Novartis Data at EASD From 45,000-Patient Study Demonstrate Real-World Effectiveness of Galvus in Patients With Type 2 Diabetes
• Data from global EDGE study show 1.19% reduction in HbA1c
when vildagliptin was added to existing oral anti-diabetes
therapies1
• A higher proportion of patients responded to vildagliptin
treatment without any of the predefined tolerability issues than
comparator oral anti-diabetes therapies2
• Results from one of the largest observational studies in type 2 diabetes are consistent with the efficacy and safety profile in vildagliptin’s clinical trial program1
Berlin, October 3, 2012 – Novartis announced today new data showing that a significantly higher proportion of type 2 diabetes patients responded to treatment with either Galvus® (vildagliptin), when added to existing oral anti-diabetes therapy, or Eucreas® (vildagliptin/metformin) compared to combinations of other oral anti-diabetes therapies2. Response to treatment in the global, 45,000-patient Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin (EDGE) study was defined as an HbA1c drop of greater than 0.3% without any of the predefined tolerability issues2. The results of the observational EDGE study were presented today at the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin2.
“The EDGE study, which was one of the largest observational studies ever conducted in type 2 diabetes, provides patients and physicians real-world evidence of the effectiveness of Galvus,” said Timothy Maloney, Global Business Franchise Head, Primary Care, Novartis. “The results of EDGE are consistent with the safety and efficacy profile established in vildagliptin’s robust clinical trial program.”
Type 2 diabetes is a progressive disease in which it becomes increasingly difficult to manage blood sugar levels with one therapy alone3,4. However, adding additional therapies can increase the risk of adverse events, including hypoglycemia, weight gain and gastro-intestinal side effects4. The EDGE study demonstrates the real-world effectiveness of vildagliptin in combination with other oral anti-diabetes therapies when treating patients with type 2 diabetes2.
Overall 55.4 percent of patients in the vildagliptin group and 51.3 percent of patients in the comparator group had a decrease in HbA1c of >0.3% without the predefined tolerability issues of peripheral edema, hypoglycemia, GI events and weight gain after 12 months of treatment (adjusted OR 1.49 [95% CI:1.42 – 1.55])2. In the EDGE study, vildagliptin in combination with another therapy was shown to achieve a 1.19% reduction in HbA1c from baseline compared to mean reductions in HbA1c of 0.99% in the comparator group1.
The incidence of adverse events was similar across both treatment groups, occurring in 5.28 percent in the vildagliptin arm and 5.73 percent in the comparator arm2.
“In addition to providing data on the benefit and risk profiles of specific treatments, EDGE is important because it offers information on when doctors around the world decide to step up oral glucose lowering therapy in type 2 diabetes,” said Chantal Mathieu, Professor of Medicine at the University of Leuven, Belgium. “Despite guidelines recommending combination treatment should be initiated when HbA1c levels remain above 7.0% for three months, clinical inertia appears to be widespread with physicians waiting until blood sugar levels are above 8.0% to add another therapy.”
Clinicians who took part in the EDGE study initiated combination therapy at a mean HbA1c baseline of 8.16%5. The baseline HbA1c for initiation of combination therapy varied considerably by region with a mean of 7.7% in East Asia, 7.9% in Europe, 8.5% in Latin America, 8.5% in the Middle East and 8.6% in India, suggesting the need for earlier use of combination therapy5.
About the EDGE study
The Novartis-sponsored EDGE study was a 12-month, multi-national,
observational cohort study that enrolled patients in 27 countries,
across five regions (East Asia, Europe, India, Latin America and
the Middle East)2.
Patients became eligible for the study after an add-on treatment
was chosen by their physician based on the patient’s need1.
Patients were assigned to one of two groups:
• Vildagliptin in combination with another oral anti-diabetic
drug (OAD)2
• Other OAD combinations, including any sulphonylurea,
thiazolidinedione, glinide, α-glucosidase inhibitor or
metformin, but excluding any DPP-4 inhibitor or GLP-1 mimetics or
analogues2
The primary endpoint was the proportion of patients responding
to treatment (HbA1c reduction of >0.3%) without any of the
following predefined tolerability issues: peripheral edema,
hypoglycemic events, discontinuation due to gastrointestinal events
or weight gain (≥5%)2.
The study also evaluated the following secondary effectiveness
endpoints:
• Decrease in HbA1c >0.3% from baseline to end of study
without peripheral edema, proven hypoglycemic events,
discontinuation due to gastrointestinal events or weight gain ≥
3%2
• Decrease in HbA1c >0.3% from baseline to end of study
without weight gain ≥ 3% or proven hypoglycemic events2
• HbA1c <7% at end of study without proven hypoglycemic
events or weight gain ≥ 3% and baseline HbA1c >7%2
The safety endpoints were the incidence of death, serious adverse events (SAEs) and adverse events (AEs) and the estimated relative death, SAE and AE risk2.
About diabetes
Diabetes is one of the world’s greatest healthcare
challenges, affecting 366 million people globally and killing one
person every seven seconds6. The obesity epidemic and an aging
world population are contributing to the escalating incidence of
type 2 diabetes and by 2030 it is projected that more than half a
billion people will be diagnosed with the disease6. Type 2 diabetes
accounts for 90 percent of all cases of diabetes7.
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 patients8.
Galvus® (vildagliptin) is approved in more than 100 countries
across Europe, Asia Pacific, Africa and Latin America1. It is
indicated for the treatment of type 2 diabetes as a monotherapy and
in combination with metformin, a sulphonylurea, a thiazolidinedione
or insulin8. Specific indications vary by country.
About Eucreas®/Galvus® Met
Eucreas®/Galvus® Met (vildagliptin and metformin) is a
single-pill fixed-dose combination of Galvus® (vildagliptin)
and metformin9. Eucreas®/Galvus® Met (vildagliptin and
metformin) is approved in more than 80 countries across Europe,
Asia Pacific, Africa and Latin America for the treatment of
patients with type 2 diabetes who are unable to control blood sugar
with metformin alone1. Specific indications vary by country.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as “suggesting,”
“projected,” “will,” 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 regulatory actions or
delays or government regulation generally; unexpected clinical
trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data;
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 2011, the
Group achieved net sales of USD 58.6 billion, while approximately
USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group.
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References
1. Novartis Pharma AG data on file.
2. Mathieu C et al. Effectiveness and safety of vildagliptin
compared with other oral anti-diabetic drugs in patients with type
2 diabetes: results from a large worldwide cohort study (EDGE).
Poster 863 presented at EASD 2012.
3. World Health Organization. Diabetes Fact Sheet Noº312.
http://www.who.int/mediacentre/factsheets/fs312/en/index.html.
Accessed September 7, 2012.
4. 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). Diabetologia
2012;55:1577-1596.
5. Bader G et al. Effectiveness of diabetes control with
vildagliptin vs. other OADs: baseline characteristics of patients
enrolled in the EDGE study. ADA abstracts 2449-PO. 72nd Scientific
Sessions: 2012;June: 61 (suppl 1).
6. International Diabetes Federation. Global diabetes plan.
http://www.idf.org/sites/default/files/Global_Diabetes_Plan_Final.pdf.
Accessed September 7, 2012.
7. International Diabetes Federation. Types of diabetes.
http://www.idf.org/types-diabetes. Accessed September 7,
2012.
8. Galvus Summary of Product Characteristics (SmPC).
9. Eucreas Summary of Product Characteristics (SmPC).
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Posted: October 2012
