Pre- and postnatal toxicity of the HMG-CoA reductase inhibitor atorvastatin in rats

Toxicological Sciences

Volumn 41, Issue 1, 1998, Pages 88-99

  Henck, J W ^a   Craft, W R ^a   Black, A ^a   Colgin, J ^a   Anderson, J A ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DEVELOPMENTAL DISORDER; FEMALE; FETOTOXICITY; FETUS; MALE; MATERNAL DISEASE; MORBIDITY; MORTALITY; NONHUMAN; PLACENTAL TRANSFER; PROGENY; RAT;

ANIMALIA; RATTUS NORVEGICUS;

EID: 0031943859     PISSN: 10966080     EISSN: None     Source Type: Journal    
DOI: 10.1006/toxs.1997.2400     Document Type: Article

References (45)

1. Beatty, W. W., and Beatty, P. A. (1970). Hormonal determinants of sex differences in avoidance behavior and reactivity to electric shock in the rat. J. Comp. Physiol. Psychol. 3, 446-455.
2. Belknap, W. M., and Dietschy, J. M. (1988). Sterol synthesis and low density lipoprotein clearance in vivo in the pregnant rat, placenta, and fetus. J. Clin. Invest 82, 2077-2085.
3. Brewer, L. M., Sheardown, S. A., and Brown, N. A. (1993). HMG-CoA reductase mRNA in the post-implantation rat embryo studied by in situ hybridization. Teratology 47, 137-146.
4. Carson, D. D., and Lennarz, W. J. (1979). Inhibition of polyisoprenoid and glycoprotein biosynthesis causes abnormal embryonic development. Proc. Natl. Acad. Sci. USA 76, 5709-5713.
5. Corsini, A., Maggi, F. M., and Catapano, A. L. (1995). Pharmacology of competitive inhibitors of HMG-CoA reductase. Pharmacol. Res. 31, 9-27.
6. Denti, A., and Epstein, A. (1972). Sex differences in the acquisition of two kinds of avoidance behavior in rats. Physiol. Behav. 8, 611-615.
7. Dostal, L. A., Schardein, J. L., and Anderson, J. A. (1994). Developmental toxicity of the HMG-CoA reductase inhibitor, atorvastatin, in rats and rabbits. Teratology 50, 387-394.
8. Dostal, L. A., Whitfield, L. R., and Anderson, J. A. (1996). Fertility and general reproduction studies in rats with the HMG-CoA reductase inhibitor, atorvastatin. Fundam. Appl. Toxicol. 32, 285-292.
9. Dunnett, C. W. (1955). A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 50, 1096-1121.
10. Dunnett, C. W. (1964). New tables for multiple comparisons with a control. Biometrics 20, 482-491.
11. Farnsworth, W. H., Hoeg, J. M., Maher, M., Brittain, E. H., Sherins, R. J., and Brewer, H. B., Jr. (1987). Testicular function in Type II hyperlipoproteinemic patients treated with lovastatin (mevinolin) or neomycin. J. Clin. Endocrinol. Metab. 65, 546-550.
12. FDA (1987). Summary basis of approval of NDA 19-643 (lovastatin), 1-28.
13. FDA (1993). Summary basis of approval of NDA 20-261 (fluvastatin), 51-54, and Amendment, pp. 1 and 2.
14. Fechter, L. D., and Young, J. S. (1983). Discrimination of auditory from nonauditory toxicity by reflex modulation audiometry: Effects of triethyltin. Toxicol. Appl. Pharmacol. 70, 216-227.
15. Fiorotto, M. L., Burrin, D. G., Perez, M., and Reeds, P. J. (1991). Intake and use of milk nutrients by rat pups suckled in small, medium, or large litters. Am. J. Physiol. 260, R1104-R1113.
16. Freeman, M. E. (1988). The ovarian cycle of the rat. In The Physiology of Reproduction, Vol. 2 (E. Knobil and J. D. Neill, Eds.), pp. 1893-1928. Raven, New York.
17. Goldstein, J. L., and Brown, M. S. (1990). Regulation of the mevalonate pathway. Nature 343, 425-430.
18. Greenhouse, S. W., and Geisser, S. (1959). On methods in the analysis of profile data. Psychometrika 32, 95-112.
19. Henck, J. W., Petrere, J. A., and Anderson, J. A. (1995). Developmental neurotoxicity of CI-943, a novel antipsychotic. Neurotoxicol. Teratol. 17, 13-24.
20. Henck, J. W., Frahm, D. T., and Anderson, J. A. (1996). Validation of automated behavioral test systems. Neurotoxicol. Teratol. 18, 189-197.
21. Hodgen, G. D., and Itskovitz, J. (1988). Recognition and maintenance of pregnancy. In The Physiology of Reproduction, Vol. 2 (E. Knobil and J. D. Neill, Eds.), pp. 1995-2021. Raven, New York.
22. Hrab, R. V., Hartmen, H. A., and Cox, R. H., Jr. (1994). Prevention of fluvastatin-induced toxicity, mortality, and cardiac myopathy in pregnant rats by mevalonic acid supplementation. Teratology 50, 19-26.
23. ICH (1994). International Conference on Harmonisation; Guideline on detection of toxicity to reproduction for medicinal products. Fed. Reg. 59, 48746-48752.
24. Iversen, S. D., and Iversen, L. L. (1981). Behavioral Pharmacology. Oxford University Press, New York.
25. Johnson, R. A., and Wichern, D. W. (1982). Applied Multivariate Statistical Analysis. Prentice-Hall, New York.
26. Kavlock, R. J., Hoyle, B. R., Rehnberg, B. F., and Rogers, E.H. (1988). The significance of the dilated renal pelvis in the nitrogen-exposed rat fetus: Effects on morphology and function. Toxicol. Appl. Pharmacol. 94, 287-296.
27. Kovanen, P. T., Bilheimer, D. W., Goldstein, J. L., Jaramillo, J. J., and Brown, M. S. (1981). Regulatory role for hepatic low density lipoprotein receptors in vivo in the dog. Proc. Natl Acad. Sci. USA 78, 1194-1198.
28. Kruskal, W. H., and Wallis, W. A. (1952). Use of ranks in one-criterion variance analysis. J. Am. Star. Assoc. 47, 583-621.
29. MacDonald, J. S., Gerson, R. J., Kornbrust, D. J., Kloss, M. W., Prahalda, S., Berry, P. H., Alberts, A. W., and Bokelman, D. L. (1988). Preclinical evaluation of lovastatin. Am. J. Cardiol. 62, 16J-27J.
30. McNamara, D. J., Quackenbush, F. W., and Rodwell, V. W. (1972). Regulation of hepatic 3-hydroxy-3-methyl-glutaryl coenzyme A reductase. J. Biol. Chem. 247, 5805-5810.
31. Minsker, D. H., MacDonald, J. S., Robertson, R. T., and Bokelman, D. L. (1983). Mevalonate supplementation in pregnant rats suppresses the teratogenicity of mevinolinic acid, and inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase. Teratology 28, 449-456.
32. Minsker, D. H., Robertson, R. T., Bokelman, D. L., Akutsu, S., and Fujii, T. (1990). Simvastatin (MK-0733): Oral late gestation and early lactation study in rats. Oyo Yakuri 39, 169-179.
33. Nawrocki, J. W., Weiss, S. R., Davidson, M. H., Sprecher, D. L., Schwartz, S. L., Lupien, P.-J., Jones, P. H., Haber, H. E., and Black, D. M. (1995). Reductions of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler. Thromb. Vasc. Biol. 15, 678-682.
34. Numan, M. (1988). Maternal behavior. In The Physiology of Reproduction, Vol. 2 (E. Knobil and J. D. Neill, Eds.), pp. 1569-1645. Raven, New York.
35. Park, Y. C. (1985). Nonparametric sequential trend test. Proceedings of the Tenth Annual SAS Users Group International Conference, pp. 809-813.
36. Parke-Davis, Division of Warner-Lambert Company (1996). Lipitor (atorvastatin calcium) tablets. [package insert]
37. Quesney-Huneeus, V., Galick, H. A., and Siperstein, M. D. (1983). The dual role of mevalonate in the cell cycle. J. Biol. Chem. 258, 378-385.
38. Robison, R. L., Suter, W., and Cox, R. H. (1994). Carcinogenicity and mutagenicity studies with fluvastatin, a new, entirely synthetic HMG-CoA reductase inhibitor. Fundam. Appl. Toxicol. 23, 9-20.
39. Soma, M. R., Corsini, A., and Paoletti, R. (1992). Cholesterol and mevalonic acid modulation in cell metabolism and multiplication. Toxicol. Lett. 64/65, 1-15.
40. Surani, M. A. H., Kimber, S. J., and Osborn, J. C. (1983). Mevalonate reverses the developmental arrest of preimplantation mouse embryos by Compactin, an inhibitor of HMG CoA reductase. J. Embryol. Exp. Morph. 75, 205-223.
41. Tukey, J. W., Ciminera, J. L., and Heyse, J. F. (1985). Testing the statistical certainty of a response to increasing doses of a drug. Biometrics 41, 295-301.
42. Wecker, J. R., Isor, J. R., and Foss, J. A. (1985). Reflex modification as a test for sensory function. Neurobehav. Toxicol. Teratol. 7, 733-738.
43. Wise, L. D., Majka, J. A., Robertson, R. T., et al. (1990a). Simvastatin (MK-0733): Oral teratogenicity study in rats pre- and postnatal observation. Oyo Yakuri 39, 143-158.
44. Wise, L. D., Minsker, D. H., Robertson, R. T., Bokelman, D. L., Akutsu, S., and Fujii, T. (1990b). Simvastatin (MK-0733): Oral fertility study in rats. Oyo Yakuri 39, 127-141.
45. Yount, N. Y., and McNamara, D. J. (1991). Dietary regulation of maternal and fetal cholesterol metabolism in the guinea pig. Biochim. Biophys. Acta 1085, 82-90.