Exploratory trial shows no incremental benefit of aliskiren add-on therapy in improving changes to cardiac shape in heart attack patients
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Novartis International AG / Exploratory trial shows no incremental benefit of aliskiren add-on therapy in improving changes to cardiac shape in heart attack patients processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
· Trial assessed addition of aliskiren to help limit changes to the
heart's shape and function in patients after heart attack (post-myocardial
infarction)[1]
· A small numerical reduction in cardiac volume from adding aliskiren to
standard therapy seen in echocardiogram results, but not statistically
significant[1]
· ASPIRE, an exploratory study, is one of 14 trials in the ASPIRE HIGHER
clinical trial program evaluating aliskiren potential benefit beyond blood
pressure reduction
Basel, March 16, 2010 - The addition of the cardiovascular medicine aliskiren to
standard therapy for patients recovering from a heart attack showed some
positive effects in helping limit changes in the heart's shape and function, but
did not demonstrate a statistically significant benefit, according to new
clinical trial results[1].
Data from the ASPIRE study (Aliskiren Study in Post-MI patients to Reduce
rEmodelling) were presented at the American College of Cardiology (ACC) Congress
in Atlanta. Results from the study showed that the addition of aliskiren did not
provide the anticipated effect of limiting adverse changes to the heart's left
ventricle, which is the organ's main pumping chamber that can often reduce its
ability to pump blood efficiently()[1].
The 36-week study involving 820 patients, all of whom had evidence of impaired
left ventricular function, assessed changes in left ventricular end systolic
volume (LVESV) through echocardiograms from baseline to the study end. A small
numerical reduction in cardiac volume (LVESV, -0.99 mL) was seen in patients
receiving aliskiren and standard therapy compared to those given standard
therapy only; however, this was not statistically significant()[1].
The combined rates of cardiovascular death, hospitalization for heart failure,
recurrent heart attack, stroke and resuscitated sudden death were similar in the
aliskiren group and the group given standard therapy. In patients receiving
aliskiren in addition to standard therapy there was a higher rate of
hyperkalemia, hypotension and kidney dysfunction when compared to the group
receiving standard therapy alone()[1].
Based on the results of this trial, Novartis does not plan to pursue an outcome
trial for post-MI patients. ASPIRE is one of 14 trials in the 35,000 patient
ASPIRE HIGHER clinical trial program that is designed to evaluate potential
benefit of aliskiren beyond blood pressure reduction.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "can," "plan," "potential," or similar expressions, or by
express or implied discussions regarding the outcome of the ASPIRE HIGHER
clinical trial program, regarding potential new indications or labeling for
aliskiren or regarding potential future revenues from aliskiren as a result. You
should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause
actual results with aliskiren to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantees regarding the potential outcome of the ASPIRE HIGHER
clinical trial program. Nor can there be any guarantee that aliskiren will be
submitted or approved for any additional indications or labeling in any market.
Neither can there be any guarantee that any such additional indications or
labeling will result in aliskiren achieving any particular levels of revenue in
the future. In particular, management's expectations regarding aliskiren could
be affected by, among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
and other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] Solomon S, et al. Effect of the Direct Renin Inhibitor Aliskiren on Left
Ventricular Remodelling Following Myocardial Infarction with Left Ventricular
Dysfunction: ASPIRE. Late Breaker presentation at American College of Cardiology
59th Annual Scientific Sessions 2010
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