CARDIOVASCULAR JOURNAL OF AFRICA • Volume 34, No 5, November/December 2023 AFRICA 267 Conclusions The importance of established data illustrating bioequivalence of generic products when compared to the innovator product has become increasingly scrutinised by the medical community at large, who view bioequivalence data merely as a requirement to register a medicine in South Africa and not a marker for efficacy of the medicine. However, data illustrating the effectiveness in patient populations carry more weight in determining the acceptance of a product in the prescriber market. This retrospective, real-world analysis showed the effectiveness of a generic form of simvastatin (Simvotin®) in controlling and maintaining lipid levels in those patients who were switched from the innovator brand (Zocor®). Consent was granted to publish all details of any images, videos, recordings, etc, and that the authors as well as Ranbaxy (Pty) Ltd, a Sun Pharma company, have been shown the article contents to be published. The authors and researchers do not wish to share their data supporting the results reported in the manuscript to protect the privacy of patients consulted. Protection of patient information is of utmost importance to the researchers and authors. Furthermore, due to historic data file format of source environment, the additional data were not captured in collection sheets. The study was funded by Ranbaxy (Pty) Ltd, a Sun Pharma company. The sponsors had no influence on the independent research and did not assist in manuscript writing. The authors collated the data and wrote the article on behalf of the Simvotin® study group. The Simvotin® real-world study group: Profs D Marx and HJ Vermaak, Drs C Rajput, S Singh and JR Snyman – a clinical research group that had no commercial interest in any of the products researched and also declares no affiliation with the sponsor. The group also acknowledges the contributions of Z Ramadas and S Badari, employed by the sponsor company Ranbaxy Laboratories (Ltd) South Africa, for co-ordinating the process. References 1. South African Medical Association and Lipid and Atherosclerosis Society of Southern Africa Working Group. Diagnosis, management and prevention of the common dyslipidaemias in South Africa – clinical guideline, 2000. Expert Rev S Afr Med J 2000; 90(2): 164–177. 2. National Cholesterol Education Program. Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Executive Summary. NIH publication no. 01-3670 May 2001: 1–28. 3. Klug EQ, Raal FJ, Marais AD, Smuts CM, Schamroth C, Jankelow D, Blom DJ, Webb DA. South African Dyslipidaemia Guideline Consensus Statement 2018 Update. Expert Rev S Afr Med J 2018; 108(11). 4. Pyörälä K , De Backer G, Graham I, Poole-Wilson P, Wood D. Prevention of coronary heart disease in clinical practice. Recommendations of the task force of the European Society of Cardiology, European Artherosclerosis Society and European Society of Hypertension. Eur Heart J 1994; 15: 1300–1331. 5. Endocrine and metabolic disorders: dyslipidemia. www.merck.com 6. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolaemia. New Eng J Med 2005: 344: 1301–1307. 7. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. New Eng J Med 1996; 335: 1001–1009. 8. Scandinavian simvastatin survival group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383–1389. 9. Heart Protection study collaborative group. Heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7–22. 10. Ward NC, Watts GF, Eckel RH. Statin toxicity: mechanistic insights and clinical implications. Circ Res 2019; 124: 328–350. 11. FDA. Generic Drug Facts. 2021. Available at: https://www.fda.gov/ drugs/generic-drugs/generic-drug-facts 12. Dainis AM, Ashley EA. Cardiovascular precision medicine in the genomics era. J Am Coll Cardiol Basic Transl Sci 2018; 3(2): 313–326. 13. Sturm AC, Knowles JW, Gidding SS, Ahmad ZS, Ahmed CD, Ballantyne CM, et al. Convened by the Familial Hypercholesterolemia Foundation. Clinical genetic testing for familial hypercholesterolemia. J Am Coll Cardiol Scien Expert Panel 2018; 72(6): 662–680. 14. Mytilinaiou M, Kyrou I, Khan M, Grammatopoulos DK, Randeva HS. Familial hypercholesterolemia: new horizons for diagnosis and effective management. Front Pharmacol 2018; 9: 707. 15. Mauro VF. Clinical pharmacokinetics and practical applications of simvastatin. Clin Pharmacokinet 1993; 24: 195–202. 16. Stoppler M. Generic drugs, are they as good as brand names? Available at: https://www.medicinenet.com/generic_drugs_are_they_as_good_as_ brand-names/views.htm 17. Larmour I, Pignataro S, Barned KL, Mantas S, Korman MG. A therapeutic equivalence program: evidence-based promotion of more efficient use of medicines. Med J Aust 2011; 194(12): 631–634. 18. KennedA.Genericsvsoriginalmedication.2017.Availableat:https://fpm. co.za/2017/05/03/generic-vs-original-medication/#:~:text=Generic%20 medicines%3A%20These%20medicines%20are,is%20also%20exactly%20the%20same
RkJQdWJsaXNoZXIy NDIzNzc=