Current medical research and opinion
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Randomized Controlled Trial
A phase 1, placebo-controlled, randomised, double-blind (within dose panels) study evaluating the safety, tolerability and pharmacokinetics of intravenous NXY-059 in Japanese subjects.
NXY-059 has a proposed mechanism of action of free-radical trapping and has been studied in clinical trials based on positive effects seen in experimental models of acute ischaemic stroke. This study evaluated the safety, tolerability and pharmacokinetics of NXY-059 in healthy Japanese male subjects compared with previous data from healthy Caucasian subjects. ⋯ This study suggests that the tolerability and pharmacokinetics of NXY-059 in healthy Japanese male subjects and Caucasians are similar.
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Clinical Trial
Effects of early use of pioglitazone in combination with metformin in patients with newly diagnosed type 2 diabetes.
Type 2 diabetes is characterised by a progressive decline in HbA1c control over time. Early combination therapy, rather than sequential introduction of individual oral glucose-lowering agents, has been proposed to prevent this gradual rise in HbA1c. This observational study assessed the effect of early dual combination oral glucose-lowering therapies within 6 months of diagnosis in newly diagnosed, drug-naïve patients with type 2 diabetes. ⋯ This preliminary analysis of an observational, non-randomised, open-label ongoing study has shown that early use of combination therapy at time of diagnosis or within the first 3-6 months following diagnosis with metformin plus pioglitazone in newly diagnosed type 2 diabetes results in a slower deterioration in glycaemic control than that with metformin combined with either gliclazide or repaglinide. This may be due to the beta-cell protective properties of pioglitazone. These results need to be confirmed by further studies with a more robust design and methodology.
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The International Society for Medical Publication Professionals (ISMPP) is an independent, nonprofit professional association with members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communications companies; academia; and medical journal staffs, including editors and publishers. ISMPP's mission is to support the educational needs of medical publication professionals by providing a forum to facilitate awareness and development of best practices in publication planning and implementation, and fostering consensus policies related to medical publishing. This position statement reflects our concern about the current climate of mistrust regarding the use of professional medical writers in the preparation of manuscripts. ⋯ ISMPP endorses use of the contributorship model, which offers detailed information on the roles of all who participated in planning, conducting, developing, and publishing medical research. Further, we propose that this model be integrated into the standard operating procedures of the diverse organizations that comprise our membership because the responsibility for authorship disclosure is shared by sponsors, authors, study investigators, and medical writers. Finally, we commend the many organizations that have worked to increase recognition and understanding of the legitimate role of the medical writer, and are eager to work in concert with them to ensure the rigorous maintenance of all ethical standards for reporting the results of medical research.
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Recent observational studies have suggested that statins can decrease the incidence and severity of various infections including pneumonia and bacteremia. However, the effect of statins on post-cardiac surgery infection has not been adequately evaluated. Therefore we sought to determine whether preoperative statin use resulted in a reduction in infection following cardiac surgery. ⋯ Preoperative statin use is associated with a reduction in patients' odds of developing a postoperative infection following cardiac surgery.