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1.
Clin Appl Thromb Hemost ; 27: 1076029621989811, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33587652

RESUMO

Antihemophilic factor (recombinant) (rAHF; ADVATE®; Baxalta US Inc., a Takeda company, Lexington, MA, USA) is indicated for the treatment and prevention of bleeding in patients with hemophilia A. We aimed to assess the safety and efficacy of standard prophylaxis versus on-demand treatment with rAHF in previously treated Chinese patients with severe/moderately severe hemophilia A. This open-label, sequential, interventional, postapproval study (NCT02170402) conducted in China included patients of any age with hemophilia A with factor VIII (FVIII) level ≤2%. Patients received 6 months' on-demand rAHF then 6 months' rAHF prophylaxis (20-40 IU/kg every 48 ± 6 hours). The primary objective was percentage reduction in annualized bleeding rate (ABR) in the per-protocol analysis set (PPAS); secondary objectives included ABR by bleeding subtype, hemostatic efficacy, immunogenicity, and safety. Of 72 patients who received ≥1 rAHF dose, 61 were included in the PPAS. Total ABR was lower during prophylaxis (mean 2.5, 95% CI 1.5-3.7; median 0) versus on-demand treatment (mean 58.3, 95% CI 52.5-64.7; median 53.9), representing a 95.9% risk reduction. Similar findings in favor of prophylaxis were observed for all types of bleeding event by cause and location. rAHF hemostatic efficacy was rated as "excellent"/"good" in 96.1% of treated bleeding events. Transient FVIII inhibitors (0.6-1.7 BU) in 4 patients resolved before study end; no unexpected safety issues were observed. rAHF prophylaxis in this study of previously treated Chinese patients with severe/moderately severe hemophilia A resulted in a clear reduction in bleeding events versus rAHF on-demand treatment, with no change in safety profile.


Assuntos
Coagulantes/administração & dosagem , Fator VIII/administração & dosagem , Hemofilia A/tratamento farmacológico , Hemorragia/prevenção & controle , Adolescente , Adulto , Criança , Pré-Escolar , China , Coagulantes/efeitos adversos , Coagulantes/farmacocinética , Esquema de Medicação , Fator VIII/efeitos adversos , Fator VIII/farmacocinética , Hemofilia A/sangue , Hemofilia A/complicações , Hemofilia A/diagnóstico , Hemorragia/etiologia , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
4.
Expert Rev Med Devices ; 17(12): 1257-1264, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33307869

RESUMO

Introduction: Flexible ureteroscopy is a commonly performed urologic procedure for visualization and treatment of the upper urinary tracts. Traditionally, ureteroscopy has been performed with reusable scopes, which have large initial purchasing costs. LithoVue was the first widely adopted single-use flexible ureteroscope clinically available in 2016 and has caused reevaluation of this paradigm. Areas covered: This review is an objective assessment of the LithoVue single-use ureteroscope based on available studies at the time of publication. The authors searched major databases for papers that included the term 'LithoVue' and included relevant papers. The state of the market, technical specifications, results from clinical studies and cost analyses, and competitors are discussed. Expert opinion: The LithoVue single-use flexible ureteroscope has comparable clinical performance to existing reusable ureteroscopes based on available data. Direct clinical comparisons to competing single-use ureteroscopes, many of which are relatively new, are limited. In numerous pre-clinical studies LithoVue performed favorably compared to available competitors. Cost analyses suggest that benefit of single-use ureteroscopes is institution-specific, and will likely be favorable at a low volume of cases and with high local costs for repairs of reusable scopes.


Assuntos
Cálculos Renais/cirurgia , Ureteroscópios/efeitos adversos , Aprovação de Equipamentos , Desenho de Equipamento , Humanos , Vigilância de Produtos Comercializados/economia , Resultado do Tratamento , Ureteroscópios/economia
5.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(6): 545-548, 2020 Dec 08.
Artigo em Chinês | MEDLINE | ID: mdl-33314866

RESUMO

OBJECTIVE: By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. METHODS: The MDR system and the related inspection system in the US were systematically analyzed. RESULTS: The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. CONCLUSIONS: By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.


Assuntos
Equipamentos e Provisões/normas , Vigilância de Produtos Comercializados , China
6.
N Engl J Med ; 383(20): 1932-1940, 2020 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-33176083

RESUMO

BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).


Assuntos
Intussuscepção/etiologia , Vacinas contra Rotavirus/efeitos adversos , Administração Oral , Estudos de Casos e Controles , Feminino , Humanos , Imunização Secundária/efeitos adversos , Incidência , Índia/epidemiologia , Lactente , Intussuscepção/epidemiologia , Masculino , Vigilância de Produtos Comercializados , Risco , Infecções por Rotavirus/prevenção & controle , Vacinação , Vacinas Atenuadas/efeitos adversos
7.
Sci Rep ; 10(1): 19199, 2020 11 05.
Artigo em Inglês | MEDLINE | ID: mdl-33154498

RESUMO

Chloroquine (CQ) and hydroxychloroquine (HCQ) are on the World Health Organization's List of Essential Medications for treating non-resistant malaria, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). In addition, both drugs are currently used off-label in hospitals worldwide and in numerous clinical trials for the treatment of SARS-CoV-2 infection. However, CQ and HCQ use has been associated with cardiac side effects, which is of concern due to the higher risk of COVID-19 complications in patients with heart related disorders, and increased mortality associated with COVID-19 cardiac complications. In this study we analyzed over thirteen million adverse event reports form the United States Food and Drug Administration Adverse Event Reporting System to confirm and quantify the association of cardiac side effects of CQ and HCQ. Additionally, we identified several confounding factors, including male sex, NSAID coadministration, advanced age, and prior diagnoses contributing to drug related cardiotoxicity. These findings may help guide therapeutic decision making and ethical trial design for COVID-19 treatment.


Assuntos
Cloroquina/efeitos adversos , Coração/efeitos dos fármacos , Hidroxicloroquina/efeitos adversos , Vigilância de Produtos Comercializados , Segurança , Cloroquina/uso terapêutico , Estudos de Coortes , Infecções por Coronavirus/tratamento farmacológico , Feminino , Humanos , Hidroxicloroquina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/tratamento farmacológico
8.
Zhonghua Liu Xing Bing Xue Za Zhi ; 41(9): 1518-1521, 2020 Sep 10.
Artigo em Chinês | MEDLINE | ID: mdl-33076610

RESUMO

Objective: To analyze the effectiveness and immunogenicity of enterovirus-A71(EV-A71) vaccine in immunization program. Methods: A cohort study was conducted in immunization clinics in Jing'an district in Shanghai from October to December 2017. Children who received EV-A71 vaccine based on a 2-dose schedule (on day 0 and day 30) were enrolled as vaccine group and those who received no EV-A71 vaccine were enrolled as control group. After 1-year follow-up, the effectiveness and neutralizing antibody level and the positive results of antibody immunogenicity in vaccine group were analyzed. Results: A total of 3 018 children aged 8-20 months were enrolled, in whom 1 211 were in vaccine group and 1 807 were in control group. The vaccine effectiveness was 100% against EV-A71-associated hand, foot, and mouth disease (HFMD) indicated by 1 year follow-up (95%CI: -66.99%-100.00%). The geometric mean titer of neutralizing antibody (GMT) was 41.76 (95%CI: 35.60-49.34) at day 60 and 28.44(95%CI: 23.59-34.54) at day 365 in 124 children in vaccine group. Conclusions: In children, EV-A71 vaccine elicited EV-A71-specific immune response. Less EV-A71-associated HFMD cases have been observed, further observation is needed.


Assuntos
Enterovirus , Doença de Mão, Pé e Boca , Vacinas Virais , China , Estudos de Coortes , Enterovirus/imunologia , Doença de Mão, Pé e Boca/prevenção & controle , Humanos , Imunogenicidade da Vacina , Lactente , Vigilância de Produtos Comercializados , Vacinas Virais/administração & dosagem , Vacinas Virais/imunologia
9.
BMJ ; 371: m3434, 2020 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-33028575

RESUMO

OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020. DATA SOURCES: Therapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy). MAIN OUTCOME MEASURES: Proportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status. RESULTS: From 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA. CONCLUSIONS: Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.


Assuntos
Aprovação de Drogas , Avaliação de Medicamentos , Serviços de Informação sobre Medicamentos , Disseminação de Informação , Vigilância de Produtos Comercializados , Aprovação de Drogas/métodos , Aprovação de Drogas/estatística & dados numéricos , Avaliação de Medicamentos/métodos , Avaliação de Medicamentos/estatística & dados numéricos , Serviços de Informação sobre Medicamentos/organização & administração , Serviços de Informação sobre Medicamentos/normas , Serviços de Informação sobre Medicamentos/estatística & dados numéricos , Europa (Continente) , Humanos , Vigilância de Produtos Comercializados/métodos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Desenvolvimento de Programas , Melhoria de Qualidade , Estudos Retrospectivos , Estados Unidos
10.
Ig Sanita Pubbl ; 76(2): 143-151, 2020.
Artigo em Italiano | MEDLINE | ID: mdl-32877397

RESUMO

The development of a vaccine, particularly one that can help against the recent pandemic, is a topic that has recently attracted public opinion. More than ninety vaccines are currently being developed against Sars-Cov2 by universities and companies around the world. They are protein-based vaccines, viral vector vaccines, DNA or RNA vaccines and inactivated or attenuated viral vaccines. The development of a vaccine starts from the identification and characterization of the microorganism that causes the disease. The second step is the preclinical phase. Then, there is the phase of clinical experimentation, which allows to study the posology, efficacy and safety of the vaccine, on an increasingly larger sample. In the European Union, vaccines are authorized through two procedures (EU and national) based on the quality, safety and efficacy requirements defined by the European and international guidelines. Timing of realization, authorization and marketing of new vaccines can be shortened in cases of particular need, through an accelerated evaluation known as "Priority Medicines". In this period, it is crucial not to neglect current vaccinations. In fact, during the pandemic period, many countries postponed vaccination campaigns against many vaccine-preventable diseases, causing a marked decrease in routine immunizations in childhood.


Assuntos
Aprovação de Drogas , Vigilância de Produtos Comercializados , Vacinas , Humanos , Vacinação , Vacinas/administração & dosagem , Vacinas Atenuadas
12.
J Stroke Cerebrovasc Dis ; 29(9): 105034, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32807446

RESUMO

BACKGROUND: Data on independent risk factors for stroke recurrence in Japanese patients with nonvalvular atrial fibrillation are limited. METHODS: We performed a subgroup analysis of a postmarketing surveillance study of apixaban (STroke prevention ANticoagulant Drug Apixaban Real-world Data study) in Japanese patients with nonvalvular atrial fibrillation receiving oral apixaban (5 mg/2.5 mg twice daily) in routine clinical practice. Patients were categorized into primary and secondary prevention groups based on the absence or presence of a history of ischemic stroke/transient ischemic attack, respectively. RESULTS: Patients in the secondary prevention group (1101 of 6306 patients [17.5%] analyzed; mean observation period, 15.7 months) had a higher risk of ischemic stroke or hemorrhage than those in the primary prevention group. The incidence rates of major (3.92%/year vs 2.06%/year), intracranial (1.87%/year vs 0.55%/year), and cerebral (1.14%/year vs 0.37%/year) hemorrhage and effectiveness outcomes (ischemic stroke/systemic embolism/transient ischemic attack, 3.25%/year vs 0.57%/year) were significantly higher (all P < 0.001) in the secondary prevention group than in the primary prevention group. Multivariate analysis identified no independent risk factors in the secondary prevention group, while prior major bleeding, alcohol abuse, advanced age, male sex, lower body weight, higher serum creatinine, and antiplatelet drug use were identified as risk factors for major hemorrhage, and advanced age and antiplatelet drug use for effectiveness outcomes in the primary prevention group. CONCLUSIONS: Among Japanese patients with nonvalvular atrial fibrillation who received apixaban, presence of a history of ischemic stroke/transient ischemic attack was associated with higher incidence rates of hemorrhage and thromboembolic events.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Inibidores do Fator Xa/administração & dosagem , Ataque Isquêmico Transitório/prevenção & controle , Prevenção Primária , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Prevenção Secundária , Acidente Vascular Cerebral/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Ataque Isquêmico Transitório/diagnóstico , Ataque Isquêmico Transitório/epidemiologia , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Prospectivos , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Recidiva , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Resultado do Tratamento
13.
J Vasc Interv Radiol ; 31(9): 1373-1381, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32800660

RESUMO

PURPOSE: To prospectively evaluate the maturation of the endovascular arteriovenous fistula system (EndoAVF) for 2-needle cannulation (2NC). MATERIALS AND METHODS: From October 2018 to June 2019, evaluation of 123 patients resulted in 95 arteriovenous fistulae, a rate of 63% (60 of 95) EndoAVF, and 37% (35 of 60) fistulae treated surgically. At 4 weeks, EndoAVF was not suitable for 2NC (defined as a palpable target vein [TV], 500 mL/min flow volume, and 5-mm diameter) underwent maturation procedures. RESULTS: Technical success of EndoAVF creation was 96.7% (60 of 62). At 4 weeks, 67% (40 of 60) fistulae underwent maturation procedures: 62% (37 of 60) had balloon dilation, 32% (19 of 60) had brachial vein embolization, and 30% (18 of 60) had cubital vein banding, increasing TV flow volume from 182 ± 123 mL/min to 572 ± 225 mL/min (P < 0.0005). Transposition was required in 33% of patients (20 of 60), reducing the mean TV depth from 10.9 to 3.7 mm (P < .0001). 2NC and fistula success (2NC × 3) was achieved in 87% (47 of 54); 10% of patients (6 of 60) were not on dialysis; 6.8% of patients (4 of 60) died; 5% of fistulas (3 of 60) were abandoned for arm swelling, steal syndrome, and thrombosis. Time to 2NC, fistula success, and tunneled catheter removal were 65.6 ± 45.7 days, 79.1 ± 50.9 days, and 113.4 ± 62 days, respectively. Patients achieving 2NC had brachial artery flow of 944 ± 284 mL/min; and TV flow, diameter, and depth of 674 ± 292 mL/min, 6.1 ± 0.8 mm, and 3.6 ± 1.3 mm, respectively. Major complications were arm swelling, steal syndrome, and thrombosis. CONCLUSIONS: Most patients had EndoAVF with maturation procedures at 4 weeks that achieved rapid maturation (Ellipsys Fistula for Hemodialysis Access; NCT03828253).


Assuntos
Derivação Arteriovenosa Cirúrgica/instrumentação , Procedimentos Endovasculares/instrumentação , Antebraço/irrigação sanguínea , Adulto , Idoso , Idoso de 80 Anos ou mais , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Velocidade do Fluxo Sanguíneo , Cateterismo , Procedimentos Endovasculares/efeitos adversos , Feminino , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Oclusão de Enxerto Vascular/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Prospectivos , Sistema de Registros , Diálise Renal , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Virginia , Adulto Jovem
14.
PLoS One ; 15(8): e0237459, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32776971

RESUMO

A surveillance system for sales volumes of antimicrobial agents for veterinary use was established in Germany in 2011. Since then, pharmaceutical companies and wholesalers have been legally obliged to report annual volumes of veterinary antimicrobial products sold to veterinary practices or clinics located in Germany. The evaluation of sales volumes for eight consecutive years resulted in a considerable total decrease by 58% from 1706 tons to 722 tons. During the investigation period, two legally binding measures to control the risk of antimicrobial resistance resulting from the veterinary use of antimicrobials were introduced, a) the German treatment frequencies benchmarking in 2014 and b) the obligation to conduct susceptibility testing for the use of cephalosporins of the 3rd and 4th generation and of fluoroquinolones in 2018. Both had a marked impact on sales volumes. Nonetheless, the category of Critically Important Antimicrobials as defined by the World Health Organization kept accounting for the highest share on sales volumes in Germany in 2018 with 403 tons, despite an overall reduction by 53%. Sales surveillance is considered essential for data retrieval on a global scale and inter-country comparison. However, the usability of a surveillance system based on sales data for risk management of antimicrobial resistance has limitations. The German system does not include off-label use of antimicrobial products authorized for human medicine and does not allow for identification of areas of high risk according to animal species, farm and production types and indications for treatment. For further reduction and enhanced promotion of a prudent use of antimicrobials, targeted measures would be required that could only be deducted from use data collected at farm or veterinary practice level. A surveillance system based on use data is currently lacking in Germany but will be established according to Regulation (EU) 2019/6 on veterinary medicinal products.


Assuntos
Anti-Infecciosos/economia , Comércio/estatística & dados numéricos , Percepção , Vigilância de Produtos Comercializados , Drogas Veterinárias/economia , Alemanha , Controle Social Formal , Tetraciclina/economia , Organização Mundial da Saúde
16.
Expert Opin Pharmacother ; 21(14): 1771-1780, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32693663

RESUMO

BACKGROUND: With limited real-world insulin glargine 300 unit/mL (Gla-300) data available, we assessed the effectiveness and safety of Gla-300 in the Japanese type 2 diabetes mellitus (T2DM) population. RESEARCH DESIGN AND METHODS: X-STAR was a prospective, observational, 12-month post-marketing study of Gla-300 from 2015 to 2018. T2DM patients received Gla-300 as the first insulin (insulin-naïve) or after treatment with another type of insulin (insulin-experienced). RESULTS: We identified 1,227 insulin-naïve and 3,394 insulin-experienced patients. Insulin-naïve group increased the Gla-300 starting dose by 2.80 U/day during 12 months (7.49 to 10.29 U/day). Mean HbA1c reduced by 1.99% (9.82 to 7.83%), and 28.4% showed HbA1c < 7.0%. Insulin-experienced group had a baseline insulin dose of 14.86 U/day, which increased by 0.73 U/day. Mean HbA1c reduced by 0.18% (7.99 to 7.81%), and 24.6% showed HbA1c < 7.0%. Adverse drug reactions occurred in 3.42% (insulin-naïve) and 4.45% (insulin-experienced); symptomatic hypoglycemia (2.93% and 3.86%, respectively) was the most common in both groups. CONCLUSIONS: Gla-300, in clinical practice, provides an effective and safe therapy as HbA1c was reduced/maintained in insulin-naïve/experienced Japanese T2DM patients without new safety signal. This study provides insights into the current Japanese clinical practices where insulin use is delayed and conservative despite relatively low HbA1c achievement.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina Glargina/uso terapêutico , Idoso , Glicemia/análise , Diabetes Mellitus Tipo 2/epidemiologia , Relação Dose-Resposta a Droga , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Insulina/uso terapêutico , Insulina Glargina/administração & dosagem , Insulina Glargina/efeitos adversos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Estudos Prospectivos , Resultado do Tratamento
17.
Clin Drug Investig ; 40(9): 847-859, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32621143

RESUMO

BACKGROUND AND OBJECTIVES: Topiroxostat, a selective xanthine oxidoreductase inhibitor, is used for the management of hyperuricemic patients with or without gout in Japan. Accumulating evidence has demonstrated the efficacy of topiroxostat for the treatment of hyperuricemia with or without gout. However, the safety and efficacy of topiroxostat in the clinical setting remain unclear, and there is little large-scale clinical evidence. We conducted a post-marketing observational study over 54 weeks. PATIENTS AND METHODS: Patients were centrally enrolled, and case report forms of 4491 patients were collected between April 2014 and March 2019 from 825 medical sites. RESULTS: Overall, 4329 patients were assessed for safety and 4253 patients for effectiveness. The overall incidence of adverse drug reactions was 6.95%, and the incidence rates of adverse drug reactions of gouty arthritis, hepatic dysfunction, and skin disorders, which are of special interest in this study, were 0.79%, 1.73%, and 0.95%, respectively. No case of serious gouty arthritis was observed. Serum urate levels decreased stably over time and showed a significant reduction rate at 54 weeks (21.19% ± 22.07%) and on the final visit (19.91% ± 23.35%) compared to the baseline. The rates for subjects who achieved serum uric acid levels ≤ 6.0 mg/dL at 18 and 54 weeks after administration were 43.80% and 48.28%, respectively. CONCLUSIONS: This study suggests that there is no particular concern about adverse drug reactions or the efficacy of topiroxostat for hyperuricemic patients with or without gout in a post-marketing setting in Japan.


Assuntos
Supressores da Gota/uso terapêutico , Gota/tratamento farmacológico , Hiperuricemia/tratamento farmacológico , Nitrilos/uso terapêutico , Vigilância de Produtos Comercializados , Piridinas/uso terapêutico , Xantina Desidrogenase/antagonistas & inibidores , Adulto , Inibidores Enzimáticos/efeitos adversos , Inibidores Enzimáticos/uso terapêutico , Feminino , Supressores da Gota/efeitos adversos , Humanos , Incidência , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Nitrilos/efeitos adversos , Piridinas/efeitos adversos , Resultado do Tratamento , Ácido Úrico/sangue
19.
Vaccine ; 38(40): 6194-6198, 2020 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-32684499

RESUMO

COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national regulatory authorities. Alongside preparations to ensure equitable access to the vaccines among people globally, preparations must be made within countries for COVID-19 vaccines safety surveillance on an urgent basis. Safety surveillance must be capable of investigating adverse events of special interest (AESI) and adverse events following immunization to determine a change in the benefit-risk profile of the vaccine, and to be able to anticipate coincidental events that might be attributed to the vaccine. Active surveillance systems should calculate the incidence of background rates of AESI prior to vaccine roll out. These background rates vary tremendously across regions, populations and case ascertainment methods. Active surveillance systems must be established or strengthened now, (including in LMIC), to calculate the background rates. Utilizing standardized case definitions and global standards for AESI will help in harmonization. Vaccine safety communication plans should be developed. Expanding the global vaccine safety system to meet the needs of COVID-19 and other emergency and routine use vaccines is a priority currently.


Assuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/imunologia , Pneumonia Viral/prevenção & controle , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologia , Sistemas de Notificação de Reações Adversas a Medicamentos , Humanos , Vigilância de Produtos Comercializados , Vacinação
20.
Yonsei Med J ; 61(7): 623-630, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32608206

RESUMO

PURPOSE: Vaccine hesitancy is among the top ten threats to global health, and access to precise data on adverse events following immunization (AEFIs) is imperative to alleviate public concerns surrounding vaccines. This study aimed to present the overall trends of AEFIs reported in South Korea. MATERIALS AND METHODS: We evaluated the trends of AEFIs using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System database between January 2005 and December 2017. AEFIs were classified into five categories to evaluate associations between vaccines and AEFIs through a case-non-case study: neurologic reactions, general systemic reactions, local reactions, allergic reactions, and others. RESULTS: Among 54378 reported adverse events (AEs) associated with all vaccines approved in South Korea, more than half (56.7%) occurred following influenza vaccination, followed by the pneumococcal (11.6%) and Bacillus Calmette-Guérin (BCG) vaccines (5.0%). After immunization with most vaccines, general systemic reactions were most common, followed by local and neurologic reactions. Adjusted reporting odds ratios were calculated for all neurologic, general, local, and allergic reactions: of all vaccines, rotavirus [neurologic 2.43, 95% confidence interval (CI), 2.25-2.62], BCG (general; 2.20, 95% CI, 1.91-2.53), BCG (local; 3.15, 95% CI, 2.69-3.68), and Japanese encephalitis (allergic 2.38, 95% CI, 1.98-2.87) vaccines showed the highest values. CONCLUSION: The majority of reported AEFIs were non-serious and mostly general systemic reactions. Sufficient knowledge on the AEFIs would secure public confidence on the safety of vaccines, thereby reducing public health burden from vaccine-preventable diseases.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hipersensibilidade/epidemiologia , Imunização/efeitos adversos , Vigilância de Produtos Comercializados , Vacinação/efeitos adversos , Adulto , Algoritmos , Vacina BCG , Bases de Dados Factuais , Feminino , Humanos , Imunização/psicologia , Masculino , República da Coreia , Vacinação/psicologia , Vacinação/estatística & dados numéricos
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