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1.
Int Orthop ; 2020 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-32036489

RESUMO

PURPOSE: Fractures are common events, but the exact incidence and severity of fractures have not been clearly determined for most anatomical sites. We estimated the incidence and severity of fractures in France regardless of the anatomical site. METHODS: Observational cross-sectional study in France in 2016 based on the national health data system. All incident fractures in patients 20 years and older were included. We determined the anatomical fracture site (12 sites) and the severity using a 4-point scale (outpatient care, hospitalization, surgery, and in-hospital death). RESULTS: We identified 562,094 incident fractures, predominantly occurring in women (319,858: 56.9%); with a mean age of 63.6 years, and an exponential increase after the age of 70 years. Distal upper limb (172,591: 30.7%), distal lower limb (84,602: 15.1%), and femoral neck (78,766: 14.0%) accounted for more than one-half of all fractures. Sex and age of onset distributions varied widely according to fracture sites, with earlier onset for distal lower limb fractures (mean age: 54.2 years) and distal upper limb fractures (mean age: 55.2 years) with a men predominance for skull fractures. Only 105,165 (18.7%) fractures were treated on an outpatient basis; 11,913 (2.1%) in-hospital deaths occurred in patients with a mean age of 79.5 years. High mortality was observed for skull (12.9%), rib (4.9%), and femoral fractures (femoral neck 4.3% and proximal lower limb 4.2%). CONCLUSION: We estimated the incidence of fractures in France by sex and anatomical site. We also showed that fractures remain common and serious life events, especially in older people.

3.
Pharmacoepidemiol Drug Saf ; 28(12): 1583-1590, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31517431

RESUMO

PURPOSE: To investigate the risk of acute kidney injury (AKI) in subjects initiating statin therapy for primary prevention of cardiovascular disease (CVD). METHODS: A nationwide cohort study using French hospital discharge and claims databases was performed, studying subjects from the general population aged 40 to 75 years in 2009, with no history of CVD and no lipid-lowering drugs during the preceding 3-year period, followed for up to 7 years. Exposure to statins (type, dose, and time since first use) and to other drugs for CVD risk was assessed. The primary outcome was hospital admission for AKI. RESULTS: The cohort included 8 236 279 subjects, 818 432 of whom initiated a statin for primary prevention. During 598 487 785 person-months exposed to statins, 700 events were observed, corresponding to an incidence of AKI of 4.59 per 10 000 person-years (7.01 in men, 3.01 in women). AKI mainly occurred in the context of organ failure, sepsis, and genitourinary disease. A 19% increased rate of AKI (hazard ratio = 1.19, 95%CI: 1.08-1.31) was observed in men exposed to statins, whereas no increase in the overall risk of AKI was observed in women. However, exposure to high-potency statins was associated with a 72% to 116% increased risk in both genders and a dose-effect relationship observed for rosuvastatin and atorvastatin. No temporal pattern of occurrence nor interaction with drugs for CVD risk was observed. CONCLUSIONS: Although the overall risk of AKI appears moderately increased, more attention should be paid to renal function in subjects taking statins for primary prevention both in clinical practice and from a research viewpoint.

4.
JAMA Oncol ; 2019 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-31294750

RESUMO

Importance: The risk stratification of adrenocortical carcinoma (ACC) based on tumor proliferation index and stage is limited. Adjuvant therapy after surgery is recommended for most patients. Pan-genomic studies have identified distinct molecular groups closely associated with outcome. Objective: To compare the molecular classification for prognostic assessment of ACC with other known prognostic factors. Design, Setting, and Participants: In this retrospective biomarker analysis, ACC tumor samples from 368 patients who had undergone surgical tumor removal were collected from March 1, 2005, to September 30, 2015 (144 in the training cohort and 224 in the validation cohort) at 21 referral centers with a median follow-up of 35 months (interquartile range, 18-74 months). Data were analyzed from March 2016 to March 2018. Exposures: Meta-analysis of pan-genomic studies (transcriptome, methylome, chromosome alteration, and mutational profiles) was performed on the training cohort. Targeted biomarker analysis, including targeted gene expression (BUB1B and PINK1), targeted methylation (PAX5, GSTP1, PYCARD, and PAX6), and targeted next-generation sequencing, was performed on the training and validation cohorts. Main Outcomes and Measures: Disease-free survival. Cox proportional hazards regression and C indexes were used to assess the prognostic value of each model. Results: Of the 368 patients (mean [SD] age, 49 [16] years), 144 were in the training cohort (100 [69.4%] female) and 224 were in the validation cohort (142 [63.4%] female). In the training cohort, pan-genomic measures classified ACC into 3 molecular groups (A1, A2, and A3-B), with 5-year survival of 9% for group A1, 45% for group A2, and 82% for group A3-B (log-rank P < .001). Molecular class was an independent prognostic factor of recurrence in stage I to III ACC after complete surgery (hazard ratio, 55.91; 95% CI, 8.55-365.40; P < .001). The combination of European Network for the Study of Adrenal Tumors (ENSAT) stage, tumor proliferation index, and molecular class provided the most discriminant prognostic model (C index, 0.88). In the validation cohort, the molecular classification, determined by targeted biomarker measures, was confirmed as an independent prognostic factor of recurrence (hazard ratio, 5.96 [95% CI, 1.81-19.58], P = .003 for the targeted classifier combining expression, methylation, and chromosome alterations; and 2.61 [95% CI, 1.31-5.19], P = .006 for the targeted classifier combining methylation, chromosome alterations, and mutational profile). The prognostic value of the molecular markers was limited for patients with stage IV ACC. Conclusions and Relevance: The findings suggest that in localized ACC, targeted classifiers may be used as independent markers of recurrence. The determination of molecular class may improve individual prognostic assessment and thus may spare unnecessary adjuvant treatment.

5.
Eur Heart J ; 40(43): 3516-3525, 2019 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-31362307

RESUMO

AIMS: The role of statin therapy in primary prevention of cardiovascular disease in persons older than 75 years remains a subject of debate with little evidence to support or exclude the benefit of this treatment. We assessed the effect of statin discontinuation on cardiovascular outcomes in previously adherent 75-year-olds treated for primary prevention. METHODS AND RESULTS: A population-based cohort study using French national healthcare databases was performed, studying all subjects who turned 75 in 2012-14, with no history of cardiovascular disease and with a statin medication possession ratio ≥80% in each of the previous 2 years. Statin discontinuation was defined as three consecutive months without exposure. The outcome was hospital admission for cardiovascular event. The hazard ratio comparing statin discontinuation with continuation was estimated using a marginal structural model adjusting for both baseline and time-varying covariates (cardiovascular drug use, comorbidities, and frailty indicators). A total of 120 173 subjects were followed for an average of 2.4 years, of whom 17 204 (14.3%) discontinued statins and 5396 (4.5%) were admitted for a cardiovascular event. The adjusted hazard ratios for statin discontinuation were 1.33 [95% confidence interval (CI) 1.18-1.50] (any cardiovascular event), 1.46 (95% CI 1.21-1.75) (coronary event), 1.26 (95% CI 1.05-1.51) (cerebrovascular event), and 1.02 (95% CI 0.74-1.40) (other vascular event). CONCLUSION: Statin discontinuation was associated with a 33% increased risk of admission for cardiovascular event in 75-year-old primary prevention patients. Future studies, including randomized studies, are needed to confirm these findings and support updating and clarification of guidelines on the use of statins for primary prevention in the elderly.

7.
Neurology ; 93(2): e167-e180, 2019 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-31189695

RESUMO

OBJECTIVE: To assess the association between exposure to monotherapy with 10 different antiepileptic drugs (AEDs) during the first 2 months of pregnancy and the risk of 23 major congenital malformations (MCMs). METHODS: This nationwide cohort study, based on the French health care databases, included all pregnancies ≥20 weeks and ending between January 2011 and March 2015. Women were considered to be exposed when an AED had been dispensed between 1 month before and 2 months after the beginning of pregnancy. The reference group included pregnant women with no reimbursement for AEDs. MCMs were detected up to 12 months after birth (24 months for microcephaly, hypospadias, and epispadias). Odds ratios (ORs) were adjusted for potential confounders for MCMs with at least 5 cases. Otherwise, we calculated crude ORs with exact confidence intervals (CIs). RESULTS: The cohort included 1,886,825 pregnancies, 2,997 of which were exposed to lamotrigine, 1,671 to pregabalin, 980 to clonazepam, 913 to valproic acid, 579 to levetiracetam, 517 to topiramate, 512 to carbamazepine, 365 to gabapentin, 139 to oxcarbazepine, and 80 to phenobarbital. Exposure to valproic acid was associated with 8 specific types of MCMs (e.g., spina bifida, OR 19.4, 95% CI 8.6-43.5), and exposure to topiramate was associated with an increased risk of cleft lip (6.8, 95% CI 1.4-20.0). We identified 3 other signals. We found no significant association for lamotrigine, levetiracetam, carbamazepine, oxcarbazepine, and gabapentin. CONCLUSIONS: These results confirm the teratogenicity of valproic acid and topiramate. Because of the small numbers of cases and possible confounding, the other 3 signals should be interpreted with appropriate caution.


Assuntos
Anticonvulsivantes/uso terapêutico , Anormalidades Congênitas/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Adulto , Estudos de Coortes , Feminino , França/epidemiologia , Humanos , Recém-Nascido , Masculino , Gravidez , Primeiro Trimestre da Gravidez , Lesões Pré-Natais/epidemiologia , Adulto Jovem
9.
Aliment Pharmacol Ther ; 50(3): 269-277, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31115919

RESUMO

BACKGROUND: CT-P13, a biosimilar of the reference product infliximab, has been approved for the treatment of ulcerative colitis on the basis of the results of trials conducted in patients with spondyloarthritis and rheumatoid arthritis. AIM: To compare the effectiveness and safety of CT-P13 and the reference product in infliximab-naive patients with ulcerative colitis METHODS: A comparative real-life equivalence cohort study was conducted using the French nationwide health administrative database. Infliximab-naive patients with ulcerative colitis over 15 years of age who started infliximab with no other indications for infliximab were included. The primary outcome was a composite endpoint (death, ulcerative colitis-related surgery, all-cause hospitalisation and reimbursement for other biologics). Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 vs the reference product, in a multivariable marginal Cox model situated within prespecified margins of (0.80-1.25). RESULTS: A total of 3112 patients were included between 1 January 2015 and 30 June 2017: 1434 received the reference product, 1678 received CT-P13. Overall, 710 patients in the reference product group and 743 patients in the CT-P13 group met the composite endpoint. In multivariable analysis of the primary outcome, CT-P13 was equivalent to the reference product (HR 1.04; 95% CI: 0.94-1.15). The number of serious infections was lower in the CT-P13 group (HR 0.65; 95% CI: 0.48-0.88). There was no difference in the incidence of solid or haematologic malignancy (HR 0.81; 95% CI: 0.41-1.60). CONCLUSIONS: The effectiveness of CT-P13 is equivalent and the risk of serious infections could be lower than that of the reference product for infliximab-naive patients with ulcerative colitis.

10.
PLoS One ; 14(4): e0215073, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30964935

RESUMO

OBJECTIVE: The aims were to review practices concerning Differential Item Functioning (DIF) detection in composite measurement scales, particularly those used in health research, and to provide guidance on how to proceed if statistically significant DIF is detected. METHODS: This work specifically addressed the Rasch model which is the subject of growing interest in the field of health owing to its particularly advantageous properties. There were three steps: 1) Literature review to describe current practices; 2) Simulation study to determine under which conditions encountered in health research studies can erroneous conclusions be drawn from group comparisons when a scale is affected by DIF but which is not considered; 3) Based on steps 1 and 2, formulation of recommendations that were subsequently reviewed by leading internationally recognized experts. RESULTS: Four key recommendations were formulated to help researchers to determine whether statistically significant DIF is meaningful in practice, according to the kind of DIF (uniform or non-uniform) and the DIF effect size. CONCLUSION: This work provides the first recommendations on how to deal in practice with the presence of DIF in composite measurement scales used in health research studies.


Assuntos
Interpretação Estatística de Dados , Modelos Estatísticos , Psicometria/métodos , Qualidade de Vida , Nível de Saúde , Humanos , Inquéritos e Questionários
11.
Resuscitation ; 140: 170-177, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30974188

RESUMO

BACKGROUND: After resuscitation of cardiac arrest (CA), an acute circulatory failure occurs in about 50% of cases, which shares many characteristics with septic shock. Most frequently, supportive treatments are poorly efficient to prevent multiple organ failure and death. We evaluated whether an early plasma removal of inflammatory mediators using high cut-off continuous veno-venous hemodialysis (HCO-CVVHD) could improve hemodynamic status and outcome of these patients. PATIENTS AND METHODS: We performed a randomized open-label trial. Patients with post-cardiac arrest shock (defined as requirement of norepinephrine or epinephrine infusion > 1 mg/h) were included. The experimental group received 2 distinct sessions of HCO-CVVHD during the first 48 h following ICU admission. The control group received continuous veno-venous hemofiltration (CVVH) with standard membranes if needed. The primary endpoint was the delay to shock resolution asssessed by the length of catecholamine infusion. Number of vasopressors-free days at day 28, arterial blood pressure measures every 6-hours, daily fluid balance and mortality (ICU and day-28) were evaluated as secondary endpoints. RESULTS: 35 patients were included: 17 (median age 68.4, 59% male) in the HCO-CVVHD group and 18 (median age 66.3, 83% male) in the control group. Baseline characteristics did not differ between the two groups. Day-28 mortality rate was 64.7% and 72.2% in the HCO-CVVHD and control group, respectively (p = 0.72). Probability of vasopressors discontinuation over time was similar in the two groups (p for logrank test = 0.67). Number of day-28 catecholamine-free days was 25.1 [0, 26.5] and 24.5 [0, 26.2] in the HCO-CVVHD and control group, respectively (p = 0.65). No difference was observed regarding the daily-dose of vasopressors, arterial pressure profile and fluid balance. CONCLUSION: In cardiac arrest patients, HCO-CVVHD did not decrease the lenght of post-resuscitation shock and had no significant effect on hemodynamic profile. REGISTRATION: NCT00780299.

12.
Ann Intern Med ; 170(2): 99-107, 2019 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-30534946

RESUMO

Background: CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD. Objective: To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD. Design: Comparative equivalence cohort study. Setting: Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017). Patients: 5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab. Measurements: The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25). Results: Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]). Limitation: The SNDS does not contain all relevant clinical data (for example, disease activity). Conclusion: This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes. Primary Funding Source: Caisse Nationale de l'Assurance Maladie.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Adolescente , Adulto , Anticorpos Monoclonais/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Feminino , França , Fármacos Gastrointestinais/efeitos adversos , Humanos , Infliximab/efeitos adversos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
13.
Eur J Prev Cardiol ; 26(5): 512-521, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29799296

RESUMO

AIMS: The purpose of this study was to investigate the risk of rhabdomyolysis in subjects initiating statin therapy for primary prevention of cardiovascular disease, focusing on the type of statin, dose and time since initiation. METHODS AND RESULTS: A nationwide cohort study using French hospital discharge and claims databases was performed, studying subjects from the general population 40-75 years in 2009, with no history of cardiovascular disease and no lipid-lowering drugs during the preceding three-year period, followed for up to seven years. The primary outcome was hospitalization for rhabdomyolysis. Event-free survival analysis and case-time-control analysis were both performed, separately by gender. The cohort included 8,236,667 subjects, 969,460 of whom initiated a lipid-lowering drug for cardiovascular disease primary prevention. During 18,407,391 person-months exposed to statins, 168 events were observed, corresponding to an incidence of rhabdomyolysis of 1.10 per 10,000 person-years (1.54 in men vs 0.81 in women); 10/168 cases were fatal, and 18/168 and 57/168 cases occurred during the first month and first trimester of treatment, respectively. Survival analysis did not reveal any increased overall risk (hazard ratio = 1.02 (0.83-1.25) in men and 0.76 (0.60-0.96) in women). However, exposure to high-potency statins was associated with an increased risk in men (hazard ratio = 1.93 (1.27-2.94)). Rosuvastatin 20 mg (in men and women) and simvastatin 40 mg (in men) were associated with hazard ratios > 5. Case-time-control analyses showed similar patterns of risk. Drug interactions did not appear to significantly contribute to rhabdomyolysis events in this study. CONCLUSION: Although the overall risk of statin-associated rhabdomyolysis in the context of primary prevention was not increased, the first months of treatment and the use of high-potency statins represent at-risk situations, which require appropriate monitoring, especially in men.

14.
J Epidemiol Community Health ; 73(1): 65-72, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30301764

RESUMO

BACKGROUND: Interest in monitoring health-related quality of life (HRQoL) in general populations has increased in the past 20 years, reinforced by population ageing and repeated economic crises. This study aims to identify temporal trends in HRQoL in France between 1995 and 2016 and to assess disparities according to demographic and socioeconomic characteristics. METHODS: Data from repeated population-based cross-sectional surveys conducted in 1995, 2003 and 2016 were used. HRQoL was measured using the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire. RESULTS: A substantial decrease in score was observed between 1995 and 2016 for both genders in almost all subscales of the SF-36, with the largest decrease being in the mental health dimension for men. However, the age group 18-54 years were the most affected with persistent negative or even worsening trends in HRQoL. The largest decreases were among men aged 45-54 years and women aged 35-44 years in most dimensions, and among the age group 18-24 years in vitality. Conversely, an overall improvement was noted among the age group 65-84 years. People in employment were more affected than the unemployed by the decline in several HRQoL dimensions. CONCLUSION: A general decline in HRQoL was found between 1995 and 2016 in the French population, but with wide disparities in trends between age groups. Young and especially middle-aged, employed people exhibited persistent negative and worsening trends. Consistent with evidence from traditional mental health morbidity and mortality indicators, our findings raise questions about the potential influence of macro-socioeconomic factors, especially the 2008 crisis; these observations deserve special attention from health policy-makers.

15.
Clin Gastroenterol Hepatol ; 17(4): 719-727.e13, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30099110

RESUMO

BACKGROUND & AIMS: We investigated perforations, bleeding, and splenic injuries after screening or diagnostic colonoscopies to identify patient-, procedure-, endoscopist-, and facility-associated risk factors. METHODS: We analyzed data from the SNIIRAM-PMSI national claims databases in France. A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy from 2010 through 2015 were identified. Rates of severe adverse events (SAEs) were estimated using stringent and broad definitions. Risk factors associated with perforations and major bleeding were estimated using multilevel logistic regression models, adjusted for patient, colonoscopy, and endoscopist characteristics. RESULTS: Perforation rates ranged from 3.5 (stringent definition) to 7.3 (broad definition) per 10,000 procedures, bleeding rates ranged from 6.5 to 23.1 per 10,000 procedures, and splenic injury rates ranged from 0.20 to 0.34 per 10,000 procedures. Rates of 30-day mortality were 13.2 per 1000 bleeds, 29.2 per 1000 perforations, and 36.1 per 1000 splenic injuries (stringent definitions). Patient characteristics associated with SAEs were increasing age (especially for perforation), cancer, and cardiovascular comorbidities. Procedure characteristics associated with SAEs included polypectomy-especially of polyps larger than 1 cm with an increased risk of perforation (odds ratio, 4.1; 95% CI, 3.4-5.0) and bleeding (odds ratio, 13.3; 95% CI, 11.7-15.1). Less-experienced endoscopists and endoscopists who performed a smaller number of colonoscopies were independently associated with a risk of SAEs. CONCLUSION: In an analysis of national claims databases in France, we found SAEs related to screening and diagnostic colonoscopies to be more frequent in older patients, in patients with comorbidities, and with less-experienced endoscopists. Patients at risk of SAE should be identified and colonoscopies should be performed or supervised by experienced endoscopists.

16.
Qual Health Res ; 29(1): 149-156, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29952223

RESUMO

A systematic review of articles using qualitative methods to generate questionnaire items identified in MEDLINE and PsycINFO from 2000 to 2014 was carried out. Articles were analyzed for (a) year of publication and journal domain, (b) qualitative data collection methods, (c) method of data content analysis, (d) professional experts' input in item generation, and (e) debriefing of the newly developed items. In total, 371 articles were included and results showed (a) an acceleration of published articles, (b) individual interviews and focus groups were common ways of generating items and no emergent approach was identified, (c) the content analysis was usually not described (43% of articles), (d) experts were involved in eliciting concepts in less than a third of articles, (e) 61% of articles involved a step of further submission of newly developed items to the population of interest. This review showed an insufficient reporting of qualitative methods used to generate new questionnaires despite previous recommendations.


Assuntos
Pesquisa Qualitativa , Inquéritos e Questionários/normas , Coleta de Dados/métodos , Coleta de Dados/normas , Humanos , Reprodutibilidade dos Testes
17.
J Clin Endocrinol Metab ; 104(3): 658-664, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30137467

RESUMO

Context: There has been concern that GH treatment of children might increase meningioma risk. Results of published studies have been inconsistent and limited. Objective: To examine meningioma risks in relation to GH treatment. Design: Cohort study with follow-up via cancer registries and other registers. Setting: Population-based. Patients: A cohort of 10,403 patients treated in childhood with recombinant GH in five European countries since this treatment was first used in 1984. Expected rates from national cancer registration statistics. Main Outcome Measures: Risk of meningioma incidence. Results: During follow-up, 38 meningiomas occurred. Meningioma risk was greatly raised in the cohort overall [standardized incidence ratio (SIR) = 75.4; 95% CI: 54.9 to 103.6], as a consequence of high risk in subjects who had received radiotherapy for underlying malignancy (SIR = 658.4; 95% CI: 460.4 to 941.7). Risk was not significantly raised in patients who did not receive radiotherapy. Risk in radiotherapy-treated patients was not significantly related to mean daily dose of GH, duration of GH treatment, or cumulative dose of GH. Conclusions: Our data add to evidence of very high risk of meningioma in patients treated in childhood with GH after cranial radiotherapy, but suggest that GH may not affect radiotherapy-related risk, and that there is no material raised risk of meningioma in GH-treated patients who did not receive radiotherapy.


Assuntos
Transtornos do Crescimento/tratamento farmacológico , Hormônio do Crescimento Humano/efeitos adversos , Neoplasias Meníngeas/epidemiologia , Meningioma/epidemiologia , Segunda Neoplasia Primária/epidemiologia , Adolescente , Adulto , Criança , Pré-Escolar , Irradiação Craniana/efeitos adversos , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Neoplasias Meníngeas/etiologia , Meningioma/etiologia , Segunda Neoplasia Primária/etiologia , Proteínas Recombinantes/efeitos adversos , Sistema de Registros/estatística & dados numéricos , Medição de Risco , Adulto Jovem
18.
Pharmacoepidemiol Drug Saf ; 27(11): 1239-1248, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30251424

RESUMO

PURPOSE: Baclofen is widely used off-label for alcohol use disorders (AUD) in France, despite its uncertain efficacy and safety, particularly at high doses. This study was designed to evaluate the safety of this off-label use compared to the main approved drugs for AUD (acamprosate, naltrexone, nalmefene). METHODS: This cohort study from the French Health Insurance claims database included patients, aged 18 to 70 years, with no serious comorbidity (assessed by the Charlson score) initiating baclofen or approved drugs for AUD between 2009 and 2015. The risk of hospitalisation or death associated with baclofen, at variable doses over time (from low doses <30 mg/day to high doses ≥180 mg/day), compared to approved drugs, was evaluated by a Cox model adjusted to sociodemographic and medical characteristics. RESULTS: The cohort included 165 334 patients, 47 614 of whom were exposed to baclofen. Patients exposed to baclofen differed from those treated with approved drugs in terms of sociodemographic and medical characteristics (more females, higher socioeconomic status, fewer hospitalisations for alcohol-related problems), but these differences tended to fade at higher doses of baclofen. Baclofen exposure was significantly associated with hospitalisation (hazard ratio [HR] = 1.13 [95%CI: 1.09-1.17]) and death (HR = 1.31 [95%CI: 1.08-1.60]). The risk increased with dose, reaching 1.46 [1.28-1.65] for hospitalisation and 2.27 [1.27-4.07] for death at high doses. Similar results were in patients with a history of hospitalisation for alcohol-related problems. CONCLUSIONS: This study raises concerns about the safety of baclofen for AUD, particularly at high doses, with higher risks of hospitalisation and mortality than approved drugs.


Assuntos
Dissuasores de Álcool/administração & dosagem , Alcoolismo/tratamento farmacológico , Baclofeno/efeitos adversos , Hospitalização/estatística & dados numéricos , Uso Off-Label , Acamprosato/administração & dosagem , Acamprosato/efeitos adversos , Demandas Administrativas em Assistência à Saúde/estatística & dados numéricos , Adulto , Idoso , Dissuasores de Álcool/efeitos adversos , Alcoolismo/mortalidade , Baclofeno/administração & dosagem , Bases de Dados Factuais/estatística & dados numéricos , Relação Dose-Resposta a Droga , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Naltrexona/administração & dosagem , Naltrexona/efeitos adversos , Naltrexona/análogos & derivados , Medição de Risco , Fatores Socioeconômicos
19.
Neurology ; 91(13): e1220-e1227, 2018 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-30143563

RESUMO

OBJECTIVE: To assess the association between Guillain-Barré syndrome (GBS) and recent surgery based on French nationwide data. METHODS: Data were extracted from the French health administrative databases (SNIIRAM/PMSI). All patients hospitalized for GBS between 2009 and 2014 were identified by ICD-10 code G61.0 as main diagnosis. Patients previously hospitalized for GBS in 2006, 2007, and 2008 were excluded. Surgical procedures were identified from the hospital database. Hospitalizations for surgery with no infection diagnosis code entered during the hospital stay were also identified. The association between GBS and a recent surgical procedure was estimated using a case-crossover design. Case and referent windows were defined as 1-60 days and 366-425 days before GBS hospitalization, respectively. Analyses were adjusted for previous episodes of gastroenteritis and respiratory tract infection, identified by drug dispensing data. RESULTS: Of the 8,364 GBS cases included, 175 and 257 patients had undergone a surgical procedure in the referent and case windows, respectively (adjusted odds ratio [OR] = 1.53, 95% confidence interval [CI]: 1.25-1.88). A slightly weaker association was observed for surgical procedures with no identified infection during the hospitalization (OR = 1.40, 95% CI: 1.12-1.73). Regarding the type of surgery, only surgical procedures on bones and digestive organs were significantly associated with GBS (OR and 95% CI = 2.78 [1.68-4.60] and 2.36 [1.32-4.21], respectively). CONCLUSION: In this large nationwide epidemiologic study, GBS was moderately associated with any type of recent surgery and was more strongly associated with bone and digestive organ surgery.


Assuntos
Síndrome de Guillain-Barré/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Estudos Cross-Over , Feminino , França/epidemiologia , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Adulto Jovem
20.
Eur Radiol ; 28(12): 5111-5120, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29869171

RESUMO

OBJECTIVES: To develop an automated density-based computed tomography (CT) score evaluating high-attenuating lung structural abnormalities in patients with cystic fibrosis (CF). METHODS: Seventy adult CF patients were evaluated. The development cohort comprised 17 patients treated with ivacaftor, with 45 pre-therapeutic and follow-up chest CT scans. Another cohort of 53 patients not treated with ivacaftor was used for validation. CT-density scores were calculated using fixed and adapted thresholds based on histogram characteristics, such as the mode and standard deviation. Visual CF-CT score was also calculated. Correlations between the CT scores and forced expiratory volume in 1 s (FEV1% pred), and between their changes over time were assessed. RESULTS: On cross-sectional evaluation, the correlation coefficients between FEV1%pred and the automated scores were slightly lower to that of the visual score in the development and validation cohorts (R = up to -0.68 and -0.61, versus R = -0.72 and R = -0.64, respectively). Conversely, the correlation to FEV1%pred tended to be higher for automated scores (R = up to -0.61) than for visual score (R = -0.49) on longitudinal follow-up. Automated scores based on Mode + 3 SD and Mode +300 HU showed the highest cross-sectional (R = -0.59 to -0.68) and longitudinal (R = -0.51 to -0.61) correlation coefficients to FEV1%pred. CONCLUSIONS: The developed CT-density score reliably quantifies high-attenuating lung structural abnormalities in CF. KEY POINTS: • Automated CT score shows moderate to good cross-sectional correlations with FEV 1 %pred . • CT score has potential to be integrated into the standard reporting workflow.


Assuntos
Fibrose Cística/diagnóstico por imagem , Pulmão/diagnóstico por imagem , Adulto , Aminofenóis/farmacologia , Aminofenóis/uso terapêutico , Agonistas dos Canais de Cloreto/farmacologia , Agonistas dos Canais de Cloreto/uso terapêutico , Estudos Transversais , Fibrose Cística/tratamento farmacológico , Fibrose Cística/fisiopatologia , Feminino , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Masculino , Variações Dependentes do Observador , Quinolonas/farmacologia , Quinolonas/uso terapêutico , Reprodutibilidade dos Testes , Testes de Função Respiratória , Estudos Retrospectivos , Tomografia Computadorizada Espiral/métodos , Adulto Jovem
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