Monday, September 12, 2005

Novartis' Starlix plus metformin may be safer...

Novartis' Starlix plus metformin may be safer initial combination therapy than glyburide plus metformin among drug-naïve type 2 diabetes patients

Novartis AG's Starlix (nateglinide) plus metformin may be a safer initial combination therapy than glyburide plus metformin among drug-naïve patients with type 2 diabetes, according to study results published in the September issue of Diabetes Care.

In a double-masked, two-year study, researchers randomized 428 drug-naïve patients with type 2 diabetes to either 120 mg of Starlix before meals or 1.25 mg of glyburide daily in addition to 500 mg of open-label, daily metformin for the initial four weeks.

During a subsequent 12-week titration period, investigators increased glyburide and metformin by 1.25-mg and 500-mg increments to maximum daily doses of 10 mg and 2,000 mg, respectively, if a subject's fasting plasma glucose (FPG) was at least 6.7 mmol/L biweekly. Starlix was not titrated. Researchers maintained blinding by using matching placebo for Starlix and glyburide.

During a subsequent 88-week monitoring period, researchers measured hemoglobin A1C, FPG and postprandial glucose excursions (PPGEs) during an oral glucose tolerance test.

Average HbA1C levels were approximately the same for both groups at baseline (8.4 percent for the Starlix arm vs. 8.3 percent for the other treatment group) and at week 104 (6.9 percent for the Starlix group vs. 6.8 percent for the glyburide arm).

Results indicated that both treatments achieved similar efficacy with differential effects on FPG versus PPGE.

However, hypoglycemia occurred in 8.2 percent and 17.7 percent of patients treated with Starlix/metformin and glyburide/metformin, respectively.

More than 90 percent of patients in both treatment groups experienced one or more adverse events (AEs); most were mild or moderate. Aside from gastrointestinal symptoms and those typically linked to falling glucose, the AE profile mirrored common ailments observed in the general population, the study authors said.

"Similar good glycemic control can be maintained for two years with either treatment regimen, but [Starlix]/metformin may represent a safer approach to initial combination therapy," the authors concluded.

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