10):1028-38. doi:10.1002/jcph.147

Population pharmacokinetics of atorvastatin and its active metabolites in children and adolescents with heterozygous familial hypercholesterolemia: Selective use of informative prior distributions from adults

Knebel W, Gastonguay MR, Malhotra B, El-Tahtawy A, Jen F and Gandelman K.  J Clin Pharmacol. 2013 May; 53 (5): 505-16. doi: 10.1002/jcph.66.

A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment of type 2 diabetes mellitus

Gross JL, Rogers JA, Polhamus D, Gillespie W, Friedrich C, Gong Y, Monz BU, Patel A, Staab A, Retlich S. BMJ Open. 5 March 2013.

Novel model-based meta-analysis to estimate comparative efficacies of 2 drugs: An example using the DPP-4 inhibitors linagliptin and sitagliptin in type 2 diabetes mellitus

Gross JL, Rogers JA, Polhamus D, Gillespie W, Patel S, Friedrich C, Gong Y, Monz B, Staab A, Retlich S.  American Diabetes Association 72nd Scientific Sessions, 2012.

Misclassification and discordance of measured blood pressure from patient’s true blood pressure in current clinical practice: A clinical trial simulation case study

Jin Y, Bies R, Gastonguay MR, Stockbridge N, Gobburu J, Madabushi R.  J Pharmacokinet Pharmacodyn. 2012 Jun;39(3):283-94.

Model-based meta-analysis comparison of the effects of linagliptin and sitagliptin on HbA1c levels in patients with type 2 diabetes mellitus

Rogers JA, Polhamus D, Gillespie W, Friedrich C, Staab A, and Retlich S. Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2448.