Okay, talk to me. I am T1 since 2004 and have been on, first, Lantus, then Levemir, now Tresiba but I am considering going back to Lantus and want some feedback.
I liked Lantus (A1C of 5.7) just fine but when talk about tumor growth came around in 2009 or so, I asked to switch to Levemir. I HATED Levemir. I would rather have my eyelashes pulled out than go back on that ever again. It had such dramatic peaks for me at night, I could never get a good night’s sleep and I had to split my dose. Low low low low, erratic highs and lows - could never get dosage right. My endo put me on Tresiba. I adore Tresiba for my diabetes. It is so flat - a flawless basal but now I am concerned about the FDA approval/studies and cardiovascular risk. While taking care of my diabetes is critical, I am also a regular human being who wants to take care of ALL of my organs (the ones I have left - haha!). I’m 51, I still have decades of medicating ahead of me. I am on no other medication, my cholesterol is gorgeous, vegetarian, very low-carb diet a la Dr. Bernstein. I balk at taking aspirin.
I am thinking of going back to Lantus, which may not handle my basal needs as well as Tresiba (similar A1C to Lantus and my daily readings say pretty flat as better confirmation of control), but have less risks for my system as a whole. What does anyone think?
Well, you know what they say, YDMV. I agree with your assessment and admiration of Tresiba. It is truly amazing as to how flat it is. But for me it was not the best solution. A split dose of Levemir works best because my basal requirements increase by about 20% at night, and I can dial it in to give me very flat basal rates. Ultimately, we’re all different and we each need to see what works best through trial and error. It looks like your solution is Tresiba. In light of what a healthy lifestyle you lead, and in light of your excellent cardiovascular numbers, and because I’m assuming you probably have a regular quarterly or bi-annual checkup with you endo, I think you’d start to see the beginnings of any cardiovascular impacts long before they become a problem. Continuing Tresiba seems like a very manageable risk, in my opinion, if it is even a risk at all.
tresiba didn’t get through the fda the first time around so they resubmitted their own trials for a, successful, second attempt. call me paranoid but submitting your own trial is a bit biased, no?
I switched from Lantus just over a month ago. I would never go back. I was fine with Lantus until I tried Tresiba. I love how flat it is.
I don’t really believe there is any significant risk in using it. It has been available in Europe for several years. The trial that the FDA used for their approval was made up of type I and type II from 40 different countries. That being said, I personally take what the FDA says with a grain of salt. I mean, take a look at their preferred diet for people with diabetes. They have grossly missed the mark on many of their edicts over the years. They are, after all, still just people.
I think we have to understand that the FDA is actually very conservative. A new drug is approved when the data submitted convinces the FDA that it is safe. But convincing and having complete proof are different things. If we waited for complete proof we would not have new drugs. In the case of a drug like Tresiba the FDA makes a tradeoff between the benefits of the new drug and the potential for harm. In the evidence submitted for Tresiba there was no evidence of CVD risk. But there was not enough evidence to establish that the CVD risk was low or none. There is a big difference between not having enough evidence of CVD risks and having the the evidence that the CVD risks are low/none.
In this case the FDA depended on some basic statistics. There were so many patients involved in the Tresiba studies that any serious CVD risk would have shown up as CVD events. But there weren’t any. Which suggests that any CVD risks if there are any a likely low. In this case it has become common for FDA to grant approval and establish an aftermarket surveillance program. If any CVD problems do appear the surveillance program will track them and the FDA can consider that evidence.
I personally use Tresiba. I see absolutely no reason to consider stopping Tresiba over fears of CVD problems. The FDA approval process has significantly narrowed those risks and in my case the improved blood sugar control I get simply by using Tresiba probably reduces my CVD risk far more than any residual risk present from the drug.
exactly the kind of smart feedback i was looking for. thank you all. i appreciate it. i was probably looking for validation from someone other than an endocrinologist (who i also only trust to a certain extent) or pharmacist. you know… another diabetic!
I would like to add that the main CVD risk is linked to the average glucose level in individuals. Starting with an average glucose level of 100 mg/dl the CVD risk will rise. First very moderate but the higher the average the higher the CVD risks. This makes it very hard to determine the real driver of CVD risks between different groups in studies. Let us assume we would see higher CVD risks with Tresiba. Is Treshiba really causing this or is this control group by coincidence less successful in managing their diabetes? For example simple seasonal changes often require adjustments to basal dosages. What if the control group was less capable or slower to adjust to these changes? Here the design of the groups can bias the result. On the other hand we know for sure that better numbers due to the use of Tresiba will reduce the CVD risks and this could easily outweigh other CVD risks - perhaps even risks introduced by the medicine itself.
So, I posted in a couple of other threads about insulin glargine and correlations with cancer, including links to peer-reviewed studies. As far as I can tell, correlations between insulin analogues (not just Lantus) and cancer are spurious or statistical anomalies. If you look at the FDA trials of Lantus, for some reason the Lantus group was largely composed of Type 2s, who have a much higher incidence of pancreatic (and other) cancers, regardless of treatment. The studies were not controlled for age, obesity, or other risk factors for cancer. Why? Because the trials were to determine the safety of Lantus for diabetics in treating diabetes.
There have been many, many studies of insulin glargine and other analogues since that time. There will never be true, double-blind, well-controlled, full factorial experiments of insulins. Why? Because the control group (those insulin-dependent diabetics receiving a placebo) would die. So the best we can do is cohort and longitudinal studies. There are a lot that have been conducted in many countries over the last twenty years. They all conclude the same thing: there is no statistically relevant correlation between insulin glargine use and cancer incidence. So basically, people concerned about such things got the “wool pulled over” by the worst kind of alarmist science writers.
I’m a scientist by training and profession, and I’m a diabetic (soon to start on insulin myself). I’ve studied the issues religiously, as I’m relatively young, have a small child, and want to be around for as long as I can. I am well read in the scientific and medical literature, and I’ve specifically researched the safety of insulin analogues. I’ve concluded there is nothing for me (or my wife) to worry about from any insulin treatment, other than the normal (reaction lows, crystallization, aging out, overheating, etc.). I’m not worried about “toxic additives” or cancer risks. I may get cancer or I may not (if I live long enough, I almost certainly will, statistically). But it likely won’t have anything to do with my insulin. I’d also rather have cancer than lose my legs, eyes, or heart, for that matter.
