VENLAFAXINE HYDROCHLORIDE (Page 6 of 13)

6.2 Vital Sign Changes

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.

Table 10: Final On-therapy Mean Changes From Baseline in Supine Systolic (SSBP) and Diastolic (SDBP) Blood Pressure (mm Hg) in Placebo-controlled Studies
Venlafaxine Hydrochloride Extended-release Capsules Placebo
Indication ≤ 75 mg per day > 75 mg per day
(Duration) SSBP SDBP SSBP SDBP SSBP SDBP
MDD
(8 to 12 weeks) -0.28 0.37 2.93 3.56 -1.08 -0.10
GAD
(8 weeks) -0.28 0.02 2.40 1.68 -1.26 -0.92
(6 months) 1.27 -0.69 2.06 1.28 -1.29 -0.74
SAD
(12 weeks) -0.29 -1.26 1.18 1.34 -1.96 -1.22
(6 months) -0.98 -0.49 2.51 1.96 -1.84 -0.65
PD
(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.

Table 11: Sustained Elevations in SDBP in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Studies
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) ].

Table 12: Approximate Mean Final On-therapy Increase in Pulse Rate (beats/min) in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Placebo-controlled Studies (up to 12 Weeks Duration)
Indication Venlafaxine Hydrochloride Placebo
(Duration) Extended-release Capsules
MDD
(12 weeks) 2 1
GAD
(8 weeks) 2 < 1
SAD
(12 weeks) 3 1
PD
(12 weeks) 1 < 1

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