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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 1, January/February 2021
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AFRICA
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Polypill plus aspirin reduces incidence of cardiovascular events by 31%: TIPS-3
Researchers have found that combined treatment with
a polypill plus aspirin led to a 31% lower incidence of
cardiovascular events than did placebo among participants
without cardiovascular disease (CVD) who were at
intermediate cardiovascular risk, according to the TIPS-3
study in the
New England Journal of Medicine
(NJEM).
No excess of major bleeding events was observed and
the NEJM writes in an editorial that ‘the findings of
TIPS-3 support the inclusion of multi-drug therapy for
cardiovascular disease prevention in the World Health
Organisation “best buys” for non-communicable disease
prevention and control as the lone health-system approach
that is potentially highly cost-effective.’
The NEJM writes:
The polypill concept garnered substantial attention in 2003
after the publication of a modelling analysis that proposed
that the use of fixed-dose combination therapy in persons
with established atherosclerotic cardiovascular disease and in
all other adults 55 years of age or older could reduce disease
burden by 80% or more.
Notably, these models overestimated the effects of aspirin
and folic acid and assumed full long-term adherence to the
regimen. Subsequent randomised trials testing the effects of
different polypills in small populations over short periods
of time showed reductions in cholesterol level and blood
pressure and increases in the percentages of participants
adhering to the regimen in both primary-prevention and
secondary-prevention settings. However, for primary
prevention, concerns remained regarding the appropriateness
of polypill components, including aspirin; the disadvantages
of being unable to adjust the doses of individual drugs,
potentially outweighing any benefits of a polypill approach;
and the issue of medicalisation of healthy populations.
Without data on clinical outcomes, debates about the polypill
remained unresolved.
In 2019, the PolyIran cluster-randomised trial reported
the first long-term outcomes of any polypill study in a
largely primary-prevention population. Among 6 838 adults
50 to 75 years of age in Iran who were followed for a mean
of five years, the polypill group had a 34% lower risk of
major cardiovascular events than the group that received
augmented usual care. This trial has now been closely
followed by the publication in this issue of the Journal
of TIPS-3 (the International Polycap Study 3). Among 2
850 intermediate-risk participants in nine countries who
were followed for a mean of 4.6 years, those who had been
randomly assigned to receive the polypill plus aspirin had a
31% lower risk of major cardiovascular events than those
who had been randomly assigned to receive double placebo.
Some important unresolved questions remain. An excess
of major bleeding events was not observed in the comparison
of polypill plus aspirin with double placebo in TIPS-3
(or in the comparison of the aspirin-containing polypill
with usual care in the PolyIran trial), but these analyses
were probably underpowered for detecting significant
harm. Furthermore, the bio-equivalence and long-term
stability of polypill formulations should be shown. Finally,
reasons for non-adherence to the polypill regimen due to
preferences among physicians, patients, or both require
further understanding.
Ischaemic heart disease and atherosclerotic stroke are
among the leading causes of health loss globally. Yet, health
systems either have not been sufficiently responsive or are
unprepared to deliver equitable, high-quality primary care in
cardiovascular disease prevention and control. The findings
of TIPS-3 support the inclusion of multi-drug therapy
for cardiovascular disease prevention in the World Health
Organisation ‘best buys’ for non-communicable disease
prevention and control as the lone health-system approach
that is potentially highly cost-effective.
Other population-based strategies still need to be
implemented urgently to achieve global goals. However,
patients with atherosclerotic cardiovascular disease and
persons who are at risk for atherosclerotic cardiovascular
disease can also derive health benefits from pharmacotherapy,
and therefore polypill therapy represents the most scalable
intervention to date, given the totality of data.
Source:
Medical Brief 2020