Thank you for this. I enjoy your videos and EBM. (Also a Veterinarian). I am currently using Librella in my own 14yr old canine. SO far no obvious side effects. He does have days where he skips his meals followed by diarrhea, but I have not charted to see if it correlates to his librella Injection. I have had my doubts about any "NEW FANTATIC" drugs a company sells, so I been trying it on my own pet first before trying to sell it to my clients. Your video gives me food for thought. Thank you.
As a vet, I had to decline this medication when offered to my baby, who was already diagnosed with canine cognitive dysfunction (I wasn't in the country) but in general, when there was some push for trying to prescribe this, I immediately said, there's no enough research for me to support this and accept this for my own dog. I think there's so much more that has to be done for us to fully understand its effects.
I gave Solensia to a senior cat with gait issues stemming from what was thought to be an untreated fracture when she was a young street cat. After three months, I saw no improvement and discontinued the injections. Two vets that I really respect had used the drug with their own cats and reported great success. My cat had no side effects.
Good video and thanks for raising these questions/concerns.. Could long-term gabapentin use potentially have a similar effect of inhibiting NGF to the point of compromising recovery or CNS function?..
This conversation goes differently about the partner product, Solensia for cats, since they don't respond well to NSAIDs and really struggle with chronic pain management. But its interesting that in dogs theres more discourse over what the best course of treatment is. Personally I've noticed Solensia has been very helpful for 2 of my senior cats. It was different for both. The first one, Olive, is 14 and was having increased aggression and decreased activity. After a couple of injections her activity levels improved and she spent more time playing and jumping to higher places and stopped being as aggressive with the other cats. My other girl, Roxy, had a full workup fo behavioral concerns of inappropriate urination. Some potential mild disc space narrowing/early arthritis were noted in radiographs we took as screening. After multiple other therapies didn't stop the urinations, we made the decision to try Solensia as a last resort. The spraying resolved almost immediately. If I do miss a dose, she starts spraying again very quickly. But as long as I keep up with her injections she uses the litterbox without fail. I will say there is potential it could be flaring up my Olive's sensitive stomach (for which a formal diagnosis has not been made, its mild and doesn't affect her quality of life, so after US was inconclusive I decided not to proceed with endoscopy/biopsies or further workup), but I'm not 100% certain its causation and not just coincidence, and even then its mild GI upset (diarrhea mostly)
Hello, I am a veterinarian who has (almost) graduated with a masters degree in epidemiology. I have finished the statistics components of the course so I feel like I'm qualified to discuss this at least a little bit. I don't agree with your analysis regarding response bias. If the drug has no effect, the response would be the same in both groups, or far more similar. The difference between the two is statistically significant. You can certainly go on to say that statistical significance and a p-value doesn't really "mean" anything without context. I agree with you, however you prosecute that point poorly. Certainly you could make an argument that more quantitative assessments such as the ones you suggested can be used. I agree with you on that. I think that is the argument that you can push with a far greater degree of success. As well as that, the scores being slightly higher in the different groups does not matter because they were randomly assigned. If the difference is due to random chance, which unless you're suggesting fraud (which I'm sure you're not), is completely suitable for a clinical trial to go ahead. In fact, attempting to make the numbers "more equal" would invalidate the study. As well as that, your conversation regarding RPOA does not mention, or at least I do not recall you mentioning it, that RPOA was much more common in those humans receiving concurrent long-term NSAID therapy. The concurrent use of a MAB and NSAID is not recommended. Regarding the use of beagles, this is the model population for dogs. You need to do it, you don't really have a choice in the matter. I don't think it's a fair criticism. Drugs need to jump through hoops, those hoops are going to include beagles. Really, bedinvetmab should be used in the patient population where OA is caused by age-related degeneration which are not neurological and long-term use of NSAIDs is either problematic due to owner compliance or co-morbidity. For example, I would not use bedinvetmab in a 1.5 year old dog with a CrCL rupture. I do not know any veterinarian in the area which I practice who use bedinvetmab in such a reckless way. Frankly, the way in which I see NSAIDs used with reckless abandon makes me far more concerned. I have taken care of dogs in my ICU that were on ACE inhibitors, ARBs and were then given meloxicam for a sore leg. I'm sure you'd never suggest using an NSAID in a patient such as that. To now disclose my own bias, I have used both the canine and feline MAB drugs semi-regularly in specific patient populations to great success when I worked as a GP (outside of North America it is common to work as a GP prior to pursuing other pathways after completing an internship). Personally, I used frunevetmab for my own senior cat in her last couple of years and it significantly improved her QOL until she died from an unrelated lung tumour. The way I see it, the studies used to approve the use of this drug are similar to those used to approve any other new medication approved for the use in animals. Clearly the FDA, Australian and European regulators agree. Frankly, no pharmaceutical company can even come close to the expense of the types of clinical trials used in the approval of human medications. For example, a similar MAB used to treat atopy in humans costs either the insurer or Government (depending on healthcare system) ~10-15 times as much.
The “statistically significant” thing you’re measuring is an owner based assessment from 0-10 where the difference in placebo group vs tx group was in certain time points 1 to 1.5 notches on that scale. Sure the numbers churn out a certain way, but the entire thing they’re based on is so subjective what do you even make of that? I’m not denying what the study found, I’m just skeptical of its utility in mass adopting a drug that inhibits NGF based off of what I would consider 1 study done twice.
@@DVMCellini yes it’s a subjective measure however there is a statistically significant difference in subjectivity. Given the size of the trial you would expect to see similar results in subjectivity between the two groups. So, to see this occur naturally (which it might) you’d have less than a 1% chance of that occurring. Even lower chance across two studies. To me, that is sufficient to make a claim that it reduces pain. I think where you’re getting mixed up is that it’s sufficient to make a claim as to the drugs safety profile or the drugs use case scenario. Initial approval is granted on this basis. This is not an uncommon thing to occur. Over the years there will be continued reporting about potential adverse side-effects. Much like there is for any medication initially approved on the human market. Eventually, it could result in a BLACKLABEL warning, withdrawal from the market, class action lawsuits, etc. That said, the approval process for this drug is not dissimilar to any other drug nor is the underlying science and statistical analysis necessarily wrong. That’s all I’m saying. They could do a broader study, however they are not required by the regulator to do so. It does not make sense for them to spend a significant amount of money on a non-required regulatory action.
I'm a recently qualified RVN in the UK, and Librela has been on the market since not long before I entered the veterinary industry so I've always seen it as one of the standard tools in the toolkit of pain management. I think the points you raise here are really interesting, and never considered how simply treating the pain caused by arthritis without tackling the problem itself could exacerbate the issue in the long run. I feel that remaining critical of the drugs we use and continuing to put them under scrutiny once in a while is important so that we can continue to improve the options we offer pets, and this has definitely encouraged me to look at pain management through a wider lens and remember that even drugs we see as standard practice have their own concequences. To ask for your insight, do you think there is any way that the inhibition of NGF could be localised? Do you think a version of this drug with less systemic effects would be feasible? Or would the underlying analgesic arthropathy make it more suitable for consideration as a palliative treatment rather than a long-term one?
There has to be a better way to measure pain in dogs than by asking their owners. A lot of time we don't know what to look for as well as a vet would. Like my parents' dog. She doesn't like walks, and we don't know if she's hurting or just lazy.
Side effects of meds aren't spoken about enough by vets in general I think. Very rarely will my vet give my pet a med with a run down of common side effects and what to look for. I will admit that's true for doctors as well, but at least then the pharmacists is there to give you the rundown. Back to pets, I do think side effects are not considered enough in the research either, so many vets might not even know what to tell their clients to look for. I think this is a really important discussion, and gives me a lot to think about.
My dachshund mix has received about seven of these shots over the past year. He grunts less when being picked up and is more active. The only thing that worries me is a gap of about three months (after five shots) when he didn’t receive any. During that time, he seemed to be in more pain-grunting more and even yelping a few times when being picked up. I can’t say for sure if this was related to the Librela.
How would you rank Libreala and the risk for neurological problems with breeds that already have a high risk for neurological problems? Like Dachshund, French Bulldog, Cavalier or any breed that has inherited familiar epilepsy in the line?
Thank you for this. I enjoy your videos and EBM. (Also a Veterinarian). I am currently using Librella in my own 14yr old canine. SO far no obvious side effects. He does have days where he skips his meals followed by diarrhea, but I have not charted to see if it correlates to his librella Injection. I have had my doubts about any "NEW FANTATIC" drugs a company sells, so I been trying it on my own pet first before trying to sell it to my clients. Your video gives me food for thought. Thank you.
As a vet, I had to decline this medication when offered to my baby, who was already diagnosed with canine cognitive dysfunction (I wasn't in the country) but in general, when there was some push for trying to prescribe this, I immediately said, there's no enough research for me to support this and accept this for my own dog. I think there's so much more that has to be done for us to fully understand its effects.
I LOVE the jab at chiropractor lol
I gave Solensia to a senior cat with gait issues stemming from what was thought to be an untreated fracture when she was a young street cat. After three months, I saw no improvement and discontinued the injections. Two vets that I really respect had used the drug with their own cats and reported great success. My cat had no side effects.
Good video and thanks for raising these questions/concerns.. Could long-term gabapentin use potentially have a similar effect of inhibiting NGF to the point of compromising recovery or CNS function?..
I don’t believe so? Unless there’s research clearly stating otherwise.
This conversation goes differently about the partner product, Solensia for cats, since they don't respond well to NSAIDs and really struggle with chronic pain management. But its interesting that in dogs theres more discourse over what the best course of treatment is.
Personally I've noticed Solensia has been very helpful for 2 of my senior cats. It was different for both. The first one, Olive, is 14 and was having increased aggression and decreased activity. After a couple of injections her activity levels improved and she spent more time playing and jumping to higher places and stopped being as aggressive with the other cats. My other girl, Roxy, had a full workup fo behavioral concerns of inappropriate urination. Some potential mild disc space narrowing/early arthritis were noted in radiographs we took as screening. After multiple other therapies didn't stop the urinations, we made the decision to try Solensia as a last resort. The spraying resolved almost immediately. If I do miss a dose, she starts spraying again very quickly. But as long as I keep up with her injections she uses the litterbox without fail. I will say there is potential it could be flaring up my Olive's sensitive stomach (for which a formal diagnosis has not been made, its mild and doesn't affect her quality of life, so after US was inconclusive I decided not to proceed with endoscopy/biopsies or further workup), but I'm not 100% certain its causation and not just coincidence, and even then its mild GI upset (diarrhea mostly)
Solensia incident rate, based on reports to agencies, is worse than dogs.
1:02
Hello, I am a veterinarian who has (almost) graduated with a masters degree in epidemiology. I have finished the statistics components of the course so I feel like I'm qualified to discuss this at least a little bit.
I don't agree with your analysis regarding response bias. If the drug has no effect, the response would be the same in both groups, or far more similar. The difference between the two is statistically significant. You can certainly go on to say that statistical significance and a p-value doesn't really "mean" anything without context. I agree with you, however you prosecute that point poorly.
Certainly you could make an argument that more quantitative assessments such as the ones you suggested can be used. I agree with you on that. I think that is the argument that you can push with a far greater degree of success. As well as that, the scores being slightly higher in the different groups does not matter because they were randomly assigned. If the difference is due to random chance, which unless you're suggesting fraud (which I'm sure you're not), is completely suitable for a clinical trial to go ahead. In fact, attempting to make the numbers "more equal" would invalidate the study.
As well as that, your conversation regarding RPOA does not mention, or at least I do not recall you mentioning it, that RPOA was much more common in those humans receiving concurrent long-term NSAID therapy. The concurrent use of a MAB and NSAID is not recommended.
Regarding the use of beagles, this is the model population for dogs. You need to do it, you don't really have a choice in the matter. I don't think it's a fair criticism. Drugs need to jump through hoops, those hoops are going to include beagles.
Really, bedinvetmab should be used in the patient population where OA is caused by age-related degeneration which are not neurological and long-term use of NSAIDs is either problematic due to owner compliance or co-morbidity. For example, I would not use bedinvetmab in a 1.5 year old dog with a CrCL rupture. I do not know any veterinarian in the area which I practice who use bedinvetmab in such a reckless way. Frankly, the way in which I see NSAIDs used with reckless abandon makes me far more concerned. I have taken care of dogs in my ICU that were on ACE inhibitors, ARBs and were then given meloxicam for a sore leg. I'm sure you'd never suggest using an NSAID in a patient such as that.
To now disclose my own bias, I have used both the canine and feline MAB drugs semi-regularly in specific patient populations to great success when I worked as a GP (outside of North America it is common to work as a GP prior to pursuing other pathways after completing an internship). Personally, I used frunevetmab for my own senior cat in her last couple of years and it significantly improved her QOL until she died from an unrelated lung tumour.
The way I see it, the studies used to approve the use of this drug are similar to those used to approve any other new medication approved for the use in animals. Clearly the FDA, Australian and European regulators agree. Frankly, no pharmaceutical company can even come close to the expense of the types of clinical trials used in the approval of human medications. For example, a similar MAB used to treat atopy in humans costs either the insurer or Government (depending on healthcare system) ~10-15 times as much.
The “statistically significant” thing you’re measuring is an owner based assessment from 0-10 where the difference in placebo group vs tx group was in certain time points 1 to 1.5 notches on that scale. Sure the numbers churn out a certain way, but the entire thing they’re based on is so subjective what do you even make of that?
I’m not denying what the study found, I’m just skeptical of its utility in mass adopting a drug that inhibits NGF based off of what I would consider 1 study done twice.
@@DVMCellini yes it’s a subjective measure however there is a statistically significant difference in subjectivity. Given the size of the trial you would expect to see similar results in subjectivity between the two groups. So, to see this occur naturally (which it might) you’d have less than a 1% chance of that occurring. Even lower chance across two studies. To me, that is sufficient to make a claim that it reduces pain. I think where you’re getting mixed up is that it’s sufficient to make a claim as to the drugs safety profile or the drugs use case scenario. Initial approval is granted on this basis. This is not an uncommon thing to occur. Over the years there will be continued reporting about potential adverse side-effects. Much like there is for any medication initially approved on the human market. Eventually, it could result in a BLACKLABEL warning, withdrawal from the market, class action lawsuits, etc. That said, the approval process for this drug is not dissimilar to any other drug nor is the underlying science and statistical analysis necessarily wrong. That’s all I’m saying. They could do a broader study, however they are not required by the regulator to do so. It does not make sense for them to spend a significant amount of money on a non-required regulatory action.
I'm a recently qualified RVN in the UK, and Librela has been on the market since not long before I entered the veterinary industry so I've always seen it as one of the standard tools in the toolkit of pain management. I think the points you raise here are really interesting, and never considered how simply treating the pain caused by arthritis without tackling the problem itself could exacerbate the issue in the long run. I feel that remaining critical of the drugs we use and continuing to put them under scrutiny once in a while is important so that we can continue to improve the options we offer pets, and this has definitely encouraged me to look at pain management through a wider lens and remember that even drugs we see as standard practice have their own concequences.
To ask for your insight, do you think there is any way that the inhibition of NGF could be localised? Do you think a version of this drug with less systemic effects would be feasible? Or would the underlying analgesic arthropathy make it more suitable for consideration as a palliative treatment rather than a long-term one?
There has to be a better way to measure pain in dogs than by asking their owners. A lot of time we don't know what to look for as well as a vet would. Like my parents' dog. She doesn't like walks, and we don't know if she's hurting or just lazy.
Oh boy ! And we wonder why all the seizures in dogs. Kind of like Prozac for dogs increases anxiety and aggression.
Side effects of meds aren't spoken about enough by vets in general I think.
Very rarely will my vet give my pet a med with a run down of common side effects and what to look for.
I will admit that's true for doctors as well, but at least then the pharmacists is there to give you the rundown.
Back to pets, I do think side effects are not considered enough in the research either, so many vets might not even know what to tell their clients to look for.
I think this is a really important discussion, and gives me a lot to think about.
My dachshund mix has received about seven of these shots over the past year. He grunts less when being picked up and is more active. The only thing that worries me is a gap of about three months (after five shots) when he didn’t receive any. During that time, he seemed to be in more pain-grunting more and even yelping a few times when being picked up. I can’t say for sure if this was related to the Librela.
Where have you been??!
Busy with lots of neurologic pets!
@ share stories! Let us live vicariously 🫶
Great video, DMV Cellini! I hope you will answer this: How is Dr. Michael Cellini doing?
He’s great!
How many dogs altogether were in the owner study was it hundreds or under 10, its pretty dodgy study if they dont declare the amount of dogs tested.
How would you rank Libreala and the risk for neurological problems with breeds that already have a high risk for neurological problems? Like Dachshund, French Bulldog, Cavalier or any breed that has inherited familiar epilepsy in the line?
Hold on! You cant just slip in that Glucosamine is ineffective and not tell us more! That’s like telling Santa’s not real to a kid and moving on!