Prescription Drug Information: Venlafaxine Hydrochloride (Page 5 of 12)

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
Indication (Duration) Venlafaxine Hydrochloride Extended-Release Capsules Placebo
≤ 75 mg per day > 75 mg per day SSBP SDBP
SSBP SDBP SSBP SDBP
MDD
(8 to 12 weeks) -0.28 0.37 2.93 3.56 -1.08 -0.1
GAD
(8 weeks) -0.28 0.02 2.4 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 were 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 (Duration) Venlafaxine Hydrochloride Extended-Release Capsules Placebo
MDD (12 weeks) 2 1
GAD (8 weeks) 2 <1
SAD (12 weeks) 3 1
PD (12 weeks) 1 <1

6.3 Laboratory Changes

Serum Cholesterol

Venlafaxine hydrochloride extended-release capsule was associated with mean final increases in serum cholesterol concentrations compared with mean final decreases for placebo in premarketing MDD, GAD, SAD and PD clinical studies (Table 13).

Table 13: Mean Final On-therapy Changes in Cholesterol Concentrations (mg/dL) in Venlafaxine Hydrochloride Extended-Release Capsules Premarketing Studies
Indication (Duration) Venlafaxine Hydrochloride Extended-Release Capsules Placebo
MDD (12 weeks) +1.5 -7.4
GAD (8 weeks) (6 months) +1 +2.3 -4.9 -7.7
SAD (12 weeks) (6 months) +7.9 +5.6 -2.9 -4.2
PD (12 weeks) 5.8 -3.7

Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled trials for major depressive disorder was associated with a mean final on-therapy increase in serum cholesterol concentration of approximately 1.5 mg/dL compared with a mean final decrease of 7.4 mg/dL for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 8 weeks and up to 6 months in premarketing placebo-controlled GAD trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 1 mg/dL and 2.3 mg/dL, respectively while placebo subjects experienced mean final decreases of 4.9 mg/dL and 7.7 mg/dL, respectively. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks and up to 6 months in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 7.9 mg/dL and 5.6 mg/dL, respectively, compared with mean final decreases of 2.9 and 4.2 mg/dL, respectively, for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.8 mg/dL compared with a mean final decrease of 3.7 mg/dL for placebo.

Patients treated with venlafaxine hydrochloride (immediate release) for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, or 2) an average on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0% of placebo-treated patients.

Serum Triglycerides

Venlafaxine hydrochloride extended-release capsule was associated with mean final on-therapy increases in fasting serum triglycerides compared with placebo in premarketing clinical studies of SAD and PD up to 12 weeks (pooled data) and 6 months duration (Table 14).

Table 14: Mean Final On-therapy Increases in Triglyceride Concentrations (mg/dL) in Venlafaxine Hydrochloride Extended-Release Capsules Premarketing Studies
Indication (Duration) Venlafaxine Hydrochloride Extended-Release Capsules Placebo
SAD (12 weeks) 8.2 0.4
SAD (6 months) 11.8 1.8
PD (12 weeks) 5.9 0.9
PD (6 months) 9.3 0.3

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