Galvus® (Vildagliptin) Achieves Significant Improvement In Type-2 Diabetes Treatment

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Main Category: Diabetes
Article Date: 15 Sep 2011 - 9:00 PDT


At the 47th Annual Meeting of the European Association for the Study of Diabetes Novartis announced results of a study that revealed Galvus® (vildagliptin) has a similar safety profile to placebo when added to anti-diabetic therapy in patients with type 2 diabetes (T2DM) and moderate or severe renal impairment. The Novartis-sponsored vildagliptin study also revealed that vildagliptin achieved significant improvements in glycemic control when added to current therapy.

Vildagliptin is the largest of a dipeptidyl peptidase-4 (DPP-4) inhibitor in patients with T2DM and moderate and severe renal impairment (n=515), a condition difficult to treat.

The 24-week, multi-center, randomized, double blind, parallel-group, placebo-controlled study evaluated the safety and tolerability of vildagliptin (50 mg qd). Researchers evaluated 294 patients with moderate renal impairment and 221 with severe renal impairment. Both groups were randomized to receive vildagliptin or placebo.

Researchers measured patients' renal function by glomerular filtration rate (GFR). The definition of moderate and severe renal impairment was estimated as GFR ≥ 30 to < 50 or < 30 mL/min/1.73m.

Findings revealed the overall safety and tolerability of vildagliptin 50 mg in patients with moderate or severe renal impairment was generally similar to placebo.

Adverse events (AE) of patients with moderate renal impairment were comparative in those receiving vildagliptin (68%) and placebo (73%) while serious adverse events (SAE) were 9% in both groups. 3% of participants developed AEs leading to discontinuation compared with 5% on placebo, while 1% of both groups died.

AE results in patients with severe renal impairment was similar to those with moderate renal impairment, with 73% of AEs caused by vildagliptin compared with 74% on placebo, while 19% of patients suffered SAEs versus 21% on placebo. 9% of participants on vildagliptin discontinued treatment compared with 21% on placebo, and 2% of vildagliptin patients died compared with 4% placebo patients.

Vildagliptin-treated patients in the moderate renal impairment group showed a slightly higher rate of hypoglycemia whereby those in the severe renal impairment group and placebo group showed similar hypoglycemia rates, confirming earlier reports that vildagliptin carries a low risk of hypoglycemia.

Ameet Nathwani, MD, Global Head of Cardiovascular and Metabolism Development Franchise at Novartis Pharmaceuticals explained:

"Safety is the primary concern in the treatment of patients with renal impairment and this study demonstrated strong safety results with vildagliptin, without compromising on efficacy. Renally-impaired patients are a particularly vulnerable and high-risk T2DM population3 with limited therapeutic options."

Researchers detected no clinically relevant differences between vildagliptin and placebo in the incidence of hepatic-, skin-, edema- and pancreatitis-related adverse events.

Vildagliptin patients with severe renal impairment showed a higher incidence of infections and infestations than placebo patients, in contrast to observations made in patients with moderate renal impairment. Most AEs were mild or moderate.

The study revealed a significant statistical and clinical decrease in A1C (blood sugar), when vildagliptin was added to anti-diabetic therapy with A1C reductions of 0.7% (from baseline 7.9%) in moderate impairment and 0.9% (from baseline of 7.7%) in severe impairment patients. A 50 mg dose of Vildagliptin administered once-daily achieved maximum efficacy in patients with average renal impairment. In patients with normal renal function maximum efficacy was achieved taking two daily doses of 50 mg.

Aliskiren data at EASD

Other interesting data presented at EASD included findings from a Novartis-sponsored study examining the blood pressure lowering effects of Rasilez® (aliskiren) in hypertensive patients with diabetes.

The pooled, retrospective analysis of 16 randomized, double-blind clinical trials involved over 10,000 patients and revealed, that patients with hypertension and T2DM treated with aliskiren monotherapy showed significant dose-related reductions in systolic and diastolic blood pressure, which were similar to the blood pressure reductions seen in patients with hypertension.

Diabetes and hypertension combined can significantly increase an individual's risk of developing life-threatening cardiovascular and renal diseases. An overactive renin angiotensin aldosterone system (RAAS) can affect blood pressure control and increase cardio-renal risk in many patients with diabetes and hypertension.

About vildagliptin and aliskiren

Vildagliptin is a DPP-4 inhibitor. It functions by inhibiting the breakdown of 'incretin' hormones in the body that stimulate insulin production in the pancreas. Its procedure of action targets the dysfunction in the pancreatic islet alpha and beta cells that cause high blood sugar levels in people with T2DM.

Galvus (vildagliptin) is currently not recommended for use in patients with moderate or severe renal impairment with the exception of treating these patients through carefully controlled and monitored clinical trials, which are designed to better understand the potential benefits and risks of the use of vildagliptin in this population.

Rasilez (aliskiren), known in the U.S. as Tekturna®, is a first-in-class, innovative high blood pressure treatment. It works at the point of activation of the RAAS, directly blocking renin activity, which is an enzyme that triggers a process that may lead to high blood pressure.

Written by Petra Rattue


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