Legislação de propriedade industrial do Brasil e México no contexto do Acordo Trips e da epidemia da AIDS: um estudo comparativo

Este trabalho teve o objetivo de analisar retrospectivamente o significado da interseção de dois fenômenos sociomodernos. Em primeiro lugar, a epidemia de HIV/AIDS (Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida), com suas características históricas pouco usuais e alta letalidade; e, por sua vez, a intrusão de leis de propriedade intelectual na sociedade, como o Acordo Trips (Trade Related Intellectual Property Subjects), com amplas repercussões sobre a saúde pública, sendo aqui tratados especificamente os casos de Brasil e México. Ambos os países modificaram suas leis de propriedade intelectual (LPI) para implementar o Acordo Trips (e, no caso do México, também o Nafta) nas últimas duas décadas, levando a patamares mais elevados de proteção de propriedade intelectual no México, quando comparado ao Brasil. Essas mudanças, porém, podem ter contribuído, no caso do México, para um menor rendimento e eficácia do seu programa de combate à epidemia de AIDS¬HIV já que, para dar uma cobertura mais adequada de tratamento com medicamentos antirretrovirais (ARVs) a sua população, teve que enfrentar maiores dificuldades para sua aquisição. No substrato dos fatores causais dessas divergências, podem ser considerados diversos fatores de natureza econômica e política, dentre eles a maior ou menor magnitude da influência política dos Estados Unidos e interesses econômicos de suas empresas transnacionais sobre ambos os países

POLÍTICA DE SAÚDE PARA A EPIDEMIA DA AIDS DO BRASIL E MÉXICO NO CONTEXTO DO ACORDO TRIPS

Durante as últimas duas décadas, a sociedade testemunhou dois fenômenos sociaisque a afetaram substancialmente: a epidemia de HIV/AIDS com suas características poucousuais e alta letalidade; e a intrusão de leis de propriedade intelectual na vida cotidiana,como o Acordo TRIPS com amplas repercussões sobre a saúde pública. O objetivo destetrabalho foi analisar retrospectivamente como foi a política de saúde de combate à epidemiado HIV/AIDS de Brasil e México. Comparativamente, o impacto da epidemia do HIVsobre a população foi maior no Brasil que no México, gerando no primeiro uma maiorpreocupação da sociedade civil, levando a classe política a tomar medidas inovadoras

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Background: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. Methods: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR)25–75 mL/min per 1·73 m 2 of body surface area, and a urine albumin-to-creatinine ratio (UACR)of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders)were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days)or end-stage kidney disease (eGFR <15 mL/min per 1·73 m 2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure)in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. Findings: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325)or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4–2·9). 79 (6·0%)of 1325 patients in the atrasentan group and 105 (7·9%)of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR]0·65 [95% CI 0·49–0·88]; p=0·0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3·5%)of 1325 patients in the atrasentan group and 34 (2·6%)of 1323 patients in the placebo group (HR 1·33 [95% CI 0·85–2·07]; p=0·208). 58 (4·4%)patients in the atrasentan group and 52 (3·9%)in the placebo group died (HR 1·09 [95% CI 0·75–1·59]; p=0·65). Interpretation: Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. Funding: AbbVie

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

The original version of this article unfortunately contained a mistake

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

The TRIPS agreement and its repercussions on access to medicine. The case of HIV/AIDS in Brazil and Mexico: \"patent right\" vs. \"right to life\"

Este trabalho teve o objetivo de analisar retrospectivamente o significado da interseção de dois fenômenos sociomodernos. Em primeiro lugar, a epidemia de HIV/AIDS (Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida), com suas características históricas pouco usuais e alta letalidade; e, por outro lado, a intrusão de leis de propriedade intelectual na sociedade, como o Acordo TRIPS (Trade Related Intellectual Property Subjects), com amplas repercussões sobre a saúde pública assim como sobre o desenvolvimento econômico e tecnológico dos países, sendo aqui tratados especificamente os casos de Brasil e México. Ambos os países modificaram suas leis de propiedade intelectual (LPI) para implementar o Acordo TRIPS (e, no caso do México, também o NAFTA) nas últimas duas décadas, levando a patamares mais elevados de proteção de propriedade intelectual no México, quando comparado ao Brasil. Estas mudanças, porém, podem ter contribuído, no caso do México, para um menor rendimento e eficácia do seu programa de combate à epidemia de AIDS/HIV já que, para dar uma cobertura mais adequada de tratamento com medicamentos antirretrovirais (ARVs) para sua população, teve que enfrentar maiores dificuldades para sua aquisição.This work analyzed retrospectively the meaning of the intersection of two modern social phenomena. Firstly, the epidemic of HIV/AIDS (Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome), with its unusual historical characteristics and high lethality; and , on the other hand, the intrusion of intellectual property laws in society as the TRIPS (Trade Related Intellectual Property Subjects) Agreement, that has far-reaching consequences on public health as well as on the economic and technological development of countries, and here we treated specifically the cases of Brazil and Mexico. Both countries changed their intellectual property laws to implement the TRIPS Agreement (and in the case of Mexico also NAFTA) during the last two decades, leading to higher levels of intellectual property protection in Mexico compared to Brazil. However these changes may have contributed in the case of Mexico to a lower performance and effectiveness of its programme to combat the epidemic of HIV/AIDS, since to give a more adequate coverage of treatment with antiretroviral drugs (ARVs) for its population, had to face major difficulties for the purchase of these medicines

Legislação de propriedade industrial do Brasil e México no contexto do Acordo Trips e da epidemia da AIDS: um estudo comparativo

Este trabalho teve o objetivo de analisar retrospectivamente o significado da interseção de dois fenômenos sociomodernos. Em primeiro lugar, a epidemia de HIV/AIDS (Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida), com suas características históricas pouco usuais e alta letalidade; e, por sua vez, a intrusão de leis de propriedade intelectual na sociedade, como o Acordo Trips (Trade Related Intellectual Property Subjects), com amplas repercussões sobre a saúde pública, sendo aqui tratados especificamente os casos de Brasil e México. Ambos os países modificaram suas leis de propriedade intelectual (LPI) para implementar o Acordo Trips (e, no caso do México, também o Nafta) nas últimas duas décadas, levando a patamares mais elevados de proteção de propriedade intelectual no México, quando comparado ao Brasil. Essas mudanças, porém, podem ter contribuído, no caso do México, para um menor rendimento e eficácia do seu programa de combate à epidemia de AIDS¬HIV já que, para dar uma cobertura mais adequada de tratamento com medicamentos antirretrovirais (ARVs) a sua população, teve que enfrentar maiores dificuldades para sua aquisição. No substrato dos fatores causais dessas divergências, podem ser considerados diversos fatores de natureza econômica e política, dentre eles a maior ou menor magnitude da influência política dos Estados Unidos e interesses econômicos de suas empresas transnacionais sobre ambos os países

Legislação de propriedade industrial do Brasil e México no contexto do Acordo Trips e da epidemia da AIDS: um estudo comparativo

Este trabalho teve o objetivo de analisar retrospectivamente o significado da interseção de dois fenômenos sociomodernos. Em primeiro lugar, a epidemia de HIV/AIDS (Vírus da Imunodeficiência Humana/Síndrome de Imunodeficiência Adquirida), com suas características históricas pouco usuais e alta letalidade; e, por sua vez, a intrusão de leis de propriedade intelectual na sociedade, como o Acordo Trips (Trade Related Intellectual Property Subjects), com amplas repercussões sobre a saúde pública, sendo aqui tratados especificamente os casos de Brasil e México. Ambos os países modificaram suas leis de propriedade intelectual (LPI) para implementar o Acordo Trips (e, no caso do México, também o Nafta) nas últimas duas décadas, levando a patamares mais elevados de proteção de propriedade intelectual no México, quando comparado ao Brasil. Essas mudanças, porém, podem ter contribuído, no caso do México, para um menor rendimento e eficácia do seu programa de combate à epidemia de AIDS¬HIV já que, para dar uma cobertura mais adequada de tratamento com medicamentos antirretrovirais (ARVs) a sua população, teve que enfrentar maiores dificuldades para sua aquisição. No substrato dos fatores causais dessas divergências, podem ser considerados diversos fatores de natureza econômica e política, dentre eles a maior ou menor magnitude da influência política dos Estados Unidos e interesses econômicos de suas empresas transnacionais sobre ambos os países