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Lurasidone/Latuda 1. why should it work? —some dope pharmacodynamics - blocks D2, partial agonist at 5HT-1, antagonist at 5HT-2 and 5HT-7; no significant affinity for H1 and M1 receptors! also only weak affinity for the alpha-2 adrenergic receptor, which correlates with its lower risk of producing orthostasis 2. does it work? —FDA approved for schizophrenia, bipolar monotherapy, and bipolar augmentation at a range of 20 mg to 120 mg --4 or 5 point difference on the MADRS --when we look at differences in response and remission rates it’s actually pretty good, 15 to 20% separation from placebo (number needed to treat/NNTs of 5 to 6) awesome —AJP, 2014, augmentation study - completion rate of 75 to 80% (many bipolar studies with much higher dropout rates! for example in the seminal BOLDER study leading to the approval of quetiapine for bipolar depression the completion rate was 54% in patients taking 600 mg/day and 67% in patients taking 600 mg/day), indicating it is truly well-tolerated; also tolerability even better for patients with schizophrenia, 8% discontinuation rate versus 4% for placebo —great study design for augmentation - worked with both Depakote and Lithium also patients more “real-world,” included those with rapid cycling —also, on the MADRS, subscales worked across domains producing significant improvements compared to placebo in sadness, lassitude, inability to feel, pessimistic thoughts, and sleep in the augmentation study; in the monotherapy study worked in these domans and also inner tension, 7/10 MADRS subscales —jmprovements in functional outcomes —like any antipsychotic, it produces side effects of EPS and akathisia BUT the absence of or minimal weight gain and other adverse metabolic effects in multiple studies and multiple treatment populations (mood and psychosis) is impressive! can be thought of as comparable to Geodon metabolically but without the QT problems cardiovascularly —for augmentation in mood studies, relatively rapid response with separation from placebo beginning in week 3 —although studies were international, the majority of patients/study sites were U.S. bummer —bipolar 1 patients only… —cost —it does raise prolactin a little but way less than halperidol, risperidone, or zyprexa how to use this drug —can be taken once daily, usually at night; for full absorption must be taken with a meal or within 30 minutes of eating; meal 350 - 1000 cal; doesn’t have to be fatty; similar to Gedon absorption can be reduced by 1/2 to 2/3 without food —most studies patients taking doses greater than 80 mg; no significant differences in adverse effects between lower and higher doses —for bipolar I, a reasonable titration schedule is the following: 20 mg/day for days 1-2, 40 mg/day for days 3-4, 60 mg/day for days 5-6, 80 mg/da on day 7; from 80 mg, adjust by 20 mg increments q 1 week if necessary —if using as an augmenting agent, same titration as above but hold at 60 mg rather than 80 mg for 1 week prior to adjusting in 20 mg increments —higher may not be better: in the monotherapy study, 20 - 60 mg doses were as effective as 80 to 120 mg —most common side effects: nausea, headache, akathisia, and somnolence