| Title |
Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
|
|---|---|
| Published in |
Neuropsychiatric Disease and Treatment, June 2017
|
| DOI | 10.2147/ndt.s136997 |
| Pubmed ID | |
| Authors |
Takeshi Terao, Atsuko Ishida, Toshifumi Kimura, Mitsuhiro Yoshida, Terufumi Hara |
| Abstract |
A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton's Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4-6 months post treatment initiation, and 10-12 months post treatment initiation. A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10-12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10-12 months post treatment. The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. |
Mendeley readers
The data shown below were compiled from readership statistics for 28 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 28 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 5 | 18% |
| Other | 3 | 11% |
| Student > Doctoral Student | 3 | 11% |
| Student > Postgraduate | 3 | 11% |
| Student > Ph. D. Student | 3 | 11% |
| Other | 6 | 21% |
| Unknown | 5 | 18% |
| Readers by discipline | Count | As % |
|---|---|---|
| Psychology | 6 | 21% |
| Medicine and Dentistry | 5 | 18% |
| Neuroscience | 4 | 14% |
| Nursing and Health Professions | 2 | 7% |
| Social Sciences | 2 | 7% |
| Other | 3 | 11% |
| Unknown | 6 | 21% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 February 2018.
All research outputs
#22,764,772
of 25,382,440 outputs
Outputs from Neuropsychiatric Disease and Treatment
#2,583
of 3,131 outputs
Outputs of similar age
#289,180
of 330,503 outputs
Outputs of similar age from Neuropsychiatric Disease and Treatment
#67
of 85 outputs
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