The results of the landmark
ONTARGET(TM) trial have demonstrated that MICARDIS(R) (telmisartan), a
second-generation angiotensin II receptor blocker (ARB), is equally
effective as the current standard, ramipril, in reducing the risk of
cardiovascular death, myocardial infarction, stroke and hospitalization for
congestive heart failure in a broad cross-section of high-risk
cardiovascular patients with normal blood pressure or controlled high blood
pressure, and resulted in fewer discontinuations.(1) These cardiovascular
events occurred in 1,423 patients (16.7 percent) receiving telmisartan
versus 1,412 patients (16.5 percent) receiving ramipril.(1) The relative
risk (ratio of the probability of the event occurring in the telmisartan
group versus the ramipril group) was 1.01, with a 95 percent CI of 0.94 -
1.09.
Telmisartan is now the only ARB to have demonstrated cardio and
vascular risk reduction benefits beyond lowering blood pressure in this
high-risk population;(1) these benefits may be attributed to the specific
pharmacological properties and mode of action of the drug. Previously, in
2000, the HOPE trial showed that the cardiovascular risk for patients
treated with the angiotensin-converting enzyme (ACE) inhibitor ramipril was
reduced by approximately 20 percent compared with placebo.(2) This meant
that every fifth serious cardiovascular event in a high risk group of
patients was prevented.(2)
"The ONTARGET trial shows that telmisartan is a well-tolerated
treatment in high-risk cardiovascular patients that is as effective as
ramipril in preventing heart attacks, stroke and hospitalizations for heart
failure and deaths," said Professor Salim Yusuf, lead investigator of the
ONTARGET Trial Program and Director of the Population Health Research
Institute at McMaster University, Hamilton, Canada. "The ONTARGET results
have important implications for the management of patients with
cardiovascular diseases."
In this trial, which was based on the HOPE study design, the benefits
of telmisartan were demonstrated in a large group (8,542) of high-risk
patients who were already receiving standard care such as statins to lower
cholesterol, antiplatelet therapy, beta blockers and other
antihypertensives.(3) Telmisartan treatment led to fewer discontinuations
than treatment with ramipril, a widely used ACE inhibitor.(1) Although
patients with an ACE inhibitor intolerance had been excluded from the
trial, 360 (4.2 percent) patients in the ramipril treatment arm stopped
their treatment because they experienced cough, a common ACE inhibitor side
effect, versus only 93 (1.1 percent) patients in the telmisartan arm.
Twenty-five patients stopped their treatment in the ramipril arm because of
angioedema, versus only 10 in the telmisartan arm.(1) The incidence of
hypotension was higher in the telmisartan arm (229 patients, 2.7 percent)
versus the ramipril (149 patients, 1.7 percent) arm.(1)
"Boehringer Ingelheim is proud to have supported ONTARGET(TM), the
largest cardiovascular outcomes trial of its kind and the first of a series
of landmark clinical studies sponsored by our company. ONTARGET is just one
example of Boehringer Ingelheim’s leadership in trying to address the needs
of people with cardiovascular disease," commented J. Martin Carroll,
president and chief executive officer of Boehringer Ingelheim
Pharmaceuticals, Inc. "We are committed to pursuing further research that
evaluates ways to reduce the risk of damaging events in the heart, brain
and other organs due to cardiovascular disease and to uncover new treatment
strategies that may improve patient outcomes and care."
ONTARGET also studied the value of combining telmisartan with ramipril,
to evaluate whether combining an ACE inhibitor and an ARB, i.e. the dual
renin-angiotensin system (RAS) blockade, could offer even better risk
reduction compared to single blockade, a key question for the clinical
community. The results announced today indicate that there was no
additional risk reduction benefit achieved and a higher discontinuation
rate if telmisartan and ramipril are combined.(1)
About the ONTARGET(TM) Trial Program
The ONTARGET Trial Program is the largest clinical trial ever
undertaken with an ARB, involving more than 31,000 high-risk cardiovascular
patients with either normal or controlled blood pressure. The ONTARGET
Trial Program encompasses two randomized, double-blind, multi-center
international outcome trials: ONTARGET, the main trial with results
reported today, and TRANSCEND(TM) (Telmisartan Randomized Assessment Study
in ACE-intolerant subjects with cardiovascular disease), the parallel trial
with results planned to be reported later in 2008.
ONTARGET evaluated more than 25,600 high-risk cardiovascular patients
with normal blood pressure or controlled high blood pressure and a history
of a broad range of cardiovascular diseases. The study compared the
effectiveness of the ARB telmisartan to the ACE inhibitor ramipril in
reducing the combined risk of cardiovascular death, myocardial infarction,
stroke and hospitalization for congestive heart failure (CHF) in patients
at risk. The study also compared the efficacy of the combination of the ARB
telmisartan and the ACE inhibitor ramipril compared to ramipril alone in
achieving the same combined endpoint.
The combined primary endpoint in the ONTARGET trial included
cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and
hospitalization for congestive heart failure. In addition, a broad variety
of secondary and tertiary endpoints were studied, including: newly
diagnosed diabetes, cognitive decline/dementia, nephropathy, atrial
fibrillation and left ventricular hypertrophy.
Treatment arms for the ONTARGET(TM) trial were telmisartan 80 mg,
ramipril 10 mg and a combination therapy with telmisartan 80 mg and
ramipril 10 mg. All treatments were applied in addition to standard care
for high-risk cardiovascular patients.
More than 700 sites throughout Asia, Australia, New Zealand, Europe,
North/South America and South Africa participated in the ONTARGET Trial
Program. The ONTARGET Steering Committee consists of scientists from
McMaster University in Ontario, Canada; Oxford University in Oxford,
England; the University of Auckland in Auckland, New Zealand; and
Boehringer Ingelheim.
The ONTARGET trial was investigational and was conducted to expand
scientific knowledge of telmisartan. Note that the trial included treatment
for conditions outside the approved indication for telmisartan.
About Cardiovascular Disease
Cardiovascular disease (CVD) is the number one cause of death and
disability globally(4) and is responsible for one of every three deaths
worldwide — an estimated 17 million people per year.(5) CVD causes more
deaths than cancer, chronic respiratory disease and diabetes combined.(6)
By 2020, it is predicted that CVD will surpass infectious diseases to
become the largest cause of death and disability worldwide.(7) It is also
contributes significantly to the escalating costs of health care. In 2006,
the cost of CVD in the U.S. was estimated at $403.1 billion.(8)
Boehringer Ingelheim and Cardiovascular Medicine
Boehringer Ingelheim continues its century-long history of innovation
and commitment to continuing research to further understand cardiovascular
disease — the number one cause of death worldwide. Boehringer Ingelheim
has introduced novel agents in the management of hypertension and treatment
of secondary stroke and continues to invest in a comprehensive
cardiovascular pipeline. The Company’s cardiovascular medicine clinical
trial program includes ONTARGET, PRoFESS, TRANSCEND and other studies
involving more than 75,000 patients in more than 40 countries. These
studies were designed to evaluate ways to reduce the risk of damaging
events in the heart, brain and other organs due to cardiovascular disease
and to uncover new treatment strategies that improve patient outcomes and
care.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is
the largest U.S. subsidiary of Boehringer Ingelheim Corporation
(Ridgefield, CT) and a member of the Boehringer Ingelheim group of
companies.
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 137 affiliates in 47 countries and approximately 38,400
employees. Since it was founded in 1885, the family-owned company has been
committed to researching, developing, manufacturing and marketing novel
products of high therapeutic value for human and veterinary medicine.
In 2006, Boehringer Ingelheim posted net sales of US $13.3 billion
(10.6 billion euro) while spending approximately one-fifth of net sales in
its largest business segment, Prescription Medicines, on research and
development.
For more information, please visit
About Micardis(R) (telmisartan)
Telmisartan is marketed in the United States by Boehringer Ingelheim as
MICARDIS(R) tablets. MICARDIS is indicated for the treatment of
hypertension.
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs
that act directly on the renin-angiotensin system can cause injury and even
death to the developing fetus. When pregnancy is detected, MICARDIS tablets
should be discontinued as soon as possible (see WARNINGS, Fetal/Neonatal
Generic lasix pills no prescription Morbidity and Mortality).
Thiazides cross the placental barrier and appear in cord blood. There
is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly
other adverse reactions that have occurred in adults.
MICARDIS is contraindicated in patients who are hypersensitive to any
of their components.
In patients with an activated renin-angiotensin system, such as volume-
and/or salt-depleted patients (e.g., those receiving high doses of
diuretics), symptomatic hypotension may occur after initiation of MICARDIS
therapy. This condition should be corrected prior to administration of
MICARDIS tablets, and treatment should start under close medical
supervision.
The most common adverse events occurring with MICARDIS tablets
monotherapy at a rate of 1% and greater than placebo, respectively, were:
upper respiratory tract infection (URTI) (7%, 6%), back pain (3%, 1%),
sinusitis (3%, 2%), diarrhea (3%, 2%), and pharyngitis (1%, 0%).
Please visit for full Prescribing Information for
MICARDIS.
References:
1 The ONTARGET Investigators. Telmisartan, ramipril, or both in
patients at high risk for vascular events. N Engl J Med 2008; 358:1547-59.
2 The Heart Outcomes Prevention Evaluation Study Investigators. Effects
of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular
events in high-risk patients. N Engl J Med 2000; 342:145-53
3 The ONTARGET/TRANSCEND Investigators. Rationale, design, and baseline
characteristics of 2 large, simple, randomized trials evaluating
telmisartan, ramipril, and their combination in high-risk patients; The
Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint
Trial/Telmisartan Randomized Assessment study In ACE Intolerant Subjects
with Cardiovascular disease
4 Facts and Figures: World Health Report 2003. World Health
Organization
5 The Atlas of Heart Disease and Stroke 2004 World Health Organization

6 World Health Organization, Cardiovascular Disease

7 Levenson J. et al. Reducing the global burden of cardiovascular
disease: the role of risk factors. Preventative Cardiology, 2002; 5:
188-189.
8 Thom T et al. Heart disease and stroke statistics - 2006 update.
Circulation. 2006; 113:e85-e151.
Boehringer Ingelheim Pharmaceuticals, Inc.

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