Evaluation of an in silico pbpk post-bariatric surgery model through simulating oral drug bioavailability of atorvastatin and cyclosporine

CPT: Pharmacometrics and Systems Pharmacology

Volumn 2, Issue 6, 2013, Pages

  Darwich, A S ^a   Pade, D ^b   Rowland Yeo, K ^b   Asberg A ^c   Jamei, M ^b   Christensen, H ^c   Ashcroft, D M ^a   Rostami Hodjegan, A ^a,b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b CERTARA UK LIMITED   (United Kingdom)

^c UNIVERSITY OF OSLO   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; CYCLOSPORIN;

AREA UNDER THE CURVE; ARTICLE; BARIATRIC SURGERY; BILIOPANCREATIC BYPASS; CONTROLLED STUDY; DRUG BIOAVAILABILITY; GASTROINTESTINAL ABSORPTION; HUMAN; MAXIMUM PLASMA CONCENTRATION; MORBID OBESITY; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ROUX Y ANASTOMOSIS; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 84881131230     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.23     Document Type: Article

References (48)

1. Flegal, K.M., Carroll, M.D., Ogden, C.L. & Curtin, L.R. Prevalence and trends in obesity among US adults, 1999-2008. JAMA 303, 235-241 (2010).
2. Organisation for Economics Co-Operation and Development (OECD). Obesity and the Economics of Prevention: Fit not Fat-United Kingdom (England) Key Facts. (2011). Accessed December 2012.
3. Buchwald, H. & Oien, D.M. Metabolic/bariatric surgery Worldwide 2008. Obes. Surg. 19, 1605-1611 (2009).
4. Picot, J. et al. The clinical effectiveness and costeffectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol. Assess. 13, 215-357 (2009).
5. Darwich, A.S. et al. Trends in oral drug bioavailability following bariatric surgery: examining the variable extent of impact on exposure of different drug classes. Br. J. Clin. Pharmacol. 74, 774-787 (2012).
6. Darwich, A.S., Pade, D., Ammori, B.J., Jamei, M., Ashcroft, D.M. & Rostami-Hodjegan, A. A mechanistic pharmacokinetic model to assess modified oral drug bioavailability post bariatric surgery in morbidly obese patients: interplay between CYP3A gut wall metabolism, permeability and dissolution. J. Pharm. Pharmacol. 64, 1008-1024 (2012).
7. Ghobadi, C. et al. Application of a systems approach to the bottom-up assessment of pharmacokinetics in obese patients: expected variations in clearance. Clin. Pharmacokinet. 50, 809-822 (2011).
8. Jamei, M. et al. Population-based mechanistic prediction of oral drug absorption. AAPS J. 11, 225-237 (2009).
9. Malone, M. & Alger-Mayer, S.A. Medication use patterns after gastric bypass surgery for weight management. Ann. Pharmacother. 39, 637-642 (2005). (Pubitemid 40396616)
10. Skottheim, I.B. et al. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin. Pharmacol. Ther. 86, 311-318 (2009).
11. Skottheim, I.B. et al. Significant increase in systemic exposure of atorvastatin after biliopancreatic diversion with duodenal switch. Clin. Pharmacol. Ther. 87, 699-705 (2010).
12. Pellegrini, C.A., Deveney, C.W., Patti, M.G., Lewin, M. & Way, L.W. Intestinal transit of food after total gastrectomy and Roux-Y esophagojejunostomy. Am. J. Surg. 151, 117-125 (1986). (Pubitemid 16143192)
13. Suzuki, S., Ramos, E.J., Goncalves, C.G., Chen, C. & Meguid, M.M. Changes in GI hormones and their effect on gastric emptying and transit times after Roux-en-Y gastric bypass in rat model. Surgery 138, 283-290 (2005).
14. Gaggiotti, G. et al. Modifications of intestinal permeability test induced by biliopancreatic diversion: preliminary results. Obes. Surg. 5, 424-426 (1995).
15. Mendieta-Zerón, H. et al. Biliopancreatic diversion induces villi elongation and cholecystokinin and ghrelin increase. Diabetes Metab. Syndr. 5, 66-70 (2011).
16. Savage, A.P., Adrian, T.E., Carolan, G., Chatterjee, V.K. & Bloom, S.R. Effects of peptide YY (PYY) on mouth to caecum intestinal transit time and on the rate of gastric emptying in healthy volunteers. Gut 28, 166-170 (1987). (Pubitemid 17027386)
17. Buell, M.G. & Harding, R.K. Effects of peptide YY on intestinal blood flow distribution and motility in the dog. Regul. Pept. 24, 195-208 (1989). (Pubitemid 19043538)
18. Garcia-Fuentes, E. et al. Different effect of laparoscopic Roux-en-Y gastric bypass and open biliopancreatic diversion of Scopinaro on serum PYY and ghrelin levels. Obes. Surg. 18, 1424-1429 (2008).
19. Darwich, A.S., Neuhoff, S., Jamei, M. & Rostami-Hodjegan, A. Interplay of metabolism and transport in determining oral drug absorption and gut wall metabolism: a simulation assessment using the "Advanced Dissolution, Absorption, Metabolism (ADAM)" model. Curr. Drug Metab. 11, 716-729 (2010).
20. Marterre, W.F., Hariharan, S., First, M.R. & Alexander, J.W. Gastric bypass in morbidly obese kidney transplant recipients. Clin. Transplant. 10, 414-419 (1996). (Pubitemid 26363119)
21. Chenhsu, R.Y., Wu, Y., Katz, D. & Rayhill, S. Dose-adjusted cyclosporine c2 in a patient with jejunoileal bypass as compared to seven other liver transplant recipients. Ther. Drug Monit. 25, 665-670 (2003). (Pubitemid 37499300)
22. Steimer, W. Performance and specificity of monoclonal immunoassays for cyclosporine monitoring: how specific is specific? Clin. Chem. 45, 371-381 (1999). (Pubitemid 29114172)
23. Venkataramanan, R. et al. Biliary excretion of cyclosporine in liver transplant patients. Transplant. Proc. 17, 286-289 (1985). (Pubitemid 15126631)
24. Mehta, M.U. et al. Effect of bile on cyclosporin absorption in liver transplant patients. Br. J. Clin. Pharmacol. 25, 579-584 (1988).
25. Wójcikowski, J., Pichard-Garcia, L., Maurel, P. & Daniel, W.A. Contribution of human cytochrome p-450 isoforms to the metabolism of the simplest phenothiazine neuroleptic promazine. Br. J. Pharmacol. 138, 1465-1474 (2003). (Pubitemid 36609642)
26. Lown, K.S. et al. Role of intestinal P-glycoprotein (mdr1) in interpatient variation in the oral bioavailability of cyclosporine. Clin. Pharmacol. Ther. 62, 248-260 (1997). (Pubitemid 27417790)
27. Paine, M.F., Davis, C.L., Shen, D.D., Marsh, C.L., Raisys, V.A. & Thummel, K.E. Can oral midazolam predict oral cyclosporine disposition? Eur. J. Pharm. Sci. 12, 51-62 (2000).
28. Knight, G.C., Macris, M.P., Peric, M., Duncan, J.M., Frazier, O.H. & Cooley, D.A. Cyclosporine A pharmacokinetics in a cardiac allograft recipient with a jejuno-ileal bypass. Transplant. Proc. 20, 351-355 (1988).
29. Lennernäs, H. Clinical pharmacokinetics of atorvastatin. Clin. Pharmacokinet. 42, 1141-1160 (2003). (Pubitemid 37357650)
30. Jamei, M., Marciniak, S., Feng, K., Barnett, A., Tucker, G. & Rostami-Hodjegan, A. The Simcyp population-based ADME simulator. Expert Opin. Drug Metab. Toxicol. 5, 211-223 (2009).
31. Mueller, E.A., Kovarik, J.M., van Bree, J.B., Tetzloff, W., Grevel, J. & Kutz, K. Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation. Pharm. Res. 11, 301-304 (1994). (Pubitemid 24076228)
32. Bernareggi, A. & Rowland, M. Physiologic modeling of cyclosporin kinetics in rat and man. J. Pharmacokinet. Biopharm. 19, 21-50 (1991).
33. Jacobsen, W. et al. Lactonization is the critical first step in the disposition of the 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor atorvastatin. Drug Metab. Dispos. 28, 1369-1378 (2000).
34. Goosen, T.C. et al. Atorvastatin glucuronidation is minimally and nonselectively inhibited by the fibrates gemfibrozil, fenofibrate, and fenofibric acid. Drug Metab. Dispos. 35, 1315-1324 (2007). (Pubitemid 47121772)
35. Prueksaritanont, T., Tang, C., Qiu, Y., Mu, L., Subramanian, R. & Lin, J.H. Effects of fibrates on metabolism of statins in human hepatocytes. Drug Metab. Dispos. 30, 1280-1287 (2002). (Pubitemid 35265837)
36. Howgate, E.M., Rowland Yeo, K., Proctor, N.J., Tucker, G.T. & Rostami-Hodjegan, A. Prediction of in vivo drug clearance from in vitro data. I: impact of inter-individual variability. Xenobiotica. 36, 473-497 (2006).
37. Lau, Y.Y., Huang, Y., Frassetto, L. & Benet, L.Z. effect of OATP1B transporter inhibition on the pharmacokinetics of atorvastatin in healthy volunteers. Clin. Pharmacol. Ther. 81, 194-204 (2007). (Pubitemid 46174816)
38. Amundsen, R., Christensen, H., Zabihyan, B. & Asberg, A. Cyclosporine A, but not tacrolimus, shows relevant inhibition of organic anion-transporting protein 1B1-mediated transport of atorvastatin. Drug Metab. Dispos. 38, 1499-1504 (2010).
39. Hedberg, J., Hedenström, H., Karlsson, F.A., Edén- Engström, B. & Sundbom, M. Gastric emptying and postprandial PYY response after biliopancreatic diversion with duodenal switch. Obes. Surg. 21, 609-615 (2011).
40. Horowitz, M. et al. Measurement of gastric emptying after gastric bypass surgery using radionuclides. Br. J. Surg. 69, 655-657 (1982). (Pubitemid 13232187)
41. Wittgrove, A.C. & Clark, G.W. Laparoscopic gastric bypass, Roux-en-Y-500 patients: technique and results, with 3-60 month follow-up. Obes. Surg. 10, 233-239 (2000).
42. Smith, C.D., Herkes, S.B., Behrns, K.E., Fairbanks, V.F., Kelly, K.A. & Sarr, M.G. Gastric acid secretion and vitamin B12 absorption after vertical Roux-en-Y gastric bypass for morbid obesity. Ann. Surg. 218, 91-96 (1993). (Pubitemid 23215198)
43. Behrns, K.E., Smith, C.D. & Sarr, M.G. Prospective evaluation of gastric acid secretion and cobalamin absorption following gastric bypass for clinically severe obesity. Dig. Dis. Sci. 39, 315-320 (1994). (Pubitemid 24073606)
44. Hedberg, J., Hedenstrom, H. & Sundbom, M. Wireless pH-metry at the gastrojejunostomy after Roux-en-Y gastric bypass: a novel use of the BRAVO system. Surg. Endosc. 25, 2302-2307 (2005).
45. Saliba, J. et al. Roux-en-Y gastric bypass reverses renal glomerular but not tubular abnormalities in excessively obese diabetics. Surgery 147, 282-287 (2010).
46. Chagnac, A., Weinstein, T., Herman, M., Hirsh, J., Gafter, U. & Ori, Y. The effects of weight loss on renal function in patients with severe obesity. J. Am. Soc. Nephrol. 14, 1480-1486 (2003). (Pubitemid 36687049)
47. Navarro-Díaz, M. et al. Effect of drastic weight loss after bariatric surgery on renal parameters in extremely obese patients: long-term follow-up. J. Am. Soc. Nephrol. 17, S213-S217 (2006). (Pubitemid 44865251)
48. Serra, A. et al. The effect of bariatric surgery on adipocytokines, renal parameters and other cardiovascular risk factors in severe and very severe obesity: 1-year follow-up. Clin. Nutr. 25, 400-408 (2006). (Pubitemid 44182760)