Plecanatide Brand Name– TRULANCE
What is Plecanatide
Plecanatide is a guanylate cyclase-C agonist approved for adults for treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). In 2 randomized, 12-week studies of more than 2,600 patients with CIC, plecanatide-treated patients achieved the primary endpoint of significantly greater efficacy responder rates compared to placebo (Study 1: 21% vs. 10%; Study 2: 21% vs. 13%, p < 0.005 for both studies).
Efficacy responders were defined as patients who had at least 3 complete spontaneous bowel movements (CSBMs) in a given week and an increase of at least 1 CSBM over baseline in the same week for at least 9 weeks out of the 12-week period, including at least 3 of the last 4 weeks.
Plecanatide-treated patients also had improvements as compared to placebo in stool frequency (as measured by the number of spontaneous bowel movements per week), stool consistency (as measured by the Bristol Stool Form Scale), and straining with bowel movements.
In 2 randomized controlled trials involving more than 2,100 patients with IBS-C, significantly more patients achieved the primary endpoint (30% or more reduction in worst abdominal pain and an increase of 1 or more CSBM vs. baseline, in the same week, for at least half of the 12 treatment weeks) with plecanatide vs. placebo (30% vs. 18%; p < 0.001 and 21% vs. 14%; p = 0.009).
Plecanatide was approved by the FDA in January 2017.
Indications
- constipation
- irritable bowel syndrome
For the treatment of chronic idiopathic constipation (CIC)
Side Effects
- diarrhea
- dizziness
- elevated hepatic enzymes
- flatulence
- infection
- nausea
- pharyngitis
- sinusitis
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- abdominal pain
- breast-feeding
- children
- cholelithiasis
- Crohn’s disease
- diarrhea
- diverticulitis
- fecal impaction
- gastric cancer
- GI disease
- GI obstruction
- infants
- inflammatory bowel disease
- neonates
- pregnancy
Interactions
There are no drug interactions associated with Plecanatide products.
