My cardiologist participates in cardio-related studies. On my most recent visit, they asked if I would like to participate in one, comparing one current on-market drug to a (as I understand it) Stage 3 drug. Double-blind; I will definitely get one or the other of the drugs.
Upsides:
making slightly better use of my time, and “feel good” contributing to science
$50 per visit to cover gas, time, inconvenience
all study medications paid for (IOW, I would no longer need to pay the $50/month for the one drug I currently take, as long as I am in the study)
study-related lab tests paid for
I’m not seeing a significant or worrisome downside, hence my poking at the Dope bear. My cardio RN daughter is aware of the candidate drug, and has heard of no concerns, officially or anecdotally.
If they’re willing to offer this to you, it sounds like they’re not too worried if you were to get the placebo. So the same would presumably be true if it doesn’t work.
I won’t* be getting a placebo; I’ll either get my current drug, or the candidate drug.
_* well, I will, but only because the two drugs are delivered in different form: one as tablet, one as capsule. So each dose will consist of two items, a tablet and capsule, and one of the two will be a placebo and one a real drug.
At a Stage 3 trial they’ve already done a safety evaluation and at least seen some level of efficacy. The biggest concern is if there are adverse side effects, or a greater variation in efficacy than the current on-market drug, so it isn’t no risk, but if your physician is regularly monitoring your condition then you’ll at least get that feedback. (You will likely get little to no feedback from the study because they don’t want to influence the outcome, and if it is a true double blind even the researchers will not know which group you are in.) If you start to experience adverse effects you can always withdraw from the study.
It’s our call, of course, but you would be contributing to the development of a drug that may benefit many people, yourself included.
Liberxia AF is the name of the study. The other drug is milvexian.
Just be aware that your physician is not disinterested here. There’s money and professional benefit in trial participation, and enrolling patients for any trial can be very difficult.
That’s a good point. ETA: the provider is a very small office (two MDs), and the main MD has been working in studies for quite some time, for better or worse.
It’s not neccesarily a bad or good thing. Clinical trials are very important! But they’re also part of an extremely wealthy biomedical industrial complex.
Side effects aside, the main question for you (and your doc) is what happens to your health if this new drug is less effective than your current one.
Prioritize your health, don’t be afraid to ask tough questions, and don’t hesitate to say no if it doesn’t feel like a good decision.
It’s a decision that it would be best to make considering factors such as how the patient is doing on present medication and the nature of the condition for which the drug was prescribed (if doing well on an anticoagulant, why risk a change?).
Something to consider is that Librexia is part of a new class of oral anticoagulants (Factor XI/XIa inhibitors), none of which to my knowledge has yet been approved, while Eliquis works on a different part of the coagulation process (Xa). Other XI/XIa inhibitors are reportedly in phase II or phase III trials; a phase III trial of one XIa inhibitor (Asundexian) was stopped because of a lack of efficacy compared to Eliquis.
Is extra monitoring part of the trial? That might be a benefit even if you stay on the same drug.
There are risks. And yes, your doctor is not disinterested. But if it were me, I’d be inclined to do it. Especially if i wasn’t wild about my current medication.
If the new drug is in stage 3, then it probably won’t make any of your body parts shrivel up and fall off, or anything like that. But there’s still a lot they don’t know about it, hence the study. In particular, they hope that it’ll work better than the old drug, but they don’t know that, and they definitely don’t know if it’ll work better for you, specifically. And it certainly has side effects (all real medicines have side effects), and they probably don’t know all of those yet, either. So the risk is that you’ll end up switching from a drug that works better for you to one that works worse for you (not being as effective at treating the condition, worse side effects, or both). Of course, it’s also possible that the new drug will be better, and so you’ll benefit if you get it.
I would probably do it, because I place a high personal value on the advancement of science. How relevant is that to you? I don’t know. Consider how well your current medicine works for you, how bad your condition would be without medicine, and what the known side effects are of the new drug.
I take eliquis and I have no way of knowing if it “works”. It’s a lot better than the rat poison (coumadin) is used to take that required a blood test and delicate recalibration of dose every 6 weeks.
When I needed a stent, my cardiologist gave me the option of participating in a study. Double blind, I’d either get the stent currently in use or a new stent that effused a drug that was hoped would improve the effect.
There was a nice paycheck as well as increased monitoring (with payment for continued participation). I signed the papers. Everything went, and continues to go, well. I did numerous surveys and received numerous checks. At some point (3 years?) they revealed that I’d received the new stent.
Just recently I got a letter from the cardiologist who I haven’t heard from in ages. The letter asked if they had my correct contact information, and would I be willing to complete more surveys. I called the office, asked if there was payment (funding had expired, so no). I declined to participate without pay and asked that there be no further contact.
The only noticeable effect, sure. But maybe you’re on the new drug, it doesn’t work very well for you, and you end up with a heart attack or stroke (I assume that risk of those is the reason you’re on anticoagulants) that would have been prevented if you had stayed on your old medicine. Is that likely? I dunno. But is it possible? Definitely, and that needs to be part of your decision-making process.