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Treatment with duloxetine for diabetic peripheral neuropathy has only a “modest” impact on glycemic control, Dr. Thomas Hardy of Eli Lilly & Co. and colleagues reported using data from three randomized controlled trials.
The researchers noted, however, that the studies they used to look at duloxetine's impact on glycemic control were not specifically designed to answer that question. “The current study does not allow definitive conclusion about the metabolic effects of duloxetine or other medications utilized in these studies,” they wrote (Diabetes Care 2007:30;21–6).
The authors pooled data from three randomized, controlled trials of adults with diabetes and diabetic peripheral neuropathic pain (DPNP). In the acute phase of the study, 1,024 participants were randomized to 60 mg duloxetine once a day or twice a day or to placebo for 12 weeks. In the study's extension phase, a subset of 867 participants was rerandomized to duloxetine or usual care in an open-label mode for another 52 weeks.
Patients with HbA1c values greater than 12% and those with major depressive disorder were excluded from the study. The authors looked at data on fasting plasma glucose (FPG), HbA1c, lipid levels, weight, and pain severity in both the acute and extension phases of the study.
The results showed that in the acute-phase studies, duloxetine-treated patients experienced an average increase in fasting glucose of 0.50 mmol/L, compared with a decrease of 0.11 mmol/L in the placebo group. In the extension studies, FPG again increased in the duloxetine-treated group, compared with the routine care group (0.67 mmol/L vs. −0.64 mmol/L).
HbA1c levels dropped slightly more in the duloxetine-treated group, compared with the placebo group during the acute phase, but the difference was not statistically significant. The longer-term studies showed an increase in HbA1c in both the duloxetine group and the group receiving routine care, with the duloxetine-treated group having a significantly larger increase (0.52 % vs. 0.19%).
This study was supported by Eli Lilly, manufacturer of Cymbalta.
Treatment with duloxetine for diabetic peripheral neuropathy has only a “modest” impact on glycemic control, Dr. Thomas Hardy of Eli Lilly & Co. and colleagues reported using data from three randomized controlled trials.
The researchers noted, however, that the studies they used to look at duloxetine's impact on glycemic control were not specifically designed to answer that question. “The current study does not allow definitive conclusion about the metabolic effects of duloxetine or other medications utilized in these studies,” they wrote (Diabetes Care 2007:30;21–6).
The authors pooled data from three randomized, controlled trials of adults with diabetes and diabetic peripheral neuropathic pain (DPNP). In the acute phase of the study, 1,024 participants were randomized to 60 mg duloxetine once a day or twice a day or to placebo for 12 weeks. In the study's extension phase, a subset of 867 participants was rerandomized to duloxetine or usual care in an open-label mode for another 52 weeks.
Patients with HbA1c values greater than 12% and those with major depressive disorder were excluded from the study. The authors looked at data on fasting plasma glucose (FPG), HbA1c, lipid levels, weight, and pain severity in both the acute and extension phases of the study.
The results showed that in the acute-phase studies, duloxetine-treated patients experienced an average increase in fasting glucose of 0.50 mmol/L, compared with a decrease of 0.11 mmol/L in the placebo group. In the extension studies, FPG again increased in the duloxetine-treated group, compared with the routine care group (0.67 mmol/L vs. −0.64 mmol/L).
HbA1c levels dropped slightly more in the duloxetine-treated group, compared with the placebo group during the acute phase, but the difference was not statistically significant. The longer-term studies showed an increase in HbA1c in both the duloxetine group and the group receiving routine care, with the duloxetine-treated group having a significantly larger increase (0.52 % vs. 0.19%).
This study was supported by Eli Lilly, manufacturer of Cymbalta.
Treatment with duloxetine for diabetic peripheral neuropathy has only a “modest” impact on glycemic control, Dr. Thomas Hardy of Eli Lilly & Co. and colleagues reported using data from three randomized controlled trials.
The researchers noted, however, that the studies they used to look at duloxetine's impact on glycemic control were not specifically designed to answer that question. “The current study does not allow definitive conclusion about the metabolic effects of duloxetine or other medications utilized in these studies,” they wrote (Diabetes Care 2007:30;21–6).
The authors pooled data from three randomized, controlled trials of adults with diabetes and diabetic peripheral neuropathic pain (DPNP). In the acute phase of the study, 1,024 participants were randomized to 60 mg duloxetine once a day or twice a day or to placebo for 12 weeks. In the study's extension phase, a subset of 867 participants was rerandomized to duloxetine or usual care in an open-label mode for another 52 weeks.
Patients with HbA1c values greater than 12% and those with major depressive disorder were excluded from the study. The authors looked at data on fasting plasma glucose (FPG), HbA1c, lipid levels, weight, and pain severity in both the acute and extension phases of the study.
The results showed that in the acute-phase studies, duloxetine-treated patients experienced an average increase in fasting glucose of 0.50 mmol/L, compared with a decrease of 0.11 mmol/L in the placebo group. In the extension studies, FPG again increased in the duloxetine-treated group, compared with the routine care group (0.67 mmol/L vs. −0.64 mmol/L).
HbA1c levels dropped slightly more in the duloxetine-treated group, compared with the placebo group during the acute phase, but the difference was not statistically significant. The longer-term studies showed an increase in HbA1c in both the duloxetine group and the group receiving routine care, with the duloxetine-treated group having a significantly larger increase (0.52 % vs. 0.19%).
This study was supported by Eli Lilly, manufacturer of Cymbalta.