MedWire News: The thiazolidinedione rosiglitazone achieves slightly better long-term glycemic control in patients with Type 2 diabetes than the dipeptidyl peptidase-4 inhibitor vildagliptin, but at the cost of increased weight, less favorable lipid profile, and higher risk for peripheral edema.
Julio Rosenstock (Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas, USA) and team previously carried out a 24-week core study comparing vildagliptin 100 mg/day with rosiglitazone 8 mg/day. The results showed a similar average reduction in glycated hemoglobin (HbA1c) of 1.24% and 1.55% in patients treated with vildagliptin and rosiglitazone, respectively.
This study extended the original study for an additional 80 weeks to 104 weeks in total. A total of 598 patients participated in the extended study, and were randomized to take either vildagliptin (n=396) or rosiglitazone (n=202) in a 2:1 fashion. The extended study participants were aged 54 years on average.
At week 104, HbA1c levels were significantly reduced by 0.82% and 1.44% from baseline in the vildagliptin and rosiglitazone groups, respectively, with a between-group difference of 0.62%.
However, although rosiglitazone appeared to reduce HbA1c more effectively long-term, individuals in the rosiglitazone group gained a significant 4.67 kg on average over the study period compared with no change in weight in the vildagliptin group.
In addition, there was a higher risk for peripheral edema in the rosiglitazone group with an incidence over the study period of 11.1% compared with 4.6% in the vildagliptin group.
Vildagliptin treatment also led to significant reductions in total cholesterol, low-density lipoprotein (LDL) cholesterol, and non-LDL cholesterol compared with rosiglitazone.
Of note, four individuals experienced mild hypoglycemia whilst taking vildagliptin, but none taking rosiglitazone.
More serious adverse events were observed in the vildagliptin compared with the rosiglitazone group at 12.5% versus 9.1%, but only one event in each group was suspected to be study-drug related.
“This study showed that the similar reduction in HbA1c seen during a short-term treatment period with both vildagliptin and rosiglitazone was more durable with rosiglitazone than with vildagliptin after 104 weeks of treatment,” conclude Rosenstock et al.
“However, this greater durability with rosiglitazone was at the expense of a weight gain of almost 5 kg, a higher incidence of peripheral edema and a less favorable plasma lipid profile than seen with vildagliptin.”
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
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