---------------https://medicalinsider.holy-cross.com-----------
 

dabigatran

Treatment and Support for Substance Use Disorder

  • Posted Apr 16, 2019
  • hchadmin

Are you concerned that you, a family member or friend may have a substance use disorder (SUD)? SUDs occur when the recurrent use of alcohol and/or drugs causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, school, or home. It's necessary that you educate yourself about the support that may be available to you or that you may need to provide to others in order to achieve a sustained recovery.

The National Institute on Drug Abuse (NIDA) offers the following information if you think you might have an addiction:

•It's important to know that addiction can be successfully treated. Contact your primary care physician who can help coordinate your care and refer you to a specialist, if needed. If you don’t have a primary care physician, just visit your insurance carrier’s website, look for the “find a doctor” area and follow the instructions. Or, visit the Substance Abuse and Mental Health Services Administration (SAMHSA) website for more information and resources.

•It takes a lot of courage to seek help because there is a lot of hard work ahead. However, treatment can work, and people recover every day.

•Your treatment approach must be tailored to address your specific substance misuse pattern and also your substance-related medical, psychiatric and social needs.

•There are different kinds of addiction specialists who will be involved in your care, including doctors, nurses, therapists, social workers, and others.

•Behavioral treatment (also known as "talk therapy") can help you engage in the treatment process, change your attitude and behaviors related to substance misuse, and increase your healthier life skills.

•Medications are available to treat addictions to alcohol and opioids (heroin and pain relievers). Other medications are available to treat possible mental health conditions.

•Self-help groups can extend the effects of professional treatment. These groups can be particularly helpful during recovery, as they are a source of ongoing communal support.

If you have an adult family member or friend who is struggling with the misuse of alcohol and/or drugs, NIDA offers the following tips:

•Recognize that you can't fix the problem by yourself. If someone you care about has asked for help, he or she has taken an important first step. If that person is resistant to help, perhaps you can at least convince him or her to get an evaluation from a doctor.

•You can always take steps to locate an appropriate physician or health professional, and leave the information with your friend or family member.

•Emphasize to your friend or loved one that it takes a lot of courage to seek help for a drug or alcohol problem because there is a lot of hard work ahead. But assure them that you will be supportive in their courageous efforts.

•The pressure of family and friends sometimes compels people to enter treatment. However, it's better that you focus on creating incentives to at least get the person to a doctor.

•If your friend or loved one was previously treated and then relapsed, they have already learned many of the skills needed to recover from addiction and should try it again. 

•People being treated or recovering from SUDs relapse about as often as do people with other chronic diseases such as hypertension and diabetes. Treatment of any chronic disease involves changing deeply imbedded behaviors, and relapse sometimes goes with the territory.

•Encourage your loved one to participate in a self-help group during and after formal treatment. These groups can be particularly helpful during recovery, as they are a source of ongoing communal support.

You may also consider contacting your site Employee Assistance Program (EAP).  Your EAP is a confidential resource that provides counseling, information and referral services to help address personal, family or work-related concerns. These services are provided to you and your family members free-of-charge as one of your employee benefits.

As your trusted health partnerf or life, Holy Cross Hospital is committed to providing resources that promote well-being though body, mind and spirit and is dedicated to helping you Live Your Whole Life.


[Disclaimer: Trinity Health is a Catholic health care facility that is firmly committed to maintaining fidelity to its Catholic identity by closely conforming to the Ethical and Religious Directives for Catholic Health Care Services (ERDs). The links provided here are independent sites and have no obligation to provide information that is always congruent with the ERDs. Trinity Health cannot guarantee their content and ask for your discretion when using information from these sites]

 

The Three Musketeers

  • Posted Jul 27, 2012
  • Alan Niederman, MD, FACC, FACP

The Musketeers were a junior unit of the military branch of the Royal Household of France and were created in 1622. Three of them - Athos, Porthos and Aramis - are prominently featured in Alexandre Dumas's novel of 1844. They were "all for one and one for all." As I have blogged about before, it took over 60 years to discover another compound which does what warfarin does. Now we have three such drugs. Each is part of the group of drugs known as the "ans." Two have been approved, dabigatran and rivaroxaban. They are known as Pradaxa and Xarelto. The third "Musketeer," and allegedly the best, has been held up by the FDA. One more strange story that starts with the study. This study is known as ARISTOTLE or Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation. Apixaban, like Pradaxa, is taken twice a day. Xarelto is taken once a day. 18,201 patients were entered and studied for 1.8 years. 212/9,120 apixaban treated patients had a stroke, as did 265/9,081 warfarin patients (another example that stroke is not eliminated in these patients, just reduced). This was a very significant difference. Further, major bleeding occurred significantly less in the apixaban group: 327 vs. 462 - again, a very significant difference. Finally, death occurred in 603 of the apixaban vs. 669 of the warfarin patients. For every 1,000 patients treated for the same amount of time (1.8 years), 6 strokes would be avoided, 15 major bleeds would be avoided and 8 deaths would be avoided. Hot Damn. Where do I sign up? No where. Say it ain't so. After giving the study and the compound apixaban, New Drug Application "priority review" in November of 2011, the FDA was supposed to meet a March deadline for scheduling the FDA Advisory Board meeting. This date was pushed back three months until June 29th. On June 28th, the FDA sent the companies Bristol-Myers Squibb and Pfizer a Complete Response Letter. This is not a good sign. Guess what? The contents of that letter are "secret." I have no idea why the letter would not be released, but it is not. Few people know what the problem is or could be. One thought is that the FDA may feel "burned" by the large number of adverse drug reports of Pradaxa, as I blogged about recently. What one drug has to do with the other, I do not know. So once again we are left with a large problem, stroke in atrial fibrillation, and several solutions that are possibly not as good as the next best thing, but the FDA which has reviewed the data won't say what is wrong with it and won't let the Advisory Board meet to discuss it. I should point out that the FDA does not do everything that the Advisory Board says it should, but in general, there is a concurrence. On June 21st, the FDA turned down a new indication for Xarelto after the Advisory Board voted against it in May. All for one and one for all. Apixaban may be the one for all in stroke prevention for atrial fibrillation, but we in the United States will have to wait. You can always go to Europe and buy it there as it is already approved. What can I say?


New drugs new problems

  • Posted Oct 06, 2011
  • Alan Niederman, MD, FACC, FACP

I have blogged about atrial fibrillation and the need for anticoagulation in the past.  Some blogs have gone over the history of Coumadin, and more recently, the development and approval of Pradaxa.  Also, there have been blogs about some of the more novel issues' with Pradaxa.

Perhaps the most novel element about Pradaxa is the fact that you can not reverse the effect of the drug.  If you have a bleeding issue on the drug, you have to allow it to wear off and support the problem.  Pradaxa, unlike warfarin or heparin, cannot be reversed.

Pradaxa is only one alternative to warfarin that is now being developed.   One other new drug, rivaroxaban, is going to be available soon.

Pradaxa is a direct thrombin inhibitor, and rivaroxaban is an oral direct factor Xa inhibitor.  Trust me, you don’t want to know anymore.  It will make your head explode.  The only reason I bring it up is so you understand that the clotting pathway of our bodies is being interacted in different places by these two drugs and so presents two different opportunities.

On September 8, 2011, the FDA advisory committee voted to approve the drug for the use in atrial fibrillation to prevent stroke.  A large study demonstrated it to be non inferior to warfarin when given once a day.  This drug is an oral compound which does the same thing as Lovenox, a drug most people who have been hospitalized recently are aware of.  Lovenox is the drug they inject in your abdomen to prevent blood clots from forming in your legs.

This drug will be known as Xarelto.  Don’t ask; I certainly don’t know how they came up with that.  The interesting thing about this drug, and the purpose of this blog is this: this drug, which is not yet approved here in the United States, appears to have a reversal agent.

Published in Circulation on September 6, 2011 (Circ2011;DOI: 10.1161/circulationaha.111.029017), this article reports on the use of PCC, or prothrombin complex concentrate, in volunteers who are test subjects.  They do not have the illness that is being treated.

This study compared rivaroxaban and dabigatran.  When given both drugs, it prolongs the PT or prothrombin time.  We can test to see whether someone is taking Pradaxa with the PT, but the intensity of the effect is not measured unlike warfarin and the INR.  When PCC was given to the volunteers, the rivaroxaban was reversed but not the Pradaxa.  So PCC may be a useful drug to immediately reverse the effect of the drug in the case of a bleeding emergency or if emergency surgery is needed.

This is a small study, and more work will need to be done before this is accepted, but it is provocative and useful information.  It may well be a great selling point between these two drugs in addition to Xarelto being used once a day.

Progress.  Slow, not always steady, but always toward better patient care.


More Than We Want to Know?

  • Posted Dec 07, 2010
  • Alan Niederman, MD, FACC, FACP

pacemakerMore than thirty years ago in 1978, a book was published that altered the way medical students and young doctors thought.  The book was titled The House of God and was written by Samuel Shem.  It was a autobiographical account of his years as a house officer at Beth Israel in Boston, Massachusetts.   In this book,  which many of us treasure, were the rules of the House of God which included, amongst others, that if you don’t take a temperature you can’t find a fever.

We all  live in a world of information overload and the “fevers” we as doctors now find on a daily basis, provide us with ever increasing conundrums about what to do and how to treat.  Hippocrates said Primum non nocere... first do no harm.  Do we harm patients when we are trying to help them avoid catastrophic problems?  Can we do better?

Pacemakers are wonderful devices.  Besides being very small at this point, especially when compared to the beginning iterations ,they now have the ability to record every single heartbeat 24/7/365.  This data can then be analyzed when patients come for their “pacer checks” and this is where these “fevers” are found.

Pertinent to this discussion is another sign of our times the “rating or scoring system”.  This one is known as the CHADS2 score and was developed by Dr. B. F. Gage and his colleagues and reported in Circulation in 2004.  This score allows us to assign risk to patients who have atrial fibrillation and place them on oral anticoagulation with either warfarin or now dabigatran. 

The scoring is simple.  You get one point for having a history of congestive heart failure, for a history of hypertension, for being over 75 years old, for having diabetes or a previous stroke or transient ischemic attack which by the way gives you 2 points.  Collect all 6 points and you have an 18.2% risk of stroke a year without anticoagulation.  Two points gives you a 4% risk, so basically most people with atrial fibrillation are on anticoagulation.

Given the above information, what do you do for patients who have brief episodes of atrial fibrillation?  This is the question asked and answered (as with everything else in medicine in part) by the following study.  This study which has not to my knowledge been published, was presented at the American Heart Association meeting this past month.

This study known as ASSERT or Asymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial enrolled 2,451 patients with pacemakers and 129 with ICD’s.  All patients had hypertension and were over age 65.  This means that they had a CHADS2 score of 1.  This means that they have a risk of 2.8% of a stroke if they go into atrial fibrillation.  Many had higher CHADS2 scores as they had other comorbidities that make up the score.

Next... what was found and what should we do about it?


Dead Cows and Progress

  • Posted Oct 05, 2010
  • Alan Niederman, MD, FACC, FACP

 

It has taken us 90 years to develop a new oral anticoagulant.  No one can accuse us of moving too quickly.  As I have discussed in previous blogs, Dabigatran has been unanimously approved by the FDA advisory panel and will soon be available.  But first let’s go back in time, back to the dead cows that started it all.

 

In the 1920s, any animal that ate hay that was made from sweet clover and allowed to “spoil” was dying of a hemorrhagic disease.  If they were castrated, they bled to death.  If they were dehorned, they bled to death.  This was, of course, a big deal as some of us will remember; we used to farm and raise cattle, sheep and cows until it was outsourced to China.

 

It was identified that it was the spoiled sweet clover, but it took work begun in 1933 until 1940 to identify the substance in the labs of the University of Wisconsin.  They named the substance dicoumarol and were able to synthesize it and produce it.  Dicoumarol is the byproduct of the substance coumarin which when degraded or “spoiled” becomes the dicoumarol.  This was the substance patented and became known as Warfarin which is an acronym for the Wisconsin Alumni Research Foundation and given the tag –arin to link it with coumarin.  Here is the hook -- it was invented to be rat poison.

 

In the early 1950’s an army inductee attempted to commit suicide by ingesting rat poison, but by then it was understood that vitamin K reversed the process; so the attempt was unsuccessful.  This, however, gave someone the bright idea that we could give it to humans (I am not making this stuff up).  The rest is history especially after it was given to President Eisenhower who, those of you who are too young to remember, was one of the most famous people in the world after having led the Allied Forces to victory in WWII.  If it was good enough for IKE, it’s good enough for me.

 

Here is perhaps the “best” factoid.  We didn’t even know how it worked until 1978, when the exact mechanism was worked out.  For the last 60 years, patients and doctors have struggled with this drug and lawyers have made a large fortune off of it.  It is one of the few substances that doctors can get sued for because the amount given is too much or to little.  Like Goldilocks' porridge, warfarin must be adjusted “just right”.

 

Now Dabigatran, which will be known as Pradaxa, has arrived.  Let the marketing begin!


The War Against Atrial Fibrillation

  • Posted Sep 16, 2009
  • Alan Niederman, MD, FACC, FACP

The care of patients with atrial fibrillation is complicated by the use of warfarin. Although it has no side effects, it needs to be stopped for procedures, it is hard to manage, and there are significant drug/drug and drug/food interactions. Life-threatening bleeding can occur if the levels are high and stroke can occur if the levels are too low.

Even though warfarin prevents 64% of the strokes in those with atrial fibrillation, it is prescribed to only two-thirds of the appropriate candidates. In real world doctor management in the dosing of warfarin, the correct dose is achieved in only 35% of patients. This causes many to be overdosed or under dosed.

The antithrombins are a class of drug which targets just the thrombin part of the effect that warfarin has on the clotting cascade. They are single-dose drugs, meaning everyone takes the same dose and they do not need to be monitored as they are with warfarin. So, patients do not have to undergo a monthly or more frequent blood test to regulate the dose.

If the drug needs to be stopped, it is gone in 24 hours and the onset of action is rapid, unlike with warfarin, which can take seven to ten days. Patients who are hospitalized often spend several extra days in the hospital as they are started on warfarin because insurance companies do not routinely pay for the transition medication as an outpatient. This adds considerably to the overall cost of health care.

Clearly, if the drug is not inferior to warfarin it would be widely accepted even at an increased cost. What if the drug is superior? That is the case with dabigatran.

The RE-LY study enrolled 18,113 patients in 951 clinical centers in 44 different countries. Two doses of dabigatran were studied 110mg twice a day or 150mg twice a day vs. warfarin. These centers were able to manage the dosing of warfarin better than in general, obtaining adequate levels around 64% of the time. The study found that the 110 mg dose of dabigatran was equal to warfarin in preventing stroke with less bleeding and that the 150mg dose of dabigatran was superior to warfarin in preventing stroke but had the same bleeding effects that warfarin did.

This is a major step forward. The most common side effects were gastrointestinal about 11% at both doses of dabigatran. If approved, everyone involved would benefit by easier management of the ever increasing problem of atrial fibrillation in our aging population. This drug is not yet studied in those patients who take warfarin for valvular heart disease. It is, at this time, just for nonvalvular atrial fibrillation. In Europe, this drug is already being used for the prevention of venous blood clots after knee or hip surgery and is known as Pradaxa. In Canada it is known as Pradax. Hopefully it will soon be available here.

categories: 

About Holy Cross Hospital

Holy Cross Hospital is a nonprofit, Catholic hospital in Fort Lauderdale, Florida, dedicated to innovative, high quality and compassionate care. For nearly six decades, Holy Cross has continuously expanded its services to provide leading-edge care for their patients in Florida and for those from elsewhere in the United States. Holy Cross also offers an International Services program to ensure that patients from outside the U.S. receive the care they need.

Blog Categories

Blog Archive