przepraszam, że nie przetlumaczoneSeptember 24, 2012 — The European Medicines Agency (EMA) has recommended authorization of linaclotide (Constella, Almirall), which would make it the first medicine in the European Union specifically intended for symptoms related to irritable bowel syndrome (IBS), according to an announcement made September 21 by the agency.
In the United States, linaclotide is marketed as Linzess (Forest Laboratories) and has received US Food and Drug Administration approval for the treatment of constipation-predominant IBS and chronic idiopathic constipation in adults aged 8 years or older. The EMA is recommending that linaclotide be authorized for adults with moderate to severe IBS with constipation.
Linaclotide is a synthetic 14-amino-acid peptide that acts as a guanylate cyclase C agonist, increases the secretion of fluid in the intestine, and accelerates the passage of fecal material through the gut.
The EMA approval is based on 2 major clinical trials that demonstrated improvement of symptoms after 12 weeks of treatment with linaclotide compared with placebo. The study also found that symptomatic relief was sustained for at least 6 months, but relief was not achieved in about half of patients taking the drug. The EMA recommends, therefore, that patients be monitored regularly and that a different treatment approach be used if symptoms have not been resolved after 4 weeks.
The most common adverse effect of the drug was diarrhea, which occurred in about 20% of patients. Other adverse effects reported with linaclotide are abdominal pain, flatulence, abdominal distension, viral gastroenteritis, and headache.
The EMA is recommending that patients with severe or prolonged diarrhea should be monitored closely when taking linaclotide and that this drug be used with caution in patients prone to water or electrolyte balance disturbances.
Linaclotide is recommended for IBS with constipation at a once-daily dose of 290 μg orally once daily and at a dose of 145 μg orally once daily. It should be taken once daily on an empty stomach at least 30 minutes before the first meal of the day.
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