Development of safety profile evaluating pharmacokinetics, pharmacodynamics and toxicity of a combination of pioglitazone and olmesartan medoxomil in Wistar albino rats

Regulatory Toxicology and Pharmacology

Volumn 62, Issue 1, 2012, Pages 7-15

  Sengupta, Pinaki ^a   Nandi, Utpal ^a   Pal, Tapan Kumar ^a  

^a JADAVPUR UNIVERSITY   (India)

Author keywords

Antidiabetic activity; Olmesartan medoxomil; Pharmacokinetics; Pioglitazone; Toxicity study

Indexed keywords

OLMESARTAN; PIOGLITAZONE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; FEMALE; LOW DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; RAT; REPEATED DRUG DOSE; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANIMALS; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; BLOOD GLUCOSE; DIABETES MELLITUS, EXPERIMENTAL; DIABETES MELLITUS, TYPE 2; DRUG COMBINATIONS; FEMALE; HYPOGLYCEMIC AGENTS; IMIDAZOLES; MALE; RATS; RATS, WISTAR; TETRAZOLES; THIAZOLIDINEDIONES;

ANIMALIA; RATTUS;

EID: 84855512452     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2011.12.008     Document Type: Article

References (28)

1. Adak M., Gupta J.K. Acute and Subacute Toxicity Study with Hypolipidemic Agent of α-alkyl Substituted Indan-1- Acetic Acids in Mice. Res. J. Med. Medical Sci. 2009, 4:345-350.
2. Bakris G., Sowers J., Epstein M., Williams M. Hypertension in patients with diabetes. Why is aggressive treatment essential?. Postgrad. Med. 2000, 107:53-56.
3. Berria R., Glass L., Mahankali A., Miyazaki Y., Monroy A., Filippis E.D., Cusi K., Cersosimo E., DeFronzo R.A., Gastaldelli A. Reduction in hematocrit and hemoglobin following pioglitazone treatment is not hemodilutional in Type II diabetes mellitus. Clin. Pharmacol. Ther. 2007, 82:275-281.
4. Brenner B.M., Cooper M.E., Zeeuw D. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N. Engl. J. Med. 2001, 345:861-869.
5. Brunner H.R. The new oral angiotensin II antagonist olmesartan medoxomil: a concise overview. J. Hum. Hypertens. 2002, 16:S13-S16.
6. Daryl N., Evans B., Bridget S., Marlon H. Olmesartan medoxomil for hypertension: a clinical review. Drug Forecast 2002, 27:611.
7. Epstein M., Sowers J.R. Diabetes mellitus and hypertension. Hypertension 1992, 19:418.
8. Fliser D., Wagner K.K., Loos A. Chronic angiotensin II receptor blockade reduces (intra)renal vascular resistance in patients with type 2 diabetes. J. Am. Soc. Nephrol. 2005, 16:1135-1140.
9. Jaakkola T., Laitila J., Neuvonen P.J., Backman J.T. Pioglitazone is metabolised by CYP2C8 and CYP3A4 in vitro: potential for interactions with CYP2C8 inhibitors. Basic Clin. Pharmacol. Toxicol. 2006, 99:44-51.
10. Lakshmi K.S., Rajesh T., Sharma S. Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms. IJPPS 2009, 1:162-166.
11. Lewis E.J., Hunsicker L.G., Clarke W.R. Renoprotective effect of the angiotensin -receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N. Engl. J. Med. 2001, 345:851-860.
12. Masiello P., Broca C., Gross R., Roye M., Manteghetti M., Hillaire-Buys D., Novelli M., Ribes G. Experimental NIDDM: development of a new model in adult rats administered streptozotocin and nicotinamide. Diabetes 1998, 47:224-229.
13. Miyazaki Y., Mahankali A., Matsuda M., Glass L., Mahankali S., Ferrannini E., Cusi K., Mandarino L.J., DeFronzo R.A. Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone. Diabetes Care 2001, 24:710-719.
14. Mogensen C.E. Diabetic renal disease in patients with type 2 diabetes mellitus: new strategies for prevention and treatment. Endocrinology 2002, 1:3-11.
15. Nafisa P.C.F., Chakradhar L., Vandana S.P., Suresh R.N. An experimental evaluation of the antidiabetic and antilipidemic properties of a standardized Momordica charantia fruit extract. BMC Complement Altern Med 2007, 7(29):1-8.
16. NIST/SEMATECH e-Handbook of Statistical Methods, 2010. http://www.itl.nist.gov/div898/handbook/eda/section3/eda3673.htm.
17. Ogata S., Sharyo S., Hinman D.J., Manabe S. Renal effects of 26-week administration of olmesartan medoxomil/hydrochlorothiazide in rats. J. Toxicol. Sci. 2004, 29:37-46.
18. Parving H.H., Lehnert H., Brochner-Mortensen J. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N. Engl. J. Med. 2001, 345:870-878.
19. Sengupta P., Bhaumik U., Ghosh A., Sarkar A.K., Chatterjee B., Bose A., Pal T.K. LC-MS-MS development and validation for simultaneous quantitation of metformin, glimepiride and pioglitazone in human plasma and its application to a bioequivalence study. Chromatographia 2009, 69:1243-1250.
20. Shannon R.S., Minakshi N., Nihal A. Dose translation from animal to human studies revisited. FASEB J. 2007, 22:659-661.
21. Spiegelman B.M. PPAR-gamma: adipogenic regulator and thiazolidinedione receptor. Diabetes 1998, 47:507-514.
22. The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure, 1997. Arch. Intern. Med.157, 2413-2446.
23. UK Prospective Diabetes Study Groupm, 1998. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ 317, 713-720.
24. Wehling M. Can the pharmacokinetic characteristics of olmesartan medoxomil contribute to the improvement of blood pressure control?. Clin. Ther. 2004, 26:A21-27.
25. Yamagishi S., Takeuchi M., Inoue H. Olmesartan medoxomil, a newly developed angiotensin II type 1 receptor antagonist, protects against renal damage in advanced glycation end product (age)-injected rats. Drugs Exp. Clin. Res. 2005, 31:45-51.
26. Yanagisawa H., Amemiya Y., Kanazaki T., Shimoji Y., Fujimoto K., Kitahara Y., Sada T., Mizuno M., Ikeda M., Miyamoto S., Furukawa Y., Koike H. Nonpeptide angiotensin II receptor antagonists: synthesis, biological activities, and structure -activity relationships of imidazole-5-carboxylic acids bearing alkyl, alkenyl, and hydroxyalkyl substituents at the 4-position and their related compounds. J. Med. Chem. 1996, 39:323-338.
27. Yukiyoshi F., Yasuhiko Y., Makiko K., Toshimasa Y., Junji K., Takashi K., Tatsuji I. Sex differences in the pharmacokinetics of pioglitazone in rats. Comp. Biochem. Physiol. C: Toxicol. Pharmacol. 2003, 136:85-94.
28. Zanchetti A., Ruilope L.M. Antihypertensive treatment in patients with type-2 diabetes mellitus: what guidance from recent controlled randomized trials?. J. Hypertens. 2002, 20(11):2099-2110.