Antidepressant efficacy and tolerance of agomelatine in daily practice in Switzerland

2016 ◽  
Vol 33 (S1) ◽  
pp. S412-S412
Author(s):  
B. Guido ◽  
H.T. Edith

IntroductionThe antidepressant efficacy and tolerance of agomelatine, MT1/MT2 agonist and 5-HT2C antagonist, has been proven in clinical trials. Non interventional studies give the opportunity to evaluate these properties in real life.ObjectiveTo evaluate the efficacy and tolerance of agomelatine in depressed outpatients in Switzerland.MethodsNon-interventional study in 934 depressed (51.2% severely) patients given 25–50 mg agomelatine for 12 and 24 weeks. Main endpoints were change in MADRS score, and response (≥50% reduction in total score) and remission (MADRS ≤12) rates. CGI was also assessed. Reported adverse drug reactions, sexual dysfunction, and weight changes were recorded. Liver function tests were performed according to the summary of product characteristics.ResultsMADRS total score decreased significantly (P < 0.0001) from baseline (29.5 ± 8.9) to weeks 12 (12.8 ± 9.6) and 24 (9.7 ± 8.6). Responder rate was 66.8% and 78.3% and remission rate 54.2% and 70.2% at weeks 12 and 24, respectively. Results corroborated by CGI scores, were similar for severely depressed patients. Early improvers (MADRS ≥ 20% reduction after 2 weeks; 461 patients) had the highest responder and remission rates. Agomelatine was well tolerated and no relevant weight changes or deleterious sexual function was reported. Ten patients had ALT/AST>3ULN, thereof 2 without baseline and one with elevated baseline. Most physicians rated the efficacy and tolerance of agomelatine as “good or very good”.ConclusionLong-term agomelatine treatment improved mood symptoms of depressed patients with high levels of response and remission and a favorable tolerance profile.Disclosure of interestThe authors have not supplied their declaration of competing interest.

2011 ◽  
Vol 26 (S2) ◽  
pp. 2178-2178
Author(s):  
G. Hajak

Agomelatine is a completely new approach to the treatment of depression thanks to its innovative mode of action. Acting as melatonergic agonist and 5-HT2C antagonist, it provides depressed patients with a distinctive antidepressant efficacy that perfectly suits patients’ needs and addresses all symptoms at each step of depression. Two years after the first launch in Europe, now is the time for an update from doctors and patients alike.The patient/doctor relation is key when initiating depression treatment, because patients are reluctant to start, fearing withdrawal symptoms, serious unwanted side effects, and “addiction”. It is important therefore that they understand that agomelatine has none of these effects.The benefits perceived by patients right from the first days of treatment are influential, because patients are reluctant to continue with classic antidepressants (delayed onset of perceived benefit, early side effects). The early improvement reported by patients on agomelatine supplements data on clinical benefits seen in clinical trials from the first week versus venlafaxine (CGI-I, rate of response, daytime alertness, feeling good) and after two weeks versus sertraline (twice as many HAM-D responders to agomelatine as to sertraline).Finally, patients are reluctant to maintain antidepressant treatment because of later side effects (weight gain, sexual dysfunction, emotional blunting). Patients on agomelatine confirm the absence of the classic side effects of antidepressants and are more likely to continue treatment than they are with other drugs. Both the antidepressant efficacy and the tolerability were confirmed in a large non-interventional study in a real-life setting in daily practice.


2018 ◽  
Vol 64 (1) ◽  
pp. 47-58 ◽  
Author(s):  
Marianne Leuzinger-Bohleber ◽  
Martin Hautzinger ◽  
Georg Fiedler ◽  
Wolfram Keller ◽  
Ulrich Bahrke ◽  
...  

Objective: For chronic depression, the effectiveness of brief psychotherapy has been limited. This study is the first comparing the effectiveness of long-term cognitive-behavioural therapy (CBT) and long-term psychoanalytic therapy (PAT) of chronically depressed patients and the effects of preferential or randomized allocation. Methods: A total of 252 adults met the inclusion criteria (aged 21-60 years, major depression, dysthymia, double depression for at least 24 months, Quick Inventory of Depressive Symptoms [QIDS] >9, Beck Depression Inventory II [BDI] >17, informed consent, not meeting exclusion criteria). Main outcome measures were depression self-rating (BDI) and rating (clinician-rated QIDS [QIDS-C]) by independent, treatment-blinded clinicians. Full remission rates (BDI ≤12, QIDS-C ≤5) were calculated. An independent center for data management and biostatistics analyzed the treatment effects and differences using linear mixed models (multilevel models and hierarchical models). Results: The average BDI declined from 32.1 points by 12.1 points over the first year and 17.2 points over 3 years. BDI overall mean effect sizes increased from d = 1.17 after 1 year to d = 1.83 after 3 years. BDI remission rates increased from 34% after 1 year to 45% after 3 years. QIDS-C overall effect sizes increased from d = 1.56 to d = 2.08, and remission rates rose from 39% after 1 year to 61% after 3 years. We found no significant differences between PAT and CBT or between preferential and randomized allocation. Conclusions: Psychoanalytic as well as cognitive-behavioural long-term treatments lead to significant and sustained improvements of depressive symptoms of chronically depressed patients exceeding effect sizes of other international outcome studies.


2020 ◽  
Vol 133 (5) ◽  
pp. 1360-1370 ◽  
Author(s):  
Mohammed J. Asha ◽  
Hirokazu Takami ◽  
Carlos Velasquez ◽  
Selfy Oswari ◽  
Joao Paulo Almeida ◽  
...  

OBJECTIVETranssphenoidal surgery is advocated as the first-line management of growth hormone (GH)–secreting adenomas. Although disease control is defined by strict criteria for biochemical remission, the length of follow-up needed is not well defined in literature. In this report, the authors present their long-term remission rate and identify various predictive factors that might influence the clinical outcome.METHODSThe authors conducted a single-institute retrospective analysis of all transsphenoidal procedures for GH-secreting adenomas performed from January 2000 to June 2016. The primary outcome was defined as biochemical remission according to the 2010 consensus criteria and measured at the 1-year postoperative mark as well as on the last recorded follow-up appointment.Secondary variables included recurrence rate, patterns of clinical presentation, and outcome of adjuvant therapy (including repeat surgery). Subgroup analysis was performed for patients who had biochemical or radiological “discordance”—patients who achieved biochemical remission but with incongruent insulin-like growth factor 1 (IGF-1)/GH or residual tumor on MRI. Recurrence-free survival analysis was conducted for patients who achieved remission at 1 year after surgery.RESULTSEighty-one patients (45 female and 36 male) with confirmed acromegaly treated with transsphenoidal surgery were included. In 62 cases the patients were treated with a pure endoscopic approach and in 19 cases an endoscopically assisted microscopic approach was used.Primary biochemical remission after surgery was achieved in 59 cases (73%) at 1 year after surgery. However, only 41 patients (51%) remained in primary surgical remission (without any adjuvant treatment) at their last follow-up appointment, indicating a recurrence rate of 31% (18 of 59 patients) over the duration of follow-up (mean 100 ± 61 months). Long-term remission rates for pure endoscopic and endoscopically assisted cases were not significantly different (48% vs 52%, p = 0.6). Similarly, no significant difference in long-term remission was detected between primary surgery and repeat surgery (54% vs 33%, p = 0.22).Long-term remission was significantly influenced by extent of resection, cavernous sinus invasion (radiologically as well as surgically reported), and preoperative and early postoperative GH and IGF-1 levels (within 24–48 hours after surgery) as well as by clinical grade, with lower remission rates in patients with dysmorphic features and/or medical comorbidities (grade 2–3) compared to minimally symptomatic or silent cases (grade 1).CONCLUSIONSThe long-term surgical remission rate appears to be significantly less than “early” remission rates and is highly dependent on the extent of tumor resection. The authors advocate a long-term follow-up regimen and propose a clinical grading system that may aid in predicting long-term outcome in addition to the previously reported anatomical factors. The role of repeat surgery is highlighted.


2016 ◽  
Vol 33 (S1) ◽  
pp. S618-S618
Author(s):  
M.D.L.C. Ramirez Dominguez ◽  
L. Hernandez Gonzalez ◽  
I. Prieto Sánchez ◽  
A. Rodriguez Martinez ◽  
S. Fernandez Leon

ObjectiveTo demonstrate the therapeutic efficacy of aripiprazole LP by a case of difficult clinical management and that we often find in our daily practice.MethodsDescription of a clinical case of a 21-year-old man, recently diagnosed with paranoid schizophrenia with no awareness of disease neither treatment adherence and harmful use of THC and cocaine that are identified as precipitating factors for multiple hospital admissions.ResultsInjectable medication with objective clinical improvement is significant, cessation of readmissions, achieving improvement in all parameters measured functionality and proper adherence to treatment as well as outpatient mental health of both devices as of drug dependence.ConclusionPsychiatry is facing the great challenge of modifying the natural history to the deterioration of schizophrenia, a disease considered one of the leading causes of years lived with disability. The objectives medium and long-term treatment of this disease are centered on the delay-avoidance disability and improving the functioning and quality of life of people with this disease.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2011 ◽  
Vol 26 (S2) ◽  
pp. 2179-2179
Author(s):  
S. Kasper

Most antidepressants acting through monoaminergic systems have limitations in efficacy and tolerability and this has led to other approaches to provide patients with adequate treatment.Agomelatine is an innovative approach to depression as it resynchronizes circadian rhythms, which are disturbed in depressed patients, thanks to its action on the melatonergic MT1 and MT2 receptors, and the 5-HT2C receptors.The efficacy of agomelatine in depressed patients has been shown in several multicenter, randomized, double-blind parallel-group studies either in comparison with placebo or in 4 head-to-head studies vs an SSRI (sertraline, escitalopram, or fluoxetine in patients with more severe depression) or vs an SNRI (venlafaxine) after 6-8 weeks of treatment.Agomelatine produced a continuous improvement by significantly reducing all core symptoms of depression. Agomelatine significantly reduced the incidence of relapse in acute responders over a 6-month period (21.7% for agomelatine versus 46.6% for placebo, P = 0.0001), even in the severely depressed patients. Agomelatine was well tolerated in the short and long term.The pooled analysis of 4 head-to-head comparison studies showed after 6-8 weeks a significant difference in favor of agomelatine vs SSRIs/SNRIs in the HAM-D total score 1.37 (P < 0.001) and for responders (7.21%, P = 0.005). In addition, fewer patients withdrew due to emergent adverse events with agomelatine (6.3%) than with SSRIs/SNRIs (10.5%, P = 0.0058).Taken together these data indicate that agomelatine is an effective treatment of depression in the short and long term, with a distinctive efficacy and better tolerability than the main current treatments.


2019 ◽  
Vol 2 (2) ◽  
pp. 3
Author(s):  
Alessandro Loglio

Mycludex B (MYR) is a new promising anti-HDV therapy, but the effectiveness and safety of long-term administration in compensated cirrhotics treated in a real-life setting are presently unknown. Aim of this study was therefore to describe the effectiveness, safety and impact on HDV/HBV-specific T cell profiles in the first two European patients treated with MYR outside clinical trials. Methods. A 69-year-old female and 51-year-old male Caucasian HBeAg-negative patients with HDV related compensated cirrhosis on long-term term TDF treatment, started MYR 10 mg/day on January and May 2018 in a compassionate use program. Liver function tests, bile acids and virological markers were monitored every 4 weeks. HDV RNA was tested by RoboGene®.


2016 ◽  
Vol 33 (S1) ◽  
pp. s251-s252
Author(s):  
P. Hjorth ◽  
P.M. Jørgensen ◽  
A. Kynde

IntroductionPatients with schizophrenia have increased somatic morbidity and increased mortality. Knowledge of how to integrate prevention and care of somatic illnesses into the treatment of psychiatric patients is required.ObjectivesForty-seven patients diagnosed with schizophrenia participated in the programme (mean age: 33.3 years, SD: 11.9).AimsTo investigate whether a 2.5-year interventional programme to improve physical health is effective.MethodThe intervention consisted of health promotion activities focusing on the patients’ health, not their diseases. The patients’ physical health parameters were intensely monitored and each patient received individual guidance on healthy food and on how to live a physically active life.ResultsExtensive problems with obesity, especially among the women, were observed, and low level of physical activity among the patients was demonstrated. The included patients were in a high risk of developing cardio vascular diseases and diabetes type 2. The main outcomes were reduction in waist circumferences and in consumption of soft drinks and an increase in coffee drinking. Furthermore, an increase in time spent on moderate and light physical activities was observed. The patients showed great interest in the programme, and it was unproblematic getting the patients to participate in the entire programme. Moreover, they willingly followed the health guidance and achieved a healthier life.ConclusionsThe intervention seems relevant and manageable in an outpatient setting. The results are promising in the ongoing process of improving physical health among patients with schizophrenia. We recommend implementation of the programme in daily practice.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2020 ◽  
Vol 2 (4) ◽  
Author(s):  
Takahiro Ito ◽  
Atsuo Maemoto ◽  
Takehiko Katsurada ◽  
Hiroki Tanaka ◽  
Satoshi Motoya ◽  
...  

Abstract Background This study clarifies the long-term effectiveness of ustekinumab based on real-life data from Japanese Crohn’s disease (CD) patients. Methods A total of 137 patients were included, and 124 patients (90.5%) were exposed to anti-tumor necrosis factor-α agents. Results The clinical remission rate at week 52 was 32.4% in moderate to severely active CD patients. The achievement of clinical remission for 8 weeks after ustekinumab therapy induction was associated with clinical remission at week 52. Ustekinumab persistence rate at week 104 was 81.4%. Conclusion Ustekinumab is effective and persistent in CD patients with the previous treatment history of several biologics.


2016 ◽  
Vol 33 (S1) ◽  
pp. S408-S408
Author(s):  
D. Gourion ◽  
F. Vinckier ◽  
S. Mouchabac

BackgroundAnhedonia is a core dimension of major depressive disorder (MDD). Paradoxically, the association between anhedonia and social impairment is poorly known.ObjectiveTo determine the longitudinal relationships between depressive symptoms, anhedonia, and social functioning in depressed patients treated with agomelatine.Material and methodOne thousand five hundred and seventy patients with MDD starting treatment with agomelatine prescribed by their GPs were included in a prospective study (follow-up: 10 to 14 weeks). Patients were assessed at baseline and at the end point of the study, using the MADRS to assess antidepressant efficacy, the SHAPS scale and an original visual analog scale exploring the subjective pleasure felt by patients in their main leisure activity to measure anhedonia, and the QFS to measure social functioning in its qualitative and quantitative dimensions. In addition to the univariate analyses, a mediation path analysis was performed using the Sobel test.ResultsThe results showed a robust and significant improvement in symptoms of depression, anhedonia, and social functioning. The correlations between the SHAPS and QFS scores were high and significant. Subsequent analyses showed that amelioration of anhedonia is a significant mediating variable between the progression of depressive symptoms and social functioning (Δ QFS G = –14.3, P < 0.0001) and explains around one third of the variance of the model (35.37%).ConclusionAnhedonia, a major dimension of depression, provides specific insights into the understanding of the complex links between residual symptoms of MDD and social functioning. In conclusion, improving the evaluation of anhedonia is a fundamental issue in primary care.Disclosure of interestThe authors have not supplied their declaration of competing interest.


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