|[March 10, 2013]
New trial results support treatment with Inspra (eplerenone) within first 24 hours of symptoms, in addition to standard therapy, in patients with acute STEMI without heart failure.
SAN FRANCISCO --(Business Wire)--
Pfizer Inc. (NYSE: PFE) today announced results from the REMINDER trial
showing statistically significant risk reductions in the primary
composite efficacy endpoint. The composite endpoint was defined as the
time to first event of cardiovascular (CV) mortality, re-hospitalization
or extended initial hospital stay due to diagnosis of heart failure
(HF), sustained ventricular tachycardia or fibrillation, ejection
fraction (EF) =40% after 1 month, or an elevation of BNP/ NT-proBNP
after 1 month.
The results were presented for the first time during the Late Breaker
Clinical Trial session at the 62nd Annual Scientific Session
of the American College of Cardiology in San Francisco today.
The REMINDER trial was a randomized, double-blind trial, involving 1,012
patients with acute ST-segment elevation myocardial infarction (STEMI)
without a history of HF or EF <40% and without signs of HF. Patients
received, preferably before myocardial reperfusion, either eplerenone
(25-50 mg OD) or placebo in addition to standard therapy. Treatment was
initiated within the first 24 hours of symptom onset (preferably within
The REMINDER trial demonstrated a statistically significant
42.9% relative risk reduction in the primary endpoint with p < 0.0001
(95% confidence interval [CI] 0.439, 0.742) in patients with acute STEMI
when eplerenone was initiated within the first 24 hours of onset of
symptoms. Overall, the adverse events reported in the REMINDER trial
were consistent with those already known for eplerenone, primarily
Eplerenone is not approved for use in the patient population studied in
the REMINDER trial in any market.
The improvement in outcome was mainly driven by a significant reduction
of the BNP / NT-proBNP biomarker component at 1 month. BNP/NT-proBNP has
been shown to be an important marker for short- and long-term prognosis
in patients with myocardial infarction in the presence or absence of
preserved ejection fraction. An elevation of BNP / NT-proBNP after 1
month was observed less frequently in the eplerenone group 81(16.0%)
than in the placebo group 131(25.9%) (adjusted HR, 0.584; 95% CI
Over the course of the study, the incidence of hyperkalemia (elevated
potassium defined as serum potassium levels exceeding 5.5 mEq/L)
occurred in 5.6% vs. 3.2% (p=0.09) in the eplerenone and placebo groups,
respectively. Hypokalemia (serum potassium level below 3.5 mEq/L)
occurred more frequently in the placebo group with 1.4% vs. 5.5%
(p=0.0002) in the eplerenone and placebo groups, respectively. The rates
of other adverse events were similar in both groups.
Commenting on the findings, the chair of the REMINDER Steering Committee
Professor Gilles Montalescot, Institute of Cardiology, Centre
Hospitalier Pitié-Salpêtriere, Paris, France said: "Eplerenone improved
the outcome of patients presenting with acute STEMI and without
concomitant heart failure. This benefit was obtained in a low-risk
population that was well treated, without serious adverse drug effect.
Adding eplerenone to standard therapy as early as within the first 24
hours of symptoms reduced heart failure-related morbidity."
About the REMINDER trial
The REMINDER trial was a randomized, double-blind trial, involving 1012
patients with acute STEMI without a history of HF or EF <40% and withut
signs of HF.
The REMINDER trial was conducted in 11 countries: Canada, Czech
Republic, France, Germany, Greece, Hungary, Netherlands, Poland,
Slovakia, Spain, UK.
The primary objective of the REMINDER trial was to assess the efficacy
of Inspra 25 -50 mg once daily, compared to placebo, in the early
treatment of acute ST-segment elevation myocardial infarction (STEMI)
within 24 hours (preferably within the first 12h).
The mean follow-up time was 10.5 months.
The study was funded by Pfizer.
INSPRA® (eplerenone) is a steroid nucleus-based
mineralcorticoid receptor (MR) antagonist with a higher degree of
selectivity than spironolactone.
Important Prescribing Information
In the United States, Inspra® (eplerenone) is indicated to improve
survival of stable patients with left ventricular (LV) systolic
dysfunction (ejection fraction less than or equal to 40%) and clinical
evidence of congestive heart failure (CHF) after an acute myocardial
infarction (MI). Eplerenone is also indicated for the treatment of
hypertension. Eplerenone may be used alone or in combination with other
Eplerenone is contraindicated in all patients with serum potassium
greater than 5.5 mEq/L at initiation, creatinine clearance less than or
equal to 30 mL/min, or concomitant administration of strong CYP3A4
inhibitors. Eplerenone is also contraindicated for the treatment of
hypertension in patients with type 2 diabetes with microalbuminuria,
serum creatinine greater than 2.0 mg/dL in males or greater than 1.8
mg/dL in females, creatinine clearance less than 50 mL/min, or
concomitant administration of potassium supplements or potassium sparing
Serum potassium should be measured before initiating eplerenone therapy,
within the first week, and at one month after the start of treatment or
dose adjustment. Serum potassium should be assessed periodically
thereafter, especially in patients at risk for the development of
hyperkalemia such as elderly patients with renal insufficiency and
patients with type 2 diabetes and microalbuminuria.
Most common adverse reactions (greater than 2% and more frequent than
with placebo) in patients with CHF Post-MI: hyperkalemia and increased
creatinine. Most common adverse reactions (greater than or equal to 2%
and more frequent than with placebo) in hypertensive patients:
dizziness, diarrhea, coughing, fatigue and flu-like symptoms.
In the European Union, eplerenone is indicated, in addition to standard
optimal therapy, to reduce the risk of cardiovascular mortality and
morbidity in adult patients with NYHA class II (chronic) heart failure
and left ventricular systolic dysfunction (LVEF =30%). Eplerenone is
also indicated to reduce the risk of cardiovascular mortality and
morbidity in stable patients with left ventricular dysfunction (LVEF
=40%) and clinical evidence of heart failure after recent myocardial
In Japan, eplerenone is approved for the treatment of hypertension.
For additional product information in the US, visit:
UK prescribing information is available at:
Other countries should refer to local prescribing information.
Pfizer Inc.: Working together for a healthier
At Pfizer, we apply science and our global resources to improve health
and well-being at every stage of life. We strive to set the standard for
quality, safety and value in the discovery, development and
manufacturing of medicines for people and animals. Our diversified
global health care portfolio includes human and animal biologic and
small molecule medicines and vaccines, and many of the world's
best-known consumer products. Every day, Pfizer colleagues work across
developed and emerging markets to advance wellness, prevention,
treatments and cures that challenge the most feared diseases of our
time. Consistent with our responsibility as the world's leading
biopharmaceutical company, we also collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For more
than 150 years, Pfizer has worked to make a difference for all who rely
on us. To learn more about our commitments, please visit us at www.pfizer.com.
# # # # #
DISCLOSURE NOTICE: The information contained in this release is as of
March 10, 2013. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about a potential
additional indication for Inspra, including its potential benefits, that
involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; whether and when supplemental drug
applications may be filed with regulatory authorities for this potential
additional indication for Inspra; decisions by regulatory authorities
regarding whether and when to approve any supplemental drug applications
that may be filed for this potential additional indication for Inspra as
well as their decisions regarding labeling and other matters that could
affect its availability or commercial potential; and competitive
A further list and description of risks and uncertainties can be
found in Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2012, and in its reports on Form 10-Q and Form 8-K.
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