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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 31, No 5, September/October 2020
AFRICA
245
The therapeutic management of South African
dyslipidaemic patients at very high cardiovascular risk
(CARDIO TRACK): a cross-sectional study
Dirk Jacobus Blom, Naresh Ranjith, Pankaj Joshi, Poobalan Naidoo, Alet van Tonder, Moji Ganiyat
Musa, Shaifali Joshi, Rory Leisegang, Julien Shane Trokis, Hemant Makan, Frederick Johan Raal
Abstract
Background:
Dyslipidaemia is a major modifiable risk factor
for atherosclerotic cardiovascular disease. At the time the
study was conducted, guidelines recommended a low-density
lipoprotein cholesterol (LDL-C) target of less than 1.8 mmol/l
and a reduction of at least 50% if the baseline LDL-C was
between 1.8 and 3.5 mmol/l in patients with either very high
cardiovascular risk or established atherosclerosis. In South
Africa, there is a paucity of data on attainment of LDL-C
goal in patients with very high cardiovascular risk who are on
maximum tolerated statin with or without ezetimibe.
Objective:
The aim was to assess the percentage of very high
cardiovascular risk South African patients with dyslipidaemia
not reaching an LDL-C goal of less than 1.8 mmol/l, despite
maximum tolerated statin with or without ezetimibe.
Methods:
This was a multi-centre, observational, cross-
sectional study conducted at 15 private healthcare sector sites
and one public sector site. Adults (
>
18 years) with very high
cardiovascular risk of familial hypercholesterolaemia receiv-
ing stable, maximum-tolerated statin therapy for at least four
weeks prior to their latest lipid profile were enrolled into the
study, and electronic case report forms were completed after
written informed consent was provided. LDL-C goal attain-
ment was modelled, first assuming an increase in the statin
dose to the registered maximum, followed by the addition of
ezetimibe or a PCSK9-inhibitor.
Results:
In total, 507 patients were screened, of whom
492 were eligible for study participation. One patient was
excluded from the analysis because of a missing LDL-C
value. Most participants were male (male 329, 67%; female
162, 33%). Most patients were either obese (223, 46.0%) or
overweight (176, 36.3%). Hypertension and diabetes mellitus
were frequent co-morbidities and were found in 381 (77.6%)
and 316 (64.4%) patients, respectively. Eighty (16.3%) patients
reported current smoking. Only 68 (13.8%) patients were
taking ezetimibe in addition to a statin. Reasons for not using
ezetimibe included no requirement for ezetimibe in the opin-
ion of the treating physician (229, 48.7%), cost (149, 31.7%),
physician’s choice (39, 8.3%), or other (53, 11.3%). Only 161
(32.8%) of the patients attained their goal LDL-C level. In
our modelling analysis, increasing the statin dose to the regis-
tered maximum and adding ezetimibe brought an additional
34.5% of patients to goal, while adding a PCSK9-inhibitor,
irrespective of any other changes to lipid-lowering therapy
brought over 90% of not-at-goal patients to goal.
Conclusion:
Most study participants were not at LDL-C
goal despite maximum-tolerated statin, highlighting the
need for treatment intensification in this high-risk popula-
tion. Although intensifying treatment by adding a PCSK9-
inhibitor brought more patients to goal, the initial addition
of ezetimibe would be more reasonable, given the cost of
PCSK9-inhibitors.
Keywords:
cardiovascular risk, dyslipidaemia, LDL cholesterol,
statins, ezetimibe, PCSK9-inhibitor
Submitted 8/10/19, accepted 16/5/20
Cardiovasc J Afr
2020;
31
: 245–251
www.cvja.co.zaDOI: 10.5830/CVJA-2020-010
Division of Lipidology and Hatter Institute for
Cardiovascular Research in Africa, Department of Medicine,
University of Cape Town, Cape Town, South Africa
Dirk Jacobus Blom, PhD,
dirk.blom@uct.ac.zaCardiovascular Research Centre, Durban, South Africa
Naresh Ranjith, MD
Diabetes Care and Clinical Trials Centre, Pretoria, South
Africa
Pankaj Joshi, MD
Shaifali Joshi, MD
Medical Affairs, Sanofi, Midrand, South Africa; Department
of Health Informatics, School of Health Professions,
Rutgers, State University of New Jersey, NJ, USA
Poobalan Naidoo, MD
Medical Affairs, Sanofi, Midrand, South Africa
Alet Van Tonder, MD
Moji Ganiyat Musa, MD
Department of Pharmaceutical Biosciences, Faculty
of Pharmacy, Uppsala University, Uppsala, Sweden;
Family Clinical Research Unit (FAM-CRU), University of
Stellenbosch, Tygerberg Hospital, Tygerberg, South Africa
Rory Leisegang, MD
Diabetes Research and Clinical Care, Kraaifontein, Cape
Town, South Africa
Julien Shane Trokis, MD
Centre for Diabetes, Lenasia, South Africa
Hemant Makan, MD
Carbohydrate and Lipid Metabolism Research Unit,
Faculty of Health Sciences, University of Witwatersrand,
Johannesburg, South Africa
Frederick Johan Raal, PhD