Long Term Efficacy of Generic Atorvastatin by a University Hospital Database

Panisa Manasirisuk; Nanthaphan Chainirun; Somsak Tiamkao; Sunee Lertsinudom; Kutcharin Phunikhom; Kittisak Sawanyawisuth

doi:10.3889/oamjms.2022.8915

Authors

Panisa Manasirisuk Department of Pharmacy Service, Faculty of Medicine, Khon Kaen University, Srinagarind Hospital, Khon Kaen, Thailand
Nanthaphan Chainirun Department of Pharmacy Service, Faculty of Medicine, Khon Kaen University, Srinagarind Hospital, Khon Kaen, Thailand; Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand
Somsak Tiamkao Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand; Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Sunee Lertsinudom Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand
Kutcharin Phunikhom Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Kittisak Sawanyawisuth Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

DOI:

https://doi.org/10.3889/oamjms.2022.8915

Keywords:

Low-density lipoprotein cholesterol, High-density lipoprotein cholesterol, HMG CoA reductase inhibitors, Atorvastatin, Glomerular filtration rate, Dyslipidemia, Generic, Renal deterioration

Abstract

Background: There is limited long term data of generic atorvastatin in terms of clinical efficacy and safety. This study aimed to evaluate the efficacy of generic atorvastatin in a 12-month period.

Methods: This study was a retrospective cohort study. The inclusion criteria were adult patients who received the original atorvastatin for at least three months and then switched to the generic atorvastatin for 12 months. Lipid profiles and safety profiles were evaluated after 12 months of switching therapy.

Results: During the study period, there were 297 patients met the study criteria. The mean (SD) age of the patients was 61.05 (11.51) years. Male sex accounted for 46.80% (139 patients). For lipid outcomes, only HDL-c was significantly increased by 2.05 mg/dL (p 0.001). Serum creatinine was increasing by 0.07 mg/dL, while eGFR was decreasing by 2.55 ml/min/1.73m². Other laboratory outcomes were not significantly changed after one year including ALT, AST, and CK.

Conclusions: Generic atorvastatin had comparable effect on LDL-c reduction compared with the original atorvastatin. Renal deterioration were found with increasing HDL-c level in this study population with generic atorvastation. Physicians should be aware of declining of renal function in long term use of generic atorvastatin.

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References

Hinton W, McGovern A, Coyle R, Han TS, Sharma P, Correa A, et al. Incidence and prevalence of cardiovascular disease in English primary care: A cross-sectional and follow-up study of the royal college of general practitioners (RCGP) research and surveillance centre (RSC). BMJ Open. 2018;8(8):e020282. https://doi.org/10.1136/bmjopen-2017-020282 PMid:30127048 DOI: https://doi.org/10.1136/bmjopen-2017-020282

Khamsai S, Chootrakool A, Limpawattana P, Chindaprasirt J, Sukeepaisarnjaroen W, Chotmongkol V, et al. Hypertensive crisis in patients with obstructive sleep apnea-induced hypertension. BMC Cardiovasc Disord. 2021;21(1):310. https://doi.org/10.1186/s12872-021-02119-x PMid:34162333 DOI: https://doi.org/10.1186/s12872-021-02119-x

Khamsai S, Mahawarakorn P, Limpawattana P, Chindaprasirt J, Sukeepaisarnjaroen W, Silaruks S, et al. Prevalence and factors correlated with hypertension secondary from obstructive sleep apnea. Multidiscip Respir Med. 2021;16(1):777. https://doi.org/10.4081/mrm.2021.777 PMid:34650797 DOI: https://doi.org/10.4081/mrm.2021.777

Khamsai S, Kachenchart S, Sawunyavisuth B, Limpawattana P, Chindaprasirt J, Senthong V, et al. Prevalence and risk factors of obstructive sleep apnea in hypertensive emergency. J Emerg Trauma Shock. 2021;14(2):104-7. https://doi.org/10.4103/jets.jets_47_20 PMid:34321809 DOI: https://doi.org/10.4103/JETS.JETS_47_20

Soontornrungsun B, Khamsai S, Sawunyavisuth B, Limpawattana P, Chindaprasirt J, Senthong V, et al. Obstructive sleep apnea in patients with diabetes less than 40 years of age. Diabetes Metab Syndr. 2020;14(6):1859-63. https://doi.org/10.1016/j.dsx.2020.09.008 PMid:32992217 DOI: https://doi.org/10.1016/j.dsx.2020.09.008

Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, et al. Association between lowering LDL-C and cardiovascular risk reduction among different therapeutic interventions: A systematic review and meta-analysis. JAMA. 2016;316(12):1289-97. https://doi.org/10.1001/jama.2016.13985 PMid:27673306 DOI: https://doi.org/10.1001/jama.2016.13985

Mills EJ, O’Regan C, Eyawo O, Wu P, Mills F, Berwanger O, et al. Intensive statin therapy compared with moderate dosing for prevention of cardiovascular events: A meta-analysis of >40 000 patients. Eur Heart J. 2011;32(11):1409-15. https://doi.org/10.1093/eurheartj/ehr035 PMid:21385791 DOI: https://doi.org/10.1093/eurheartj/ehr035

Akunne OO, Godman B, Adedapo AD, Truter I, Fadare J. Statin prescribing among hypertensive patients in southwest Nigeria: Findings and implications for the future. J Comp Eff Res. 2016;5(3):281-8. https://doi.org/10.2217/cer.15.65 PMid:27097045 DOI: https://doi.org/10.2217/cer.15.65

Karlson BW, Palmer MK, Nicholls SJ, Barter PJ, Lundman P. Effects of age, gender and statin dose on lipid levels: Results from the VOYAGER meta-analysis database. Atherosclerosis. 2017;265:54-9. https://doi.org/10.1016/j.atherosclerosis.2017.08.014 PMid:28863328 DOI: https://doi.org/10.1016/j.atherosclerosis.2017.08.014

Chen Y, Li D, Jing J, Yan H, Liu J, Shen Z, et al. Treatment trends, effectiveness, and safety of statins on lipid goal attainment in Chinese percutaneous coronary intervention patients: A multicenter, retrospective cohort study. Clin Ther. 2017;39(9):1827-39.e1. https://doi.org/10.1016/j.clinthera.2017.07.042 PMid:28807393 DOI: https://doi.org/10.1016/j.clinthera.2017.07.042

Manasirisuk P, Chainirun N, Tiamkao S, Lertsinudom S, Phunikhom K, Sawunyavisuth B, et al. Efficacy of generic atorvastatin in a real-world setting. Clin Pharmacol. 2021;13:45-51. https://doi.org/10.2147/cpaa.s285750 PMid:33707972 DOI: https://doi.org/10.2147/CPAA.S285750

Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: A multicenter, prospective, open-label, randomized trial. Clin Ther. 2013;35(1):77-86. https://doi.org/10.1016/j.clinthera.2012.11.009 PMid:23274145 DOI: https://doi.org/10.1016/j.clinthera.2012.11.009

Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, et al. 2016 ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J. 2016;37(39):2999-3058. https://doi.org/10.1093/eurheartj/ehw272 PMid:27567407 DOI: https://doi.org/10.1093/eurheartj/ehw272

McTaggart F, Jones P. Effects of statins on high-density lipoproteins: A potential contribution to cardiovascular benefit. Cardiovasc Drugs Ther. 2008;22(4):321-38. https://doi.org/10.1007/s10557-008-6113-z PMid:18553127 DOI: https://doi.org/10.1007/s10557-008-6113-z

Katsiki N, Mikhailidis DP, Banach M. Lipid-lowering agents for concurrent cardiovascular and chronic kidney disease. Expert Opin Pharmacother. 2019;20(16):2007-17. https://doi.org/10.1080/14656566.2019.1649394 PMid:31344332 DOI: https://doi.org/10.1080/14656566.2019.1649394

Coste J, Karras A, Rudnichi A, Dray-Spira R, Pouchot J, Giral P, et al. Statins for primary prevention of cardiovascular disease and the risk of acute kidney injury. Pharmacoepidemiol Drug Saf. 2019;28(12):1583-90. https://doi.org/10.1002/pds.4898 PMid:31517431 DOI: https://doi.org/10.1002/pds.4898

Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, et al. Atorvastatin has a dose-dependent beneficial effect on kidney function and associated cardiovascular outcomes: Post hoc analysis of 6 double-blind randomized controlled trials. J Am Heart Assoc. 2019;8(9):e010827. https://doi.org/10.1161/jaha.118.010827 PMid:31020900 DOI: https://doi.org/10.1161/JAHA.118.010827

Mohamed MF, Salameh OK, Saeed AA. Statin-induced rhabdomyolysis, acute kidney injury, and hepatitis leading to death. Am J Case Rep. 2019;20:709-12. https://doi.org/10.12659/ajcr.914707 PMid:31101801 DOI: https://doi.org/10.12659/AJCR.914707

Dormuth CR, Hemmelgarn BR, Paterson JM, James MT, Teare GF, Raymond CB, et al. Use of high potency statins and rates of admission for acute kidney injury: multicenter, retrospective observational analysis of administrative databases. BMJ. 2013;346:f880. https://doi.org/10.1136/bmj.f880 PMid:23511950 DOI: https://doi.org/10.1136/bmj.f880

Ishikawa A, Kawarazaki H, Ando K, Fujita M, Fujita T, Homma Y. Renal preservation effect of ubiquinol, the reduced form of coenzyme Q10. Clin Exp Nephrol. 2011;15(1):30-3. https://doi.org/10.1007/s10157-010-0350-8 PMid:20878200 DOI: https://doi.org/10.1007/s10157-010-0350-8

McMurray JJ, Dunselman P, Wedel H, Cleland JG, Lindberg M, Hjalmarson A, et al. Coenzyme Q10, rosuvastatin, and clinical outcomes in heart failure: A pre-specified substudy of CORONA (controlled rosuvastatin multinational study in heart failure). J Am Coll Cardiol. 2010;56(15):1196-204. https://doi.org/10.1016/s0084-3873(11)00294-x PMid:20883926 DOI: https://doi.org/10.1016/S0084-3873(11)00294-X

Sawunyavisuth B. What are predictors for a continuous positive airway pressure machine purchasing in obstructive sleep apnea patients? Asia Pac J Sci Technol. 2018;23(3):119469.

Jeerasuwannakul B, Sawunyavisuth B, Khamsai S, Sawanyawisuth K. Prevalence and risk factors of proteinuria in patients with Type 2 diabetes mellitus. Asia Pac J Sci Technol. 2021;26(4):248718.

Sawunyavisuth B, Ngamjarus C, Sawanyawisuth K. Any effective intervention to improve CPAP adherence in children with obstructive sleep apnea: A systematic review. Glob Pediatr Health. 2021;8:2333794X211019884. https://doi.org/10.1177/2333794x211019884 PMid:34104700 DOI: https://doi.org/10.1177/2333794X211019884

Kaewkes C, Sawanyawisuth K, Sawunyavisuth B. Are symptoms of obstructive sleep apnoea related to good continuous positive airway pressure compliance? ERJ Open Res. 2020;6(3):00169-2019. https://doi.org/10.1183/23120541.00169-2019 PMid:33015148 DOI: https://doi.org/10.1183/23120541.00169-2019

Sawunyavisuth B. What personal experiences of CPAP use affect CPAP adherence and duration of CPAP use in OSA patients? J Med Assoc Thai. 2018;101(7):S245-9.