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(Viibryd©) Vilazodone 3/28/2013 ANTIDEPRESSANT UPDATE: What’s New? The Cardiac Debate The Efficacy Debate ?Pharmacogenomics? WHAT’S NEW Rex S. Lott, Pharm.D., BCPP Professor, ISU College of Pharmacy Short Answer???? Mental Health Clinical Pharmacist, Boise VAMC Clinical Associate Professor, University of Washington, School of Medicine, Department of Psychiatry & Behavioral Sciences Vilazodone (Viibryd ©) Vilazodone - Dosing • Initiate at 10 mg/day X 7days, then 20 • SSRI with partial agonist activity at 5HT 1A mg/day X 7 days receptors. • Target dose = 40 mg/day • Pharmacology of buspirone “built in” • Reduce dose by 50% if co-medication with • CYP3A4 Substrate potent CYP3A4 inhibitors (ketoconazole, • No clinically significant CYP inhibition some macrolide antibiotics) • QD dosing – 25 hour half-life 1 3/28/2013 Ketamine Vilazodone – Pluses / Minuses • NMDA Receptor Antagonist • Potential Pluses: – Less sexual dysfunction than other SSRI’s? • THEORY: – Enhanced anti-anxiety activity (NOT FDA – NMDA Antagonism ↑ Glutamate release labeled for anxiety)? (?compensatory?) • Potential Minuses: Still an SSRI – Stimulation of AMPA glutamate receptors, AND – Repair / regeneration of glutamate-related – GI side effects circuits. – Sleep disturbance – Cost Ketamine Ketamine – Relevant PK • T = ~ 2.5 hours • IV Sub-anesthetic doses 1/2 – 0.5 mg/kg IV infused over ~40 min • Distribution T 1/2 = ~ 10 min – One study of repeated doses (6) • Hepatic Metabolism: CYP 450 • RAPID (hours) remission of depression – 2B6, 3A4 symptoms in treatment-resistant patients – 2C9 (minor) • Possible significant reduction in suicidality • Bioavailability: • “Moderate” to “Large” Statistical Effect Sizes – IM: 93% – Intranasal: 25 – 50% • SHORT duration of effect days - weeks – Oral: 16 – 20% Mathew et. CNS Drugs. 2012;26:189-204 2 3/28/2013 Ketamine - Results Ketamine: Adverse Effects • Relatively well-tolerated at studied doses • Side effects generally transient • Transient BP elevations • Mild dissociative effects (short-lived) • Non-specific psychiatric/neurlogic – “Heady” or “Muzzy” feelings – Visual distortions – Dizziness Rot et al. Biol Psychiatry 2012;72:537-547 ; Rot et al. Biol Psychiatry 2010; 67:139-145 FDA Warning • 8/24/2011 & 3/27/2012 • Post-marketing reports of QTc interval prolongation and Torsade de Pointes Cardiac Debate • Thorough QT study of 20 mg and 60 mg of citalopram in 119 patients showing dose- What do we know about QTc related QTc prolongation prolongation and citalopram? • “Thou shalt no longer Rx 60 mg doses and thou shalt not use > 20 mg in those over 60 or those on CYP2C19 inhibitors” • Doses above 40 mg “confer no added benefit” 3 3/28/2013 FDA Data The Clinical Evidence?? Citalopram Escitalopram • Published cases of citalopram-related Dose Change in QTc Dose Change in QTc cardiotoxicity (TdP) are extremely rare (90% Confidence (90% Confidence Interval) Interval) • CIT was the most widely Rx’d (ms) (ms) antidepressant in the U.S. 20 mg 8.5 (6.2, 10.8) 10 mg 4.5 (2.5, 6.4) • Prudence 40 mg* 12.6 (10.9, 14.3) 20 mg* 6.6 (5.3, 7.9) 60 mg 18.5 (16.0, 21.0) 30 mg 10.7 (8.7, 12.7) • Is it true that 60 mg offers no additional Moxifloxacin 400 13.4 (10.9, 15.9) Moxifloxacin 400 9.0 (7.3, 10.8) benefit over 40 mg? mg mg – Population phenomenon? vs Individual Patient Phenomenon? * Estimate based on the relationship between citalopram (and escitalopram) blood concentrations and QT interval Vieweg et al. Am J Med. 2012;125:859-868 Negative Publications - ADs The Efficacy Debate • PUBLISHED AD Trials – 94% positive outcomes • UNPUBLISHED AD Trials (FDA) Do Antidepressants Work in Other than – 51% positive outcomes Very Severe Depression? – Statistical Effect Sizes were 25% smaller in How Well do Antidepressants Work? entire FDA AD Study database than in published literature EH Turner, Matthews AM, Linardatos E et al. NEJM 2008;358:252-260 4 3/28/2013 Are ADs better than placebo? AD Meta-Analysis Multiple Meta-analyses • Pooled data; mean changes in rating scale scores – Kirsch: AD 9.6 vs 7.8 placebo, difference 1.8 – Fountoulakis reanalysis: AD 10.04 vs 7.85, difference 2.15 – Overall drug versus placebo difference = ~2 points – NICE criterion for clinical significance = 3 points • Is NICE right? • Mean not valid in skewed distribution – Severe depression – about 5 point benefit • “ADs are INEFFECTIVE in all but most severe” Kirsch I, et al. PLoS Med 2008;5(2):e45. Turner EH, et al. N Engl J Med 2008;358(3):252-60. Fournier JC, et al. JAMA. 2010;303(1):47-53. Fountoulakis KN, Möller HJ. Int J Neuropsychopharmacol 2011; 405-12.. Kirsch I, et al. PLoS Med 2008;5(2):e45. Floor Effect Relative Effect Size Difference (Hamilton Depression Rating Scale – HDRS) • Comparing absolute rating scale score changes or differences ignores this - Scores can’t go below Zero Drug Placebo Depression Mean Mean Relative Mean Mean Final Relative baseline final effect Baseline change in effect size • 50% drug improvement 40 40 40 Severity * HDRS change size HDRS HDRS score measure • 25% placebo improvement 35 score in measure score (%) 30 HDRS (%) ** • Severe depression 30 score – Drug vs. placebo is 10 pts 25 Baseline Mild (23%) 22.6 8.8 39 23.2 8 34 20 20 20 • Mild depression 20 End Moderate 25.6 10.5 41 25.4 7.4 29 15 – Drug vs placebo is 5 pts 15 Baseline (54%) 10 End 10 Severe 28.75 12.0 42 28.2 7.2 26 (23%) 5 * Mild= At least one arm (drug or placebo) is rated <24 on HDRS 0 Moderate= At least one arms is rated > 24< 28 on HDRS Drug Severe= At least one arm (drug or placebo) is rated > 28 on HDRS ** Relative effect size = absolute mean HDRS change/mean baseline HDRS score Ghaemi SN. Making Sense of Antidepressants. CPNP Annual Meeting 2012 Vohringer PA, Ghaemi SN. Clinical Therapeutics 2011;33:B49–B61. Ghaemi SN. Making Sense of Antidepressants. CPNP Annual Meeting 2012 5 3/28/2013 Efficacy Debate: Conclusions Pharmacogenomics & Depression • ACTIVE Research Effort • Antidepressants are not placebos • Pharmacodynamic Effects • Not accurate that ADs are less effective in mild – Serotonin Transporter Gene variability depression • 5HTTLPR-promoter region – ADs appear about equally effective in all severity of • Long ( l) allele associated with twice the expression of depression serotonin transporter & improved outcomes with SSRI antidepressant therapy • PBO is less effective in more severe depressions • Pharmacokinetic Effects – CYP450 metabolizer status • Poor metabolizers of 2D6 substrates experience more side effects. Martin & Lee. Ment Health Clin. 2012;1(9):17 CYP2D6 & Antidepressants CYP2D6 & Antidepressants: PK Interactions • CYP2D6 Substrates • Genetic Range: – Most TCAs (amitriptyline, nortriptyline, – Poor Ultra-Rapid Metabolizers imipramine, etc.) – PM’s – Duloxetine, venlafaxine, paroxetine • Lower dose requirements • Poor tolerance to med • CYP2D6 Inhibitors – UM’s – Paroxetine, Bupropion & Fluoxetine ++++ • Higher dose requirements – Duloxetine +++ • Improved tolerance to med • Phenoconversion: 2D6 inhibitors can convert “good” metabolizers to poor metabolizers. 6 3/28/2013 CYP2D6 & Antidepressants: More of the Story • Pooled data from four DBPC clinical trials of venlafaxine • Desvenlafaxine/venlafaxine ratios >1 – Extensive 2D6 metabolizers – Significantly higher rates of response & remission compared to both placebo AND poor 2D6 metabolizers. • Why? Pharmacology of desvenlafaxine and venlafaxine is the same. D’Emaaire et al. J Psychiatr Practice 2011;17:330339; Meyer UA. Nat Rev Genet. 2004;5:669-676 Lobello et al. J Clin Psychiatry. 2010:71: 1482-1487 CYP2D6 & Antidepressants: More of the Story (cont.) • CYP2D6 significantly expressed in CNS – role in serotonin metabolism – Metabolizer status may correlate with some personality subtypes • CYP2D6 Poor metabolizer status MAY be a genetic marker for poor or non-responders to noradrenergic or serotonergic antidepressants ( ≤ 40% per STAR*D) • And there may be more……………. aEM vs PM p < 0.02 bVEN vs Placebo p < 0.04 D’empaire et al. J Psychiatric Practice . 2011;17:330-339; Macaluso & Preskorn. J Clin Lobello et al. J Clin Psychiatry. 2010:71: 1482-1487 Psychopharmacol. 2011;31:143-145. 7 3/28/2013 Nortriptyline – TX Window? CYP2D6 & Antidepressants: * The Rest of the Story??? * 7 H A • Relationship between CYP2D6 metabolizer M D status and antidepressant response MAY also S explain: C O – Curvilinear “Therapeutic Window” for R nortriptyline plasma concentrations E * – Population phenomenon vs. individual patient * phenomenon >20 • NOT known if drug-induced phenoconversion 50 150 is problematic Nortriptyline Plasma Concentration ng/mL Macaluso & Preskorn. J Clin Psychopharmacol. 2011;31:143-145. 8.
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