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
/www.w3.org/1999/xhtml'>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
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 . Processed and transmitted by Thomson Reuters ONE. 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
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.
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References
- 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.
- Ginsberg A. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) Lipid Trial. Diabetes Care 2011.34;107-108.
- 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.
- Kirkman MS et al. Diabetes in older adults. Diabetes Care 2012;35:2650-64.
- 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.
- 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.
- 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.
- 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.
- Pratley RE, Gilbert M. Clinical management of elderly patients with type 2 diabetes mellitus. Postgrad Med 2012;124:133-43.
- Tilling M et al. Falls as a complication of diabetes mellitus in older people. Journal of Diabetes and Its Complications 2006;3:158-162.
- Novartis data on file.
- 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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