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Medically reviewed by, Russell Braun RPH
What is Trulance used for?
Trulance (Plecanatide) is used to treat constipation in patients over age 18. The Food and Drug Administration (FDA) has approved Trulance for the following types of constipation.
- Chronic Idiopathic Constipation (CIC)
- Irritable Bowel Syndrome with Constipation (IBS-C)
Idiopathic constipation simply means the cause is unknown. If the constipation lasts for more than three months without a cause identified, it is classified as CIC.
Irritable bowel syndrome is a group of problems that normally cause diarrhea. However, some patients have both diarrhea and then at times constipation and that is when IBS-C is diagnosed.
Non drug remedies
Knowledge of what is happening in your body is one of the best defenses for how to avoid constipation. In addition to drugs such as Trulance, a great reference is the book Cure Constipation Now. It should be on your reading list if you suffer from either form of constipation.
What does Trulance do?
Trulance belongs to a class of drugs called guanylate cyclase-C agonists. That simply means it works by increasing the amount of chloride and bicarbonate in the intestines. This causes water to be pulled into the intestines thus relieving the constipation.
For both conditions Trulance comes as a 3mg tablet that only needs to be taken once per day. It should be taken about the same time each day with or without food.
When should you consider Trulance?
Chronic Idiopathic Constipation (CIC)
As mentioned diagnosis of CIC can take up to three months. During that time you will likely have used another form of laxative. Trulance should not be considered until you have tried and failed the following.
- Bulk forming laxative
Examples: psyllium, methylcellulose
- Stimulant laxative
Examples: senna, bisacodyl
- Osmotic laxative
Examples: polyethylene glycol
If you have constipation due to Irritable bowel syndrome (IBS-C) then you should not try Trulance until you have failed a bulk forming laxative. Talk to your doctor before trying stimulant or osmotic laxatives.
Review of the clinical trials
Reviews of Trulance by individual patients can vary widely from one person to another. Relying on the word of a patient with totally different circumstances than you is not that helpful. Instead, lets look at what the data the FDA used to approve Trulance broken down in an easy to understand way.
The manufacturer of Trulance used a double blind, placebo-controlled, randomized clinical trials lasting 12 weeks. These are the kind of studies that can prove cause and effect. The patients were either given a placebo (sugar pill with no actual drug in it) or Trulance 3mg once per day.
- Mean age of patients was 45
- 80% were women
- Patients used an electronic diary to track effectiveness of medication
Symptoms before taking Trulance
The patients had to have at lest two of the symptoms below to be considered to be included in the study.
- Sense of blockage when trying to defecate
- Lumpy stools
- Straining when going to the bathroom
- Feeling like it did not all come out when defecating
How did they know if the drug worked?
A patient was considered a responder if they had at least three bowel movements in a week. In addition, they had to have an increase of at least one bowel movement per week over there previous week(s) before starting the trial drug.
The bowel movements had to be spontaneous and give the sense of complete evacuation. In other words once the study patients went to the bathroom they did not feel like they had to go again afterwards.
Trulance vs. placebo
Two different studies were done for CIC, both had approximately 900 total patients with about 450 in each of the Trulance and placebo groups.
In study 1, Trulance had a 21% response rate and placebo was 10%. In study 2, Trulance again had a 21% response rate and placebo was 13%.
What does that mean for you?
It means that 2 out of 10 patents with CIC had more bowel movements when taking Trulance. Therefore, 8 out of 10 did not. Keep in mind that with placebo 1 out of 10 had more bowel movements. That means just thinking the drug was going to help, did so for 1 out of every 10 patients taking placebo. Remember placebo had no active drug in it.
Certainly if you suffer with constipation you would be willing to try Trulance to see if it could help you. However, keep in mind these results are not that impressive especially compared to placebo.
Don’t forget certain patients were excluded
Patients who didn’t maintain a stable diet for 30 days prior to starting Trulance were excluded. Is your diet “stable” for 30 days?
In addition, patients who had disease states or took drugs that could cause constipation were excluded. Do you have a disease state that could add to your constipation, such as hypothyroidism? Are you taking a drug that can cause constipation?
If you answered yes to any of these then you may not see the same results as occurred in the study.
For IBS-C, two double-blind, placebo-controlled, randomized studies lasting 12 weeks were completed. Again these are by far the best type of clinical trials and the only ones that can prove cause and effect. Patients were given Trulance 3mg once daily or placebo (sugar pill), with or without food.
- The mean age was 44
- 74% of study participants were women
- One study had 699 patients the other 754, they were split evenly between Trulance and placebo groups
- An electronic phone diary was used to track the patients response
Trulance vs. placebo
Trulance did not show improvements in the number of bowel movements per week or spontaneous bowel movements. These were the main focus of the trials called a primary endpoint. There was a small improvement in stool consistency and the amount of straining in the Trulance group.
Due to an overall low amount of positive response the manufacturer started another group of patients on Trulance 6mg once per day. They found no significant benefits in the 6mg group vs. the 3mg group.
What the means for you is if you use Trulance for IBS-C and don’t see results, then going up in the dose probably won’t help either. In fact, it might just open you up for more side effects.
What are the side effects of Trulance?
Trulance is not very well absorbed after you take it by mouth. That means it is less likely to cause side effects outside of your stomach and GI tract.
In the clinical trials the biggest side effect was diarrhea, which occurred in 5% of Trulance patients vs 1% of placebo patients. To someone with constipation, this may not be a side effect that you worry too much about. However, if diarrhea occurs for extended periods it can become an issue due to losing large amount of fluid and electrolytes.
Severe diarrhea for Trulance patients happened 0.6% of the time vs. 0.3% for the placebo group. Severe diarrhea should always be reported to your doctor to determine if they want you to stop using the drug due to the diarrhea. Dehydration and electrolyte loss can cause severe consequences including heart arrhythmias that could cause death.
Other less common side effects
- Abdominal distention
- Upper respiratory tract infection
- Increased liver enzymes
These side effects were reported in less than 2% of study participants.
Does Trulance make you gain weight?
Weight gain was not reported as a side effect in any of the large clinical trials. Typically, helping a constipated patient deficate would cause a small amount of weight loss.
What should you do?
Trulance is a very expensive medication. It may not be a preferred medication on your insurance formulary. That could result in a large copay.
What about if you have a high deductible health plan? Then get ready for a large expense this month!
What if you could have a trial period where you determine if Trulance helps you for no cost?
That seems like a best case scenario… but how you ask?
Make sure to ask your doctor for samples if you are going to try Trulance. This should give you at least two weeks to trial the drug. If symptoms are documented before starting Trulance and through the sample period with bullet journaling, you will know if it is for you.
This can save you from an expensive copay you would end up with if you didn’t use the samples. According to GoodRx a 30 day supply of Trulance is $435!
Is Trulance better than Linzess?
Linzess (Linaclotide) is another drug in the same class as Trulance. Both work on guanylate cyclase-C to cause more fluid to enter the intestines. They also are both approved by the FDA for CIC and IBS-C.
Unfortunately, no direct clinical trials comparing Trulance and Linzess to each other has been done to date. Typically, drug manufacturers shy away from this because if one drug is shown to be better than the other, the loser will not sell very well. That risk is great to the manufacturers especially when you consider how much these drugs cost.
For a more in depth comparison see 9 Key Takeaways for Linzess vs. Trulance
The bottom line
Constipation impacts millions of Americans. According to the National Institute of Health, 16% of Americans under 60 years old suffer from constipation. Over one third of all Americans over age 60 are affected.
The pain can be downright crippling at times. It can impact quality of life and make other activities less enjoyable.
Laxatives are available that can help with the symptoms. However, what if you have tried those and failed? In that case when newer classes of drugs come along the hope is they will be the miracle cure.
Beware of the marketing
Commercials on television showing a perfect life by someone who never had constipation to begin with by simply taking Trulance is a farce. Don’t get caught up in the hype.
As noted the clinical trials showed a modest benefit for Trulance over a sugar pill. Couple that with the cost of this drug and your constipation could turn into anxiety over how to pay for the medication.
The best course
Talk to your doctor about combining agents if laxatives or Trulance did not work for you. Sometimes having multiple drugs working in different ways can get the relief you need.
In addition, trying other new drugs such as Linzess or Amitiza by using samples is another way to find the best solution for you.
Check back to my blog for more actionable advice on high cost medications. Teaching you how keep medication affordable.