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1.
J Hypertens ; 2024 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-38690936

RESUMO

BACKGROUND: Although the clinical importance of preeclampsia is widely recognized, few treatment options are available for prevention. TNF-α inhibitors have been hypothesized to potentially prevent the disease. We aimed to examine whether exposure to TNF-α inhibitors during pregnancy reduces the risk of preeclampsia. METHODS: We conducted a population-based pregnancy cohort study using nationwide samples of publicly (Medicaid data, 2000-2018) and commercially (MarketScan Research Database, 2003-2020) insured pregnant women linked to their liveborn infants. Exposure was ascertained based on a filled prescription or administration code for TNF-α inhibitors during the first and second trimester of pregnancy. The outcomes included early-onset preeclampsia, late-onset preeclampsia, and small-for-gestational age. For baseline confounding adjustment, we leveraged propensity score overlap weights to estimate risk ratios (RR). RESULTS: Among 4 315 658 pregnancies in the Medicaid and the MarketScan cohort, 2736 (0.063%) were exposed to TNF-α inhibitors during the first trimester and 1712 (0.040%) during the second trimester. After adjustment, the risk of early-onset preeclampsia was not decreased among mothers exposed during the first trimester compared with unexposed women with treatment indications [RRpooled: 1.25, 95% confidence interval (CI) 0.93-1.67]. Similarly, the risk of late-onset preeclampsia was not decreased among mothers exposed during the second trimester compared with unexposed women (RRpooled: 0.99, 95% CI 0.81-1.22). CONCLUSION: Contrary to the hypothesis, exposure to TNF-α inhibitors during pregnancy did not appear to be associated with a reduced risk of early-onset or late-onset preeclampsia. These findings do not support consideration of the use of TNF-α inhibitors for the prevention of preeclampsia.

3.
Int J Dermatol ; 2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38563446

RESUMO

Sentinel lymph node biopsy is the most powerful prognostic indicator to date for cutaneous melanoma. Even though elderly patients have a lower incidence of sentinel node involvement, its results are still necessary for access to adjuvant therapies. This is highly relevant considering that the Western population shows an aging trend, and the incidence of melanoma has grown exponentially over the years, making elderly patients more likely to die from melanoma than younger ones. We performed a systematic review to investigate the prognostic significance of sentinel lymph node biopsy in elderly patients with melanoma. The systematic review was conducted following the PRISMA guidelines and registered in PROSPERO. The authors searched the Cochrane Database, EMBASE, PubMed, and WOS. Eligible studies for the systematic review were clinical trials, observational population studies, clinical or hospital-based cohort studies, and case-control studies. The meta-analysis was conducted using the R software program applying the meta package. Six reports were identified to meet the inclusion criteria. All studies were retrospective, non-randomized cohorts. The results obtained in this systematic review show a statistically significant influence of sentinel lymph node biopsy on disease-specific survival (HR = 2.87; 95% CI: 1.73-4.74) but also suggest that a positive result negatively impacts disease-free survival (HR = 3.41; 95% CI: 0.96-12.11). This meta-analysis shows that a positive sentinel lymph node biopsy does not imply differences in overall survival but significantly influences disease-specific survival and suggests an unfavorable impact on disease-free survival.

4.
Am J Epidemiol ; 2024 Apr 06.
Artigo em Inglês | MEDLINE | ID: mdl-38583933

RESUMO

Fertility procedures recorded in healthcare databases can be used to estimate the start of pregnancy, which can serve as a reference standard to validate gestational age estimates based on International Classification of Diseases (ICD) codes. In a cohort of 17,398 pregnancies conceived by fertility procedures in MarketScan (2011-2020), we estimated gestational age at the end of pregnancy using algorithms based on (1) days since fertility procedure (the reference); (2) ICD-9/ICD-10 (before/after October 2015) codes indicating gestational length recorded at the end of pregnancy (method A); and (3) ICD-10 enhanced with Z3A codes denoting specific gestation weeks recorded at prenatal visits (method B). We calculated the proportion of pregnancies with an estimated gestational age within 14 days of the reference. Method A accuracy was similar for ICD-9 and ICD-10 codes. After 2015, method B was more accurate than method A: For term births, within-14-day-agreements were 90.8% for method A and 98.7% for method B. Corresponding estimates were 70.1% and 95.6% for preterm births; 35.3% and 92.6% for stillbirths; 54.3% and 64.2% for spontaneous abortions; and 16.7% and 84.6% for elective terminations. ICD-10-based algorithms that incorporate Z3A codes improve the accuracy of gestational age estimation in healthcare databases, especially for preterm and non-live births.

5.
N Engl J Med ; 390(12): 1069-1079, 2024 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-38507750

RESUMO

BACKGROUND: Maternal use of valproate during pregnancy has been associated with an increased risk of neurodevelopmental disorders in children. Although most studies of other antiseizure medications have not shown increased risks of these disorders, there are limited and conflicting data regarding the risk of autism spectrum disorder associated with maternal topiramate use. METHODS: We identified a population-based cohort of pregnant women and their children within two health care utilization databases in the United States, with data from 2000 through 2020. Exposure to specific antiseizure medications was defined on the basis of prescription fills from gestational week 19 until delivery. Children who had been exposed to topiramate during the second half of pregnancy were compared with those unexposed to any antiseizure medication during pregnancy with respect to the risk of autism spectrum disorder. Valproate was used as a positive control, and lamotrigine was used as a negative control. RESULTS: The estimated cumulative incidence of autism spectrum disorder at 8 years of age was 1.9% for the full population of children who had not been exposed to antiseizure medication (4,199,796 children). With restriction to children born to mothers with epilepsy, the incidence was 4.2% with no exposure to antiseizure medication (8815 children), 6.2% with exposure to topiramate (1030 children), 10.5% with exposure to valproate (800 children), and 4.1% with exposure to lamotrigine (4205 children). Propensity score-adjusted hazard ratios in a comparison with no exposure to antiseizure medication were 0.96 (95% confidence interval [CI], 0.56 to 1.65) for exposure to topiramate, 2.67 (95% CI, 1.69 to 4.20) for exposure to valproate, and 1.00 (95% CI, 0.69 to 1.46) for exposure to lamotrigine. CONCLUSIONS: The incidence of autism spectrum disorder was higher among children prenatally exposed to the studied antiseizure medications than in the general population. However, after adjustment for indication and other confounders, the association was substantially attenuated for topiramate and lamotrigine, whereas an increased risk remained for valproate. (Funded by the National Institute of Mental Health.).


Assuntos
Anticonvulsivantes , Transtorno do Espectro Autista , Lamotrigina , Efeitos Tardios da Exposição Pré-Natal , Topiramato , Ácido Valproico , Criança , Feminino , Humanos , Gravidez , Anticonvulsivantes/efeitos adversos , Anticonvulsivantes/uso terapêutico , Transtorno do Espectro Autista/induzido quimicamente , Transtorno do Espectro Autista/epidemiologia , Transtorno do Espectro Autista/etiologia , Transtorno Autístico/induzido quimicamente , Transtorno Autístico/epidemiologia , Transtorno Autístico/etiologia , Lamotrigina/efeitos adversos , Lamotrigina/uso terapêutico , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Efeitos Tardios da Exposição Pré-Natal/tratamento farmacológico , Topiramato/efeitos adversos , Topiramato/uso terapêutico , Ácido Valproico/efeitos adversos , Ácido Valproico/uso terapêutico , Epilepsia/tratamento farmacológico
6.
Front Pediatr ; 12: 1335891, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38445078

RESUMO

Objective: To develop predictive clinical models of bronchopulmonary dysplasia (BPD) through competing risk analysis. Methods: Retrospective observational cohort study, including preterm newborns ≤32 weeks gestational age, conducted between January 1, 2013 and September 30, 2022 in a third-level Neonatal Intensive Care Unit in Spain. A prediction study was carried out using competing risk models, where the event of interest was BPD and the competing event was death. A multivariate competing risk model was developed separately for each postnatal day (days 1, 3, 7 and 14). Nomograms to predict BPD risk were developed from the coefficients of the final models and internally validated. Results: A total of 306 patients were included in the study, of which 73 (23.9%) developed BPD and 29 (9.5%) died. On day 1, the model with the greatest predictive capacity was that including birth weight, days since rupture of membranes, and surfactant requirement (area under the receiver operating characteristic (ROC) curve (AUC), 0.896; 95% CI, 0.792-0.999). On day 3, the final predictive model was based on the variables birth weight, surfactant requirement, and Fraction of Inspired Oxygen (FiO2) (AUC, 0.891; 95% CI, 0.792-0.989). Conclusions: Competing risk analysis allowed accurate prediction of BPD, avoiding the potential bias resulting from the exclusion of deceased newborns or the use of combined outcomes. The resulting models are based on clinical variables measured at bedside during the first 3 days of life, can be easily implemented in clinical practice, and can enable earlier identification of patients at high risk of BPD.

7.
Sci Rep ; 14(1): 5968, 2024 03 12.
Artigo em Inglês | MEDLINE | ID: mdl-38472231

RESUMO

To delineate the phenotype of erosive hand osteoarthritis (EHOA) in a Spanish population and assess its correlation with metabolic syndrome. We conducted a cross-sectional study using baseline data from the Prospective Cohort of Osteoarthritis from A Coruña (PROCOAC). Demographic and clinical variables, obtained through questionnaires, clinical examinations, and patient analytics, were compared among individuals with hand OA, with and without EHOA. We performed appropriate univariate and multivariate stepwise regression analyses using SPSS v28. Among 1039 subjects diagnosed with hand OA, 303 exhibited EHOA. Multivariate logistic regression analysis revealed associations with inflamed joints, nodular hand OA, and total AUSCAN. Furthermore, the association with a lower prevalence of knee OA remained significant. The influence of metabolic syndrome (MetS) on EHOA patients was analyzed by including MetS as a covariate in the model. It was observed that MetS does not significantly impact the presence of EHOA, maintaining the effect size of other factors. In conclusion, in the PROCOAC cohort, EHOA is associated with nodular hand OA, inflammatory hand OA, and a higher total AUSCAN. However, EHOA is linked to a lower prevalence of knee OA. Importantly, in our cohort, no relationship was found between EHOA and MetS.


Assuntos
Síndrome Metabólica , Osteoartrite , Humanos , Estudos Transversais , Síndrome Metabólica/complicações , Estudos Prospectivos , Osteoartrite/complicações , Mãos
8.
Fertil Steril ; 2024 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-38373676

RESUMO

OBJECTIVE: To use machine learning methods to develop prediction models of pregnancy complications in women who conceived with assisted reproductive techniques (ART). DESIGN: A nation-wide register-based cohort study with prospectively collected data. SETTING: Swedish national registers and nationwide quality IVF register. PATIENT(S): all nulliparous women who achieved birth within the first 3 ART treatment cycles between 2008 and 2016 in Sweden. INTERVENTION(S): Characteristics before the use of ART, such as demographics and medical history, were considered potential predictors in the development of before treatment prediction models. ART treatment details were further included in after treatment prediction models. MAIN OUTCOME MEASURE(S): Potential diagnoses of preeclampsia, placental complications (previa, accreta, and abruption), and postpartum hemorrhage were identified using the International Classification of Diseases recorded in the Swedish Medical Birth and Patient registers, respectively. Multiple prediction model algorithms were performed and compared for each outcome and treatment cycle, including logistic regression, decision tree model, naïve Bayes classification, support vector machine, random forest, and gradient boosting. The performance of each model was assessed with C statistic, and nested cross-validation was used to aid model selection and hyperparameter tuning. RESULT(S): A total of 14,732 women gave birth after the first (N = 7,302), second (N = 4,688), or third (N = 2,742) ART cycle, representing birth rates of 24.1%, 23.8%, and 22.0%. Overall prediction performance did not vary much across the different methods used. In the first cycle, the before treatment prediction performance was at best 66%, 66%, and 60% for preeclampsia, placental complications, and postpartum hemorrhage, respectively. Inclusion of after treatment characteristics conferred slight improvement (approximately 1%-5%), as did prediction in later cycles (approximately 1%-5%). The top influential and consistent predictors included age, region of residence, infertility diagnosis, and type of embryo transfer (fresh or frozen) in the later (2nd and 3rd) cycles. Body mass index was a top predictor of preeclampsia and was also influential for placental complications but not for postpartum hemorrhage. CONCLUSION(S): The combined use of demographics, medical history, and ART treatment information was not enough to confidently predict serious pregnancy complications in women who conceived with ART. Future studies are needed to assess if additional longitudinal follow-up during pregnancy can improve the prediction to allow clinical protocol development.

9.
medRxiv ; 2024 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-38343813

RESUMO

The analysis of perinatal studies is complicated by twins and other multiple births even when they are not the exposure, outcome, or a confounder of interest. Common approaches to handling multiples in studies of infant outcomes include restriction to singletons, counting outcomes at the pregnancy-level (i.e., by counting if at least one twin experienced a binary outcome), or infant-level analysis including all infants and, typically, accounting for clustering of outcomes by using generalised estimating equations or mixed effects models. Several healthcare administration databases only support restriction to singletons or pregnancy-level approaches. For example, in MarketScan insurance claims data, diagnoses in twins are often assigned to a single infant identifier, thereby preventing ascertainment of infant-level outcomes among multiples. Different approaches correspond to different causal questions, produce different estimands, and often rely on different assumptions. We demonstrate the differences that can arise from these different approaches using Monte Carlo simulations, algebraic formulas, and an applied example. Furthermore, we provide guidance on the handling of multiples in perinatal studies when using healthcare administration data.

10.
JAMA Intern Med ; 184(3): 242-251, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38252426

RESUMO

Importance: Use of buprenorphine or methadone to treat opioid use disorder is recommended in pregnancy; however, their teratogenic potential is largely unknown. Objective: To compare the risk of congenital malformations following in utero exposure to buprenorphine vs methadone. Design, Setting, and Participants: This population-based cohort study used health care utilization data from publicly insured Medicaid beneficiaries in the US from 2000 to 2018. A total of 13 360 pregnancies with enrollment from 90 days prior to pregnancy start through 1 month after delivery and first trimester use of buprenorphine or methadone were included and linked to infants. Data were analyzed from July to December 2022. Exposure: A pharmacy dispensing of buprenorphine or a code for administration of methadone in the first trimester. Main Outcomes and Measures: Primary outcomes included major malformations overall and malformations previously associated with opioids (any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, clubfoot, and oral clefts). Secondary outcomes included other organ system-specific malformations. Risk differences and risk ratios (RRs) were estimated comparing buprenorphine with methadone, adjusting for confounders with propensity score overlap weights. Results: The cohort included 9514 pregnancies with first-trimester buprenorphine exposure (mean [SD] maternal age, 28.4 [4.6] years) and 3846 with methadone exposure (mean [SD] maternal age, 28.8 [4.7] years). The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone. After confounding adjustment, buprenorphine was associated with a lower risk of malformations compared with methadone (RR, 0.82; 95% CI, 0.69-0.97). Risk was lower with buprenorphine for cardiac malformations (RR, 0.63; 95% CI, 0.47-0.85), including both ventricular septal defect (RR, 0.62; 95% CI, 0.39-0.98) and secundum atrial septal defect/nonprematurity-related patent foramen ovale (RR, 0.54; 95% CI, 0.30-0.97), oral clefts (RR, 0.65; 95% CI, 0.35-1.19), and clubfoot (RR, 0.55; 95% CI, 0.32-0.94). Results for neural tube defects were uncertain given low event counts. In secondary analyses, buprenorphine was associated with a decreased risk of central nervous system, urinary, and limb malformations but a greater risk of gastrointestinal malformations compared with methadone. These findings were consistent in sensitivity and bias analyses. Conclusions and Relevance: In this cohort study, the risk of most malformations previously associated with opioid exposure was lower in buprenorphine-exposed infants compared with methadone-exposed infants, independent of measured confounders. Malformation risk is one factor that informs the individualized patient decision regarding medications for opioid use disorder in pregnancy.


Assuntos
Buprenorfina , Pé Torto Equinovaro , Forame Oval Patente , Cardiopatias Congênitas , Comunicação Interventricular , Defeitos do Tubo Neural , Transtornos Relacionados ao Uso de Opioides , Complicações na Gravidez , Gravidez , Lactente , Feminino , Humanos , Adulto , Metadona/efeitos adversos , Buprenorfina/efeitos adversos , Primeiro Trimestre da Gravidez , Estudos de Coortes , Pé Torto Equinovaro/complicações , Pé Torto Equinovaro/tratamento farmacológico , Forame Oval Patente/complicações , Forame Oval Patente/tratamento farmacológico , Complicações na Gravidez/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Analgésicos Opioides/efeitos adversos , Cardiopatias Congênitas/induzido quimicamente , Cardiopatias Congênitas/epidemiologia , Cardiopatias Congênitas/complicações , Defeitos do Tubo Neural/complicações , Defeitos do Tubo Neural/tratamento farmacológico , Comunicação Interventricular/complicações , Comunicação Interventricular/tratamento farmacológico
11.
JAMA Psychiatry ; 81(5): 477-488, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38265792

RESUMO

Importance: Use of medications for attention-deficit/hyperactivity disorder (ADHD) during pregnancy is increasing in the US. Whether exposure to these medications in utero impacts the risk of neurodevelopmental disorders in children is uncertain. Objective: To evaluate the association of childhood neurodevelopmental disorders with in utero exposure to stimulant medications for ADHD. Design, Setting, and Participants: This cohort study included health care utilization data from publicly insured (Medicaid data from 2000 to 2018) and commercially insured (MarketScan Commercial Claims Database data from 2003 to 2020) pregnant individuals aged 12 to 55 years in the US with enrollment from 3 months prior to pregnancy through 1 month after delivery, linked to children. Children were monitored from birth until outcome diagnosis, disenrollment, death, or end of the study (December 2018 for Medicaid and December 2020 for MarketScan). Exposures: Dispensing of amphetamine/dextroamphetamine or methylphenidate in the second half of pregnancy. Main Outcomes and Measures: Autism spectrum disorder, ADHD, and a composite of any neurodevelopmental disorder were defined using validated algorithms. Hazard ratios were estimated comparing amphetamine/dextroamphetamine and methylphenidate to no exposure. Results: The publicly insured cohort included 2 496 771 stimulant-unexposed, 4693 amphetamine/dextroamphetamine-exposed, and 786 methylphenidate-exposed pregnancies with a mean (SD) age of 25.2 (6.0) years. The commercially insured cohort included 1 773 501 stimulant-unexposed, 2372 amphetamine/dextroamphetamine-exposed, and 337 methylphenidate-exposed pregnancies with a mean (SD) age of 31.6 (4.6) years. In unadjusted analyses, amphetamine/dextroamphetamine and methylphenidate exposure were associated with a 2- to 3-fold increased risk of the neurodevelopmental outcomes considered. After adjustment for measured confounders, amphetamine/dextroamphetamine exposure was not associated with any outcome (autism spectrum disorder: hazard ratio [HR], 0.80; 95% CI, 0.56-1.14]; ADHD: HR, 1.07; 95% CI, 0.89-1.28; any neurodevelopmental disorder: HR, 0.91; 95% CI, 0.81-1.28). Methylphenidate exposure was associated with an increased risk of ADHD (HR, 1.43; 95% CI, 1.12-1.82]) but not other outcomes after adjustment (autism spectrum disorder: HR, 1.06; 95% CI, 0.62-1.81; any neurodevelopmental disorder: HR, 1.15; 95% CI, 0.97-1.36). The association between methylphenidate and ADHD did not persist in sensitivity analyses with stricter control for confounding by maternal ADHD. Conclusions and Relevance: The findings in this study suggest that amphetamine/dextroamphetamine and methylphenidate exposure in utero are not likely to meaningfully increase the risk of childhood neurodevelopmental disorders.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Transtorno do Espectro Autista , Estimulantes do Sistema Nervoso Central , Metilfenidato , Transtornos do Neurodesenvolvimento , Efeitos Tardios da Exposição Pré-Natal , Humanos , Feminino , Gravidez , Estimulantes do Sistema Nervoso Central/efeitos adversos , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Criança , Transtorno do Deficit de Atenção com Hiperatividade/epidemiologia , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Transtorno do Deficit de Atenção com Hiperatividade/induzido quimicamente , Adolescente , Adulto , Adulto Jovem , Estados Unidos/epidemiologia , Transtornos do Neurodesenvolvimento/induzido quimicamente , Transtornos do Neurodesenvolvimento/epidemiologia , Metilfenidato/efeitos adversos , Transtorno do Espectro Autista/epidemiologia , Transtorno do Espectro Autista/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/epidemiologia , Estudos de Coortes , Anfetamina/efeitos adversos , Dextroanfetamina/efeitos adversos , Medicaid/estatística & dados numéricos
12.
Neurology ; 102(2): e207996, 2024 Jan 23.
Artigo em Inglês | MEDLINE | ID: mdl-38165339

RESUMO

BACKGROUND AND OBJECTIVES: Valproate should be avoided in pregnancy, but it is the most effective drug for generalized epilepsies. Alternative treatment may require combinations of other drugs. Our objectives were to describe first trimester use of antiseizure medication (ASM) combinations that are relevant alternatives to valproate and determine whether specific combinations were associated with a lower risk of major congenital malformations (MCM) compared with valproate monotherapy. METHODS: We conducted a population-based cohort study using linked national registers from Denmark, Finland, Iceland, Norway, and Sweden and administrative health care data from the United States and New South Wales, Australia. We described first trimester use of ASM combinations among pregnant people with epilepsy from 2000 to 2020. We compared the risk of MCM after first trimester exposure to ASM combinations vs valproate monotherapy and low-dose valproate plus lamotrigine or levetiracetam vs high-dose valproate (≥1,000 mg/d). We used log-binomial regression with propensity score weights to calculate adjusted risk ratios (aRRs) and 95% CIs for each dataset. Results were pooled using fixed-effects meta-analysis. RESULTS: Among 50,905 pregnancies in people with epilepsy identified from 7.8 million total pregnancies, 788 used lamotrigine and levetiracetam, 291 used lamotrigine and topiramate, 208 used levetiracetam and topiramate, 80 used lamotrigine and zonisamide, and 91 used levetiracetam and zonisamide. After excluding pregnancies with use of other ASMs, known teratogens, or a child diagnosed with MCM of infectious or genetic cause, we compared 587 exposed to lamotrigine-levetiracetam duotherapy and 186 exposed to lamotrigine-topiramate duotherapy with 1959 exposed to valproate monotherapy. Pooled aRRs were 0.41 (95% CI 0.24-0.69) and 1.26 (0.71-2.23), respectively. Duotherapy combinations containing low-dose valproate were infrequent, and comparisons with high-dose valproate monotherapy were inconclusive but suggested a lower risk for combination therapy. Other combinations were too rare for comparative safety analyses. DISCUSSION: Lamotrigine-levetiracetam duotherapy in first trimester was associated with a 60% lower risk of MCM than valproate monotherapy, while lamotrigine-topiramate was not associated with a reduced risk. Duotherapy with lamotrigine and levetiracetam may be favored to treat epilepsy in people with childbearing potential compared with valproate regarding MCM, but whether this combination is as effective as valproate remains to be determined. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in people with epilepsy treated in the first trimester of pregnancy, the risk of major congenital malformations is lower with lamotrigine-levetiracetam duotherapy than with valproate alone, but similar with lamotrigine-topiramate.


Assuntos
Epilepsia Generalizada , Ácido Valproico , Feminino , Humanos , Gravidez , Estudos de Coortes , Lamotrigina/uso terapêutico , Levetiracetam , Topiramato , Ácido Valproico/efeitos adversos , Zonisamida , Recém-Nascido , Combinação de Medicamentos
13.
Environ Sci Technol ; 58(2): 1097-1108, 2024 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-38175714

RESUMO

Associations between gaseous pollutant exposure and stillbirth have focused on exposures averaged over trimesters or gestation. We investigated the association between short-term increases in nitrogen dioxide (NO2) and ozone (O3) concentrations and stillbirth risk among a national sample of 116 788 Medicaid enrollees from 2000 to 2014. A time-stratified case-crossover design was used to estimate distributed (lag 0-lag 6) and cumulative lag effects, which were adjusted for PM2.5 concentration and temperature. Effect modification by race/ethnicity and proximity to hydraulic fracturing (fracking) wells was assessed. Short-term increases in the NO2 and O3 concentrations were not associated with stillbirth in the overall sample. Among American Indian individuals (n = 1694), a 10 ppb increase in NO2 concentrations was associated with increased stillbirth odds at lag 0 (5.66%, 95%CI: [0.57%, 11.01%], p = 0.03) and lag 1 (4.08%, 95%CI: [0.22%, 8.09%], p = 0.04) but not lag 0-6 (7.12%, 95%CI: [-9.83%, 27.27%], p = 0.43). Among participants living in zip codes within 15 km of active fracking wells (n = 9486), a 10 ppb increase in NO2 concentration was associated with increased stillbirth odds in single-day lags (2.42%, 95%CI: [0.37%, 4.52%], p = 0.02 for lag 0 and 1.83%, 95%CI: [0.25%, 3.43%], p = 0.03 for lag 1) but not the cumulative lag (lag 0-6) (4.62%, 95%CI: [-2.75%, 12.55%], p = 0.22). Odds ratios were close to the null in zip codes distant from fracking wells. Future studies should investigate the role of air pollutants emitted from fracking and potential racial disparities in the relationship between short-term increases in NO2 concentrations and stillbirth.


Assuntos
Poluentes Atmosféricos , Poluição do Ar , Ozônio , Gravidez , Feminino , Humanos , Poluição do Ar/análise , Estudos Cross-Over , Dióxido de Nitrogênio/análise , Material Particulado/análise , Natimorto/epidemiologia , Poluentes Atmosféricos/análise , Ozônio/análise , Exposição Ambiental/análise
14.
JAMA Intern Med ; 184(2): 144-152, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38079178

RESUMO

Importance: Increasing use of second-line noninsulin antidiabetic medication (ADM) in pregnant individuals with type 2 diabetes (T2D) may result in fetal exposure, but their teratogenic risk is unknown. Objective: To evaluate periconceptional use of second-line noninsulin ADMs and whether it is associated with increased risk of major congenital malformations (MCMs) in the infant. Design, Setting, and Participants: This observational population-based cohort study used data from 4 Nordic countries (2009-2020), the US MarketScan Database (2012-2021), and the Israeli Maccabi Health Services database (2009-2020). Pregnant women with T2D were identified and their live-born infants were followed until up to 1 year after birth. Exposure: Periconceptional exposure was defined as 1 or more prescription fill of sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and sodium-glucose cotransporter 2 (SGLT2) inhibitors, or insulin (active comparator) from 90 days before pregnancy to end of first trimester. Main Outcomes and Measures: Relative risks (RRs) and 95% CIs for MCMs were estimated using log-binomial regression models, adjusting for key confounders in each cohort and meta-analyzed. Results: Periconceptional exposure to second-line noninsulin ADMs differed between countries (32, 295, and 73 per 100 000 pregnancies in the Nordics, US, and Israel, respectively), and increased over the study period, especially in the US. The standardized prevalence of MCMs was 3.7% in all infants (n = 3 514 865), 5.3% in the infants born to women with T2D (n = 51 826), and among infants exposed to sulfonylureas was 9.7% (n = 1362); DPP-4 inhibitors, 6.1% (n = 687); GLP-1 receptor agonists, 8.3% (n = 938); SGLT2 inhibitors, 7.0% (n = 335); and insulin, 7.8% (n = 5078). Compared with insulin, adjusted RRs for MCMs were 1.18 (95% CI, 0.94-1.48), 0.83 (95% CI, 0.64-1.06), 0.95 (95% CI, 0.72-1.26), and 0.98 (95% CI, 0.65-1.46) for infants exposed to sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors, respectively. Conclusions and Relevance: Use of second-line noninsulin ADMs is rapidly increasing for treatment of T2D and other indications, resulting in an increasing number of exposed pregnancies. Although some estimates were imprecise, results did not indicate a large increased risk of MCMs above the risk conferred by maternal T2D requiring second-line treatment. Although reassuring, confirmation from other studies is needed, and continuous monitoring will provide more precise estimates as data accumulate.


Assuntos
Diabetes Mellitus Tipo 2 , Inibidores da Dipeptidil Peptidase IV , Inibidores do Transportador 2 de Sódio-Glicose , Gravidez , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/complicações , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon , Estudos de Coortes , Compostos de Sulfonilureia/efeitos adversos , Insulina/efeitos adversos , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas
15.
Drug Saf ; 47(3): 195-204, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37973784

RESUMO

BACKGROUND AND OBJECTIVE: Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol. METHODS: The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest. DISCUSSION: The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517.


Assuntos
COVID-19 , Recém-Nascido , Humanos , Feminino , Gravidez , SARS-CoV-2 , Tratamento Farmacológico da COVID-19 , Estudos de Coortes , Resultado do Tratamento , Sistema de Registros
16.
BJOG ; 131(3): 334-342, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37555464

RESUMO

OBJECTIVE: To assess whether aspirin treatment can be discontinued in pregnancies with normal uterine artery pulsatility index (≤90th percentile) at 24-28 weeks. DESIGN: Post-hoc analysis of a clinical trial. SETTING: Nine maternity hospitals in Spain. POPULATION OR SAMPLE: Pregnant individuals at high risk of pre-eclampsia at 11-13 weeks and normal uterine artery Doppler at 24-28 weeks. METHODS: All participants received treatment with daily aspirin at a dose of 150 mg. Participants were randomly assigned, in a 1:1 ratio, either to continue aspirin treatment until 36 weeks (control group) or to discontinue aspirin treatment (intervention group), between September 2019 and September 2021. In this secondary analysis, women with a UtAPI >90th percentile at 24-28 weeks were excluded. The non-inferiority margin was set at a difference of 1.9% for the incidence of preterm pre-eclampsia. MAIN OUTCOME MEASURES: Incidence of preterm pre-eclampsia. RESULTS: Of the 1611 eligible women, 139 were excluded for UtAPI >90th percentile or if UtAPI was not available. Finally, 804 were included in this post-hoc analysis. Preterm pre-eclampsia occurred in three of 409 (0.7%) women in the aspirin discontinuation group and five of 395 (1.3%) women in the continuation group (-0.53; 95% CI -1.91 to 0.85), indicating non-inferiority of aspirin discontinuation. CONCLUSIONS: Discontinuing aspirin treatment at 24-28 weeks in women with a UtAPI ≤90th percentile was non-inferior to continuing aspirin treatment until 36 weeks for preventing preterm pre-eclampsia.


Assuntos
Aspirina , Pré-Eclâmpsia , Feminino , Humanos , Recém-Nascido , Gravidez , Aspirina/uso terapêutico , Pré-Eclâmpsia/prevenção & controle , Pré-Eclâmpsia/tratamento farmacológico , Ultrassonografia Doppler , Artéria Uterina/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
17.
Arch Gerontol Geriatr ; 117: 105276, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-37984196

RESUMO

BACKGROUND: This study aims to describe the distribution and temporal trends of the centenarian population and their hospital admissions in Spain over the past two decades, focusing on regional and sex-based differences. METHODS: A retrospective study was conducted using data from the Spanish National Health System's Hospital Discharge Records-Minimum Basic Data Set. The analysis included all hospitalized patients ≥100 years between January 2004 and December 2020. The crude annual centenarian population and admission rates were calculated. Joinpoint regression analysis and cross-correlation analysis were used to identify trends and associations. RESULTS: From 2004 to 2020, the centenarian population in Spain increased by 89.0 %, with a larger increase observed in women (86.6 %) than men (32.9 %). Significant geographic variability was found, with rates from 1.1 to 5.2 × 10,000 inhabitants per year across different regions. Joinpoint analysis identified three trends: a decline from 2004 to 2008, an increase from 2008 to 2015, and a slower increase from 2015 to 2020. Hospital admissions of centenarians increased by 121.5 %, with a larger increase in women than men (212.1% vs 90.7 %); women represented 75.4 % of admissions. The proportion of centenarian admissions to total hospitalizations showed an upward trend until 2015 and then stabilized; it also varied among regions. CONCLUSION: There was a significant increase in the centenarian population and hospital admissions of centenarians in Spain. There are regional disparities in their distribution, with women representing a larger proportion of centenarians and hospital admissions. Understanding these trends and differences is crucial for implementing interventions that ensure adequate healthcare for centenarians.


Assuntos
Centenários , Hospitalização , Masculino , Idoso de 80 Anos ou mais , Humanos , Feminino , Estudos Retrospectivos , Espanha/epidemiologia , Dinâmica Populacional , Hospitais
18.
Dig Liver Dis ; 2023 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-38087671

RESUMO

AIM: To investigate the usefulness of multistate models (MSM) for determining colorectal cancer (CRC) recurrence rate, to analyse the effect of different factors on tumour recurrence and death, and to assess the impact of recurrence for CRC prognosis. METHODS: Observational follow-up study of incident CRC cases disease-free after curative resection in 2006-2013 (n = 994). Recurrence and mortality were analyzed with MSM, as well as covariate effects on transition probabilities. RESULTS: Cumulative incidence of recurrence at 60 months was 13.7%. Five years after surgery, 70.3% of patients were alive and recurrence-free, and 8.4% were alive after recurrence. Recurrence has a negative impact on prognosis, with 5-year CRC-related mortality increasing from 3.8% for those who are recurrence-free 1-year after surgery to 33.6% for those with a recurrence. Advanced stage increases recurrence risk (HR = 1.53) and CRC-related mortality after recurrence (HR = 2.35). CRC-related death was associated with age in recurrence-free patients, and with comorbidity after recurrence. As expected, age≥75 years was a risk factor for non-CRC-related death with (HR = 7.76) or without recurrence (HR = 4.26), while its effect on recurrence risk was not demonstrated. CONCLUSIONS: MSM allows detailed analysis of recurrence and mortality in CRC. Recurrence has a negative impact on prognosis. Advanced stage was a determining factor for recurrence and CRC-death after recurrence.

19.
Biomedica ; 43(4): 427-437, 2023 12 01.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38109141

RESUMO

INTRODUCTION: Diet-based interventions may be a culturally acceptable option to decrease mercury levels and thus prevent the adverse effects of this metal on population health. Selenium is an element present in Colombian geology that can act as a chelator, decreasing mercury concentrations in the human body. OBJECTIVE: To identify potentially useful selenium-rich foods to control the effects of mercury exposure among Afro-Colombians. MATERIALS AND METHODS: A cross-sectional study was carried out with 320 individuals from five municipalities of Chocó. They were asked about the frequency of consumption of selenium-rich foods, and their association with mercury concentrations in hair was estimated with multiple robust regression. RESULTS: Guava, whole wheat flour, strawberries, cow liver, spinach and yeast extract were the foods with higher consumption. Walnuts, whole wheat flour, and yeast extract were identified in multiple robust regression as foods to consider in future interventions. CONCLUSION: It is proposed that the banana juice, the pineapple colada, the borojó (Borojoa patinoi) sorbet, the cucas, and the enyucado are basic elements for a culturally acceptable intervention.


Introducción: Las intervenciones basadas en la dieta pueden ser una opción culturalmente aceptable para disminuir los niveles de mercurio y prevenir los efectos adversos de este metal en la salud de la población. El selenio es un elemento presente en la geología colombiana que puede actuar como quelante, disminuyendo las concentraciones de mercurio en el cuerpo humano. Objetivo: Identificar los alimentos ricos en selenio potencialmente útiles para controlar los efectos de la exposición a mercurio entre afrocolombianos. Materiales y métodos: Se realizó un estudio transversal con 320 individuos de cinco municipios del departamento del Chocó. Se les preguntó sobre la frecuencia de consumo de alimentos ricos en selenio y su asociación con las concentraciones de mercurio en cabello fue estimada con regresión múltiple robusta. Resultados: La guayaba, la harina de trigo integral, las fresas, el hígado de vaca, la espinaca y el extracto de levadura fueron los alimentos de mayor consumo. Las nueces, la harina de trigo integral y el extracto de levadura fueron identificados en regresión múltiple robusta como alimentos por considerar en futuras intervenciones. Conclusiones: Se propone que el jugo de plátano, la piña colada, el sorbete de borojó (Borojoa patinoi), las cucas, el enyucado y la sábida de plátano primitivo maduro son elementos básicos para una intervención culturalmente aceptable.


Assuntos
Dieta , Mercúrio , Selênio , Feminino , Humanos , Colômbia , Estudos Transversais , Selênio/administração & dosagem , Triticum
20.
Biomédica (Bogotá) ; 43(4)dic. 2023.
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1533955

RESUMO

Introduction. Diet-based interventions may be a culturally acceptable option to decrease mercury levels and thus prevent the adverse effects of this metal on population health. Selenium is an element present in Colombian geology that can act as a chelator, decreasing mercury concentrations in the human body. Objective. To identify potentially useful selenium-rich foods to control the effects of mercury exposure among Afro-Colombians. Materials and methods. A cross-sectional study was carried out with 320 individuals from five municipalities of Chocó. They were asked about the frequency of consumption of selenium-rich foods, and their association with mercury concentrations in hair was estimated with multiple robust regression. Results. Guava, whole wheat flour, strawberries, cow liver, spinach and yeast extract were the foods with higher consumption. Walnuts, whole wheat flour, and yeast extract were identified in multiple robust regression as foods to consider in future interventions. Conclusion. It is proposed that the banana juice, the pineapple colada, the borojó (Borojoa patinoi) sorbet, the cucas, and the enyucado are basic elements for a culturally acceptable intervention.


Introducción. Las intervenciones basadas en la dieta pueden ser una opción culturalmente aceptable para disminuir los niveles de mercurio y prevenir los efectos adversos de este metal en la salud de la población. El selenio es un elemento presente en la geología colombiana que puede actuar como quelante, disminuyendo las concentraciones de mercurio en el cuerpo humano. Objetivo. Identificar los alimentos ricos en selenio potencialmente útiles para controlar los efectos de la exposición a mercurio entre afrocolombianos. Materiales y métodos. Se realizó un estudio transversal con 320 individuos de cinco municipios del departamento del Chocó. Se les preguntó sobre la frecuencia de consumo de alimentos ricos en selenio y su asociación con las concentraciones de mercurio en cabello fue estimada con regresión múltiple robusta. Resultados. La guayaba, la harina de trigo integral, las fresas, el hígado de vaca, la espinaca y el extracto de levadura fueron los alimentos de mayor consumo. Las nueces, la harina de trigo integral y el extracto de levadura fueron identificados en regresión múltiple robusta como alimentos por considerar en futuras intervenciones. Conclusiones. Se propone que el jugo de plátano, la piña colada, el sorbete de borojó (Borojoa patinoi), las cucas, el enyucado y la sábida de plátano primitivo maduro son elementos básicos para una intervención culturalmente aceptable.

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