Prucalopride therapy or Resolor is a highly selective 5HT4 agonist that stimulates bowel movements in women with refractory constipation and Irritable Bowel Syndrome.
It is not currently licensed for use in men as the studies have yet to confirm safety in males.
5HT4 receptors can be found within your bowel wall and are dotted throughout your gastrointestinal tract.
These receptors are activated by the drug, resulting in increased contractions of your bowel.
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Studies of the drug have shown a drug response rate of between 19.5% and 28%.
Whilst this may seem rather small numbers, you have to remember that this drug is for use in refractory constipation i.e. it is for use in women who have failed the usual constipation treatments.
The studies actually did involve both men and women, but the results were in 85% of women v 15% of men so statistically it wasn't possible to confirm its safety in men.
There are studies looking at men, but these are yet to be published.
Other bowel stimulants, or prokinetics as they are known such as Tagaserod, were withdrawn from the market on safety concerns.
Because they weren’t selective for the bowel only, they were having effects on the heart, causing conduction abnormalities. This put sufferer’s lives at risk and was the reason for their withdrawal.
The studies on this particular drug have looked at safety carefully in women and have found none of these issues.
Supplied by the trade name Resolor as 2 mg tablets, the normal dose in adults is 2 mg once a day.
The dose is normally halved in the elderly (>65 years).
This drug shouldn't be taken in pregnancy or in women who are breast feeding.
It is also contraindicated in anyone on renal dialysis and in inflammatory bowel disease (Crohn’s and Ulcerative colitis).
The main side effects of Rosolor are diarrhea (3-19% in studies), headaches (25-30% in studies), nausea (8-24% in studies) and abdominal pain (11-23% in studies).
Most symptoms settle after 24 hours.
This drug is clearly an advance if you suffer from refractory constipation. The drug’s safety has been carefully evaluated and shown to have no major side-effects and importantly no effects on your heart.
I suspect that it will be licensed for men in due course, when the safety aspect has been confirmed for them.