När det gäller effekt på depressiva symtom visar arbetet att det inte föreligger några statistiskt signifikanta skillnader mellan agomelatin och SSRI/SNRI. Utifrån respons- och remissionsandelar i de enskilda studierna visades kliniskt fördelaktiga resultat för agomelatin jämfört med SSRI/SNRI.
Statistiskt sett visar arbetet på fördelaktig effekt på sömnbesvär för agomelatin i jämförelse med SSRI/SNRI. En sammantagen bedömning av den kliniska relevansen av resultat gällande effekt på sömnbesvär är att den är likartad vid behandling med agomelatin, SSRI och SNRI.
I framtiden finns det ett behov av fler jämförande studier mellan agomelatin och SSRI respektive SNRI med tillräcklig styrka och med den kliniska relevansen av resultaten i fokus.
58
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Comparable efficacy and safety of 8 weeks treatment with agomelatine 25-50mg or fluoxetine 20-40mg in Asian out-patients with major depressive disorder. Asian J Psychiatr. 2014;8:26-32.
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62
Bilaga A
Beräkningar av Number Needed to Treat
Kasper S, Hajak G, Wulff K, Hoogendijk WJ, Montejo AL, Smeraldi E, et al. Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. J Clin Psychiatry. 2010;71(2):109-20.
Remissionsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 32,7 % 𝑆𝑒𝑟𝑡𝑟𝑎𝑙𝑖𝑛: 28,8 %
Beräkning av NNT
𝐴𝑅𝑅 = 32,7% − 28,8% = 3,9 %
𝑁𝑁𝑇 𝑟𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,039 = 25,69 ≈ 26
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 70 % 𝑆𝑒𝑟𝑡𝑟𝑎𝑙𝑖𝑛: 61,5 % Beräkning av NNT
𝐴𝑅𝑅 = 70 % − 61,5 % = 8,5 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,085 = 11,7647059 ≈ 12
63
Hale A, Corral RM, Mencacci C, Ruiz JS, Severo CA, Gentil V. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. Int Clin Psychopharmacol. 2010;25(6):305-14.
Remissionsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 32 % 𝐹𝑙𝑢𝑜𝑥𝑒𝑡𝑖𝑛: 28,4 % Beräkning av NNT
𝐴𝑅𝑅 = 32% − 28,4% = 3,6 %
𝑁𝑁𝑇 𝑟𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,036 = 27,7 ≈ 28
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 71,7 % 𝐹𝑙𝑢𝑜𝑥𝑒𝑡𝑖𝑛: 63,8 % Beräkning av NNT
𝐴𝑅𝑅 = 71,7 % − 63,8 % = 7,9 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,079 = 12,6582270 ≈ 13
Corruble E, de Bodinat C, Belaidi C, Goodwin GM. Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial. Int J Neuropsychopharmacol. 2013;16(10):2219-34.
Remissionsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 69,6 % 𝐸𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚: 63,1 %
Beräkning av NNT
𝐴𝑅𝑅 = 69,6 % − 63,1 % = 6,5 %
64
𝑁𝑁𝑇 𝑟𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,065 = 15,38 ≈ 15
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 82,6 % 𝐸𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚: 81,3 % Beräkning av NNT
𝐴𝑅𝑅 = 82,6 % − 81,3 % = 1,3 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,013 = 76,92307 ≈ 77
Quera-Salva MA, Hajak G, Philip P, Montplaisir J, Keufer-Le Gall S, Laredo J, et al.
Comparison of agomelatine and escitalopram on nighttime sleep and daytime condition and efficacy in major depressive disorder patients. Int Clin Psychopharmacol. 2011;26(5):252-62.
Remissionsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 48 % 𝐸𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚: 42 %
Beräkning av NNT
𝐴𝑅𝑅 = 48 % − 42 % = 6 %
𝑁𝑁𝑇 𝑟𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,06 = 16,6666667 ≈ 17
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 77 % 𝐸𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚: 74 % Beräkning av NNT
𝐴𝑅𝑅 = 77 % − 74 % = 3 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,03 = 33,3333333 ≈ 33
65
Kennedy SH, Rizvi S, Fulton K, Rasmussen J. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J Clin Psychopharmacol. 2008;28(3):329-33.
Remissionsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 73 % 𝑉𝑒𝑛𝑙𝑎𝑓𝑎𝑥𝑖𝑛: 66,9 % Beräkning av NNT
𝐴𝑅𝑅 = 73 − 66,9 % = 6,1 %
𝑁𝑁𝑇 𝑟𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,061 = 16,39 ≈ 16
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 82,5 % 𝑉𝑒𝑛𝑙𝑎𝑓𝑎𝑥𝑖𝑛: 79,9 % Beräkning av NNT
𝐴𝑅𝑅 = 82,5 % − 79,9 % = 2,6 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,026 = 38,4615385 ≈ 39
Lemoine P, Guilleminault C, Alvarez E. Improvement in subjective sleep in major depressive disorder with a novel antidepressant, agomelatine: randomized, double-blind comparison with venlafaxine. J Clin Psychiatry. 2007;68(11):1723-32.
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 76,4 % 𝑉𝑒𝑛𝑙𝑎𝑓𝑎𝑥𝑖𝑛: 70,6 % Beräkning av NNT
𝐴𝑅𝑅 = 76,4 − 70,6 % = 5,8 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 ∕ 0,058 = 17,2413793 ≈ 17
66
Shu L, Sulaiman AH, Huang YS, Fones Soon Leng C, Crutel VS, Kim YS. Comparable efficacy and safety of 8 weeks treatment with agomelatine 25-50mg or fluoxetine 20-40mg in Asian out-patients with major depressive disorder. Asian J Psychiatr. 2014;8:26-32
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 68,1 % 𝐹𝑙𝑢𝑜𝑥𝑒𝑡𝑖𝑛: 67,9 % Beräkning av NNT
𝐴𝑅𝑅 = 68,1 % − 67,9% = 0,2 % 𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑎𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛 = 1 0,002⁄ = 500
Udristoiu T, Dehelean P, Nuss P, Raba V, Picarel-Blanchot F, de Bodinat C. Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50mg/day) and escitalopram (10-20mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study.
J Affect Disord. 2016;199:6-12
Responsandelar
𝐴𝑔𝑜𝑚𝑒𝑙𝑎𝑡𝑖𝑛: 62,9 % 𝐸𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚: 68,4 % Beräkning av NNT
𝐴𝑅𝑅 = 68,4 % − 62,9% = 6,5 %
𝑁𝑁𝑇 𝑟𝑒𝑠𝑝𝑜𝑛𝑠 𝑒𝑠𝑐𝑖𝑡𝑎𝑙𝑜𝑝𝑟𝑎𝑚 = 1 0,065⁄ = 15,3846154 ≈ 15
67