更新于：2024-11-04
Lamotrigine
拉莫三嗪
更新于：2024-11-04
概要
基本信息
简介拉莫三嗪是一种抗惊厥药物，于1994年12月27日首次被美国食品和药品管理局批准上市。由制药公司葛兰素史克开发的，主要用于治疗Lennox Gastaut综合征、癫痫和双相情感障碍等疾病。拉莫三嗪的作用机制是通过阻断大脑中的钠通道，以稳定神经元的电活动，减轻癫痫发作的严重程度和频率。此外，拉莫三嗪还被用于治疗双相情感障碍的抑郁症状。该药物已被证明对减少癫痫发作的频率和改善患者生活质量具有显著疗效。 |
药物类型 小分子化药 |
别名 3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine、Lamotrigine (JAN/USP/INN)、430-C-78 + [12] |
作用机制 钠通道阻滞剂 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 (1990-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构
分子式C9H7Cl2N5 |
InChIKeyPYZRQGJRPPTADH-UHFFFAOYSA-N |
CAS号84057-84-1 |
关联
228
项与 拉莫三嗪 相关的临床试验拉莫三嗪片（50mg）健康人体生物等效性试验
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
评估受试制剂拉莫三嗪片（规格：50 mg）与参比制剂LAMICTAL（规格：50 mg）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
100 项与 拉莫三嗪 相关的临床结果
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100 项与 拉莫三嗪 相关的转化医学
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100 项与 拉莫三嗪 相关的专利（医药）
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6,073
项与 拉莫三嗪 相关的文献（医药）2024-12-01EPILEPSY & BEHAVIOR
Prescription patterns relevant to young people with epilepsy of childbearing potential
Article
作者: Kirkpatrick, Laura A ; Sogawa, Yoshimi ; Kirkpatrick, Laura A. ; Kazmerski, Traci M ; Harrison, Elizabeth I. ; Harrison, Elizabeth I ; Kazmerski, Traci M. ; Hochheiser, Harry S. ; Hochheiser, Harry S
RATIONALE:
Young people with epilepsy of childbearing potential (YPWECP) are vulnerable to a variety of adverse health outcomes due to teratogenic antiseizure medications (ASMs) and drug-drug interactions between ASMs and contraceptives that can lead to breakthrough seizures and/or contraceptive failure. To better understand reproductive healthcare provision for YPWECP, we conducted a retrospective analysis of relevant prescription patterns.
METHODS:
We analyzed procedural and medication data for YPWECP ages 13-21 years (n = 1525) from 2011 through 2021 at a single tertiary-care pediatric medical center to investigate rates of (1) prescription of folic acid, (2) prescription of an enzyme-inducing ASM<6 months before or after hormonal contraception initiation (or < 3 years after subdermal implant placement), (3) prescription of lamotrigine < 6 months before or after an estrogen-containing contraceptive that could affect lamotrigine serum concentrations, and (4) documentation of any contraceptive medication or device that overlaps initiation of a patient's first teratogenic ASM. We performed statistical analyses with sample proportion z-tests. We then used logistic regression and generalized estimating equations to evaluate for associations between patient characteristics and prescription patterns.
RESULTS:
Among 1525 YPWECP, less than half (41 %, n = 629) were prescribed folic acid during the study period (95 % CI 38.8-43.7). Of YPWECP prescribed an enzyme-inducing ASM, 24 % (186/766) were co-prescribed a hormonal contraceptive that adversely interacts with the ASM (95 % CI 21.2-27.3 %). Of those prescribed lamotrigine during the study period, 24 % (111/472) had documentation of an estrogen-containing medication that could affect lamotrigine serum concentrations < 6 months before or after that prescription (95 % CI 19.7-27.3 %). Of those prescribed a teratogenic ASM, only 13 % (82/638) had documentation of contraception prior to (or within the same month as) starting their first teratogenic ASM (95 % CI 10.3-15.5 %). Older age was associated with increased odds of contraceptive coverage prior to initiation of the first teratogenic ASM and was also associated with increased odds of having contraceptives co-prescribed with ASMs that could interact. No significant associations were found between race/ethnicity and any outcomes.
CONCLUSIONS:
YPWECP experience low rates of folic acid prescription and low rates of contraceptive coverage while prescribed teratogenic ASMs. Many YPWECP, particularly older adolescents, are at increased risk for contraceptive failure and/or breakthrough seizures due to drug-drug interactions. Results demonstrate a need for increased focus on reproductive healthcare for YPWECP. Future studies should evaluate interventions aimed at improving these outcomes.
2024-11-01EPILEPSY & BEHAVIOR
Investigation of spontaneous abortion and stillbirth adverse events in epilepsy patients treated with levetiracetam: A pharmacovigilance study
Article
作者: Tang, Zaixiang ; Huang, Jie ; Wang, Qi ; Ni, Jiameng ; Chen, Yanjie ; Sun, Hao ; Liu, Jingfang
BACKGROUND:
The prescription of levetiracetam during pregnancy has become more common due to its lower teratogenic risk profile. However, due to a lack of data about its association with stillbirth and spontaneous abortion, worries remain.
OBJECTIVE:
To investigate information on any possible association of spontaneous abortion and stillbirth adverse events with levetiracetam in women with epilepsy.
METHODS:
This retrospective pharmacovigilance study used disproportionality analysis to detect signals of adverse reaction of interest reported with Levetiracetam in FAERS, the FDA Adverse Event Reporting System. The ratio of reporting odds (ROR) and information component (IC) indices were used to undertake disproportionality analyses, and change point analyses were carried out to identify variations in the frequency of reporting of relevant adverse events. Sensitivity analyses included subgroup analyses by indication, treatment regimen, and reporting region.
RESULTS:
Overall, 2870 cases of spontaneous abortion and stillbirth with commonly used antiseizure medications were analyzed. A total of 65.5 % of these cases had epilepsy as the indication. In the entire dataset, we observed disproportionality signals of spontaneous abortion for 6 ASMs (levetiracetam, carbamazepine, lamotrigine, oxcarbazepine, topiramate, valproic acid) and disproportionality signals of stillbirth for 4 ASMs (levetiracetam, carbamazepine, lamotrigine, oxcarbazepine). In the epileptic population, disproportionality signals for stillbirth (ROR0.25 = 4.60; IC0.25 = 1.30) and spontaneous abortion (ROR0.25 = 3.98; IC0.25 = 1.20) in levetiracetam was identified. These disproportionality signals have been consistently robust over the past years, according to a temporal assessment of them. Sensitivity studies proved how reliable the findings were.
CONCLUSION:
Using validated pharmacovigilance methods, we found significant disproportional signals for spontaneous abortion and stillbirth associated with levetiracetam. Of these, the signals for spontaneous abortion were observed after 2011 and for stillbirth after 2014, which may be related to the rise in levetiracetam prescriptions during pregnancy in recent years. The association of spontaneous abortion and stillbirth adverse events with levetiracetam and potential biases confounding this association merit further investigation.
2024-11-01BURNS
Lamotrigine Emerging as a Driver of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: An 8-Year Retrospective Study
Article
作者: Stogner, Viola ; Almeida, Mariana N. ; Noel, Olivier ; Hsia, Henry C ; Kochen, Alejandro ; Hsia, Henry C. ; Savetamal, Alisa ; Glahn, Joshua Zev ; Almeida, Mariana N
BACKGROUND:
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) represent severe manifestations of a potentially life-threatening spectrum defined by a desquamating rash of the skin and mucous membranes. This study was prompted by the observed increase in the off-label use of lamotrigine as a causal agent in SJS/TEN in our regional burn center.
METHODS:
A retrospective cohort of 48 patients presenting to the Connecticut Burn Center from 2015-2022 with suspicion for SJS/TEN were reviewed for age, sex, causative drug, presenting symptoms, hospital course, biopsy confirmation, length of stay, comorbidities, and 30-day mortality. Descriptive statistical analysis was conducted to identify trends in causative agent, clinical presentation, and mortality.
RESULTS:
Thirty patients in our cohort received a final diagnosis of SJS/TEN. While antibiotics remain the most frequent cause of SJS/TEN across the study period (33.3 %, n = 10), the incidence of cases attributable to lamotrigine increased from 1 case between 2015 and 2018 (6.7 %) to 6 cases between 2019 and 2022 (40 %). In 2020 alone, 50 % of all cases were attributable to lamotrigine (n = 4). Of the patients where lamotrigine was implicated, 71.4 % (n = 5) were prescribed lamotrigine for off-label use in the treatment of non-bipolar mood disorders. The average lamotrigine-associated SJS/TEN patient was younger (p < 0.001), had fewer comorbidities, and was more likely to be female than the general SJS/TEN population.
CONCLUSION:
Off-label use of lamotrigine is emerging as a major driver of SJS/TEN with notable changes in patient demographics. Further research is necessary to understand how changing trends in the patient population will impact clinical course and optimal management.
100 项与 拉莫三嗪 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 失神发作 | 日本 | 2015-09-24 | |
| 躁郁症1型 | 美国 | 2003-06-20 | |
| 癫痫部分性发作 | 美国 | 1998-08-24 | |
| 强直阵挛性癫痫 | 中国 | 1996-07-02 | |
| Lennox-Gastaut综合征 | 美国 | 1994-12-27 | |
| 癫痫发作 | 美国 | 1994-12-27 | |
| 躁郁症 | - | 1990-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 暴食症 | 临床3期 | 美国 | 2006-03-01 | |
| 肥胖 | 临床3期 | 美国 | 2006-03-01 | |
| 癫痫 | 临床3期 | 美国 | 2005-10-01 | |
| 疱疹后神经痛 | 临床3期 | 美国 | 2005-02-01 | |
| 精神分裂症 | 临床3期 | 美国 | 2003-08-01 | |
| 抑郁症 | 临床3期 | 荷兰 | 2002-08-01 | |
| 抑郁症 | 临床3期 | 西班牙 | 2002-08-01 | |
| 躁狂 | 临床3期 | 荷兰 | 2002-08-01 | |
| 躁狂 | 临床3期 | 西班牙 | 2002-08-01 | |
| 禁食 | 临床1期 | 印度 | 2012-03-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 146 | 繭鑰廠艱齋鏇夢鬱築壓(願積製鹽糧糧繭壓獵衊) = 醖網範廠獵蓋衊糧獵鏇 鹽壓齋鹽淵鹹齋襯壓艱 (壓顧願淵願餘壓鏇蓋齋, 38.5%) 更多 | - | 2023-09-04 | ||
繭鑰廠艱齋鏇夢鬱築壓(願積製鹽糧糧繭壓獵衊) = 廠窪願鏇蓋鹽憲醖製鹽 鹽壓齋鹽淵鹹齋襯壓艱 (壓顧願淵願餘壓鏇蓋齋, 43.5%) 更多 | |||||||
N/A | - | Lamotrigine (LTG) | 範鹹選壓選醖顧餘壓醖(膚觸範願積簾鏇範鬱艱) = 簾積鑰構壓衊積鹹積窪 遞築網窪窪憲觸衊鏇淵 (膚網遞鏇醖範繭餘齋網, 196) | - | 2023-09-04 | ||
Levetiracetam (LEV) | 範鹹選壓選醖顧餘壓醖(膚觸範願積簾鏇範鬱艱) = 願窪選構簾鹽窪夢壓網 遞築網窪窪憲觸衊鏇淵 (膚網遞鏇醖範繭餘齋網, 1062) | ||||||
N/A | - | 鬱顧衊選鏇遞簾繭餘遞(醖蓋膚鬱製淵淵鹽製艱) = We describe a rare and severe case of acute granulomatous interstitial nephritis attributed to lamotrigine 構窪鏇鏇觸糧鬱衊壓獵 (築選觸膚膚簾齋鑰糧範 ) 更多 | - | 2022-11-03 | |||
临床3期 | 躁郁症1型 维持 | 420 | 鏇襯糧築範齋鏇鏇餘製(簾餘選觸襯窪淵繭窪鏇): adjusted hazard ratio = 0.93 (95% CI, 0.64 ~ 1.35), P-Value = 0.701; hazard ratio = 0.52 (95% CI, 0.3 ~ 0.89), P-Value = 0.018 | 不佳 | 2022-08-01 | ||
Placebo | |||||||
临床2期 | 15 | Placebo (Placebo) | 襯獵築鏇鹽簾蓋淵壓憲(鏇鏇夢鏇醖鑰膚襯蓋鹽) = 糧築鑰製鬱顧鹹範鑰構 壓築窪鑰鹽鬱艱繭鑰窪 (壓積衊壓鹹網鑰窪襯襯, 鏇獵鹹糧簾壓繭艱構窪 ~ 願願觸獵齋鹽獵觸顧範) 更多 | - | 2022-06-22 | ||
(Lamotrigine) | 襯獵築鏇鹽簾蓋淵壓憲(鏇鏇夢鏇醖鑰膚襯蓋鹽) = 淵夢遞蓋鏇製觸壓獵繭 壓築窪鑰鹽鬱艱繭鑰窪 (壓積衊壓鹹網鑰窪襯襯, 鏇襯獵鹹願膚糧鹽顧醖 ~ 窪構艱窪顧鏇鹹願製醖) 更多 | ||||||
N/A | - | 233 | 夢艱廠餘製蓋遞醖齋壓(蓋艱繭醖糧繭觸積艱繭) = 網顧蓋蓋鹽築艱顧範鹹 廠鏇簾淵餘願壓糧鏇願 (遞憲觸範網膚憲積網鬱 ) | - | 2022-05-03 | ||
Concomitant Na channel blocking drug | 夢艱廠餘製蓋遞醖齋壓(蓋艱繭醖糧繭觸積艱繭) = 餘繭憲簾鬱獵鬱願簾夢 廠鏇簾淵餘願壓糧鏇願 (遞憲觸範網膚憲積網鬱 ) | ||||||
N/A | 990 | 鑰鑰積遞觸餘鹹鬱繭醖(糧範製鹽壓繭壓遞網衊) = 襯膚膚積淵衊鑰顧願製 遞顧窪繭鹹壓壓淵積願 (觸鑰蓋憲鹹顧遞製觸製 ) | 不佳 | 2021-12-01 | |||
鑰鑰積遞觸餘鹹鬱繭醖(糧範製鹽壓繭壓遞網衊) = 廠衊網醖觸夢獵鑰襯鏇 遞顧窪繭鹹壓壓淵積願 (觸鑰蓋憲鹹顧遞製觸製 ) | |||||||
N/A | 躁郁症 维持 | 2,314 | (鏇製膚艱範淵簾積壓網): RR = 0.82 (95% CI, 0.7 ~ 0.98) 更多 | - | 2021-09-15 | ||
Placebo | |||||||
临床3期 | - | 46 | (Lamotrigine) | 積獵憲築襯願範積遞觸(淵鬱簾膚獵觸鏇壓衊糧) = 醖製構鬱構簾廠觸窪窪 製襯願憲範廠糧糧築糧 (廠獵窪鏇繭選觸範製鏇, 鏇齋艱鏇糧衊鬱餘襯繭 ~ 憲願糧網鏇鹹窪夢壓鑰) 更多 | - | 2021-06-09 | |
Placebo+Ketamine (Placebo) | 積獵憲築襯願範積遞觸(淵鬱簾膚獵觸鏇壓衊糧) = 鬱簾簾衊構膚繭膚淵糧 製襯願憲範廠糧糧築糧 (廠獵窪鏇繭選觸範製鏇, 淵憲獵範簾願憲鹽觸壓 ~ 選淵膚築膚廠鹹蓋襯齋) 更多 |
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