CARDIOVASCULAR JOURNAL OF AFRICA • Vol 21, No 4, July/August 2010
232
AFRICA
Drug Trends in Cardiology
ARBs and possible cancer risk
The recent meta-analysis published in the
Lancet Oncology
, with comment from
Dr Steve Nissen,
1,2
has raised questions
around a possible cancer risk and the use
of ARBs. The
Cardiovascular Journal of
Africa
will be publishing a fuller report
on this matter in a forthcoming issue of
the Journal.
In the interim, Boehringer-Ingelheim
has issued the following pertinent
comments.
J Aalbers, Special Assignments Editor
Comment from Boehringer
Ingelheim
Boehringer Ingelheim affirms safety of
telmisartan with an analysis of 50 000
patients and strongly disagrees with the
publication of Sipahi
et al
.
1
in
Lancet
Oncology
June 2010
Telmisartan, an angiotensin receptor
blocker, is one of the best-researched
drugs worldwide. It has been studied
in clinical trials in more than 50 000
patients. Its positive safety profile has
been confirmed also in a market exposure
of 34.5 million patient years.
Convincing safety data for patients
with a high cardiovascular risk were
collected in the three long-term outcome
trials ONTARGET, PRoFESS and
TRANSCEND, which followed some of
the patients for up to five years. Following
rigorous assessment of the data from
these studies it was concluded that there
was no association with an increased risk
of cancer in the telmisartan arms.
Sipahi
et al
.
1
published a meta-analysis
in the June issue of
Lancet Oncology
,
claiming that angiotensin receptor block-
ers (ARBs) used to lower hypertension
are associated with a modestly increased
risk of new cancer diagnosis. The find-
ing is mainly based on the combina-
tion arm of telmisartan and ramipril, an
angiotensin converting enzyme (ACE)
inhibitor, and not on the trial arms of each
compound separately.
Patient health and safety is the primary
concern of Boehringer Ingelheim. The
company continually monitors safety
data for all medical products. Boehringer
Ingelheim’s comprehensive internal safe-
ty data analysis of primary data contra-
dicts the conclusions about an increased
risk of potential malignancies mentioned
by Sipahi
et al
.
1
All studies with telmisartan includ-
ed patients with cardiovascular risk
factors due to age and co-morbidities.
Specifically, in ONTARGET, with more
than 25 000 patients, no statistically signif-
icant difference with respect to malignan-
cies was observed in patients treated with
telmisartan vs ramipril. In TRANSCEND,
a 6 000 patient trial, the difference did not
reach significance either. In the PRoFESS
trial, another large-scale trial with more
than 20 000 patients, the telmisartan arm
showed fewer cases of malignancies than
the placebo arm. Considering the analysis
of all three trials, an effect of telmisartan
on malignancies was not observed.
In ONTARGET, the one treatment arm
with a combination of telmisartan and
ramipril was associated with a modestly
increased risk of malignancies. Consistent
with our commitment to transparency,
data from ONTARGET, TRANSCEND
and PRoFESS have all been published
and been widely shared with regulatory
authorities since 2008. It should be noted
that product labelling for telmisartan
does not recommend the combination of
telmisartan and ACE inhibitors such as
ramipril.
‘Our research efforts have centred on
the need to protect patients, especially
older patients, from cardiovascular risks
such as myocardial infarction or stroke.
Telmisartan fulfills this need. It is the
only ARB that has cardiovascular protec-
tion in its label and has become a valu-
able treatment option in the management
of hypertension and cardiovascular risk.
Doctors and patients appreciate its excel-
lent safety profile.
In pre-clinical trials, clinical trials
and day-to-day patient exposure with
telmisartan, we have not seen any signif-
icant finding related to malignancies.
Patients should consult with their physi-
cians before making any decision regard-
ing their antihypertensive therapy’, said
Prof Dr Klaus Dugi, Corporate Senior
Vice President, Medicine at Boehringer
Ingelheim.
Peer-reviewed meta-analyses of aggre-
gate published data like Sipahi
et al
.
1
have their appropriate place in scien-
tific research. However, these analyses
have well-recognised limitations, such as
combining study summaries rather than
analysing individual patient data.
Telmisartan is one of the most studied
antihypertensives in clinical trials, which
have all been made publically availa-
ble. It is widely used as medication to
lower blood pressure and protect patients
against severe cardiovascular events such
as myocardial infarction and stroke.
Please be advised: In some countries
Micardis has not yet been registered for
the cardiovascular protection indication.
Please refer to the package insert approved
by the local regulatory authority.
S3 Micardis
®
40 and 80 mg. Each tablet
contains telmisartan 40 and 80 mg,
respectively.
S3 Pritor
®
40 and 80 mg. Each tablet
contains telmisartan 40 and 80 mg,
respectively.
For further information please contact:
Dr Kevin Ho, medical director:
Tel: + 27 11 348-2517; e-mail: kevin.ho@
boehringer-ingelheim.com
Sue Thomas, medical information manager:
Tel: + 27 11 348-2514; e-mail: sue.thomas@
boehringer-ingelheim.com
1. Sipahi I, Debanne SM, Rowland DY, Simon
DI, Fang J. Angiotensin-receptor block-
ade and risk of cancer: meta-analysis of
randomised controlled trials. Published
online June 14, 2010 DOI:10.1016/51470-
2045(10)70106-6.
2. Nissen SE. Comment: Angiotensin-receptor
blockers and cancer: urgent regulatory review
needed. Published online June 14 2010;
DOI:10.1016/51470-2045(10)70142X.
