In placebo-controlled premarketing studies, there were increases in mean blood pressure (see Table 10). Across most indications, a dose-related increase in mean supine systolic and diastolic blood pressure was evident in patients treated with venlafaxine hydrochloride extended-release capsules. Across all clinical studies in MDD, GAD, SAD and PD, 1.4% of patients in the venlafaxine hydrochloride extended-release capsules groups experienced an increase in SDBP of ≥15 mm Hg along with a blood pressure ≥ 105 mm Hg, compared to 0.9% of patients in the placebo groups. Similarly, 1% of patients in the venlafaxine hydrochloride extended-release capsules groups experienced an increase in SSBP of ≥ 20 mm Hg with a blood pressure ≥ 180 mm Hg, compared to 0.3% of patients in the placebo groups.
|Venlafaxine Hydrochloride Extended-release Capsules||Placebo|
|Indication||≤ 75 mg per day||> 75 mg per day|
|(8 to 12 weeks)||-0.28||0.37||2.93||3.56||-1.08||-0.10|
|(10 to 12 weeks)||-1.15||0.97||-0.36||0.16||-1.29||-0.99|
Venlafaxine hydrochloride extended-release capsules treatment was associated with sustained hypertension (defined as treatment-emergent Supine Diastolic Blood Pressure [SDBP] ≥ 90 mm Hg and ≥ 10 mm Hg above baseline for three consecutive on-therapy visits (see Table 11). An insufficient number of patients received mean doses of venlafaxine hydrochloride extended-release capsules over 300 mg per day in clinical studies to fully evaluate the incidence of sustained increases in blood pressure at these higher doses.
|Indication||Dose Range (mg per day)||Incidence (%)|
|MDD||75 to 375||19/705 (3)|
|GAD||37.5 to 225||5/1011 (0.5)|
|SAD||75 to 225||5/771 (0.6)|
|PD||75 to 225||9/973 (0.9)|
Venlafaxine hydrochloride extended-release capsules were associated with mean increases in pulse rate compared with placebo in premarketing placebo-controlled studies (see Table 12) [ see Warnings and Precautions ( 5.3, 5.4) ].
|(8 weeks)||2||< 1|
|(12 weeks)||1||< 1|
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