Objective: The objective of the study was to assess symptom-free days (SFDs) in younger (< 60 years) and older (³ 60 years) patients with generalized anxiety disorder (GAD).
Design: Data from 5 randomized, double-blind, placebo-controlled, 8-week long trials of venlafaxine extended-release (VENXR) in GAD patients (overall ITT = 1,839; 544 placebo, 1,295 VENXR) were retrospectively pooled and analyzed using the last-observation-carried forward (LOCF) procedure.
Materials and Methods: The resulting data were used to construct SFDs. SFDs were defined as the number of days the patient was free of symptoms of GAD. SFDs were estimated by assigning a value of 1 SFD to a HAM-A score £7 (the remission threshold), a value of 0 SFD to a HAM-A score ³18 (minimum threshold for anxiety), and weighting SFDs proportionately to HAM-A scores between 7 and 18. Median SFDs were compared using Wilcoxon rank-order test of differences. A p-value of <0.05 in a two-tailed test was considered significant.
Results: The younger and older group included 496 and 48 patients randomized to placebo, and 1,159 and 136 patients given VENXR, respectively. Median SFDs among younger patients were 19 for VENXR versus 10 for placebo (P<0.0001). Median SFDs among older patients were 17 for VENXR versus 5 for placebo (P<0.05).
Conclusion: VENXR, a serotonin and norepinephrine reuptake inhibitor is shown to significantly increase SFDs in both younger and older patients with GAD.
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