Key vildagliptin data in The Lancet show for the first time individualized HbA1c treatment goals can be reached in elderly type 2 diabetes patients with no major tolerability issues
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Novartis International AG /
Key vildagliptin data in The Lancet show for the first time individualized HbA1c
treatment goals can be reached in elderly type 2 diabetes patients with no major
tolerability issues
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The issuer is solely responsible for the content of this announcement.
* INTERVAL study marks first assessment of the feasibility of setting and
achieving individualized goals in this difficult-to-treat population of type
2 diabetes patients[1]
* Study shows elderly type 2 diabetes patients three times more likely to
reach an individualized HbA1c goal with no tolerability issues with
vildagliptin than placebo[1]
* Previous studies raised questions of uniform HbA1c targets for elderly type
2 diabetes patients, but no trials of individualized targets had been
conducted[2],[3]
Basel, May 23, 2013 - Results of the INTERVAL study were published online in The
Lancettodayand for the first time demonstrated the feasibility of setting and
achieving individualized treatment targets in elderly patients with type 2
diabetes[1]. Previous large-scale studies, which used aggressive, identical
HbA1c targets for all patients with type 2 diabetes, raised questions due to
failure of elderly patients to reach treatment goals and detrimental
outcomes[2],[3]. Accordingly, current treatment guidelines recommend
individualized goals in elderly patients based on characteristics such as age,
comorbidities and frailty; however, no studies using individual targets have
previously been conducted[1],[4-6].
The INTERVAL study introduced the unique endpoint of investigator-defined
individualized HbA1c targets, reflecting guidance in current guidelines[1],[4-
6]. In the study, elderly patients with type 2 diabetes who were treated with
Galvus(®) (vildagliptin) achieved greater reductions in HbA1c and were three
times more likely to reach individualized treatment goals without major
tolerability issues than those treated with placebo on top of background oral
antidiabetic treatment[1].
"Novartis is committed to supporting research that has the potential to advance
the management of type 2 diabetes and provide new insights on ways to improve
patient care," said David Epstein, Division Head of Novartis Pharmaceuticals.
"This first of its kind study shows the effectiveness of a patient-centric
approach in the treatment of elderly patients with type 2 diabetes and
demonstrates that individualized treatment targets are achievable with
vildagliptin without tolerability issues."
In the 24-week INTERVAL study, 52.6 percent of patients treated with
vildagliptin achieved unique, investigator-identified individualized treatment
goals compared to 27 percent of patients treated with placebo (adjusted odds
ratio 3.16, 96.2% CI 1.81 to 5.52; p<0.0001)[1]. Patients treated with
vildagliptin also achieved clinically relevant reductions in HbA1c of 0.9% from
a baseline compared to a 0.3% reduction from a baseline in those treated with
placebo, a difference of 0.6% (98.8% CI -0.81 to -0.33; p<0.0001)[1]. Average
baseline HbA1c values for both groups were 7.9%. The overall safety and
tolerability profile was similar in the vildagliptin and placebo groups, with a
low incidence of hypoglycemia, no reported cases of pancreatitis or clinically
significant hepatic-related events, and no new safety signals[1].
About the INTERVAL study
The Novartis-sponsored INTERVAL study was a 24-week, multi-center, randomized,
double-blind, placebo-controlled study that enrolled 278 patients from 45
outpatient centers across several European countries (Belgium, Bulgaria,
Germany, Finland, Slovakia, Spain and the UK)[1].
Patients aged 70 years or older with type 2 diabetes who were treatment naïve,
or inadequately controlled with HbA1c levels of 7.0% or greater or 10.0% or less
were eligible, with investigators setting individualized treatment goals
according to local guidelines and based on age, baseline HbA1c, comorbidities
and frailty status[1]. Patients were randomized to receive either vildagliptin
(50 mg once or twice daily) or placebo[1].
The co-primary efficacy endpoints of the study were the proportion of patients
reaching their investigator-defined treatment goal and/or conventional HbA1c
reduction from baseline[1].
About diabetes in the elderly
Type 2 diabetes is one of the most common chronic disorders in older adults,
with a prevalence of approximately 20 percent in people older than 65 years[7].
Controlling blood sugar in elderly patients with type 2 diabetes is challenging
due to higher rates of comorbidities, a higher burden of physical disability,
cognitive impairment and frailty, an increased risk of complications such as
hypoglycemia, and a greater frequency of concomitant treatments that can lead to
adverse reactions[8],[9]. Research suggests that nearly 40 percent of elderly
patients with diabetes experience falls, with most occurring in patients with
poor diabetic control, lack of mobility or with existing comorbidities[10].
About Galvus(®)
Galvus(®) (vildagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class
of oral diabetes medications that enhance the body's natural ability to control
blood sugar. The Galvus(®) (vildagliptin) safety and efficacy profile has been
established in a comprehensive clinical trial program that included more than
15,000 type 2 diabetes patients[11].
Galvus(®) (vildagliptin) is approved in more than 100 countries across Europe,
Asia Pacific, Africa and Latin America[11]. It is indicated for the treatment of
type 2 diabetes as a monotherapy and in combination with metformin, a
sulphonylurea, a thiazolidinedione or insulin[12]. Specific indications vary by
country.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "feasibility," "committed," "potential," "suggests," or
similar expressions, or by express or implied discussions regarding potential
new indications or labeling for the Novartis vildagliptin products or regarding
potential future revenues from the Novartis vildagliptin products. 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 to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that the Novartis vildagliptin products will be submitted or approved for any
additional indications or labeling in any market. Nor can there be any guarantee
that the Novartis vildagliptin products will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding these
products 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; competition in general; government, industry
and general public pricing pressures; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection;
unexpected manufacturing issues; 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 129,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
1. Strain D et al. Individualised treatment targets for elderly patients with
type 2 diabetes mellitus using vildagliptin add-on or lone therapy
(INTERVAL): a 24-week, randomised, double-blind, placebo-controlled study.
The Lancet, Early Online Publication, 23 May 2013. doi:10.1016/S0140-
6736(13)60995-2. Last accessed 23 May 2013.
2. Ginsberg A. The ACCORD (Action to Control Cardiovascular Risk in Diabetes)
Lipid Trial. Diabetes Care 2011.34;107-108.
3. Patel A et al, for the ADVANCE Collaborative Group. Intensive blood glucose
control and vascular outcomes in patients with type 2 diabetes. N Engl J
Med 2008;358:2560-72.
4. Kirkman MS et al. Diabetes in older adults. Diabetes Care 2012;35:2650-64.
5. Inzucchi SE et al. Management of hyperglycemia in type 2 diabetes: a
patient-centered approach: position statement of the American Diabetes
Association (ADA) and the European Association for the Study of Diabetes
(EASD). Diabetes Care 2012;35:1364-79.
6. Sinclair AJ et al. European Diabetes Working Party for Older People 2011
clinical guidelines for type 2 diabetes mellitus: executive summary.
Diabetes Metab 2011;37(3):S27-38.
7. International Diabetes Federation 2011. IDF Diabetes Atlas, 5th edn.
Brussels, Belgium. [Online] Available at:
http://www.idf.org/diabetesatlas/5e/Update2012. Last accessed 23 may 2013.
8. Sinclair AJ et al. Diabetes mellitus in older people: position statement on
behalf of the International Association of Gerontology and Geriatrics
(IAGG), the European Diabetes Working Party for Older People (EDWPOP), and
the International Task Force of Experts in Diabetes. J Am Med Dir Assoc
2012;13(6):497-502.
9. Pratley RE, Gilbert M. Clinical management of elderly patients with type 2
diabetes mellitus. Postgrad Med 2012;124:133-43.
10. Tilling M et al. Falls as a complication of diabetes mellitus in older
people. Journal of Diabetes and Its Complications 2006;3:158-162.
11. Novartis data on file.
12. Galvus Summary of Product Characteristics (SmPC) for the European Union.
[Online] Available at:
http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000771/WC500020327.pdf. Last accessed 23 May
2013.
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