Safety and Tolerability | let's talk about SEX baby | What competition | the Forest through the weeds | Katona ...EHH? |
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What is nausea constipation and vomiting
PI 6 text above table 2
These three are the most commonly reported adverse reactions to Brintellix at greater than 5% and twice placebo
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What is section 6 PI
Males Females
Which gender had the highest rates of sexual dysfunction when on Brintellix when
voluntarily reported : When Asked ASEX |
What is Fetzima
This product was approved by the FDA with 3 studies and has dose related adverse reactions including urinary hesitancy and erectile dysfunction
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What is viibryd
This forest product unlike Brintellix has a dosing recommendation to be taken with food, if not, the product may have a diminished effect.
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What is 5 mgs Brintellix and 60 mg Duloxetine
These were the doses of Brintellix and the reference med, in the 2012 double blinded placebo study published in International Clinical Psychopharmacology , by Katona et al.
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What is 2 weeks PI 2.4
This is the amount of time needed from discontinuing a patient from an MAOI to Brintellix or the time it takes to reach steady state
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What is
Sex drive, Ease of arousal Ability to achieve an erection (men) lubrication ( women) Ease of researching orgasm Satisfaction of orgasm
These are the 5 categories of questions asked in the ASEX scale
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What is Pristiq
This antidepressant shows no evidence of greater efficacy at doses higher than the starting dose, has a caution for hypertension, has a 12 % discontinuation rate compared to placebo and a half life of apx 11 hours.
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What is Fetzima
Unlike Brintellix, this Forest Product has dosing adjustment for patients with renal impairments
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What is the the change from baseline HAM d 24 at week 8
This was the primary efficacy measure/ timeframe in the Katona Study
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What is 8%
This percentage rate An adverse event was reported at both the 15 and 20 mg dose and the reason for discontinuation
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What is 3 Brintellix 2 placebo
Boulanger pg 1415
The number of patients who reported sexual dysfunction in the Brintellix group versus the placebo group in the 24 to64 week of the long term study
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What is Cymbalta
This 2d6inhibitor antidepressant has nausea rates at 23% and a 53% remission rate in its long term study and a half life of apx 7 hours
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What is viibryd
Unlike 2 Brintellix studies where the mean MADRS change from placebo was -5.9, -5.7 -5.5 and-7.1; this forest product had a MADRS change of -3.2 and -2.5
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What is significantly greater improvement compared to placebo a change of -3.3 Ham 24 at week 8 also statistically superior to placebo at week 6
This was the primary efficacy end points and results for Brintellix in the Katona study
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What is 10%
Pi 6.1
This is the % of patients who continued to experience Nausea at the conclusion of the pooled 6 to 8 week studies at 10 and 20 mgs.
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What is 0%
This percentage of patients reported sexual dysfunction in the Katona study; the same percentage compared to placebo but 6% less than the duloxteine group
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What is viibryd
This branded antidepressant is recommended to be titrated over 3 weeks to the recommended 40 mgs per day and has a half life of 25 hours and has common side effects like diarrhea, nausea vomiting and trouble sleeping
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What is Fetzima
At its highest therapeutic dose This Forest product a
Had a mean change from baseline of 15 points , unlike Brintellix whose mean change from baseline across all doses was a17 point change |
What is Nausea, Headache, and Dizziness
22, 11, 9 %
These were the three most common adverse events were reported during the treatment period for Brintellix in the Katona study
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What is 75 mgs in men
Pi 10.1 human experience
This was the maximum single dose and gender tested for Brintellix
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What is
2 females 0 males Brintellix 3 females 11 males Venlafaxine
In the Alvarez study, how many total patients had reported sexual dysfunction in the Brintellix doses compared to the 225 dose of venlafaxine
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What is Wellbutrin
This antidepressant has reported nausea rates as high as 18%, dry mouth rates as high as 24% and headaches at 26% , with a mean half life of 21 hours and was previously marketed under another brand name Zyban
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What is Savella
This Forest product with a complicated dosing regimen in increments of 12.5 mgs upto 100 mgs by day 7 , was approved in Europe as an antidepressant but in US for Fibromyalgia
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What is the REY auditory, verbal learning test (RAVLT)
And the Digit symbol substitution test (DSST)
These 2 tests were used in Katona Trial to evaluate cognitive effects, verbal learning and memory
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