Concept: French people
Adverse Drug Reactions to Gabapentin and Pregabalin : A Review of the French Pharmacovigilance Database
- Drug safety : an international journal of medical toxicology and drug experience
- Published over 7 years ago
BACKGROUND: Gabapentin and pregabalin are widely used as antineuropathic pain drugs. Their use is also associated with the development of adverse drug reactions (ADRs), mainly neuropsychiatric. OBJECTIVE: The aim of this work was to study ‘serious’ and/or ‘unexpected’ adverse reactions associated with pregabalin and gabapentin. STUDY DESIGN: We studied ADRs reported to the French Pharmacovigilance System occurring between 1995 and 2009. MAIN OUTCOME MEASURE: For each ADR associated with gabapentin or pregabalin, we noted year, patient age and sex, type of adverse reaction, as well as the imputability score. Reporting rate of serious ADRs for gabapentin and pregabalin was estimated with regard to data of use (obtained from the French National Health Insurance Fund) using the defined daily dose. A global and descriptive analysis of the adverse reactions for each drug is presented. Secondly, details of deaths and ADRs with an imputability score of at least ‘probable’ or ‘likely’ were presented. RESULTS: Overall, 1333 cases were recorded (725 related to gabapentin, 608 related to pregabalin), mainly neuropsychiatric ADRs. Among the 22 deaths recorded, 8 were related to gabapentin in obstetrical situations. Other less well-documented ADRs were identified, such as hepatitis associated with gabapentin and haematological ADRs associated with pregabalin. CONCLUSION: This study confirmed the prevalence of neuropsychiatric ADRs associated with gabapentin or pregabalin. A high rate of death occurred with gabapentin in an obstetrical context. New adverse reactions have been noted, such as haematological or hepatic adverse reactions associated with pregabalin and gabapentin, respectively.
BACKGROUND: The aims of this study were to: (1) evaluate the psychometric properties of a French Canadian version of the Hospital Anxiety and Depression Scale (HADS-FC) in a large population of primary care patients in Quebec, Canada; (2) conduct a transcultural validation of the original HADS in a subsample of English-speaking patients; (3) explore HADS properties in subgroups with or without multimorbidity. METHODS: A sample of 14,833 adults recruited in 64 primary care clinics completed the HADS, including 3,382 patients at elevated risk of mental disorders that also completed the Composite International Diagnostic Interview-Simplified (CIDIS). The HADS' internal consistency and discriminant validity were assessed, its factor structure was evaluated, and receiver operating characteristic (ROC) analyses were undertaken to evaluate its case finding abilities. RESULTS: The HADS-FC had good reliability (Cronbach’s alphas ranging from 0.79 to 0.89 depending on language version and subscales) and discriminant validity, and a two-factor structure reflecting anxiety and depression factors. Results were similar in patient subgroups with or without multimorbidity. Optimal cut-off values were calculated: HADS: ≥16 (sensitivity 62%, specificity 77%), HADS-A: ≥10 (sensitivity 66%, specificity 73%) and HADS-D:≥7 (sensitivity 65%, specificity 75%). LIMITATIONS: Our cohort selection process and use of the CIDIS as a gold standard may have contributed to the limited case-finding performance of the HADS-FC. CONCLUSIONS: The HADS-FC and English HADS presented good psychometric properties in primary care patients, including patients with and without multimorbidity. However, its performance as a screening instrument in these settings with patients of varying clinical profiles requires more scrutiny.
To determine the feasibility of fertility preservation in adolescent males with cancer.
To provide trends in incidence, management and survival of cancer of the ampulla of Vater in a well-defined French population.
Abstract The Canadian Interprofessional Health Collaborative recommends that future professionals be prepared for collaborative practice. To do so, it is necessary for them to learn about the principles of interprofessional collaboration. Therefore, to ascertain if students are predisposed, their attitude toward interprofessional learning must be assessed. In the French Canadian context such a measuring tool has not been published yet. The purpose of this study is to translate in French an adapted version of the RIPLS questionnaire and to validate it for use with undergraduate students from seven various health and social care programmes in a Canadian university. According to Vallerand’s methodology, a method for translating measuring instruments: (i) the forward-backward translation indicated that six items of the experimental French version of the RIPLS needed to be more specific; (ii) the experimental French version of the RIPLS seemed clear according to the pre-test assessing items clarity; (iii) evaluation of the content validity indicated that the experimental French version of the RIPLS presents good content validity and (iv) a very good internal consistency was obtained (α = 0.90; n = 141). Results indicate that the psychometric properties of the RIPLS in French are comparable to the English version, although a different factorial structure was found. The relevance of three of the 19 items on the RIPLS scale is questionable, resulting in a revised 16-item scale. Future research aimed at validating the translated French version of the RIPLS could also be conducted in another francophone cultural context.
In France, most cases of opioid use disorder are treated with buprenorphine by general practitioners in private practice. Using reimbursement data of a representative sample of the French population, Echantillon Généraliste des Bénéficiaires, we investigated mortality during periods when patients were in and out of treatment in a cohort of 713 new users of buprenorphine having a mean (SD) follow-up of 4.5 (1.5) years. The mortality rate was 0.63 per 100 person-years (95% CI, 0.40-0.85) overall. In a multivariate Cox regression model, compared with being in treatment, being out of treatment was associated with a markedly increased risk of death (hazard ratio = 29.04; 95% CI, 10.04-83.99). Buprenorphine appears to be a strong protective factor against mortality.
Diffuse malignant peritoneal mesothelioma: Evaluation of systemic chemotherapy with comprehensive treatment through the RENAPE Database: Multi-Institutional Retrospective Study
- European journal of cancer (Oxford, England : 1990)
- Published almost 4 years ago
Diffuse malignant peritoneal mesothelioma (DMPM) is a severe disease with mainly locoregional evolution. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is the reported treatment with the longest survival. The aim of this study was to evaluate the impact of perioperative systemic chemotherapy strategies on survival and postoperative outcomes in patients with DMPM treated with curative intent with CRS-HIPEC, using a multi-institutional database: the French RENAPE network.
Whole-exome or gene targeted resequencing in hundreds to thousands of individuals has shown that the majority of genetic variants are at low frequency in human populations. Rare variants are enriched for functional mutations and are expected to explain an important fraction of the genetic etiology of human disease, therefore having a potential medical interest. In this work, we analyze the whole-exome sequences of French-Canadian individuals, a founder population with a unique demographic history that includes an original population bottleneck less than 20 generations ago, followed by a demographic explosion, and the whole exomes of French individuals sampled from France. We show that in less than 20 generations of genetic isolation from the French population, the genetic pool of French-Canadians shows reduced levels of diversity, higher homozygosity, and an excess of rare variants with low variant sharing with Europeans. Furthermore, the French-Canadian population contains a larger proportion of putatively damaging functional variants, which could partially explain the increased incidence of genetic disease in the province. Our results highlight the impact of population demography on genetic fitness and the contribution of rare variants to the human genetic variation landscape, emphasizing the need for deep cataloguing of genetic variants by resequencing worldwide human populations in order to truly assess disease risk.
Tracheotomy is widely used in intensive care units, albeit with great disparities between medical teams in terms of frequency and modality. Indications and techniques are, however, associated with variable levels of evidence based on inhomogeneous or even contradictory literature. Our aim was to conduct a systematic analysis of the published data in order to provide guidelines. We present herein recommendations for the use of tracheotomy in adult critically ill patients developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. These guidelines were conducted by a group of experts from the French Intensive Care Society (Société de Réanimation de Langue Française) and the French Society of Anesthesia and Intensive Care Medicine (Société Francaise d'Anesthésie Réanimation) with the participation of the French Emergency Medicine Association (Société Française de Médecine d'Urgence), the French Society of Otorhinolaryngology. Sixteen experts and two coordinators agreed to consider questions concerning tracheotomy and its practical implementation. Five topics were defined: indications and contraindications for tracheotomy in intensive care, tracheotomy techniques in intensive care, modalities of tracheotomy in intensive care, management of patients undergoing tracheotomy in intensive care, and decannulation in intensive care. The summary made by the experts and the application of GRADE methodology led to the drawing up of 8 formal guidelines, 10 recommendations, and 3 treatment protocols. Among the 8 formal guidelines, 2 have a high level of proof (Grade 1+/-) and 6 a low level of proof (Grade 2+/-). For the 10 recommendations, GRADE methodology was not applicable and instead 10 expert opinions were produced.
Durable HIV-1 remission after interruption of combined antiretroviral therapy (ART) has been reported in some adults who started treatment during primary infection; however, whether long-term remission in vertically infected children is possible was unknown. We report a case of a young adult perinatally infected with HIV-1 with viral remission despite long-term treatment interruption.