Cardiovascular Journal of Africa: Vol 32 No 1 (JANUARY/FEBRUARY 2021)

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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 1, January/February 2021 46 AFRICA
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Yale study adds to evidence of diabetes drug’s link to heart risk
Rosiglitazone was associated with a 33% increased risk
of a composite cardiovascular event (heart attack, heart
failure, cardiovascular and non-cardiovascular related death)
compared with controls, found a Yale analysis of 130 trials
involving 48,000 patients.
This study is the most comprehensive evaluation of the
cardiovascular risk of rosiglitazone ever done. Rosiglitazone
belongs to a class of drugs called thiazolidinediones. It helps
control blood sugar levels in patients with type 2 diabetes, but
it can also increase the risk of serious heart problems. This
has led to suspension of the drug in Europe and previous
restrictions on its use in the US.
However, since 2007, studies have reported conflicting
findings about whether rosiglitazone increases the risk of
heart attacks. But these studies didn’t have access to the raw
data, also known as individual patient level data (IPD), from
clinical trials and mostly relied on summary level data (results
reported in publications and clinical trial registries), which
are not as reliable when estimating the true safety profile of
drugs.
Recent efforts by GlaxoSmithKline (GSK) – the maker
of rosiglitazone – to make IPD available to external
investigators, prompted a team of US researchers at Yale
School of Public Health and the Yale-New Haven Health
System, to re-analyse the data and clarify some of the
uncertainties about rosiglitazone’s cardiovascular risk. They
analysed the results of more than 130 trials involving over
48,000 adult patients that compared rosiglitazone with any
control for at least 24 weeks. IPD were available for 33 trials,
which included 21,156 patients; the remaining trials only had
summary level data available.
When the researchers analysed the IPD from trials made
available by GSK, they found rosiglitazone was associated
with a 33% increased risk of a composite cardiovascular
event (heart attack, heart failure, cardiovascular and
non-cardiovascular related death) compared with controls.
This was estimated from the 274 events among 11,837
rosiglitazone patients and 219 events among 9,319 control
patients.
When examining cardiovascular events independently, the
analyses of the 33 GSK trials with IPD resulted in higher
estimates of the risk of heart attacks than the analyses of
trials with IPD and summary level data.
These findings highlight the potential for different results
derived from different data sources, and demonstrate the
need for greater clinical trial transparency and data sharing
to accurately assess the safety of drugs, say the researchers.
“Our study suggests that when evaluating drug safety and
performing meta-analyses focused on safety, IPD might be
necessary to accurately classify all adverse events,” they write.
“By including these data in research, patients, clinicians, and
researchers would be able to make more informed decisions
about the safety of interventions.”
They add: “Our study highlights the need for independent
evidence assessment to promote transparency and ensure
confidence in approved therapeutics, and post-market
surveillance that tracks known and unknown risks and
benefits.”
Source: Medical Brief 2020