Duloxetine Dosing May Influence Efficacy and Safety
Duloxetine Dosing May Influence Efficacy and Safety
This viewpoint offers commentary on important clinical research in the area of pharmacy.
Mallinckrodt CH, Prakash A, Andorn AC, Watkin JG, Fava M
J Psychiatr Res. 2006;40:337-348
This posthoc analysis included data from 4 of the placebo-controlled clinical studies that were submitted in support of US approval of the serotonin-norepinephrine reuptake inhibitor duloxetine. Two of the trials used a dose of 20 mg twice daily, and the other 2 studies used a dose of 60 mg daily, with similar study designs used for each pair of studies. Patients included in the studies had to be at least 18 years of age and meet criteria for major depressive disorder. For all of the studies, the primary efficacy variable was the mean change from baseline to endpoint in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. Patients in both studies of the 60-mg dose showed a statistically significant mean change in HAMD-17 compared with placebo, whereas the 20-mg twice-daily dosing of duloxetine only showed superiority over placebo in 1 of the 2 studies.
Secondary efficacy measures using Clinical Global Impression of Severity, Patient Global Impression of Improvement, and visual analogue scales (as duloxetine is also effective for neuropathic pain) also demonstrated better efficacy with the 60-mg daily dose. The most common adverse effect was different for each dosing strategy, with nausea most common in patients receiving 60 mg daily and headache most common in the patients receiving 20 mg twice daily. However, the rate of discontinuation due to nausea was higher in patients who received the 20-mg twice-daily dosing than in those receiving 60 mg daily. Study discontinuation due to adverse events was more common for patients receiving the 60-mg dose than for those receiving the 20-mg twice-daily dose.
Data from pooled analyses such as those used in this study must always be viewed with caution; these 2 doses were not evaluated head-to-head, and minor variations in study design might skew the analysis. Nonetheless, these data provide the practicing clinician with some information beyond what is found in the package insert about adverse events and treatment response. These trials were all placebo-controlled and do not provide insight into possible issues related to transitioning a patient from one antidepressant to another.
Abstract: www.medscape.com/medline/abstract/16271726
This viewpoint offers commentary on important clinical research in the area of pharmacy.
Mallinckrodt CH, Prakash A, Andorn AC, Watkin JG, Fava M
J Psychiatr Res. 2006;40:337-348
This posthoc analysis included data from 4 of the placebo-controlled clinical studies that were submitted in support of US approval of the serotonin-norepinephrine reuptake inhibitor duloxetine. Two of the trials used a dose of 20 mg twice daily, and the other 2 studies used a dose of 60 mg daily, with similar study designs used for each pair of studies. Patients included in the studies had to be at least 18 years of age and meet criteria for major depressive disorder. For all of the studies, the primary efficacy variable was the mean change from baseline to endpoint in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. Patients in both studies of the 60-mg dose showed a statistically significant mean change in HAMD-17 compared with placebo, whereas the 20-mg twice-daily dosing of duloxetine only showed superiority over placebo in 1 of the 2 studies.
Secondary efficacy measures using Clinical Global Impression of Severity, Patient Global Impression of Improvement, and visual analogue scales (as duloxetine is also effective for neuropathic pain) also demonstrated better efficacy with the 60-mg daily dose. The most common adverse effect was different for each dosing strategy, with nausea most common in patients receiving 60 mg daily and headache most common in the patients receiving 20 mg twice daily. However, the rate of discontinuation due to nausea was higher in patients who received the 20-mg twice-daily dosing than in those receiving 60 mg daily. Study discontinuation due to adverse events was more common for patients receiving the 60-mg dose than for those receiving the 20-mg twice-daily dose.
Data from pooled analyses such as those used in this study must always be viewed with caution; these 2 doses were not evaluated head-to-head, and minor variations in study design might skew the analysis. Nonetheless, these data provide the practicing clinician with some information beyond what is found in the package insert about adverse events and treatment response. These trials were all placebo-controlled and do not provide insight into possible issues related to transitioning a patient from one antidepressant to another.
Abstract: www.medscape.com/medline/abstract/16271726
Source...