Prokinetics: What You Should Know – by Nancy Brown

Prokinetics: What You Should Know

by Nancy Brown

5/25/17

Prokinetics are class of medications that enhance motility for those who suffer from Gastroparesis and other slow motility diseases.  They are prescribed to improve the nausea, vomiting and bloating symptoms that people with those diseases commonly suffer from.

Prokinetics work by increasing movement of the stomach and intestines, improving overall digestion.  There is currently only one FDA approved prokinetic for Gastroparesis, though other prokinetics are prescribed off-label by doctors.  Off-label drugs were developed for other purposes, but have been found to improve motility for some Gastroparesis patients.  Below is a description of several prokinetics:

  Prokinetic Requires Rx Avail in US Recommended Duration of Use FDA Approved for GP
Metoclopramide

(Reglan)

YES YES No more than 3 months unless otherwise approved by doctor YES
Domperidone

(Motlium)

YES NO Depends on medical condition NO*
Erythromycin

(Erythrocin)

YES YES No more than 3 months unless otherwise approved by doctor NO
Tegaserod

(Zelnorm, Zelmac)

YES NO Restricted usage for emergency only NO

*Domperidone is actually approved for Gastroparesis patients but doctors must obtain advanced approval from the FDA to prescribe it.

Metoclopramide (Brand names include Reglan, Metozolv ODT, and PCP 100) is the only FDA approved drug for Gastroparesis.  It aids in digestion by causing stomach muscles to contract.  Metoclopramide also decreases incidents of nausea and vomiting.  Metoclopramide may cause tardive dyskinesia, a serious movement disorder.  The risk of tardive dyskinesia increases if Metoclopramide is used for longer than 12 weeks. Talk to your doctor about the risks and benefits of this medication.

Domperidone (Brand name Motilium) is approved in Canada, Europe, Japan and other countries, but not in the US. Originally developed to enhance breast milk production in lactating women, the FDA did not approve Domperidone due to risk of cardiac arrhythmias or cardiac arrest.  The FDA recognizes that Domperidone improves motility, nausea, and vomiting.  Doctors must request FDA approval to prescribe and order Domperidone.

Erythromycin is used to treat and prevent a variety of bacterial infections.  It speeds up motility, but its effectiveness reduces after several weeks of use.   Intravenous Erythromycin used in a hospital setting is effective for patients with severe Gastroparesis.  Lower doses of oral erythromycin improve Gastroparesis symptoms; unfortunately, side effects include stomach cramps and nausea.

Tegaserod (Brand name Zelnorm or Zelmac) is only available for emergency situations with approval by the FDA.  Originally developed for treatment of Irritable Bowel Syndrome (with diarrhea) or Chronic Idiopathic Constipation, Tegaserod increased stomach emptying and movement through the bowels.  Due to FDA concerns with cardiovascular side effects, it was removed for use in 2007.

The following drugs are in use for Gastroparesis, but they are not available in the US:  Levosulpiride, Mosapride Citrate, Itopride hydrochloride, and Pruclopride.

 

Future developments:

A clinical study has been completed in the US for Renzapride.  This drug is currently being developed by EndoLogic LLC for distribution.  Renzapride was tested for both gastroparesis and IBS-D.

Several other clinical trials are in process for evaluating drugs (beyond prokinetics) to treat Gastroparesis:  Promethazine, VLY-686, Prucalopride, RQ-10 (Parkinson and Gastroparesis) and Lixisenatide.  Please refer to https://ClinicalTrials.Gov and search for Gastroparesis for additional information on clinical trials.

Prokinetic medications may not be an option for all Gastroparesis patients.  Side effects may be too severe or the prokinetic may interact with other medications the patient is prescribed.  Gastroparesis patients often use prokinetics in combination with other treatment options or not at all.  Gastroparesis patients should work with their doctor to determine the best treatment plan based on the severity of gastroparesis.

 

About the author:

Nancy Brown lives in Virginia with her husband of 38 years, Ed.  They’re empty nesters and are enjoying retirement.  Prior to retiring, Nancy was a Manager of Requirement Analysis at Navy Federal Credit Union.

Resources for article:

http://webmd.com
http://www.aboutgastroparesis.org/medications.html
http://www.digestivedistress.com/motility-rx
http://www.medscape.com/viewarticle/514206_4
https://clinicaltrials.gov/ct2/show/NCT02130622?term=gastroparesis&recr=Open&rank=3
https://globenewswire.com/news-release/2017/01/03/902783/0/en/EndoLogic-Acquires-Renzapride-from-Alizyme-plc.html
https://www.fda.gov
https://www.ncbi.nlm.nih.gov

The Right-To-Try legislation

Right To Try is a legislative effort to expand the ability of terminally ill patients to gain access to experimental medicines. It would prohibit the federal government, including the US Food and Drug Administration, from taking any action to prevent patient access to life saving treatments.
“The FDA does have its own Compassionate Use program aimed at providing access to therapies still under evaluation — however the application is cumbersome, largely unworkable for practicing physicians, and time consuming when a patient’s time is running out. State Right-to-Try laws give patients who have exhausted every government-approved option another chance to fight for their lives. The laws are aimed at reducing the often two to four month waiting period under the FDA’s Compassionate Use down to two to four weeks, and eventually two to four days.”

To learn more search “Right-to-try legislation”

Malnutrition Awareness Week -ASPEN

Malnutrition Awareness Week TM

Date: September 26 – 30, 2016

Website: http://www.nutritioncare.org/maw

Contact Information: (301) 587-6315, info@nutritioncare.org
Join the American Society for Parenteral and Enteral Nutrition (ASPEN) September 26 – 30, 2016 for their fifth annual Malnutrition Awareness Week™.

The purpose of this week is to raise awareness in healthcare professionals to consider assessing and intervening earlier and for the pubic to realize that they need to ask about their nutrition status and advocate for optimal nutrition care as much as possible.
In 2009, ASPEN recognized a need for greater awareness of malnutrition, which is common in hospitalized patients in the United States and is associated with unfavorable outcomes including higher infection rates, poor wound healing, longer lengths of stay, and higher frequency of readmission. Not unexpectedly, these outcomes are associated with increased costs. In some studies, 30-50% of patients become malnourished, often during a hospital stay.
The 2016 week is scheduled to have three webinars* and a chat with the experts

 Improving Malnutrition from the Physician Perspective*

 Combating Malnutrition in Spanish Speaking Population: Available Programs and Resources*

 Malnutrition Interventions and Programs for Older Adults*

 Aging Does Not Matter: Malnutrition in the Aging Population

Visit the official Malnutrition Awareness Week site to register or for more information about the week. Participants will receive continuing education credits. ASPEN is accredited to provide medical, pharmacy, nursing and dietetic credits.

 

G-PACT is sharing this post because we collaborate with ASPEN

 

 

 

Nominate G-PACT!

Let me share with you who the folks at WEGO Health are:

“We are WEGO Health — a network of over 100,000 of the most influential members of the online health community. We are bloggers, tweeters, pinners, and leaders of Facebook pages — we are the empowered patients that drive the healthcare conversation online, across virtually every health topic and condition.”

If you’re reading this, you may be part of WEGO Health too. 

We at G-PACT have been nominated for recognition in BEST TEAM PERFORMANCE, and let me tell you, we are honored, but also proud of the hard work we do with you to keep Gastroparesis on the minds of lawmakers, clinicians and researchers. 

We are there FOR you and WITH you. So please take a moment to nominate your team, G-PACT for BEST TEAM PERFORMANCE in the annual WEGO Health, Health Activist Awards. 

Follow this link to nominate:

Nominate G-PACT for BEST TEAM PERFORMANCEt

Maybe you’re wondering what your G-PACT has done for you lately? You can learn about G-PACT’s many activities HERE but I’d like to tell you about my favorite…

G-PACT, partnering with Generic Alliance , created and maintains the very first ever Platform for Engaging Everyone Responsibly (PEERAGE) patient Registry. 

In short, The Registry, which has been filled out by over 500 people, collects the vital information about an individual’s history and experience with Gastroparesis & Digestive Tract Paralysis. You, as the provider of information, get to decide who gets to use your responses. It’s an unprecedented program. Several other organizations have worked with the PEER system too, but G-PACT was the first. 

It took a lot of teamwork to make this happen. Consulting with Institutional Review Boards, learning FDA regulated data collection systems, engaging medical experts in GP, and recruiting the right volunteer talent to support all those efforts. I can fairly say that every professional resource at G-PACT was tapped to make this come to life. 

By the way, if you have not yet taken part in the G-PACT patient Registry you can do so now.

But PLEASE take a moment right now to Nominate YOUR G-PACT for BEST TEAM PERFORMANCE in the WEGO Health Activist Awards.

Thank you so much. 

Malnutrition Awareness Week 9/26 – 9/30/16

Malnutrition Awareness WeekTM
Date: September 26 – 30, 2016
Website: www.nutritioncare.org/maw
Contact Information: (301) 587-6315, info@nutritioncare.org

Join the American Society for Parenteral and Enteral Nutrition (ASPEN) September 26 – 30, 2016 for their fifth annual Malnutrition Awareness WeekTM. 

The purpose of this week is to raise awareness in healthcare professionals to consider assessing and intervening earlier and for the pubic to realize that they need to ask about their nutrition status and advocate for optimal nutrition care as much as possible.

In 2009, ASPEN recognized a need for greater awareness of malnutrition, which is common in hospitalized patients in the United States and is associated with unfavorable outcomes including higher infection rates, poor wound healing, longer lengths of stay, and higher frequency of readmission. Not unexpectedly, these outcomes are associated with increased costs. In some studies, 30-50% of patients become malnourished, often during a hospital stay.

The 2016 week is scheduled to have three webinars* and a chat with the experts
 Improving Malnutrition from the Physician Perspective

  1.  Combating Malnutrition in Spanish Speaking Population: Available Programs and Resources*
  2.  Malnutrition Interventions and Programs for Older Adults*
  3.  Aging Does Not Matter: Malnutrition in the Aging Population*

Visit the official Malnutrition Awareness Week site to register or for more information about the week. 

*Participants will receive continuing education credits. ASPEN is accredited to provide medical, pharmacy, nursing and dietetic credits. 

G-PACT is an official supporter of #MAW2016 learn more about the week here http://ow.ly/LgcQ300l2XS

August is Gastroparesis Awareness Month

Are you ready to know some of the plans for Awareness Month this year? 

We have rolled out a new website dedicated specifically to the month which describes the things we have planned thus far. We will continue to add to the site as events occur this month, post pictures of past years since 2009, develop more ways to easily get involved through the awareness month website, and provide a downloadable media kit that you may begin to share with your local media in order to increase awareness in the community. 

We are excited about having a location off of social media to share more information about the month and things people who are not on Facebook or Twitter can do! 

Check it out and check back often for updates! 

www.gastroparesisawarenessmonth.org

Gastroparesis Awareness Month website