PMC:4235387 / 11210-21738 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/4235387","sourcedb":"PMC","sourceid":"4235387","source_url":"http://www.ncbi.nlm.nih.gov/pmc/4235387","text":"Results\nA total of 836 study participants were enrolled: 387 from the US study and 449 from the non-US study. Two study participants did not receive study treatment and were not included in the analysis (Fig. 2). Study participants were predominantly women (63%) and White (83%), with a mean age of 45.5 years (Table 1). Mean compliance with study medication (([number of capsules dispensed−number of capsules returned]/[date of last dose−date of first dose+1])×100) was ∼100%, with the majority of study participants having a compliance rate of 80–120%. The mean exposure to the 2.5, 5, and 10 mg dose levels was 22.9, 15.5, and 31.1 weeks, respectively. Sixty-seven percent of the study participants received vortioxetine 10 mg for at least one week and 40% received vortioxetine 10 mg for at least 24 weeks. Medical histories from the acute efficacy trials were transcribed into the open-label extension subject database, with any ongoing AEs from the original studies recorded as concurrent conditions. The most common medical history/concurrent conditions (defined as occurring in ≥10% of the study participants in the overall population) included headache, hypertension, nausea, back pain, and insomnia. These conditions were more common in the US study than in the non-US study: headache (41.5 vs. 11.4%), hypertension (19.4 vs. 19.0%), nausea (22.0 vs. 8.5%), back pain (13.7 vs. 9.2%), and insomnia (17.4 vs. 4.0%).\nFig. 2 CONSORT flow diagram.\nTable 1 Baseline clinical and demographic characteristics\n\nSafety\nAmong the 834 evaluable study participants, the mean duration of vortioxetine exposure was 39.5±18.1 (range, 0.1–56.9) weeks. TEAEs were reported by 589 (70.6%) of the 834 study participants, who experienced a total of 2117 events (Table 2). Most TEAEs were mild or moderate in severity. The most frequently reported TEAEs (incidence≥5%) were nausea, headache, nasopharyngitis, diarrhea, dizziness, and upper respiratory tract infection (Table 3). There tended to be a higher TEAE rate in the study participants from the US study compared with the non-US study, with any TEAE reported in 79.3 and 63.2% of the study participants, from the two studies, respectively, although the rates of TEAE-related withdrawal (7.0 vs. 5.1%) and serious TEAEs (4.1 vs. 2.9%) were generally similar between studies. A total of 29 (3.5%) of the study participants experienced 38 serious AEs and five were considered by the investigator to be related to vortioxetine (left hemispheric ischemic stroke, depression, major depression, supraventricular tachycardia, and paroxysmal tachycardia). TEAEs leading to treatment discontinuation occurred in 50 study participants (6.0%), with nausea, somnolence, dizziness, and depression occurring in more than two study participants (Table 2). Three of the study participants with serious related TEAEs withdrew from the study: participants with ischemic stroke, depression, and major depression. The other two study participants, with supraventricular tachycardia and paroxysmal tachycardia, recovered from the events and completed the study as scheduled. The study participant with ischemic stroke was a 78-year-old woman [body mass index (BMI)=33 kg/m2] who had previously received duloxetine 60 mg during the double-blind phase. The study participant had no identifiable risk factors (i.e. hypertension, hyperlipidemia, previous transient ischemic attack, or cardiovascular concerns); however, she did have a previous history of falls that required hospitalization, including a fall during the double-blind phase and a fall after initiation on vortioxetine. The study participant received vortioxetine for a total of 17 days at a daily dose of 5 mg for the initial 7 days and 2.5 mg for 10 days before hospitalization for left hemispheric ischemic stroke. The patient was discharged with right-side weakness and speech deficits. No deaths were reported during the study.\nTable 2 Summary of treatment-emergent adverse events\nTable 3 Treatment-emergent adverse events occurring in at least 5% of the study participants An AE subanalysis during the first 14 days of open-label treatment showed that study participants treated previously with duloxetine (this treatment arm only in the short-term US study), when abruptly switched to vortioxetine as part of this long-term study, experienced a significantly higher rate of dizziness (19.4%) compared with those who had previously received placebo (0.9%) or vortioxetine 2.5 and 5 mg (3.5 and 5.6%, respectively).\nThe incidence of treatment-emergent sexual dysfunction was low, with 18 events among the 834 study participants. Decreased libido was the most commonly reported sexual complaint (n=8; 1%), followed by erectile dysfunction (n=4; 0.5%) and delayed ejaculation (n=2; 0.2%). None of the study participants discontinued the study because of sexual dysfunction-related AEs. With respect to weight, no clinically meaningful differences were observed among the groups administered vortioxetine 2.5, 5, or 10 mg/day. Overall, there was a mean increase in weight of 0.67 kg at the final visit relative to the open-label baseline. Weight changed (increase or decrease) by at least 7% in 155 (18.6%) of 834 study participants (n=105 with an increase≥7% and n=50 with a decrease≥7%). There were 36 study participants (4.3%) with TEAEs of weight increased and 10 study participants (1.2%) with TEAEs of weight decreased. Insomnia was reported in 17 study participants (2.0%).\nSerum chemistry test results showed no clinically meaningful differences among the treatment groups. Alanine aminotransferase and aspartate aminotransferase values of at least three times the upper limit of normal occurred in three (0.4%) and six (0.7%) study participants, respectively; however, these elevations did not lead to discontinuation from the study. No identifiable trend was observed in changes in levels of serum cholesterol or triglycerides. Mean changes from baseline in urinalysis were minimal and not considered clinically meaningful. There were also no clinically meaningful treatment-related trends for vital signs, physical findings, or ECG readings. There were two ECG-related events that were considered serious: one instance of atrial fibrillation (considered unrelated to vortioxetine) and one case of supraventricular tachycardia (possibly related to vortioxetine). One participant had a prolonged Bazett-corrected QT interval; however, this participant had been newly diagnosed with Wolff–Parkinson–White syndrome, and the QT prolongation was not considered by the investigator to be related to vortioxetine. This participant was discontinued from the study.\nOf the 834 study participants included in the analysis, 204 (24.5%) and 74 (8.9%) reported a previous history of suicidal ideation and behavior, respectively (Table 4). During the study, 83 (10%) and three (0.4%) study participants reported suicidal ideation and behavior, respectively. One suicide attempt and two cases of suicidal ideation were reported as serious. None of the three events were considered related to vortioxetine; all study participants recovered.\nTable 4 Suicide-related events on the basis of C-SSRS\n\nSymptoms of depression and anxiety\nThe changes in severity of depressive and anxiety symptoms as measured by HAM-D24, HAM-A, and CGI-S during the double-blind phase and the open-label extension phase are summarized in Table 5 and Figs 3–5. These results indicate that the improvements achieved during the double-blind phase were maintained when study participants were continued on or switched to vortioxetine, with scores decreasing further from the open-label baseline values irrespective of the original double-blind assigned treatment. For example, the mean (±SD) HAM-D24 scores decreased from 31.2 (±5.5) at the double-blind lead-in baseline to 17.6 (±9.4) at the open-label baseline, with a further improvement to 9.7 (±8.2) at the final visit (OC analysis). These results reflect a total mean change from double-blind baseline to the end point of the open-label study of –21.5 (±9.4) (Fig. 3). Response (defined as a ≥50% decrease in the HAM-D24 score from the open-label baseline to the final visit) was achieved in 423/829 (51.0%) study participants (OC analysis). Improvements in HAM-D24 scores were evident irrespective of the dosage assignment in the lead-in trial (i.e. there was no difference in response rates on the basis of treatment in the lead-in study). Decreases in HAM-D24 scores ranged from 16.2 to 25.0 across all vortioxetine dose groups relative to the double-blind baseline, with a further improvement of 4.0–10.2 points at the final visit relative to the open-label baseline. Remission, defined as a HAM-D17 total score of up to 7, was achieved in 461/829 (55.6%) study participants at the final visit. These overall improvements in HAM-D24 scores were similar to those observed in the subgroup of study participants who received duloxetine during the double-blind trial (US study). Here, that subgroup showed a decrease of 18.2 points at the final visit relative to the double-blind baseline and a decrease of 3.4 points relative to the open-label baseline.\nTable 5 Efficacy measures\nFig. 3 Mean HAM-D24 total scores by study visit. BL, baseline; HAM-D24, 24-item Hamilton Depression Scale.\nFig. 4 Mean HAM-A total scores by study visit. BL, baseline; HAM-A, Hamilton Anxiety Scale.\nFig. 5 Mean CGI-S total scores by study visit. BL, baseline; CGI-S, Clinical Global Impressions Scale – Severity of Illness Scale. Similar changes in symptom severity were noted for the MADRS total score, MADRS response (defined as a ≥50% decrease in the total score from baseline), and MADRS remission (defined as a total score≤10). Mean changes in HAM-A and CGI-S scores from double-blind baseline to the final visit were –12.4 (±7.4) and –2.5 (±1.3) points, respectively, among those treated with vortioxetine, with decreases continuing after the initiation of the open-label phase (Table 5 and Figs 4 and 5). For the double-blind duloxetine group, the improvement in HAM-A and CGI-S scores was –9.5 (±6.88) and –2.18 (±1.255) points, respectively. For patient-reported outcomes, study participants receiving vortioxetine experienced improvements in all SF-36 subscale scores from open-label baseline for all previous treatment groups. Similarly, study participants experienced improvements from double-blind baseline and open-label baseline in the mean SDS scores and in individual items, indicating continued improvement.\n","divisions":[{"label":"Title","span":{"begin":0,"end":7}},{"label":"Figure caption","span":{"begin":1425,"end":1456}},{"label":"Table caption","span":{"begin":1455,"end":1515}},{"label":"Section","span":{"begin":1515,"end":7184}},{"label":"Title","span":{"begin":1515,"end":1521}},{"label":"Table caption","span":{"begin":3919,"end":3974}},{"label":"Table caption","span":{"begin":3973,"end":4068}},{"label":"Table caption","span":{"begin":7127,"end":7183}},{"label":"Section","span":{"begin":7183,"end":10527}},{"label":"Title","span":{"begin":7183,"end":7217}},{"label":"Table caption","span":{"begin":9170,"end":9198}},{"label":"Figure caption","span":{"begin":9197,"end":9306}},{"label":"Figure caption","span":{"begin":9305,"end":9399}},{"label":"Figure 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