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Aliment Pharmacol Ther. 2008 Jan 28 [Epub ahead of print] Links
Clinical trial: phase 2 trial of lubiprostone for irritable bowel syndrome with constipation.Johanson JF, Drossman DA, Panas R, Wahle A, Ueno R.
University of Illinois College of Medicine, Rockford, Illinois, USA.
Background: Analyses of a trial in constipated patients indicated that lubiprostone may be an effective treatment for IBS-C. Aim: To assess efficacy and safety of 3 lubiprostone doses for IBS-C. Methods: 195 IBS-C patients received daily doses of 16 mcg (8 mcg twice daily [BID]), 32 mcg (16 mcg BID), or 48 mcg (24 mcg BID) lubiprostone or placebo BID for 3 months. Gastrointestinal parameters were recorded by patients in daily diaries. Results: After 1 month, lubiprostone showed significantly greater improvements in mean abdominal discomfort/pain scores vs. placebo (p=0.023). After 2 months, all lubiprostone groups showed significantly greater improvements in mean abdominal discomfort/pain scores (p</=0.039). After 3 months of treatment, the improvement in each lubiprostone arm was greater than placebo, but the test for trend was no longer significant. Treatment with lubiprostone showed significantly higher rates of gastrointestinal adverse events (AEs; p=0.020), especially diarrhea and nausea. Conclusion: Lubiprostone significantly improved gastrointestinal symptoms of IBS-C at all doses. Higher doses of lubiprostone, especially the 48 mcg/day group, were associated with more gastrointestinal AEs. From these data, the 16 mcg/day dose demonstrated the optimal combination of efficacy and safety. These results warrant further study of lubiprostone for treatment of IBS-C patients.
http://www.ncbi.nlm.nih.gov/pubmed/18248656?ordinalpos=19&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
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Zelnorm (tegaserod maleate) Information
Novartis, the manufacturer of Zelnorm, has notified the FDA that they will no longer provide Zelnorm (tegaserod maleate) under a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.
Novartis has agreed to continue to supply Zelnorm for use in emergency situations. Requests for Zelnorm for this purpose may be made to the FDA which in turn authorizes shipment of the drug by the manufacturer.
An emergency situation is defined as one that is immediately life-threatening or serious enough to qualify for hospitalization. FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients. The following conditions are cause for denial of authorization:
prior history of heart attack or stroke
unstable angina
hypertension
hyperlipidemia
diabetes
age greater than 55 years
smoking
obesity
depression
anxiety
suicidal ideation
Physicians with patients who may qualify for treatment with Zelnorm for emergency use may contact FDA's Division for Drug Information about the emergency IND process at druginfo@fda.hhs.gov.
http://www.fda.gov/CDER/DRUG/infopage/zelnorm/default.htm
Zelnorm History and Information, Plus Safer Alternatives
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FDA Approves Amitiza for IBS-C
The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.
Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.
"For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."
The safety and efficacy of Amitiza was established in two major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8 percent were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least two of the following additional symptoms: 1) fewer than 3 spontaneous bowel movements per week (that did not result from laxative use); 2) hard stools; or 3) moderate or severe straining with bowel movements. In the studies some patients received Amitiza and others were given a placebo. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12 week treatment period than patients who received placebo. The safety of long term treatment was assessed in a study in which all patients were treated with Amitiza for a duration that ranged 9 to 13 months.
The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing), and heart palpitations.
Amitiza should be taken twice-a-day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.
Amitiza is not approved for use in children and men. It is not to be administered to patients suffering from severe diarrhea or patients with known or suspected bowel obstructions. Its safety and efficacy has not been established in patients with renal or hepatic impairment, pregnant, or nursing mothers.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html
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Take the survey here http://ibd-cannabis-survey.limequery.com/index.php?sid=63892&newtest=Y&lang=en
The University of Calgary, Canada has a research project about capturing cannabis use in patients with IBS and the attempt to identify patten of use, symptoms that subjectively benefit and side effects, in order to finally capture which patient group may be a target for future clinical trials in this.
As this internet questionnaire is a international approach it will additionally answer whether the presumed effects / pattern vary by regional or cultural factors.
Reports from patients suggest that use of cannabis/marijuana reduces symptoms associated with Irritable Bowel Syndrome (IBS).
We are conducting a study that is assessing the use, the benefits and the side effects of cannabis/marijuana for the self-treatment of irritable bowel syndrome . This questionnaire is directed to all patients with IBS that use cannabis/marijuana for their IBS.
We are asking you to complete the internet based questionnaire. Please make sure that you respond to all questions which may take you approximately 10 minutes.
This research study has been approved by the University of Calgary Conjoint Health Research Ethics Board. You are under no obligation to complete this questionnaire. Your responses to this questionnaire will be kept strictly anonymous.
Thank you for taking the time to read this material and fully respond to the questionnaire.
If you have any questions please contact us at: Cannabis_use_in_IBS@gmx.com
There are 31 questions in this survey.
A note on privacy:
This survey is anonymous.
The record kept of your survey responses does not contain any identifying information about you unless a specific question in the survey has asked for this. If you have responded to a survey that used an identifying token to allow you to access the survey, you can rest assured that the identifying token is not kept with your responses. It is managed in a separate database, and will only be updated to indicate that you have (or haven't) completed this survey. There is no way of matching identification tokens with survey responses in this survey.
Take the survey here http://ibd-cannabis-survey.limequery.com/index.php?sid=63892&newtest=Y&lang=en
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Children's Belly Aches Don't Disappear With Antidepressant
Elavil worked no better than placebo in study of kids with gastrointestinal disorders
THURSDAY, Oct. 1 (HealthDay News) -- Contradicting some previous research in adults, a new study suggests that the antidepressant amitriptyline (Elavil), is no better than a placebo at treating painful gastrointestinal disorders in children.
"The high placebo effect we identified in this study suggests that further studies of the use of certain antidepressants in children with functional bowel disorders are needed. While several trials have demonstrated a beneficial effect of antidepressants, including amitriptyline, for the treatment of irritable bowel syndrome in adults, more research is needed to determine how effective this drug is, if at all, in children," study author Dr. Miguel Saps of Children's Memorial Hospital in Chicago, said in a news release from the American Gastroenterological Association.
The drug is used to treat depression, but it is sometimes prescribed on an "off-label" basis to children who have certain painful gastrointestinal disorders. The drug is thought to reduce pain, the researchers noted.
"Off label" means that the drug is not federally approved for use to treat a condition. However, doctors can still prescribe it for that purpose.
In the study, 83 children with painful gastrointestinal disorders were randomly assigned to take the drug or a placebo. Of those who took the drug, 63 percent reported feeling better, while 5 percent felt worse. Among those taking the placebo, 57.5 reported feeling better and 2.5 percent felt worse, the study authors reported.
The study findings appear online in advance of publication in an upcoming print issue of the journal Gastroenterology.
"Many pharmaceutical products are prescribed for off-label use in children due to the lack of clinical trials testing the efficacy of the drugs in children and adolescents," Saps explained in the news release. "Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," he added.
More information
Learn more about abdominal pain in children from the American College of Gastroenterology.
-- Randy Dotinga
SOURCE: American Gastroenterological Association, news release, Oct. 1, 2009
http://healthday.com/Article.asp?AID=631484
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Clinical Gastroenterology, Volume 24, Issue 2, Pages 133-141 (April 2010)
ABSTRACT
Adverse effects of drugs on small intestine and colon
Zeino Zeino, Guy Sisson, Ingvar Bjarnason
The small and large intestine are one of the most common sites for the adverse action of drugs, accounting for 20–40% of all drug side effects. The most important factor in the diagnosis of drug-induced intestinal side effect is awareness.
The mechanisms of damage are invariably complex, but may be due to topical effects, a known pharmacologic action of the drug on motility (for instance cholinergic/anti-cholinergic effect) and/or secretion, immune suppression and in the case of cytotoxic drug treatment a combination of many actions.
The diagnosis of damage may be simple and widely recognised (NSAID-induced enteropathy resulting in bleeding, protein loss and rarely perforation and diaphragm disease), or at other times ignored (tricyclic antidepressants increasing constipation) or life threatening (docetaxene).
Some associations require further research (statin and anti-retroviral associated irritable bowel symptoms). Diagnosis is traditionally made by symptom improvement on discontinuation of the drug. More lately capsule enteroscopy is used to aid diagnosis.
Department of Gastroenterology, King's College Hospital, Denmark Hill, London SE5 9RS, UK
PII: S1521-6918(10)00022-3
doi:10.1016/j.bpg.2010.02.008
© 2010 Elsevier Ltd. All rights reserved.
http://www.bpgastro.com/article/PIIS1521691810000223/abstract?rss=yes
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Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation – a double-blind, randomized, placebo-controlled, study
A. J. LEMBO*, F. CREMONINI*, N. MEYERS† & R. HICKLING†
*Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center (BIDMC), Harvard Medical School, Boston, MA, USA ; †Alizyme Therapeutics Ltd, Cambridge, UK
Correspondence to Dr A. J. Lembo, Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Rabb/Rose 1, Boston, MA 02215, USA.
Copyright Journal compilation © 2010 Blackwell Publishing Ltd
Aliment Pharmacol Ther 31, 979–990
ABSTRACT
Background
Renzapride, a 5-hydroxytryptamine type-4 (5-HT4) receptor agonist and 5-HT3 receptor antagonist, has been proposed as a new treatment of irritable bowel syndrome with constipation (IBS-C).
Aim
To assess the efficacy and safety of renzapride in women with IBS-C.
Methods
Women with IBS-C were randomized to renzapride 4 mg daily, 2 mg b.d. or placebo for 12 weeks. The primary outcome measure was global relief of IBS symptoms. A subset of patients were enrolled in a 12-month, open-label study of renzapride 4 mg daily.
Results
A total of 1798 patients were included in the efficacy analysis and 971 patients entered the long-term study. The mean (S.E.M.) number of months with relief of overall IBS symptoms was 0.55 (0.04), 0.60 (0.04) and 0.44 (0.04) in the renzapride 4 mg daily, 2 mg b.d. and placebo groups (P = 0.027 and P = 0.004 respectively). Small yet statistically significant differences in favour of renzapride were observed on stool consistency and frequency, and bloating/abdominal distension scores. Renzapride was generally well tolerated; however, three episodes of ischaemic colitis were reported in the long-term study.
Conclusion
Given the limited increase in efficacy over placebo and the incidence of ischaemic colitis observed, our data suggest that the benefit/risk ratio of renzapride is not sufficient to warrant further study in IBS-C.
Publication data Submitted 9 November 2009 First decision 30 November 2009 Resubmitted 8 February 2010 Accepted 10 February 2010 Epub Accepted Article 16 February 2010
http://www3.interscience.wiley.com/journal/123286564/abstract
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By Charles Bankhead, Staff Writer, MedPage Today
Published: July 08, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Nonprescription treatment for chronic constipation, polyethylene glycol, appears superior to commonly used prescription drug lactulose.
An over-the-counter drug for constipation offers superior symptom relief compared with a commonly used prescription agent, results of a systematic review suggest.
Polyethylene glycol (brand name Miralax) led to greater improvement in stool frequency and form, relief of abdominal pain, and need for additional treatments as compared with lactulose (brand names Enulose, Generlac, Kristalose, Chronulac, Cephulac, Constilac, Cholac, Duphalac, Constulose, Evalose, Heptalac), according to combined data from 10 randomized clinical trials involving more than 850 adults and children.
With the exception of relief of abdominal pain, PEG demonstrated superiority in children and adults alike, authors of the review reported in the Cochrane Database of Systematic Reviews.
"We conclude that polyethylene glycol should be used in preference to lactulose in the treatment of chronic constipation," Heather Lee-Robichaud, MD, of Northern General Hospital in Sheffield, England, and co-authors wrote.
Chronic constipation affects a substantial proportion of adults and children. Owing to the subjective nature of symptoms and lack of consensus about a clinical definition, prevalence estimates range from 2% to 35%, the authors noted.
Numerous factors have been cited as possible causes of chronic constipation, but the etiology remains largely unknown, they continued. Treatment recommendations usually begin with hygienic measures, such as increased physical activity and hydration and dietary modification. If these steps fail to relieve symptoms, patients usually turn to suppositories, laxatives, enemas, and manual evacuation.
Pharmacologic therapy for chronic constipation spans a wide range of prescription and nonprescription agents, which generally have a modest impact on symptoms, owing to the poor understanding of the pathophysiology of chronic constipation, the authors wrote. A group of drugs known collectively as "laxatives" constitute the most common type of drug therapy.
The laxative class includes PEG and lactulose, both of which are osmotic laxatives that work by increasing the amount of water in the large bowel. More than a dozen randomized clinical trials have compared the two agents, but their relative efficacy and cost-effectiveness remain unclear. To address that uncertainty, Lee-Robichaud and co-authors performed a systematic review and meta-analysis of the clinical trials.
A literature search identified 16 randomized comparisons of PEG and lactulose, 10 of which the authors included in their analysis. The trials included children and adults who had chronic constipation by Rome III diagnostic criteria (Gastroenterology 2006; 130: 1480-1491) or fecal impaction. The primary outcome of the analysis was change in stool frequency. Secondary outcomes included need for additional therapies (such as enemas or other types of laxatives), global symptom improvement, and relief of abdominal pain.
The 10 trials included a total of 868 patients, 322 adults and 546 children.
Five trials involving 407 patients compared PEG and lactulose effects on stool frequency. All five studies favored PEG, resulting in a mean treatment effect of 0.65 (0.15 to 1.15) versus lactulose. Separate analyses of children and adults also showed a consistent advantage for PEG, with mean treatment effects of 1.57 for children and 0.28 for adults.
Two trials examined stool form, and both demonstrated superiority for PEG, resulting in a mean treatment effect of 0.89 (0.43 to 1.35). Results were similar for children and adults. The three trials that assessed relief of abdominal pain showed a mean treatment effect of 2.09 in favor of PEG (1.26 to 3.44). The three trials that assessed need for additional products yielded a mean treatment effect difference of 4.00 in favor of PEG (2.01 to 7.95).
Co-author Richard L. Nelson, MD, also of Northern General Hospital, cautioned that drug treatment should be reserved for patients with chronic constipation, not for those who have only occasional episodes. Moreover, the decision to use drug therapy is complicated by the subjective nature of patient symptoms and complaints.
"The border between normal variation and a symptom of disease can be very hazy," Nelson said in a statement.
The authors reported no disclosures.
Primary source: Chochrane Database of Systematic Reviews
Source reference:
Lee-Robichaud H, et al "Lactulose versus polyethylene glycol for chronic constipation" Cochrane Database Syst Rev 2010; DOI: 10.1002/14651858.CD007570.pub2.
http://www.medpagetoday.com/Gastroenterology/GeneralGastroenterology/21063
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Ironwood And Forest Announce Positive Linaclotide Results From Phase 3 Trial In Patients With Irritable Bowel Syndrome With Constipation
Article Date: 14 Sep 2010 - 4:00 PDT
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).
Analyses of the data indicate clinically meaningful and statistically significant improvement was achieved for linaclotide-treated patients compared to placebo-treated patients for all four primary efficacy endpoints, which included two composite responder endpoints encompassing abdominal pain and complete spontaneous bowel movements (CSBMs), as well as individual responder endpoints for abdominal pain and CSBMs.
Significant improvement was also achieved for linaclotide-treated patients compared to placebo-treated patients for all pre-specified secondary endpoints, which are measures of abdominal pain, abdominal discomfort, bloating, and bowel symptoms. The safety results were consistent with those observed in previous linaclotide trials, with diarrhea being the most common adverse event in linaclotide-treated patients. A second Phase 3 trial of linaclotide in IBS-C is ongoing with top-line results expected in Q4 2010.
"There are millions of patients suffering from IBS-C and limited treatment options to address both their abdominal pain and bowel symptoms, which were improved in this first clinical study"
"The results of this Phase 3 trial, combined with the previously reported positive IBS-C and chronic constipation trial results, further support our belief that linaclotide has the potential to improve abdominal pain and bowel symptoms, offering a promising treatment for more than 30 million individuals suffering from these chronic gastrointestinal disorders," said Peter Hecht, Chief Executive Officer of Ironwood.
"There are millions of patients suffering from IBS-C and limited treatment options to address both their abdominal pain and bowel symptoms, which were improved in this first clinical study," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "These results are very promising. We believe linaclotide will be a valuable treatment for these patients. We look forward to receiving the results of the second pivotal trial in Q4 2010."
This trial, LIN-MD-31, is part of Ironwood and Forest's Phase 3 program investigating the effect of linaclotide treatment on patients with IBS-C or chronic constipation (CC). Previously, Ironwood and Forest reported positive results of two Phase 3 trials in patients with CC. The companies expect to file a New Drug Application in mid-2011 in the United States. The IBS-C trials were designed to also support regulatory submission in Europe. Today, in a separate press release, Ironwood and its European partner, Almirall, announced top line results from LIN-MD-31 for the E.U. endpoints. Trial LIN-MD-31 Primary Efficacy Endpoint Results
http://www.medicalnewstoday.com/articles/200947.php?nfid=79339
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PPI Use Tied to 80% Increase in Clostridium difficile Risk
By: HEIDI SPLETE, Internal Medicine News Digital Network
SAN ANTONIO – Proton pump inhibitor use was associated with an 80% increase in the risk of Clostridium difficile–associated diarrhea, based on data from a meta-analysis of 21 studies.
Proton pump inhibitors (such as Prilosec or Prevacid) are generally considered safe, resulting in some degree of indiscriminate use, said Dr. Sailajah Janarthanan of Wayne State University in Detroit. PPIs have faced scrutiny for a possible association with C. difficile–associated diarrhea (CDAD), but results from previous studies have yielded mixed results, Dr. Janarthanan said.
increase in the risk of Clostridium difficile–associated diarrhea, an analysis indicates.
"Given the millions of individuals on PPIs, even a slight increase in the risk of CDAD conferred by these drugs will have major public health implications," she emphasized.
To explore the relationship between PPIs and CDAD, Dr. Janarthanan and her colleagues looked at data from 21 peer-reviewed published studies. The 7 cohort studies and 14 case-control studies included 133,054 individuals.
Overall, there was a significant increase in the risk of CDAD in patients taking PPIs (risk estimate, 1.80). The risk estimate in the case-control studies was 1.55 and in the cohort studies 2.07. The CDAD risk was significantly higher for patients taking PPIs whether the types of studies were considered separately or as a whole.
C. difficile represents an escalating threat to public health, and CDAD cost the United States an estimated $3 billion in 2005, Dr. Janarthanan said at the annual meeting of the American College of Gastroenterology.
The results of the studies reviewed by Dr. Janarthanan and her associates were limited by the lack of randomized, controlled trials, she noted, and the impact of PPIs on CDAD remains controversial.
"Indiscriminate use of PPIs without proper indication should be discouraged," she said. "There is a real-time need for guidelines on the use of PPIs, especially in hospitals."
http://www.internalmedicinenews.com/news/gastroenterology/single-article/ppi-use-tied-to-80-increase-in-iclostridium-difficilei-risk/bdda11aa8b.html
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