January 26, 2010

Victoza: A New Competitor for Byetta

The FDA finally approved Novo Nordisk's long delayed GLP-1 analog, Liraglutide, which is marketed under the name, "Victoza."

This drug was developed in the same time frame as Byetta and is similar in concept. But it's side effect profile was more troubling, hence the delay. It's being released with a warning that it might produce thyroid cancers, though this supposedly is mostly a problem in rodents. Even so, the fact that the thyroid cancer issue can't be completely dismissed would make a reasonable person ask, "What does this drug offer that makes it worth taking on even a tiny bit more risk than is found with Byetta?"

You can read the full European prescribing information for Victoza here:

Victoza Prescribing Information.

As far as I can see the only possible benefit to taking Victoza over Byetta is that it requires a once a day shot, rather than the twice a day schedule of Byetta. That said, it appears to produce less blood sugar control than Byetta does--when Byetta works, which isn't always--and reading between the lines, it doesn't look to me as Victoza has as good an impact on weight as Byetta does.

When looking at statistics for both these drugs, keep in mind that other research has found that Byetta is a drug that is worthless for two thirds of of those who take it and magic for the other third. This means that the averages published in Prescribing Information documents aren't a good guide to its effect.

If out of ten people taking a drug, three people drop 30 lbs each and the other seven gain 3 pounds each, the average weight loss is 7 lbs, but that statistic fails to reflect reality in any meaningful way.

The same is true with blood sugar control, as some people respond dramatically to Byetta and others who take it actually see their blood sugar go up.

With this in mind, it's hard to compare Byetta to Victoza based on published statistics. The average A1c drop reported when patients take Victoza and Metformin is 1%, which is really no better than the drop achieved taking Metformin alone.

Most tellingly the Victoza prescribing information presents no statistic for the impact of Victoza on blood sugar when it is not being given in combination with another blood sugar lowering drug.

This suggests very strongly that on average the drug has no impact on A1c, but because it might have a stronger impact on a subset, as Byetta does, it can't be dismissed.

My take on this drug is this: There is little reason to take it. The longer duration means that if you get the serious gastrointestinal reaction that GLP-1 analogs can cause, it's going to take a lot longer to wash out of your body. If you aren't going to respond to Byetta, it isn't likely you'll respond to this drug either, as non-response suggests that fiddling with GLP-1 isn't going to help you. The impact is less than Byetta and the side effects more troubling, especially since it is a new drug and hasn't been prescribed to a large group of patients as Byetta has.

To me the most worrisome side effect is this. As the prescribing information reports,
The overall rates of thyroid adverse events in all intermediate and long-term trials are 33.5 [Victoza], 30.0 [Placebo] and 21.7 events per 1000 subject years of exposure for total liraglutide, placebo and total comparators; 5.4 [Victoza], 2.1 [Placebo] and 0.8 events, respectively concern serious thyroid adverse events. In liraglutide-treated patients, thyroid neoplasms, increased blood calcitonin and goiters are the most frequently thyroid adverse events and were reported in 0.5%, 1% and 0.8% of patients respectively.
Bottom Line: Stick with Byetta and keep an eye on longer-term research findings about this drug. There's no reason to take it that trumps the mediocre performance and possible thyroid risk.

 

17 comments:

The Old Man and His Dog said...

I was hoping you would mention this today when I saw it in the news.I agree with you. I LOVE Byetta! It has been a miracle for me. Lowered my BS and I lost about 25 lbs( I wasn't too over weight). Nothing helps me more than Byetta. I take it twice a day with 40 units of Lantus once a day and it's works like a charm. Who cares if I stick myself twice a day. You can't even feel it anyway. I'll stick with it until this new stuff proves it's better. Do wish it was cheaper though. Maybe with the new arrival of Victoza the price of Byetta will go down?

renegadediabetic said...

Big pharma has to come up with new drugs to keep up their brand-name profits. It's all about $$$$ rather than health.

Dan said...

I have been taking Victoza for about 1 month. Biggest effect is a huge loss of appetite. I no longer forage after supper. I am starting to follow BS101 diet guidelines with good (mostly) blood sugar reaction. A few years ago I was using Bayetta but never got rid of upset stomach. Not a problem with Victoze. BTW does the slowing of stomach emptying have an effect on your 1 & 2 hour BS guidelines? DDRM1

Jenny said...

Dan,

Yes, the slow stomach emptying may delay the blood sugar spike when you eat carbs. Try testing an hour or two later and see what you find. A bit of experimenting should help you determine if this effect is happening. Not everyone will see it, but with Byetta some people do report it.

Steve said...

Jenny-
Just found your site while doing research on Victoza. Wish I’d found it a while ago. Anything new on Victoza? I've been on Byetta for 3.5 years (w/Metformin 500 2x/day). My A1c has been in the 5.5-6.0 range ever since going on Byetta - I couldn't get it below 7 with metformin alone even with loosing 40+lbs. Needless to say I'm VERY happy with Byetta, except the 2 shots per day. Due to lifestyle issues, I’m sometimes unable to get that 2nd shot in before my evening meal, and if I’ve not very careful in what I eat, I pay for it. That makes a med, like Victoza, which is not meal dependant and administered once a day very attractive to me.

That said, I’m very reluctant to change from Byetta because it’s working so well for me. I guess my question is, do I switch to Victoza, or wait for Byetta LAR if I’m going to make a change.

Jenny said...

The stats for Victoza look like it isn't as strong as Byetta. So since you are doing so well with Byetta, it might be best to wait for the longer acting version of Byetta.

PBER57 said...

Hi Jenny, I could not handle the side effects of Byetta. The Dr put me on Victoza and I am getting great control. My fastings are now 82. I am also on Metformin. I have lost some weight but kinda plateaued even on low carb.

Dr Bernstein recommends Victoza on his internet radio show for his patients and he says he is getting great results. Is there anything new about his drug I should know? Also is this like the Glimpride where it stimulates my pancereas. sometimes I go low and have to treat it? This happened to me all the time on Glimipride. thanks Ginny

Pauly

Jenny said...

The GLP-1 analog drugs should not cause hypos like Glipizide because the mechanism is different.

I would never recommend taking any brand new drug until it has had a few years for the real side effects to show up.

The fact that it works isn't enough. Januvia worked very well for me, but it also turned out to turn off a part of the immune system that fights melanoma. I'm a melanoma survivor, and so that discovery was very disturbing.

If you take a new drug you really have to ask yourself how you'd feel if it turned out to have some very bad side effect on YOU in a few years. Would what it does for you be worth it if it shortened your life, or gave you memory loss, or harmed your liver.

I have no idea if Victoza will do anything bad, but because the FDA approval procedure is based on small short studies (2 or 3 years) and because the drug companies lie and twist data, you can't rule the possibility out.

Robert said...

Hi,

I would not call Victoza a COMPETITOR to Byetta.

They are both doing similar things, yet different enough to effect the BS differently for different people.

I took a lot of pills (one from each "group") yet my BS was never really under control.

Then I took Byetta ... great BS control ... but ended up in the ER with an allergic shock after two weeks.

Now I am trying out Victoza ... and I seem to react similar to Byetta ... yet not allergic reaction what however.

All in all DIABETEASE II has a lot of different causes … thus the need for different drugs … at the end everyone has to find out for him / herself what works best.

I think it is wrong to dismiss a drug just because one did not benefit from it.

Just my $0.02

Jenny said...

Robert,

Byetta and Victoza are similar enough chemically, that if you were allergic to one, it would seem like a poor idea to take the other. Doctors don't have enough information to know if it is safe to take this drug with a Byetta allergy because it is too new.

People like you will give them an answer, eventually, but for now you are an unpaid research subject--one who hasn't signed the consent forms that state the real risks you are taking on.

fishookhair said...

I have type two and my blood sugar readings have gone up recently, in am 8.2 to 9.6 , after bkfst they seem to drop, to 7.8 or even lower, at noon before eating they are 7.0 and at bed time 7.0 usually, my diet usually is vegies m raw, or veg soup. h made 3-4 oz meat ,1nce a wk, no breads no sweets, no alchol, having hard time to loose weight , work out at gym daily on bike and olyptical trainer and other, take 1 &1/2 met formi n daily , , was going to try victoza , any suggestions Thanks Bob

fishookhair said...

intresting , i have type two , high blood sugar, was just told I should use victoza , any input , thanks bob

Glenda TF said...

I have been on Victoza for a few months now, it has been great for me with Metformin. BS are about 5 now - first time in years (even before being officially diagnosed with type 2). I have lost about 20lb in 3 months - I just don't eat like I did. I think that alot of medication is just unknown - what it can do and how it react with different people is all over the place. There are meds that have been out for years - and all of a sudden they are recalled. I trust my doctor and I do my research and would never take anything that would damage my health. Good luck.

Jenny said...

Glenda,

Most of us start out trusting our doctors--until we suffer a severe, often life-threatening side effect that is listed in the drug's FDA-approved prescribing information, but which our doctor didn't know about.

Doctors are too busy to study drugs, so they rely on what they read in newsletters (often funded by drug company advertising) or from what drug reps tell them.

A wise patient will read up on every drug they take before they take it. None of us take drugs we know could harm us, but if we don't research them thoroughly, we won't know.

Note: I was warning about Avandia a full year before the stories about its connection to heart problems hit the news. The data was already available, but the drug company had threatened the "thought leaders" in the medical research community with billion dollar lawsuits so they stayed silent.

Unknown said...

I have poorly controlled BS levels. My blood sugars are high too. My DR suggested I try Victoza in combination with several other oral meds, so I did. My nausea factor was comparable to having morning sickness ALL THE TIME, often I felt that throwing up was imminent. I had headaches and found I was even getting cramps in my calf muscles. I tried lowering the dosage and injecting twice a day, to no avail. I also suffered from dizzyness when standing, and several times I found I had to hold on to something and wait for my head to clear. It did lower my blood sugars and I always felt full and therefore had no desire to eat (nausea made that unappealing as well). However good the results were, the side effects SCARED me. I will NOT ever try Victoza again. The black box warning about thyroid cancer was also an issue....my mother had a huge goiter and thyroid issues, and genetics do matter.
By the way, within 2 weeks of stopping Victoza, all side effects were gone and I'm back to HIGH blood sugars. May try Byetta.

Jenny said...

Unknown,

Have you tried the technique described HERE.

If that didn't work, have you tried using a combination of a long-acting insulin like Lantus or Levemir for fasting control and a fast acting insulin for meals (like novolog or humalog) under the supervision of a doctor who works with you to adjust the doses to match your level of insulin resistance and your carb intake (not all do)?

Insulin with a modest amount of carbohydrate restriction works for most of us. If it doesn't a young, talented endocrinolgist might still be able to help you. (Young because they tend to be up-to-date on the latest techniques while doctors trained 15 years ago often aren't.)

Too many doctors put people on the newest, most expensive drugs before trying the tried and true, especially family doctors who are too influenced by drug salespeople.

Dallee said...

Unknown has described symptoms which would likely spring from Januvia (note the reference made to taking several oral medications).

As noted in this blog (thanks, Jenny!), arthritic symptoms can be produced or heightened by Januvia -- I know mine were and I had dizziness at the same time. I stopped taking Januvia for just that reason and, no, it hadn't done much to lower my BG readings anyway.

Doziness and leg pains are not particularly associated with Byetta.

That's my thought ...