Background and Objectives A recent Food and Drug Administration warning concerning an arrhythmogenic potential of lamotrigine created concern in the neurologic community. This warning was based on... Show moreBackground and Objectives A recent Food and Drug Administration warning concerning an arrhythmogenic potential of lamotrigine created concern in the neurologic community. This warning was based on in vitro studies, but no clinically relevant risk was considered. This rapid systematic review aims to elucidate the risk of lamotrigine on sudden death or ECG abnormalities. Methods We conducted a systematic search of Ovid Medline and Ovid Embase, including randomized controlled trials and observational studies and studies of people with or without epilepsy, with the outcome measures sudden unexpected death in epilepsy (SUDEP) or sudden cardiac death as well as the development or worsening of ECG abnormalities. We evaluated the sudden death definitions used in all included studies, as some could have used unclear or overlapping definitions. We used the American Academy of Neurology risk of bias tool to evaluate the class of evidence and the GRADE approach to evaluate our confidence in the evidence. Results We included 26 studies with 24,962 participants, of whom 2,326 used lamotrigine. Twelve studies showed no significant risk of SUDEP for lamotrigine users. One study reporting on sudden cardiac death and 3 studies with unclear sudden death definitions did not report an elevated risk of death in lamotrigine users compared to controls. In 10 studies reporting on ECG measures, there was no statistically significant increased risk among lamotrigine users except in 2 studies. These 2 studies reported either "slight increases" in PR interval or an increased PQ interval that the primary study authors believed to be related to structural cardiac differences rather than an effect of lamotrigine. One study was rated Class II; all others were Class III or IV. We had very low confidence in the evidence following the GRADE assessment. None of the studies examined the risk of lamotrigine in people with preexisting cardiac conditions. Discussion There is insufficient evidence to support or refute that lamotrigine is associated with sudden death or ECG changes in people with or without epilepsy as compared to antiseizure medication or placebo, due to the high risk of bias in most studies and low precision and inconsistency in the reported results. Show less
Objective: To determine the outcome of patients with psychogenic pseudosyncope (PPS) aftercommunication of the diagnosis.Methods: This was a retrospective cohort study of patients with PPS referred... Show moreObjective: To determine the outcome of patients with psychogenic pseudosyncope (PPS) aftercommunication of the diagnosis.Methods: This was a retrospective cohort study of patients with PPS referred in 2007 to 2015 toa tertiary referral center for syncope. We reviewed patient records and studied attack frequency,factors affecting attack frequency, health care use, and quality of life using a questionnaire. Weexplored influences on attack freedom and attack frequency in the 6 months before follow-up forage, sex, education level, duration until diagnosis, probability of diagnosis, additional syncope,and acceptance of diagnosis.Results: Forty-seven of 57 patients with PPS could be traced, of whom 35 (74%) participated.Twelve (34%) were attack-free for at least 6 months. The median time from diagnosis tofollow-up was 50 months (range 6–103 months). Communicating and explaining the diagnosisresulted in immediate reduction of attack frequency (p 5 0.007) from the month before diagnosis(median one attack, range 0–156) to the month after (median one attack, range 0–16). In the6 months before follow-up, the number of admissions decreased from 19 of 35 to 0 of 35 (p 50.002). The use of somatic and mental health care shifted toward the latter (p , 0.0001). Qualityof life at follow-up (Short Form Health Survey 36) showed lower scores for 7 of 8 domainscompared to matched Dutch control values; quality of life was not influenced by attack freedom.Conclusions: After communication of the diagnosis in PPS, attack frequency decreased andhealth care use shifted toward mental care. Low quality of life underlines that PPS is a serious condition. Show less
