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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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Amitiza (Lubiprostone)

Health Tip: Help Control Constipation (HealthDay)
Source: Y! Health Digestive Health News [2009.11.12]
HealthDay - (HealthDay News) -- Constipation occurs when it becomes difficult or painful to have regular bowel movements. What's "regular" varies by person, however.

Health Tip: Help Control Constipation
Source: MedicineNet Constipation Specialty [2009.11.12]
Title: Health Tip: Help Control Constipation
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009

Ironwood And Forest Announce Positive Linaclotide Results From Two Pivotal Phase 3 Trials In Patients With Chronic Constipation
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.11.04]
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC).

Health Tip: Help Prevent Your Child's Constipation
Source: MedicineNet Constipation Specialty [2009.09.25]
Title: Health Tip: Help Prevent Your Child's Constipation
Category: Health News
Created: 9/25/2009 8:10:00 AM
Last Editorial Review: 9/25/2009

Health Tip: When Constipation Requires a Doctor's Appointment
Source: MedicineNet Laxatives For Constipation Specialty [2009.08.03]
Title: Health Tip: When Constipation Requires a Doctor's Appointment
Category: Health News
Created: 8/1/2009 7:00:00 AM
Last Editorial Review: 8/3/2009

more news >>

Published Studies Related to Amitiza (Lubiprostone)

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...

Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial. [2008.09]
OBJECTIVES: Proper colonic cleansing prior to colonoscopy is paramount to ensuring complete mucosal visualization and polyp identification. In a double-blind fashion, we compared single-dose lubiprostone (24 microg) versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation without dietary restriction to determine the efficacy, safety, and patient tolerability... CONCLUSIONS: Single-dose lubiprostone prior to split-dose PEG-E without dietary restriction significantly improves colonic mucosa visualization during colonoscopy and is well tolerated by patients.

Single-Dose Lubiprostone Along With Split-Dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy: A Randomized, Double-Blind, Placebo-Controlled Trial. [2008.08.05]
OBJECTIVES: Proper colonic cleansing prior to colonoscopy is paramount to ensuring complete mucosal visualization and polyp identification. In a double-blind fashion, we compared single-dose lubiprostone (24 mug) versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation without dietary restriction to determine the efficacy, safety, and patient tolerability... CONCLUSIONS: Single-dose lubiprostone prior to split-dose PEG-E without dietary restriction significantly improves colonic mucosa visualization during colonoscopy and is well tolerated by patients.

Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation. [2008.04]
BACKGROUND: Analyses of a trial in constipated patients indicated that lubiprostone may be an effective treatment for irritable bowel syndrome with constipation. AIM: To assess the efficacy and safety of three lubiprostone doses for irritable bowel syndrome with constipation... CONCLUSION: Lubiprostone significantly improved gastrointestinal symptoms of irritable bowel syndrome with constipation at all doses. Higher doses of lubiprostone, especially the 48 microg/day group, were associated with more gastrointestinal adverse events. From these data, the 16 microg/day dose demonstrated the optimal combination of efficacy and safety. These results warrant further study of lubiprostone for treatment of irritable bowel syndrome with constipation patients.

more studies >>

Clinical Trials Related to Amitiza (Lubiprostone)

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 (Amitiza®) Vs. Standard Care in Opioid-Induced Constipation After Surgery in Inpatient Rehabilitation [Recruiting]
Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.

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.

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation [Recruiting]
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Lubiprostone as a Treatment for Constipation in Parkinson's Disease [Recruiting]
Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:

1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)

2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)

3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Amitiza has an overall score of 9. The effectiveness score is 8 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.

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Page last updated: 2009-11-12

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