• Trajenta®
demonstrated a similar long-term cardiovascular and kidney safety
profile compared to placebo in adults with type 2 diabetes1
• The results of CARMELINA® were presented at the 54th EASD Annual Meeting today
INGELHEIM, Germany & INDIANAPOLIS, US-Thursday 4 October 2018 [ AETOS Wire ]
(BUSINESS
WIRE)-- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)
today presented the full results of the long-term cardiovascular outcome
trial, CARMELINA®, which studied the impact of Trajenta® (linagliptin)
on cardiovascular and kidney safety in adults with type 2 diabetes at
high risk for heart and/or kidney disease.1,2 The study met its primary
endpoint,* with linagliptin demonstrating a similar cardiovascular
safety profile compared to placebo when added to standard of care.1
CARMELINA® also included a key secondary composite endpoint,† showing a
similar kidney safety profile compared to placebo.1
The
overall safety profile of linagliptin in CARMELINA® was consistent with
previous data and no new safety signals were observed.1 CARMELINA® also
showed a similar rate of hospitalisation for heart failure for
linagliptin compared to placebo.1
The
full results were presented at the 54th European Association for the
Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.
“Heart
disease is a major complication and the leading cause of death for
people living with type 2 diabetes. CARMELINA® adds important new
evidence for type 2 diabetes patients at high risk of heart and/or
kidney disease, a population that has been underrepresented in other
cardiovascular outcome trials, but whom we see in our daily practice.
The trial confirmed that linagliptin can be used with confidence in this
patient population,” commented Bernard Zinman, M.D., Professor in the
Department of Medicine, University of Toronto and Senior Scientist at
the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital,
Toronto, Canada.
In
CARMELINA®, cardiovascular events that contributed to the primary
endpoint* occurred in 12.4 percent (434 people) of the linagliptin group
compared to 12.1 percent (420 people) in the placebo group,
demonstrating a similar long-term cardiovascular safety profile in
adults with type 2 diabetes.1 Linagliptin also showed a similar
long-term kidney safety profile compared to placebo. This was
demonstrated on the composite endpoint reflecting declining kidney
function† occurring in 9.4 percent (327 people) of the linagliptin group
compared to 8.8 percent (306 people) of the placebo group.1
An
increase in the risk of hospitalisation for heart failure has been
observed in some other cardiovascular outcome trials in diabetes.3,4 In
CARMELINA®, this endpoint was pre-specified and assessed thoroughly via
adjudication.‡ Hospitalisation for heart failure occurred in 6 percent
(209 people) of the linagliptin group compared to 6.5 percent (226) of
the placebo group.1 “These results are particularly meaningful given the
patient population in CARMELINA, including those most vulnerable to
developing heart failure,” said Waheed Jamal, MD, Corporate Vice
President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“While
many guidelines5,6 now recognise the importance of choosing a diabetes
treatment with a proven benefit on reducing cardiovascular risk and
mortality in people with type 2 diabetes and heart disease, there
remains a need for additional glucose-lowering options,” Waheed Jamal
pointed out. “CARMELINA®reinforces confidence in linagliptin as an
effective and well-tolerated treatment, with a simple dosing regimen for
adults with type 2 diabetes.”
“We
have created a unique cardiovascular outcome trial programme for
linagliptin with two trials — CARMELINA®, whose results are released
today, as well as CAROLINA®, which will report initial results in the
near future,” added Jeff Emmick, MD, PhD, Vice President, Product
Development, Lilly Diabetes. “This programme will provide clinical data
on the long-term safety profile of linagliptin in a broad range of
adults with type 2 diabetes, which reflects patients that doctors see in
their daily practice.7”
About CARMELINA®
CARMELINA®
is a multi-national, randomised, double-blind, placebo-controlled
clinical trial that involved 6,979 adults with type 2 diabetes from 27
countries at more than 600 sites observed for a median duration of 2.2
years.2,8 The study was designed to assess the effect of linagliptin
(5mg once daily) compared to placebo (both added to standard of care) on
cardiovascular outcomes in adults with type 2 diabetes and high
cardiovascular risk, the majority of whom also had kidney disease.2,8
This population of people with high risk of cardiovascular and/or kidney
disease reflects patients that doctors see in their daily
practice.7Standard of care included both glucose lowering agents and
cardiovascular drugs (including antihypertensive and lipid lowering
agents).
CARMELINA®
was led by an academic trial steering committee and the Boehringer
Ingelheim and Eli Lilly and Company Diabetes Alliance. Compared to other
recently reported outcome trials of dipeptidyl peptidase-4 (DPP-4)
inhibitors in type 2 diabetes, CARMELINA® included the highest number of
patients with impaired kidney function.§
To learn more about CARMELINA®, please visit: https://www.carmelinatrial.com/
About Trajenta® (linagliptin)
Trajenta®
is a one dose, once daily DPP-4 inhibitor that provides significant
efficacy in the reduction of blood sugar levels for adults with type 2
diabetes. It can be prescribed for adult patients with type 2 diabetes
regardless of age, disease duration, ethnicity, body mass index (BMI),
liver and kidney function.9 Trajenta® has the lowest kidney excretion
rate of all DPP-4 inhibitors.9-13
About our cardiovascular outcome trials
As
cardiovascular disease is a major complication and the leading cause of
death in type 2 diabetes,14 cardiovascular safety of all type 2
diabetes treatments is important. Worldwide, most people with type 2
diabetes die of a cardiovascular event.15 In 2015, Boehringer Ingelheim
and Eli Lilly and Company announced results from the landmark
cardiovascular outcome trial EMPA-REG OUTCOME® with the SGLT2 inhibitor
empagliflozin.16,17
CARMELINA®
is one of two cardiovascular outcome trials with the DPP-4 inhibitor
linagliptin. CAROLINA®,18 will be the first DPP-4 inhibitor
cardiovascular outcome trial to compare commonly used second line
treatments — linagliptin and the sulphonylurea glimepiride. This trial
includes adults with relatively early type 2 diabetes and increased
cardiovascular risk or established complications, with less than
optimised blood sugar control. The majority did not yet have heart and
kidney disease. The study will report initial results in the near
future. CARMELINA® and CAROLINA® will provide clinical data on the
long-term safety profile of linagliptin in a broad range of adults with
type 2 diabetes, which reflects patients that doctors see in their daily
practice.7
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/CARMELINA
______________________________
*
Primary endpoint defined as time to first occurrence of the 3-P MACE
(cardiovascular death, non-fatal myocardial infarction or non-fatal
stroke)
†
Key secondary endpoint defined as time to first occurrence of sustained
end stage kidney disease (ESKD), death due to kidney disease, or a
sustained decrease in eGFR from baseline of ≥40 percent compared to
placebo
‡ Assessed by an independent clinical event committee in a blinded way
§ Glomerular filtration rate below 30 mL/min/m2
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181004005553/en/
Contacts
Boehringer Ingelheim
Katharina Opitz
Product Communication
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 2012
or
Lilly Diabetes and Lilly USA
Gregory Andrew Kueterman
Director of Communications
Email: kueterman_gregory_andrew@lilly.com
Phone: +1 (317) 432-5195
Permalink
:
https://www.aetoswire.com/news/boehringer-ingelheim-and-lilly-present-full-results-of-trajentaregrsquos-carmelinaregnbspcardiovascular-outcome-trial/en
No comments:
Post a Comment