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More data confirm DPP-4 inhibitor vildagliptin (Galvus) offers special advantages for elderly Type 2 diabetes patients

Posted on: 24 Sep 07
More data confirm DPP-4 inhibitor vildagliptin (Galvus) offers special advantages for elderly Type 2 diabetes patients

Summary

Elderly people are among the patients most likely to benefit from treatment with vildagliptin, one of the new class of incretin-enhancing dipeptidyl-peptidase IV (DPP-4) inhibitors, according to data presented at the 43rd annual meeting of the European Association for the Study of Diabetes in Amsterdam, The Netherlands. Vildagliptin, in development by Novartis, is expected to become available in Europe before the end of 2007 and will have the brand name of Galvus.

A pooled analysis of data from five randomised phase III monotherapy trials, of 24 weeks duration, compared efficacy, safety and tolerability of vildagliptin 100mg and 50mg among patients younger and older than 65. Data were presented by Dr Richard E. Pratley MD, Professor of Medicine and Director of the Diabetes and Metabolism Translational Medicine Unit, University of Vermont, Burlington, VT.

The study was conducted because oral anti-diabetic medicines have always been a concern in older people. “The elderly are a challenging population partly because almost half of over 65s have complications of renal impairment,” he told doctors attending EASD. “They have a high number of comorbidities, a high use of polypharmacy and a high prevalence – around 85 per cent - of cardiovascular risk factors.“

Metformin, the current gold standard, can cause a build up of lactic acidosis so is not suitable for some patients. In addition, hypoglycemia is usually more common in older patients taking insulin or other oral antidiabetic drug classes and has limited physicians in the optimal therapeutic strategies for this age group, he added. As a result, acceptable glycaemic control is currently achieved by fewer than half of patients over 65 and there is a substantial unmet need for safe and effective therapeutic agents.

The pooled analysis found elderly patients (mean age 70) receiving vildagliptin at both the 100mg and 50mg doses fared just as well, and somewhat better on some parameters, as younger patients (mean age 50). Reassuringly, older patients rarely experienced hypoglycemic episodes; these were reported by only 10 of 2264 patients (0.4%) receiving vildagliptin monotherapy overall and by only three (0.8%) of the elderly subgroup of 374 patients. All episodes were mild in nature.

Efficacy was consistently greater in patients over 65 than those under 65 regardless of baseline HbA1c or body mass index, the study found. A significantly higher proportion of older versus younger patients achieved an HbA1c of below 7%, the ADA-recommended target, despite older patients having a baseline HbA1c of 8.3% compared to 8.7% in the younger group.

Older patients who were obese lost significantly more weight than younger counterparts – up to 0.9kg from baseline weight. “Nausea and diarrhoea were infrequent in elderly patients thus gastro-intestinal upset is unlikely to underlie the decrease in body weight seen in this subgroup,” he commented. Both older and younger patients saw modest improvements in fasting lipids and modest reductions in blood pressure.

“Although serious adverse events (SAEs) were reported by a somewhat higher percentage of older than younger patients receiving vildagliptin (6.4% vs 3.1%) none of the SAEs in vildagliptin-treated elderly patients was suspected to be drug-related,” said the study investigators. The most common adverse events occurring in more than 5% of elderly patients were nasopharyngitis (7%), dizziness (5.3%) and upper respiratory tract infections (6.4%). “Importantly there was no excess of adverse events in elderly versus younger patients with mild renal impairment receiving vildagliptin” they added. The adverse event rate observed for patients with this condition taking comparator treatments was higher.

“The good efficacy and tolerability and lack of drug interactions seen with this DPP-4 inhibitor makes it a viable, treatment alternative for elderly patients with Type 2 diabetes where there are concerns about renal impairment or side effects of other therapies,” Dr Pratley concluded.

• A further study from pooled clinical trial data examined safety,efficacy and tolerability of the drug in patients of all ages with mild or moderate renal impairment who added vildagliptin to other treatments including metformin, thiazolidinediones and insulin. Data presented by Tom Thuren of Novartis, USA, showed no differences in efficacy, adverse events or discontinuations between patients with mild renal impairment and normal renal function taking vildagliptin or placebo. “There were slightly more events, albeit mainly mild ones, in patients taking other active drugs” he commented.”So this is a reassuring result for vildagliptin and we have no specific concerns.” Prospective studies of vildagliptin in patients with moderate and severe renal impairment have been designed and will get underway following approval by the FDA. The US FDA issued an approvable letter for vildagliptin in February but requested further studies in patients with more severe renal conditions prior to approval. The data are expected to be available in 2009.

Olwen Glynn Owen - Pharmiweb Field Reporter

Last updated on: 27/08/2010 11:40:18

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