Цитата:
The US Food and Drug Administration (FDA) has issued a new boxed warning to the label of canagliflozin (Invokana, Invokamet, Janssen) to describe the risk for leg and foot amputations.
This heightened warning follows a May 2016 safety alert based on interim data from one of two ongoing trials in which the risk had been seen in one but not the other. Now, final results from both trials ― CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) ― indicate an approximate doubling of the risk for both leg and foot amputations in canagliflozin-treated patients compared to those randomly assigned to receive placebo.
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- FDA Adds Boxed Warning to Canagliflozin for Amputation Risk, Miriam E. Tucker, May 16, 2017 - ссылка на [
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Цитата:
The FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo.
A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.
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