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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 30, No 1, January/February 2019
16
AFRICA
impose co-payments on certain statins or ezetimibe, thus, in
effect making them unavailable to many patients if they cannot
afford the co-payments.
The International Cholesterol Management Practice Study
(ICLPS) was a multinational observational study that investigated
the achievement of European Society of Cardiology (ESC)/
European Atherosclerosis Society (EAS) guideline LDL-C targets
5
and their determinants in real-world clinical practice in countries
outside of Western Europe.
15
In this article, we report the findings
from ICLPS participants in South Africa and assess whether the
management of patients with dyslipidaemia has improved since
reporting of the CEPHEUS SA
13
and DYSIS
14
studies.
Methods
This cross-sectional, observational study was conducted in 19
centres in South Africa. The study was conducted according to
the principles laid out by the 18th World Medical Assembly in
the Declaration of Helsinki (Helsinki, 1964) and all subsequent
amendments, the guidelines for Good Epidemiology Practice,
and according to local regulations. Ethics approval was obtained
from university ethics committees for academic sites (Universities
of Cape Town and the Witwatersrand) and from a central ethics
committee (Pharma Ethics) for all other sites. All patients
provided written informed consent.
Patients (
≥
18 years of age) who had been receiving a
stable dose and type of LMT for at least three months before
enrolment, and who had their LDL-C value measured on stable
LMT in the previous 12 months, were eligible to participate.
Patients participating in a clinical trial or who had received a
PCSK9 inhibitor in the previous six months were excluded. The
first patient was enrolled in August 2015 and the last patient in
February 2016.
A national expert advised on the relative contribution of
each medical speciality to the management of patients with
dyslipidaemia in South Africa. This information, together with
a feasibility study, was used to identify suitable physician
investigators and to ensure the results would adequately reflect
the real-world management of patients with dyslipidaemia.
Bias in the selection of study sites was limited by independently
selecting participating centres and physicians in a randomised
manner from pre-established lists, aiming to ensure a balanced
representation of each speciality. To limit bias in patient
selection, investigators were instructed to approach all eligible
patients consecutively and recruit all patients who provided
consent (minimum of five patients recruited per site) during a
predefined two-week interval at each site.
Physicians completed a questionnaire collecting demographic
data, medical speciality, years of practice, type of practice and
its location, main workplace, mean number of patients consulted
per day, choice of and adherence to practice guidelines for lipid
disorders [that is, ESC/EAS,
5
American College of Cardiology/
American Heart Association (ACC/AHA),
7
other international
guidelines or local/national guidelines], and the definition of
statin intolerance used in their practice (that is, intolerance to
one, two or three or more statins).
For each patient, the investigator completed a case-report form
during a single visit. Data collected included demographic data,
physical examination findings, cardiovascular risk factors, medical
history, type of hypercholesterolaemia (primary or familial),
LDL-C and other lipid values (calculated or measured directly
at the site’s local laboratory, on current treatment and untreated
if available), current LMTs, socio-economic profile and the
investigator’s assessment of the patient’s cardiovascular risk level.
Data quality control was performed at a randomly selected
sample (
≥
10%) of sites by trained personnel.
Statistical analysis
Baseline characteristics are presented as descriptive statistics
with mean
±
standard deviation (SD) or median (interquartile
range) for continuous variables, and as counts (percentages) for
categorical data. The primary outcome was the proportion of
patients taking LMT who had failed to achieve their appropriate
LDL-C targets at enrolment, as defined by the 2011 ESC/EAS
guidelines:
<
1.8 mmol/l (
∼
70 mg/dl) or 50% LDL-C reduction
(for those patients for whom baseline untreated LDL-C was
available) when target levels could not be reached for very high-
risk patients,
<
2.5 mmol/l (
∼
100 mg/dl) for high risk, and
<
3.0
mmol/l (
∼
115 mg/dl) for moderate risk.
5
The Systematic Coronary
Risk Estimation (SCORE) chart
5
for high-risk countries was
used to retrospectively risk stratify patients in whom the relevant
data were available. The high-risk chart was used owing to the
increasing rate of CVD in non-European countries.
The SCORE algorithm
16
assesses 10-year risk of fatal CVD,
based on gender, age, smoking status, systolic blood pressure and
total serum cholesterol. In the ICLPS SA, pre-treatment total
serum cholesterol values were used; consequently, not all patients
could be classified according to risk level. Low-risk patients were
those with a SCORE value
<
1% and moderate risk was a SCORE
value
≥
1% and
<
5%. Patients with a SCORE value
≥
5% or with
systolic blood pressure
≥
180 mmHg and diastolic blood pressure
≥
110 mmHg, or with familial hypercholesterolemia as per the
Dutch Lipid Clinic Network algorithm (definite or probable),
or with diabetes without target-organ damage were classified in
the high-risk group. The very high-risk group included patients
with a 10-year risk of fatal CVD
≥
10% or with at least one of
the following conditions: documented coronary artery disease
(CAD), cerebrovascular disease or peripheral artery disease,
type 2 diabetes with target-organ damage, and history of chronic
kidney disease (glomerular filtration rate
<
60 ml/min/1.73 m²).
Patients without a serious pathology classifying them as very
high or high cardiovascular risk, and in whom the SCORE
could not be calculated owing to missing data (most commonly
baseline LDL-C) were categorised as non-assessable.
Results
A total of 19 physicians participated in the study as investigators
(age 50.6
±
8.4 years; 63.2% men). (A full list of participating
physician investigators is provided at the end.*) More than half
(57.9%) were general practitioners or family physicians, and the
rest included specialists in endocrinology (10.5%), cardiology,
lipidology, internal medicine (each 5.3%) or another field
(15.8%). Participating physicians had been in practice for a mean
±
SD of 22.9
±
8.3 years.
Most physicians (57.9%) were in practices that treated mostly
private patients, 21.1% were in practices that treated mostly
public patients, and 21.1% were in mixed practices that treated
both public and private patients. Overall, 78.9% of practices were