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28

VOLUME 12 NUMBER 1 • JULY 2015

RESEARCH ARTICLE

SA JOURNAL OF DIABETES & VASCULAR DISEASE

calendar when patients filled their first prescription.

40

There is likely

no single strategy that will work for all patients but studies show

that adherent patients have much better cardiovascular outcomes

than non-adherent patients, although some of the improvement

may also be ascribed to the correlation between adherence and

other healthy behaviours.

41-44

According to a mathematical model of statin use in a population,

increasing statin adherence from 50 to 75% at five years would

prevent more events than lowering the risk threshold for prescribing

statins.

45

Lastly, novel LDL-C-lowering therapies may be necessary

for patients with very high baseline LDL-C levels, such as is seen in

familial hypercholesterolaemia, and when patients are unable to

tolerate adequate doses of potent statins.

46

In South Africa, the modal statin dose potency prescribed

to patients was 3, which was prescribed to 42.2% of the

individuals. Interestingly, although the very high-risk patients had

a disproportionately high share of the statin prescriptions with a

potency of 4 and 5, they also had a disproportionately high amount

of prescriptions with a potency of 2, and a disproportionately

low share of the prescriptions with a potency of 6. In addition,

although combination therapies may have the potential to benefit

some patients,

37

we found that the use of combination treatment

with lipid-lowering therapies was rare in South Africa. Only seven

patients were co-prescribed statins and ezetimibe in this study.

DYSIS-South Africa had several limitations, including its cross-

sectional design, which did not permit follow up to assess the

effects of statins over time in either reducing CVD risk factors

or their ultimate effects in reducing CVD. In addition, the cross-

sectional nature of the study precludes us from drawing conclusions

of temporality based on observed associations. The study was

also only conducted in the private sector and does not therefore

provide any information on the care provided in the public sector,

which accounts for about 80% of patients in South Africa. As this

study was conducted in the private sector, the ethnic make-up of

the DYSIS study cohort is not representative of the South African

population at large.

Furthermore physicians were aware of the study purpose,

possibly making the results prone to a selection bias towards

patients with better-than-average lipid goal attainment. DYSIS by

its design is also unable to provide data on the important public

health question on what proportion of patients with an indication

for lipid-lowering therapy is actually being treated. Analysing

patients that return for follow-up consultation and are still taking

statins is not reflective of the entire statin treatment experience, as

patients discontinuing early and defaulting on follow up are not

captured. However, in spite of these potential limitations, the data

obtained during this cross-sectional, observational study of South

Africa has furthered our knowledge of CV risk and the factors that

contribute to persistent dyslipidaemia in statin-treated patients.

Conclusions

The DYSIS study for South Africa, like the DYSIS studies in other

countries and regions, indicates that large proportions of statin-

treated patients have persisting lipid abnormalities, which place

them at ongoing risk for CVD. While some observations with regard

to co-morbid conditions and demographics associated with lipid

goal attainment were expected, observations also demonstrate a

decreased likelihood of obtaining lipid goals among two ethnic

minority groups, independent of treatment, demographics and

other co-morbidities. These findings deserve further attention. As

statins remain among the most effective agents for preventing

CVD, the findings of this study emphasise the necessity for more

aggressive therapy in order to achieve recommended lipid targets,

so as to reduce the burden of cardiovascular disease, which is on

the increase not only in South Africa but worldwide.

Acknowledgements

The authors thank Dr Claus Jünger and Dr Steffen Schneider, Stiftung Institut für

Herzinfarktforschung, Ludwigshafen, Germany, for performing the statistical analyses,

Dr Myrga Zankel (MSD International) for general support of the study, and Dr Lori D

Bash (Merck & Co, Inc) for critical content review. We are indebted to all investigators

and patients in South Africa who participated in DYSIS. This study was funded by

Merck & Co, Ltd (New Jersey, USA).

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