Clinical Equivalence of Proprietary and Generic Atorvastatin in Lipid Clinic Patients

Canadian Journal of Cardiology

Volumn 29, Issue 4, 2013, Pages 418-422

  Rahalkar, Amit R ^a   Ban, Matthew R ^a   Hegele, Robert A ^a  

^a ROBARTS RESEARCH INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; CREATINE KINASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; TRIACYLGLYCEROL;

ADULT; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DRUG FORMULATION; DYSLIPIDEMIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; TRIACYLGLYCEROL BLOOD LEVEL;

AGED; ANTICHOLESTEREMIC AGENTS; BIOLOGICAL MARKERS; CANADA; CHOLESTEROL, HDL; CHOLESTEROL, LDL; COHORT STUDIES; DRUGS, GENERIC; DYSLIPIDEMIAS; FEMALE; FLUOROBENZENES; HEPTANOIC ACIDS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; PYRIMIDINES; PYRROLES; RETROSPECTIVE STUDIES; SULFONAMIDES; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; TRIGLYCERIDES;

EID: 84875606418     PISSN: 0828282X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cjca.2012.05.010     Document Type: Article

References (28)

1. Jackevicius C.A., Chou M.M., Ross J.S., Shah N.D., Krumholz H.M. Generic atorvastatin and health care costs. N Engl J Med 2012, 366:201-204.
2. Bilheimer D.W., Grundy S.M., Brown M.S., Goldstein J.L. Mevinolin and colestipol stimulate receptor-mediated clearance of low density lipoprotein from plasma in familial hypercholesterolemia heterozygotes. Proc Natl Acad Sci U S A 1983, 80:4124-4128.
3. Ray K.K., Cannon C.P., McCabe C.H., et al. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol 2005, 46:1405-1410.
4. Barter P., Gotto A.M., LaRosa J.C., et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med 2007, 357:1301-1310.
5. Lessons from Lipitor and the broken blockbuster drug model. Lancet 2011, 378:1976.
6. Koytchev R., Ozalp Y., Erenmemisoglu A., van der Meer M.J., Alpan R.S. Bioequivalence study of atorvastatin tablets. Arzneimittelforschung 2004, 54:573-577.
7. Mendoza L., Hajduch M., Plausinaitis R., Platilova V., Emritte N., Svoboda M. Pharmacokinetic and bioequivalence testing of atorvastatin formulations in healthy male volunteers. Pharmazie 2006, 61:805-806.
8. Liu Y.M., Pu H.H., Liu G.Y., et al. Pharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: a single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males. Clin Ther 2010, 32:1396-1407.
9. Corp E.V., Antoniou S., Wright P.G., Khachi H., Vercaeren S., Wald D.S. Use and cost of branded and generic drugs in patients with coronary heart disease-results from a prospective survey of 1008 patients in two London hospitals. QJM 2009, 102:843-849.
10. Athyros V.G., Tziomalos K., Karagiannis A., Mikhailidis D.P. To switch (statins) or not to switch?. That is the question. Expert Opin Pharmacother 2010, 11:2943-2946.
11. Assawawitoontip S., Wiwanitkit V. A randomized crossover study to evaluate LDL-cholesterol lowering effect of a generic product of simvastatin (Unison Company) compared to simvastatin (Zocor) in hypercholesterolemic subjects. J Med Assoc Thai 2002, 85(suppl 1):S118-S124.
12. Najib N.M., Idkaidek N., Adel A., et al. Pharmacokinetics and bioequivalence evaluation of two simvastatin 40 mg tablets (Simvast and Zocor) in healthy human volunteers. Biopharm Drug Dispos 2003, 24:183-189.
13. Lohitnavy M., Lohitnavy O., Chaijittiprasert K., Taytiwat P., Polnok S. Bioequivalence study of two formulations of simvastatin tablets in healthy Thai volunteers. Arzneimittelforschung 2004, 54:31-34.
14. Almeida S., Filipe A., Almeida A., et al. Comparative study on the bioequivalence of two formulations of pravastatin. Data from a crossover, randomised, open-label bioequivalence study in healthy volunteers. Arzneimittelforschung 2006, 56:70-75.
15. Bae S.K., Kim E.J., Lim C.H., Lee J.S., Kim Y.G., Lee M.G. Bioequivalence of pravastatin tablet formulations assessed in Korean males. Int J Clin Pharmacol Ther 2004, 42:301-306.
16. Mignini F., Tomassoni D., Streccioni V., Traini E., Amenta F. Pharmacokinetics and bioequivalence study of two tablet formulations of lovastatin in healthy volunteers. Clin Exp Hypertens 2008, 30:95-108.
17. Kim S.H., Park K., Hong S.J., et al. Efficacy and tolerability of a generic and a branded formulation of atorvastatin 20 mg/d in hypercholesterolemic Korean adults at high risk for cardiovascular disease: a multicenter, prospective, randomized, double-blind, double-dummy clinical trial. Clin Ther 2010, 32:1896-1905.
18. Boh M., Opolski G., Poredos P., Ceska R., Jezovnik M. Therapeutic equivalence of the generic and the reference atorvastatin in patients with increased coronary risk. Int Angiol 2011, 30:366-374.
19. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects. Minister of Public Works and Government Services Canada, 1992 Health Canada, Accessed June 30, 2012. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/bio-a-eng.php.
20. Chennell A., Sullivan D.R., Penberthy L.A., Hensley W.J. Comparability of lipoprotein measurements, total:HDL cholesterol ratio and other coronary risk functions within and between laboratories in Australia. Pathology 1994, 26:471-476.
21. Kafonek S.D., Donovan L., Lovejoy K.L., Bachorik P.S. Biological variation of lipids and lipoproteins in fingerstick blood. Clin Chem 1996, 42:2002-2007.
22. Kahn R.F., McCord R.S. Interlaboratory variability in serum lipid measurements. Fam Pract Res J 1991, 11:415-420.
23. Haider T., Foss O.P. The analytical variation and mean difference of serum lipid values in duplicate samples subjected to different times of storage. Scand J Clin Lab Invest 1983, 43:439-443.
24. Chiba K., Watanabe T., Ikeda M. Variability of serum high density lipoprotein cholesterol concentration in healthy subjects in a three year term. J Epidemiol Community Health 1984, 38:195-197.
25. Davidson M., Ma P., Stein E.A., et al. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia. Am J Cardiol 2002, 89:268-275.
26. McKenney J.M., Jones P.H., Adamczyk M.A., Cain V.A., Bryzinski B.S., Blasetto J.W. Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals: results from the STELLAR trial. Curr Med Res Opin 2003, 19:689-698.
27. Stein E.A., Strutt K., Southworth H., Diggle P.J., Miller E. Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol 2003, 92:1287-1293.
28. Genest J., McPherson R., Frohlich J., et al. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol 2009, 25:567-579.