Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability

Adair, Michael; Christensen, Michael Cronquist; Florea, Ioana; Loft, Henrik; Fagiolini, Andrea

doi:10.1016/j.jad.2023.01.074

Cited by 11 publications

(11 citation statements)

References 51 publications

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“…In keeping with the results of previous analyses, 20 , 28 earlier improvements in anxiety symptoms vs placebo were also achieved in patients treated with vortioxetine 20 mg/day than in those who received vortioxetine 10 mg/day. Of note, the observed dose–response relationship for vortioxetine in terms of improvement in anxiety appears more pronounced than that seen for improvement in depressive symptoms.…”

Section: Discussionsupporting

confidence: 87%

“…Vortioxetine is a multimodal antidepressant shown to be efficacious and well tolerated for the treatment of MDD across the approved dosage range of 5–20 mg/day 18 19 Vortioxetine is one of the few antidepressants shown to have a clear dose–response relationship across the spectrum of symptoms experienced by patients with MDD, including depressive, cognitive, physical, and anxiety symptoms, and functional impairment, both in randomized, controlled clinical trials 20 - 28 and in observational studies in routine clinical practice settings 29 30 …”

Section: Introductionmentioning

confidence: 99%

“…17 Vortioxetine is a multimodal antidepressant shown to be efficacious and well tolerated for the treatment of MDD across the approved dosage range of 5-20 mg/day. 18,19 Vortioxetine is one of the few antidepressants shown to have a clear dose-response relationship across the spectrum of symptoms experienced by patients with MDD, including depressive, cognitive, physical, and anxiety symptoms, and functional impairment, both in randomized, controlled clinical trials [20][21][22][23][24][25][26][27][28] and in observational studies in routine clinical practice settings. 29,30 A recent analysis of data from six pivotal clinical trials in patients with MDD showed vortioxetine 20 mg/day to be significantly more effective than vortioxetine 10 mg/day in terms of improvement in depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).…”

Section: Introductionmentioning

confidence: 99%

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Clinical benefits of vortioxetine 20 mg/day in patients with major depressive disorder

et al. 2023

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Background Vortioxetine has demonstrated dose-dependent efficacy in patients with major depressive disorder (MDD), with the greatest effect observed with vortioxetine 20 mg/day. This analysis further explored the clinical relevance of the more rapid and greater improvement in depressive symptoms observed with vortioxetine 20 mg/day vs 10 mg/day. Methods Analysis of pooled data from six short-term (8-week), randomized, placebo-controlled, fixed-dose studies of vortioxetine 20 mg/day in patients with MDD (N = 2620). Symptomatic response (≥50% decrease in Montgomery–Åsberg Depression Rating Scale [MADRS] total score), sustained symptomatic response, and remission (MADRS total score ≤10) were assessed by vortioxetine dosage (20 or 10 mg/day). Results After 8 weeks, 51.4% of patients receiving vortioxetine 20 mg/day had achieved symptomatic response vs 46.0% of those receiving vortioxetine 10 mg/day (P < .05). Significantly more patients achieved symptomatic response vs placebo from week 2 onwards for vortioxetine 20 mg/day and from week 6 onwards for vortioxetine 10 mg/day (both P ≤ .05). Sustained response was achieved from week 4 for 26.0% of patients receiving vortioxetine 20 mg/day vs 19.1% of those receiving vortioxetine 10 mg/day (P < .01), increasing to 36.0% and 29.8%, respectively, over the 8-week treatment period (P < .05). At week 8, 32.0% of patients receiving vortioxetine 20 mg/day were in remission vs 28.2% of those receiving vortioxetine 10 mg/day (P = .09). Rates of adverse events and treatment withdrawal were not increased during the week following vortioxetine dose up-titration to 20 mg/day. Conclusion Vortioxetine 20 mg/day provides more rapid and more sustained symptomatic response than vortioxetine 10 mg/day in patients with MDD, without compromising tolerability.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical benefits of vortioxetine 20 mg/day in patients with major depressive disorder

et al. 2023

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“…Treatment is initiated at one drop per day (vortioxetine 1 mg) and increased by one drop per day up to 10 drops (vortioxetine 10 mg) after 10 days. Up-titration then continues by increasing dosing by one or two drops per day, up to 20 drops (equivalent to vortioxetine 20 mg), the dose at which maximum therapeutic benefit is achieved (Adair et al, 2023; Christensen et al, 2023b). Likewise, dosing can be titrated up or down using an oral drop solution to achieve an optimal balance of efficacy, safety and tolerability when treating a patient with vortioxetine.…”

Section: Discussionmentioning

confidence: 99%

“…Vortioxetine is one of the few antidepressants shown to have a clear dose–response relationship across the spectrum of symptoms experienced by patients with MDD, including depressive, cognitive and physical symptoms, anxiety and functional impairment (Adair et al, 2023; Christensen et al, 2023b; Florea et al, 2017; Iovieno et al, 2021; Thase et al, 2016). An analysis of data from six pivotal clinical trials in patients with MDD demonstrated that vortioxetine 20 mg/day was significantly more effective than vortioxetine 10 mg/day in improving depressive symptoms as assessed by the Montgomery-Åsberg Depression Rating Scale, including response at week 2, sustained response and proportion of patients achieving remission without compromising tolerability.…”

Section: Introductionmentioning

confidence: 99%

Clinical benefits and bioequivalence of vortioxetine oral drop solution versus oral tablets

Fagiolini,

Adair,

Buchberg Petersen

et al. 2023

J Psychopharmacol

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Background: Vortioxetine is efficacious and well tolerated in patients with major depressive disorder (MDD) and is available as an immediate-release tablet and oral drop solution. The oral drop solution may offer clinical benefits versus a tablet, such as the reduced risk of nausea, personalised dosing and ease of administration. Aims: To investigate the bioequivalence of vortioxetine 20 mg/mL oral drop solution versus a 20 mg immediate-release tablet. Methods: Healthy adults were randomised 1:1 to receive vortioxetine 20 mg oral drop solution or immediate-release 20 mg tablet after fasting on days 1 and 29 in an open-label, single-centre, single-dose crossover study. The area under the plasma concentration–time curve from 0 to 72 h (AUC0–72h) and maximum plasma concentration ( Cmax) were analysed. Bioequivalence was concluded if the 90% CI for the oral drop solution-to-immediate-release tablet ratio for AUC0–72h and Cmax were contained within a range of 0.80−1.25. Results: Vortioxetine oral drop solution was bioequivalent to the tablet ( n = 26; estimated AUC0–72h ratio 1.06 (90% CI: 1.03–1.10); Cmax ratio 1.01 (90% CI: 0.97–1.05)). A similar proportion of participants reported adverse events in each study arm but more headache events (7 vs 1) were reported with the oral drop solution versus tablet. The most common adverse event was nausea (16–23% of participants; all mild intensity). Conclusions: Vortioxetine oral drop solution is bioequivalent to immediate-release tablets. Oral drop solution provides an alternative to tablets and facilitates clinical benefit through individualised treatment, including gradual dose up-titration, for patients with MDD.

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Effectiveness of Vortioxetine in Patients with Major Depressive Disorder Associated with Chronic Pain: An Observational Study in a Spanish Population

Folch Ibáñez,

Vargas Domingo,

Coma Alemany

et al. 2024

Pain Ther

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Introduction Chronic pain (CP) and depression/anxiety often coexist, worsening each other's symptoms. Treating this comorbidity is challenging. Tricyclic antidepressants and serotonin noradrenaline reuptake inhibitors are the first-line treatment options for this comorbidity, although sometimes they are not effective and/or well tolerated by patients, and there is little clinical evidence that selective serotonin reuptake inhibitors are useful for controlling CP. The antidepressant vortioxetine, with a multimodal mechanism that may help reduce pain, has proven clinical efficacy in patients with major depressive disorder (MDD). This study investigated vortioxetine's effectiveness for MDD and CP in clinical practice. Methods This was a 3-month, multicenter, prospective, open-label, non-interventional pharmacoepidemiologic study. Patients ( n = 64) with MDD (9-item Patient Health Questionnaire [PHQ-9] score ≥ 15) and CP (visual analogue scale [VAS] score ≥ 4) were treated with vortioxetine for 3 months (initiated with 10 mg/day, with flexible dosing thereafter [5–20 mg/day]). VAS, Clinical Global Impression (CGI), and Patient Global Impression (PGI) scales were used at baseline and at 1 and 3 months. Brief Pain Inventory (BPI), PHQ-9 scale, and Satisfaction with Medicines Questionnaire (SATMED-Q) were used at baseline and at 3 months. Adverse Events (AEs) were recorded. Descriptive statistics, chi-square tests, and Student's t -tests were used for paired data. Results MDD patients showed a statistically significant improvement in VAS from baseline (mean [standard deviation (SD)]: 7.42 [0.69]) to 1 month (mean [SD]: 6.1 [0.81], P < 0.001) and 3 months (mean [SD]: 5.09 [1.26], P < 0.0001). Similarly, BPI and PHQ-9 scores showed significant improvement from baseline (mean [SD]: 6.20 [0.80] and 16.63 [1.47], respectively) to 3 months (mean [SD]: 4.73 [0.98] and 7.30 [2.60], P < 0.0001, respectively). Patients showed clinical improvement with CGI and PGI scales and reported being satisfied with the treatment in the SATMED-Q. A few mild EAs were registered. Conclusion Vortioxetine can relieve depressive and pain symptoms, with a good safety profile, in patients with MDD and CP. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-024-00597-3.

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Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability

Cited by 11 publications

References 51 publications

Clinical benefits of vortioxetine 20 mg/day in patients with major depressive disorder

Clinical benefits of vortioxetine 20 mg/day in patients with major depressive disorder

Clinical benefits and bioequivalence of vortioxetine oral drop solution versus oral tablets

Effectiveness of Vortioxetine in Patients with Major Depressive Disorder Associated with Chronic Pain: An Observational Study in a Spanish Population

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