RESUMEN
There is currently no efficacious intervention for preventing post-traumatic epilepsy (PTE). Preclinical studies support the potential use of anticholinergics for this condition. The purpose of this study was to evaluate the effects of biperiden as an intervention for preventing PTE. A randomized, double-blinded clinical trial was conducted at HC/FMUSP between 2018-2022. Adults with acute traumatic brain injury (TBI) were randomly assigned to receive biperiden or placebo, for 10 days. The primary outcome was the incidence of PTE while the secondary outcomes included the frequency of seizures, the frequency of any adverse events and mortality after 24 months. The study was powered at a planned enrolment of 132 patients. The trial began in January 2018 and was halted by researchers on March 2020 (and terminated in December 2022) in the face of the global COVID-19 pandemic. Overall, 123 participants were randomized and 112 contributed with data for modified mITT analysis, being that 61 (49.5%) participants completed the 24-month follow-up consult. Data analysis indicated lack of evidence of biperiden for either, the incidence of post-traumatic epilepsy (2.6, 95%CI, 0.65-10.57; p = 0.170) or the mortality rate (1.57, 95%CI, 0.73-3.38; p = 0.248). The frequency of late post-traumatic seizures was higher for biperiden group (2.03, 95%CI = 0.912-3.1597; p <0.001). The present study suggests that there was insufficient evidence regarding the effect of biperiden in preventing PTE after TBI, which underpins the need for larger studies. Clinical trial registration: ClinicalTrials.gov, identifier: NCT01048138.
RESUMEN
OBJECTIVE: To evaluate the frequency of metabolic syndrome in dermatomyositis (DM) patients and to analyze the possible association of metabolic syndrome with traditional cardiovascular disease (CVD) risk factors and DM-related clinical and laboratory features. METHODS: The present cross-sectional single-center study included 84 DM patients and 105 healthy controls. Metabolic syndrome was diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III. RESULTS: The median age was similar in both the DM and control groups (41.5 and 42.0 years, respectively; P = 0.378), with a comparable predominance of women (P = 0.904) and white race (P = 0.623). The DM patients had a higher prevalence of metabolic syndrome (41.7% versus 7.0%; P < 0.001), diabetes mellitus (17.9% versus 1.0%; P < 0.001), stroke (4.8% versus 0%; P = 0.024), and family history of CVD (23.8% versus 8.6%; P = 0.004). However, the frequency of sedentarism, hypothyroidism, smoking, and alcohol intake was similar in both groups (P > 0.05). Further analysis of the DM patients with (n = 35) and without (n = 49) metabolic syndrome revealed that the patients with this complication were older (mean ± SD age 50.0 ± 14.5 years versus 40.9 ± 14.6 years; P = 0.006) and had a similar disease duration (P = 0.925) and higher prevalence of systemic arterial hypertension prior to the onset of disease symptoms (54.3% versus 10.2%; P < 0.001). In a multivariate analysis, only hypertension diagnosed prior to the disease was associated with metabolic syndrome (odds ratio 10.47 [95% confidence interval 2.62-44.81]). CONCLUSION: Metabolic syndrome is highly prevalent in DM, and prior hypertension seems to be a major determinant of its development, while disease- and therapy-related factors do not appear to play a relevant role.