How to switch to agomelatine after an unsuccessful try with paroxetine or venlafaxine

CNS Spectrums ◽  
2013 ◽  
Vol 20 (1) ◽  
pp. 29-38 ◽  
Author(s):  
Michel Lejoyeux ◽  
Sophie Matharan ◽  
Christian de Bodinat

Objective/introductionThe present trial informs clinicians about switching conditions with the antidepressant agomelatine after the failure of a treatment with either paroxetine or venlafaxine.MethodsThe total number of discontinuation-emergent symptoms, according to the Discontinuation-Emergent Signs and Symptoms checklist, was compared in double-blind conditions after 3 switching options: immediate substitution or initiation of agomelatine (25 mg/day p.o.) with either a short- or long-tapering of the previous drug. Secondary objectives included tolerability and safety assessments and the early clinical benefit after the switch.ResultsFor all switching options, a withdrawal syndrome was observed 1 week after cessation of the selective serotonin reuptake inhibitor (SSRI)/serotonin–norepinephrine reuptake inhibitor (SNRI) treatment. Psychic symptoms were the most frequently reported, and somatic symptoms were comparatively few. Early discontinuation symptoms after cessation of SSRI/SNRI treatment did not prejudice the antidepressant benefits of agomelatine over 8 weeks.ConclusionsBoth abrupt and start–taper switching with agomelatine are options in everyday practice for those patients who have not responded to either paroxetine or venlafaxine. However, regardless of the switching strategy, the present double-blind study shows that early discontinuation symptoms that arise upon cessation of SSRI/SNRI can alter the patients’ perception of the clinical benefit of the new antidepressant. Both practitioners and patients must be warned about these early discontinuation symptoms to prevent the symptoms from being confounded with a lack of therapeutic benefit of the new treatment.

PEDIATRICS ◽  
1987 ◽  
Vol 80 (2) ◽  
pp. 275-282
Author(s):  
Caroline Breese Hall ◽  
Raphael Dolin ◽  
Christine L. Gala ◽  
David M. Markovitz ◽  
Yu Qin Zhang ◽  
...  

Treatment with rimantadine of influenza in children and the potential development of resistance in clinical isolates associated with therapy have not been previously studied. We compared rimantadine to acetaminophen therapy in a controlled, double-blind study of 91 children with influenza-like illness. Of 69 children with proven influenza A/H3N2 infection, 37 received rimantadine and 32 received acetaminophen for five days. Children receiving rimantadine showed significantly greater reduction in fever and improvement in daily scores for symptoms and severity of illness during the first three days. Viral shedding also diminished significantly during the first two days but subsequently increased such that by days 6 and 7 the proportion of children shedding virus, as well as the quantity of virus shed, was significantly greater in the rimantadine group. During the seven-day study, of the 22 children in the rimantadine group with serial isolates tested, ten (45.5%) had resistant isolates compared with two (12.5%) of those with serial isolates in the acetaminophen group (P < .03). Thus, of the total 37 children in the rimantadine group, 27% were found to have resistant isolated compared with 6% in the total group receiving acetaminophen (P < .04). Furthermore, the mean inhibitory concentration of rimantadine increased with time in the rimantadine group (r = .4, P = .002) but not in the acetaminophen group. Rimantadine therapy, thus, appears to be significantly more effective than acetaminophen in ameliorating the clinical signs and symptoms of influenza in children. Treatment with rimantadine was also associated with increased viral shedding after the medication was discontinued and with the development of resistance in the clinical isolates, the significance of which is unknown.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS9128-TPS9128
Author(s):  
Mark A. Socinski ◽  
Alexander I. Spira ◽  
Luis G. Paz-Ares ◽  
Martin Reck ◽  
Shun Lu ◽  
...  

TPS9128 Background: Monotherapy with programmed death 1 (PD-1)/PD-L1 antibodies has improved clinical outcomes for patients (pts) with non-oncogenic driven NSCLC but clinical responses are limited by primary and secondary resistance, and improvements in durability of response are required. T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain (TIGIT) is a co-inhibitory, immune checkpoint receptor upregulated on T-cells and natural killer cells in multiple solid tumors, which can inhibit anticancer immune responses. OCI (BGB-A1217) is a novel, humanized mAb that binds to TIGIT with high affinity and specificity, which has demonstrated competent binding with C1q and all Fcγ receptors while inducing antibody-dependent cellular cytotoxicity. Preclinical and clinical studies suggest that dual targeting with anti-TIGIT and anti-PD-1 antibodies produces synergistic immune cell activation and enhanced antitumor activity. Methods: AdvanTIG-302 is a Phase 3, multicenter, international, randomized, double-blind study (NCT04746924) investigating OCI in combination with TIS compared with PEM in adult pts (≥ 18 years of age) with PD-L1 selected, previously untreated, locally advanced, unresectable or metastatic NSCLC without oncogenic EGFR or ALK mutation. Approximately 605 pts will be randomized 5:5:1 to receive: OCI 900 mg intravenously (IV) plus TIS 200 mg IV every three weeks (Q3W; Arm A), PEM 200 mg IV plus placebo IV Q3W (Arm B) or TIS 200 mg IV plus placebo IV Q3W (Arm C). Pts will be treated until disease progression, loss of clinical benefit, intolerable toxicity or withdrawal of consent. Stratification factors include histology (squamous vs non-squamous) and region (Asian vs non-Asian). Cross-over is not permitted. Key eligibility criteria include histologically confirmed disease, PD-L1 expression ≥ 50%, no known EGFR or ALK mutations and no prior checkpoint inhibitor therapy. Dual primary endpoints are investigator-assessed progression-free survival (PFS; RECIST v1.1) and overall survival (Arms A and B) in the Intention-to-Treat population. Secondary endpoints include PFS (assessed by Blinded Independent Review Committee), investigator-assessed overall response rate and duration of response, safety and tolerability, and patient-reported health-related quality of life (EORTC-QLQ-C30, QLQ-LC13 and EQ-5D-5L; Arms A and B). Exploratory endpoints include disease control rate, clinical benefit rate and time to response. This study will also evaluate the association between biomarkers and response or resistance. Study enrollment has begun and recruitment is ongoing. Clinical trial information: NCT04746924.


1980 ◽  
Vol 8 (6) ◽  
pp. 391-394 ◽  
Author(s):  
Juan Carlos Tarasido

The symptoms of seasonal allergic rhinitis can be alleviated by the use of an antihistamine and a decongestant. The efficacy and safety of the combination of azatadine maleate and pseudoephedrine sulfate were examined in this double-blind study comparing active drug to placebo. While 74% of the patients administered the combination drug showed marked improvement in the signs and symptoms of seasonal allergic rhinitis, only 29% of patients receiving placebo demonstrated improvement. Adverse reactions were mild and transient.


1986 ◽  
Vol 100 (9) ◽  
pp. 1055-1060 ◽  
Author(s):  
D. A. Parker ◽  
K. P. Gibbin ◽  
R. M. Noyelle

SummaryPost-tonsillectomy analgesia from ibuprofen, aspirin and placebo is compared in a double-blind study. The results are reported showing ibuprofen to have greater therapeutic benefit than placebo whereas aspirin did not. Methods of providing pain relief after tonsillectomy and the relative clinical merits of ibuprofen and aspirin are discussed.


2000 ◽  
Vol 8 (3) ◽  
pp. 226-231 ◽  
Author(s):  
David C. Mamo ◽  
Robert A. Sweet ◽  
Benoit H. Mulsant ◽  
Bruce G. Pollock ◽  
Mark D. Miller ◽  
...  

1997 ◽  
Vol 15 (3) ◽  
pp. 969-973 ◽  
Author(s):  
C L Loprinzi ◽  
S Abu-Ghazaleh ◽  
J A Sloan ◽  
C vanHaelst-Pisani ◽  
A M Hammer ◽  
...  

PURPOSE Vaginal dryness and dyspareunia are significant estrogen-depletion symptoms that affect many breast cancer survivors. The present trial was developed to evaluate the nonhormonal vaginal lubricating preparation, Replens, for alleviating these symptoms. MATERIALS AND METHODS A double-blind, crossover, randomized clinical trial was developed. Patients received 4 weeks of Replens (Columbia Research Laboratories, Rockville Centre, NY) followed by a 1-week washout period followed by 4 weeks of a placebo lubricating product, or vice versa. Weekly patient-completed diaries were used for measuring efficacies and toxicities of therapy. RESULTS The 45 assessable patients provided well-balanced treatment groups. During the first 4 weeks, average vaginal dryness decreased by 62% and 64% in the placebo and Replens groups, respectively (P = .3). Average dyspareunia scores also improved by 41% and 60%, respectively (P = .05). Crossover analysis indicated that the bulk of the beneficial effects appeared within the first 2 weeks of the first treatment and remained constant thereafter. Both treatments were relatively well tolerated. CONCLUSION Both Replens and the placebo appear to substantially ameliorate vaginal dryness and dyspareunia in breast cancer survivors.


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