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Amitiza (Lubiprostone) - Summary

 
 



AMITIZA SUMMARY

Lubiprostone is a locally acting chloride channel activator that enhances a chloride-rich intestinal fluid secretion without altering sodium and potassium concentrations in the serum.

Amitiza® (Lubiprostone) is indicated for the following:

Chronic Idiopathic Constipation

Amitiza® is indicated for the treatment of chronic idiopathic constipation in adults.

Irritable Bowel Syndrome with Constipation

Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old.


See all Amitiza indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amitiza (Lubiprostone)

A drug that strengthens the analgesic effect of opioids without increasing constipation has been tested successfully on animals
Source: Pain / Anesthetics News From Medical News Today [2014.03.31]
Scientists from the University of Granada have taken part, alongside the Esteve laboratory, in the development of a new drug that multiplies the analgesic effect of opioids (drugs for treating...

Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Source: MedicineNet Irritable Bowel Syndrome Specialty [2013.05.09]
Title: Digestive Disorders Pictures Slideshow: Constipation Myths and Facts
Category: Slideshows
Created: 5/9/2013 12:00:00 AM
Last Editorial Review: 5/9/2013 12:00:00 AM

Linzess (Linaclotide) For IBS With Constipation Or Chronic Idiopathic Constipation Now Available, USA
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.12.27]
Linzess (linaclotide), a medication for irritable bowel syndrome (IBS) with constipation or chronic idiopathic constipation is now available in American pharmacies, Ironwood Pharmaceuticals Inc.

Linaclotide Given Positive CHMP Opinion For Irritable Bowel Syndrome With Constipation
Source: Irritable-Bowel Syndrome News From Medical News Today [2012.10.01]
Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) have announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion...

Constipation
Source: MedicineNet Anal Fissure Specialty [2012.09.19]
Title: Constipation
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/19/2012 12:00:00 AM

more news >>

Published Studies Related to Amitiza (Lubiprostone)

Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. [2011.06]
BACKGROUND: Lubiprostone is a prostone analog with a novel mechanism of action involving type-2 chloride channel activation. The aim of this work was to perform a dose-finding study for lubiprostone for the treatment of constipation with or without irritable bowel syndrome (IBS) in Japan... CONCLUSIONS & INFERENCES: Our results suggest that lubiprostone produced a steady and effective improvement in the symptoms of CIC with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population.

Efficacy and safety of lubiprostone in patients with chronic constipation. [2010.04]
AIMS: The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation... CONCLUSIONS: In patients with chronic constipation, lubiprostone produced a bowel movement in the majority of individuals within 24 h of initial dosing, with sustained improvement in frequency as well as other constipation symptoms over 4 weeks of treatment.

Lubiprostone neither decreases gastric and small-bowel transit time nor improves visualization of small bowel for capsule endoscopy: a double-blind, placebo-controlled study. [2009.11]
BACKGROUND: Lubiprostone, a selective activator of type 2 chloride channels, is approved for treatment of chronic idiopathic constipation and recently constipation-predominant irritable bowel syndrome. It has been suggested that lubiprostone has a prokinetic effect. OBJECTIVE: This investigation was designed to evaluate lubiprostone as a preparation and propulsive agent for small-bowel capsule endoscopy. The PillCam Small Bowel capsule endoscopy system with the PillCam SB1 capsule and Rapid 5 software platform were used. DESIGN: The study was designed as a double-blind, placebo-controlled trial. PATIENTS: Forty healthy adults. MAIN OUTCOME MEASURES: Gastric transit time (GTT), small-bowel transit time (SBTT), and adequacy of small-bowel cleansing preparation. INTERVENTIONS: The study subjects received 24 mug lubiprostone or placebo 30 minutes before PillCam capsule ingestion... CONCLUSION: Lubiprostone produced a significant increase in GTT but did not result in a significant decrease in SBTT compared with placebo. The administration of lubiprostone before capsule ingestion did not result in improved overall preparation of the small bowel for capsule endoscopy or increase the percentage of visualized small bowel. (The trial was registered at www.clinicaltrials.gov, identifier NCT00746395.).

Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. [2009.02.01]
BACKGROUND: Effective treatments for irritable bowel syndrome with constipation (IBS-C) are lacking. AIM: To assess the efficacy and safety of lubiprostone in IBS-C... CONCLUSIONS: The percentage of overall responders based on patient-rated assessments of IBS-C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.

Effect of a chloride channel activator, lubiprostone, on colonic sensory and motor functions in healthy subjects. [2009.02]
Lubiprostone, a bicyclic fatty acid chloride channel activator, is efficacious in treatment of chronic constipation and constipation-predominant irritable bowel syndrome. The study aim was to compare effects of lubiprostone and placebo on colonic sensory and motor functions in humans...

more studies >>

Clinical Trials Related to Amitiza (Lubiprostone)

Amitiza in Constipation Associated With PD (Parkinson's Disease) [Recruiting]
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.

Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation [Recruiting]
The primary objective is to compare the effectiveness and tolerance of Amitiza® (lubiprostone) plus GoLYTELY® (polyethylene glycol-electrolyte solution) versus placebo and GoLYTELY ® (polyethylene glycol-electrolyte solution) as a bowel cleansing preparation for colonoscopy.

Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation [Not yet recruiting]
The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation.

To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone.

The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation [Not yet recruiting]
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility.

Lubiprostone, a novel drug that works by activating the colonic ClC-2 chloride channel, has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms.

The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i. e. stomach, small bowel, colon) transit time.

The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone.

The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.

Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation [Recruiting]
The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation

more trials >>

Reports of Suspected Amitiza (Lubiprostone) Side Effects

Dyspnoea (38)Chest Discomfort (26)Nausea (16)Chest Pain (12)Diarrhoea (9)Anxiety (8)Pain (7)Confusional State (6)Drug Ineffective (6)Constipation (6)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Amitiza has an overall score of 6. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Amitiza review by 33 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   IBS
Dosage & duration:   12mcg (dosage frequency: 3 times a day) for the period of still taking
Other conditions:   allergies,chronic back pain, acid reflux
Other drugs taken:   zyrtec, celexa, nexium
  
Reported Results
Benefits:   My stomach aches went away. I wasn't as nauseated as I would have been without anything.
Side effects:   I have been getting headaches sporadically and the doctor said this is a possbile side effect. Also, I was very nauseated the first 2 weeks, which they say happens in 30% of the population taking this drug, but then it subsided.
Comments:   I am taking this medication after being diagnosed with Irritable Bowel Syndrome. I was on Zelnorm for this and it was like a miracle drug!! It fixed all my problems for months, then it went off the market. The doctor then told me to try this as an option. It definately helps more than not taking anything at all and I can tell when I get these stomach pains that I forgot to take the drug.

 

Amitiza review by 50 year old male patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   stomach/digestive disorder
Dosage & duration:   24 mcg 2x per day (dosage frequency: daily) for the period of 3 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I experienced some alleviation to the constipation but it was not ongoing. It was temporary & it was not regular. I expected that the treatment would be a cure not jsu a temporary relief.
Side effects:   I felt nauseous & bloated.
Comments:   I experienced constipation as a side effect to pain meds from surgery. I did not have previous problems with it. It never got better even a long time after the surgery. My doctor recommended I try amitiza after many over the counter products failed. I used it for 3 months. I had some relief but it definitely was not a cure. I quit using the drug since it did not give me significant relief.

See all Amitiza reviews / ratings >>

Page last updated: 2014-03-31

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