What is Constella?
Constella is a medicine that contains the active substance linaclotide, available as capsules (290 micrograms).
What is Constella used for?
Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome (IBS) with constipation in adults. IBS is a chronic disorder of bowel function characterized by abdominal pain or discomfort, accompanied by bloating and changes in the "alvo.
The medicine can only be obtained with a prescription.
How is Constella used?
The recommended dose of Constella is one capsule once a day, taken at least 30 minutes before a meal.
The physician should periodically evaluate the need for further treatment. If patients do not experience improvement in symptoms after four weeks of treatment, the benefits and risks of continuing treatment should be reconsidered.
How does Constella work?
The active substance in Constella, linaclotide, binds to a receptor in the intestine called guanylate cyclase C. This relieves pain and increases fluid secretion in the intestine, softening the stool and improving peristalsis.
How has Constella been studied?
Constella's effects were first tested in experimental models before being studied in humans.
Constella was studied in two main studies involving a total of 1 608 IBS patients with constipation, in which it was compared with a placebo (substance with no effect on the body). The main parameters of effectiveness were the number of patients who reported an improvement of at least 30% in pain and discomfort and the number of patients in whom IBS symptoms were significantly or completely reduced for at least 6 out of 12 weeks of treatment. One of the studies also looked at the effects of Constella after 26 weeks of treatment.
What benefit has Constella shown during the studies?
Constella was more effective than placebo in improving symptoms of IBS. In the first study, 55% of patients treated with Constella reported a 30% or greater improvement in intestinal pain and discomfort for at least 6 out of 12 weeks of treatment. compared to 42% of placebo subjects In addition, there was significant improvement or complete disappearance of symptoms for at least 6 out of 12 weeks of treatment in 37% of patients treated with Constella compared with 19% of subjects treated with placebo.
Similar results were obtained in the second study, at the end of which 54% of patients treated with Constella had an improvement in pain and discomfort, while 39% experienced significant relief or total disappearance of symptoms due to at least 6 out of 12 weeks of treatment compared with 39% and 17% of patients treated with placebo.
Results after 26 weeks of treatment showed improvement in pain (for at least 13 out of 26 weeks) in 54% of patients treated with Constella compared to 36% of subjects treated with placebo, as well as relief of symptoms for at least 13 weeks in the 37% of patients treated with Constella compared with 17% of subjects given placebo.
What is the risk associated with Constella?
The most common side effect of Constella is diarrhea, mostly mild to moderate in intensity, reported by 10-20 out of 100 patients. In rare and more severe cases, diarrhea can lead to the onset of dehydration, hypokalaemia (lack of potassium in the blood), decreased bicarbonate in the blood, dizziness and orthostatic hypotension (drop in blood pressure when the patient stands up).
Constella must not be used in people who are hypersensitive (allergic) to linaclotide or any of the other ingredients. It should also not be used in patients with known or suspected gastric or intestinal blockage.
Why has Constella been approved?
The CHMP noted that Constella has been shown to have clinically important beneficial effects in patients with long-term (up to six months) IBS associated with constipation. It has also been shown to have a beneficial impact on patients' quality of life. However, the Committee noted that around half of the patients did not benefit adequately from the treatment and therefore recommended that the continuation of treatment after four weeks be reconsidered. Regarding safety, the CHMP concluded that the effects Constella's side effects, including diarrhea, are manageable The CHMP therefore decided that Constella's benefits are greater than its risks and recommended that it be given a Marketing Authorization for the medicine.
More information about Constella
On November 26, 2012, the European Commission issued a "marketing authorization" for Constella, valid throughout the European Union.
For the complete version of Constella's EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Constella therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: November 2012.
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