Is there evidence for recommending specific intravenous immunoglobulin formulations? A systematic review of head-to-head randomized controlled trials.

Intravenous immunoglobulins (IVIG) have been used for several licensed and off-label indications. Each IVIG product is a unique formulation of IgG and excipients, making them distinct products. How these differences impact on individual IVIG product efficacy and safety are not well established but can be investigated by head-to-head randomized controlled trials (RCT). A systematic review of head-to-head RCT comparing different formulations of IVIG, regardless of the target condition and outcomes investigated. Two reviewers screened 4084 citations retrieved from MEDLINE, Embase, Cochrane and LILACS, and 23 citations were fully-text evaluated. Eight trials were included. The clinical conditions, outcomes and risk of bias were assessed. Of the eight trials included only two investigated products that are currently on the market. One evaluated two Grifols brands used in patients with primary immunodeficiency and another evaluated two Baxter brands used in patients with chronic inflammatory demyelinating polyradiculoneuropathy. There were no differences between the formulations for the outcomes evaluated. In the other trials, either the manufacturers were acquired by other companies or the formulation was withdrawn from the market. As consequence, evidence concerning these products could not be considered. The quality of the studies was low, showing high risk of bias. Direct evidence about the different IVIGs is scarce and, at present, there is no scientific evidence that can be applied for a specific brand or formulation. Further comparative effectiveness studies are highly desirable for a better understanding of the differences in safety and efficacy of IVIGs.

[The impact of diabetes mellitus on the mortality of acute coronary syndromes]. / Impacto do diabetes mellitus na mortalidade em síndromes coronarianas agudas.

Diabetes mellitus (DM) is a leading cause of mortality in the world, mainly on account of cardiovascular diseases. At present we know that not only DM but also other hyperglycemic states are a risk factor for coronary arterial disease. In the context of acute coronary syndromes, DM determines a worst prognosis, either in short- or long-term outcomes. Since the absolute risk of death is greater among diabetic patients when compared to non-diabetic patients, therapeutical interventions have a greater impact in terms of benefits to these patients as well. Strategies such as strict control of hyperglycemia during hospitalization, acute reperfusion management (either by thrombolysis or by percutaneous coronary intervention), use of platelet glycoprotein IIb/IIIa inhibitors and angiotensin-converting enzyme (ACE)-inhibitors have recently proven to be of greater benefit for diabetics over non-diabetic patients. Meanwhile, in spite of all proven benefits of the use of evidence-based interventions to the treatment of acute coronary syndromes on diabetic patients, there is still an under utilization of these measures. Therefore, taking into account the predictions of an increasing number of diabetics in the world for the future years, and the fact that acute coronary syndromes will be the leading cause of death among them, it becomes increasingly necessary for both cardiologists and endocrinologists to work together in order to reduce the unfavorable outcomes that are expected to arise.

Impacto do diabetes mellitus na mortalidade em síndromes coronarianas agudas / The impact of diabetes mellitus on the mortality of acute coronary syndromes

O diabetes mellitus (DM) é uma das grandes causas de morte no mundo, principalmente em decorrência das doenças cardiovasculares. Atualmente, sabe-se que não somente o DM, como também os demais estados hiperglicêmicos, determinam um risco aumentado de doença arterial coronariana. No contexto das síndromes coronarianas agudas (SCA), o DM determina um pior prognóstico, tanto a curto quanto a longo prazo. Sendo o risco absoluto de mortalidade maior em diabéticos, as intervenções nessa população trazem maior impacto quanto aos benefícios. Estudos têm comprovado um maior benefício em diabéticos contra não-diabéticos na adoção de medidas como controle rigoroso da hiperglicemia intra-hospitalar, terapia de reperfusão (seja por trombólise, seja por intervenção percutânea), uso de inibidores da glicoproteína IIb/IIIa e de inibidores da enzima conversora da angiotensina (ECA). Apesar dos benefícios da adoção de intervenções baseadas em evidências no tratamento das SCA em diabéticos, chama atenção a sub-utilização dessas medidas. Tendo em vista o aumento da prevalência do diabetes mellitus previsto para os próximos anos e levando-se em conta que as síndromes coronarianas agudas serão a principal causa de mortalidade nessa população, torna-se cada vez mais necessário que cardiologistas e endocrinologistas passem a interagir, de maneira a modificar o panorama previsto.

Diabetes mellitus (DM) is a leading cause of mortality in the world, mainly on account of cardiovascular diseases. At present we know that not only DM but also other hyperglycemic states are a risk factor for coronary arterial disease. In the context of acute coronary syndromes, DM determines a worst prognosis, either in short- or long-term outcomes. Since the absolute risk of death is greater among diabetic patients when compared to non-diabetic patients, therapeutical interventions have a greater impact in terms of benefits to these patients as well. Strategies such as strict control of hyperglycemia during hospitalization, acute reperfusion management (either by thrombolysis or by percutaneous coronary intervention), use of platelet glycoprotein IIb/IIIa inhibitors and angiotensin-converting enzyme (ACE)-inhibitors have recently proven to be of greater benefit for diabetics over non-diabetic patients. Meanwhile, in spite of all proven benefits of the use of evidence-based interventions to the treatment of acute coronary syndromes on diabetic patients, there is still an under utilization of these measures. Therefore, taking into account the predictions of an increasing number of diabetics in the world for the future years, and the fact that acute coronary syndromes will be the leading cause of death among them, it becomes increasingly necessary for both cardiologists and endocrinologists to work together in order to reduce the unfavorable outcomes that are expected to arise.