CARDIOVASCULAR JOURNAL OF AFRICA • Volume 34, No 5, November/December 2023 264 AFRICA Cardiovascular Topics A retrospective study: efficacy of an originator versus a generic formulation of simvastatin in patients who suffer from hyperlipidaemia JR Snyman, KR Snyman on behalf of Simvotin® study group Abstract Background: South Africa is home to a multi-ethnic society with a large range of cultures and lifestyles. Cardiovascular disease is a major cause of morbidity and mortality. South Africa is known to have one of the highest incidence rates of hypercholesterolaemia in the world, especially among the Caucasian population. Aim: The aim of this retrospective chart review was to establish whether a multisource simvastatin (Simvotin®, Ranbaxy, a Sun Pharma company) maintained the cholesterol-lowering effect after switching from the innovator brand Zocor® (MSD South Africa) in the public-sector hospitals. Since prescribers often doubt the registration requirements of multisource products based on bioequivalence alone, this research was done to confirm similar clinical outcomes in a real-world setting. Methods: More than 200 charts were identified from patients treated for hyperlipidaemia. Patients were treated for at least six months prior to and again six months after the switching of brands in order to meet criteria to be eligible for inclusion. The lipid values at initiation of therapy as well as before switching (visit 1 and 2) had to be available and again six months after treatment on the multisource product (visit 3). Results: No significant change was observed in the lipid control after switching, confirming similarity. Conclusion: This real-world evidence should allay any fears of generic inferiority of this important medicine in the treatment and prevention of high cardiovascular risk in patients requiring lipid-lowering therapy. Keywords: hyperlipidaemia, simvastatin, cholesterol, lipid, hypercholesterolaemia Submitted 26/9/21; accepted 10/10/22 Published online 8/12/22 Cardiovasc J Afr 2023; 34: 264–267 www.cvja.co.za DOI: 10.5830/CVJA-2022-053 This study investigated the originator and generic formulations of simvastatin to determine whether clinical equivalence exists in a real-world setting. This study was undertaken in order to investigate whether there was indeed clinical or therapeutic equivalence between the originator and generic formulations of simvastatin, researching treated patient data retrospectively, before and after switching between two branded versions of simvastatin, one the originator and the other a multisource equivalent. In practice, the most important and common form of dyslipidaemia is hypercholesterolaemia.1 Research from animal and laboratory investigations, epidemiology and genetic forms of hypercholesterolaemia indicate that an elevated low-density lipoprotein cholesterol (LDL-C) level is a major cause of coronary heart disease (CHD).2 The South African guidelines advocate that the use of drug therapy must balance the cost against the clinical efficacy and risk of CHD.1,3 The recommendations, when initiating drug therapy, are indicated as follows: lipid-lowering drugs should be recommended to patients with a 10-year risk of an overt CHD event of > 20%, projected to the age of 60 years.4 Although clinical judgement plays an important role in initiation of treatment, patients with familial hypercholesterolaemia or the presence of established CHD (including a previous acute myocardial infarction) should be candidates for lipid-lowering drugs. The response to medicinal interventions varies from person to person and the general consensus is that an ‘anti-coronary’ diet, weight loss as well as a regular exercise routine are able to enhance the effects of lipid-lowering agents significantly.1,3 One of the pharmacological interventions used to treat increased cholesterol levels is a class of drugs called the statins. Statins are by far the most prescribed treatment choice for LDL-C reduction, which demonstrably reduce cardiovascular mortality rate.5 Statins act by inhibiting hydroxy-methylglutaryl co-enzyme A reductase, a key enzyme in cholesterol synthesis, leading up to an increased LDL-C clearance. The statins reduce LDL-C levels by up to 60% and produce small increases in highdensity lipoprotein cholesterol (HDL-C) and triglycerides (TG). Statins also appear to decrease intra-arterial and/or systemic inflammation by stimulating production of endothelial nitric oxide.5 This class of drug may also decrease LDL-C deposition in endothelial macrophages as well as decrease cholesterol in inflammatory cell membranes. This anti-inflammatory effect is anti-atherogenic, even in the absence of elevated lipid levels.5 Clinical pharmacologist, Pretoria, South Africa JR Snyman, MB ChB, MPharm Med, MD, jacques@dermav.co.za Pharmaceutics, Cape Town, South Africa KR Snyman, BPharm, MSc
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