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Sustained Hypertension Venlafaxine treatment is associated with sustained increases in blood pressure in some patients. Among patients treated with 75 to 375 mg/ day of Effexor XR in premarketing studies in patients with major depressive disorder, 3 (19/ 705) experienced sustained hypertension [defined as treatment-emergent supine diastolic blood pressure (SDBP) 90 mm Hg and 10 mm Hg above baseline for 3 consecutive on-therapy visits]. Among patients treated with 37.5 to 225 mg/ day of Effexor XR in premarketing GAD studies, 0.5 (5/ 1011) experienced sustained hypertension. Among patients treated with 75 to 225 mg/ day of Effexor XR in premarketing Social Anxiety Disorder studies, 1.4% (4/ 277) experienced sustained hypertension. Text Continues Below
Experience with the immediate-release venlafaxine showed that sustained hypertension was dose-related, increasing from 3% to 7 at 100 to 300 mg/ day to 13 at doses above 300 mg/ day. An insufficient number of patients received mean doses of Effexor XR over 300 mg/ day to fully evaluate the incidence of sustained increases in blood pressure at these higher doses. In placebo-controlled premarketing studies in patients with major depressive disorder with Effexor XR 75 to 225 mg/ day, a final on-drug mean increase in supine diastolic blood pressure (SDBP) of 1.2 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 0.2 mm Hg for placebo-treated patients. In placebo-controlled premarketing GAD studies with Effexor XR 37.5 to 225 mg/ day, up to 8 weeks or up to 6 months, a final on-drug mean increase in SDBP of 0.3 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 0.9 and 0.8 mm Hg, respectively, for placebo-treated patients. In placebo-controlled premarketing Social Anxiety Disorder studies with Effexor XR 75 to 225 mg/ day up to 12 weeks, a final on-drug mean increase in SDBP of 1.6 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 1.1 mm Hg for placebo-treated patients. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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