drip, drip. A drug given to many patients maintain their blood volume may do more harm than good.
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evidence is mounting that one of the most frequently used in ICU interventions (ICU) does more harm than good. Data from a clinical trial published today show that patients who received anti-shock drug known as hydroxyethyl starch (HES) were more likely to need kidney dialysis or a kidney transplant than those treated with saline. HES patients were also more likely to die within 0 days, although this difference was not statistically significant.
HES, a synthetic derivative of ordinary starch, is a large molecule that binds liquid and is usually given to patients who have lost a lot of blood. The compound maintains blood volume and prevents their circulation collapse. A first study indicating that HES could be harmful for patients was published in The Lancet in 01, but was largely ignored by regulators, says Tobias Welte, a pulmonologist at the School of medicine in Hanover, Germany, who studied the compound. In June this year, a clinical trial conducted in Denmark, published in The New England Journal of Medicine , concluded that septic patients with HES were much more likely to die within 0 days and need a renal replacement therapy that patients treated with an alternative called Ringer's acetate.
This study has sparked a row between the author Anders Perner University Hospital of Copenhagen, who argued that the results applied to all HES compounds, and the German drug company Fresenius Kabi, who felt his own compound, Voluven, was unjustly accused by the paper. Some researchers have called for the drug to be withdrawn from the market, but regulators have argued that the data from a second clinical trial which was about to finish and uses Voluven essential.
The results of this trial, which took place in Australia and New Zealand, were published today in The New England Journal of Medicine . The crystalloid against Hydroxyethyl Starch Trial (SAFE) includes data from over 60 patients treated in the ICU. Among patients treated with HES, 18% died, against 17% for those treated with saline.
The difference is not significant, but the study author John Myburgh of the George Institute for Global Health in Sydney, Australia, said that perhaps because the patient groups with a rate higher mortality were excluded from the trial, making it difficult to detect a statistically significant difference. "Perner looked septic patients. Our population was a general population of adult ICU patients," said Myburgh, which presents its communication to the Annual Congress of the European Society of Intensive Care in Lisbon today. It also emphasizes that therapy renal replacement was often necessary and there was much higher rates of adverse events such as bleeding or itching in the HES group. Together, the two studies provide no evidence that HES compounds benefit the patient and instead raise safety concerns, he argues.
Perner agrees that the evidence in the same direction. "it has never been shown that any of these compounds benefit patients, "he said." at the very least, they should be labeled that they are against-indicated in patients with sepsis and that extreme caution should be taken when using with other patients at increased risk kidney failure or bleeding. " This includes most patients who routinely receive HES in an intensive care unit, he said.
But the discussion has wider implications, said Myburgh. "We need to examine more closely this fluid we give to specific patients and how" -and perhaps the fluid authorization process must be reformed. "These are really intravenous drugs and must be treated as such . "
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