Librella approval study

Hello Summarians!

Librela has gained FDA approval. According to our Rep it is set to be released in a Septemberish time frame. I thought it might be useful to review the original study. I will be interested to hear Zoeti’s thoughts on if they expect similar issues to the human product that was shelved and about concurrent NSAID use.

Please give me feedback on ways I can make it more useful to you.

If it is valuable to you please consider sending it on to a friend 😄 

Librella approval study — a chance to educate before the release

Canine osteoarthritis (OA) is a degenerative disease causing chronic pain and mobility issues in dogs. Current treatments like NSAIDs have limitations, prompting the need for alternatives. Bedinvetmab, a monoclonal antibody targeting nerve growth factor (NGF), was evaluated in this study. Dogs received monthly subcutaneous injections of bedinvetmab for up to 9 months, and efficacy and safety were assessed using the canine brief pain inventory (CBPI), physical examinations, and absence of adverse events. Bedinvetmab demonstrated long-term efficacy and safety, with a low incidence of adverse events. The CBPI results were comparable to other pain medications. The study concluded that bedinvetmab is a safe and effective treatment for OA-associated pain in dogs. The monthly injectable form may improve treatment compliance. Further research and post-marketing surveillance are necessary to confirm its efficacy and safety in real-world settings.

Corral MJ, Moyaert H, Fernandes T, Escalada M, Kira S Tena J, Walters RR, Stegemann MR. A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis. Vet Anaesth Analg. 2021 Nov;48(6):943-955. doi: 10.1016/j.vaa.2021.08.001. Epub 2021 Aug 22. PMID: 34565678 .

Bottom line — A new tool for multimodal pain protocols

Antibiograms help with AB sensitivity issues

This study aimed to create antibiograms following CLSI guidelines for commonly cultured sites and compare local resistance profiles to ISCAID recommendations in a veterinary tertiary care center. The results supported the hypothesis that isolates from this center would display a high level of resistance to ISCAID-recommended first-line therapies. The study found higher susceptibility rates for urinary isolates compared to skin and respiratory samples. E. coli, the most common urinary isolate, showed higher susceptibility to amoxicillin-clavulanate compared to amoxicillin. However, the study highlighted the need for more evidence-based research to determine if the addition of clavulanic acid provides a clinical benefit. For skin infections, a significant percentage of S. pseudintermedius isolates (40%) were methicillin-resistant, and MRSP isolates showed limited efficacy against recommended antimicrobials. MSSP had higher rates of susceptibility. The study emphasized the growing concern for methicillin-resistant staphylococci in veterinary patients and the need for cultures to guide therapy in cases of superficial bacterial folliculitis. Respiratory isolates had generally low susceptibility rates, and the antimicrobials associated with higher susceptibility were those suggested or reserved for multi-drug resistant infections. The study questioned the common practice of using amoxicillin-clavulanate or doxycycline as monotherapy for pneumonia cases and highlighted the need for further studies to determine optimal treatment recommendations. The study acknowledged the limitations of antibiograms, such as the selection bias of cultured cases and the inability to distinguish between colonizing and pathogenic organisms. It also discussed the challenges in developing veterinary antibiograms, including limited availability of veterinary species- and site-specific MIC breakpoints and the need for more comprehensive breakpoints and engagement with laboratories and antimicrobial susceptibility testing platforms. In conclusion, the study demonstrated the importance of antibiograms in antimicrobial stewardship programs and the need for evidence-based prescribing in veterinary medicine. It emphasized the utility of antibiograms in providing locally relevant resistance profiles and supplementing national guidelines, particularly in referral centers with complicated patient populations. Clinicians should consider the limitations of antibiograms and exercise caution in interpreting and applying the results to their prescribing decisions.

Leet-Otley, K., Fellman, C. L., Wayne, A. S., Beaulac, K., DeStefano, I. M., Chambers, K., Marino, K. B., & Doron, S. (2023). Demonstrating the importance of local culture and susceptibility data: antibiograms from dogs at a veterinary tertiary care center,Journal of the American Veterinary Medical Association https://doi.org/10.2460/javma.22.12.0545  

Bottom line — These would be great but the resistance alone is pretty scary …

More thoughts on guiding clients who face hemoabdomen

Nontraumatic hemoabdomen or hemoperitoneum (NTH) is a common, life-threatening emergency in dogs, often resulting from abdominal tumors. Treatment options include surgery, palliative care, or euthanasia, and the choice is emotionally and financially challenging for the pet owners due to the unpredictable diagnosis and prognosis. This large retrospective study aimed to understand the factors influencing pet owners' decision-making process and their satisfaction with the chosen treatment. Quality of life (QOL) was found to be the most critical factor affecting the decision, with over 90% of owners stating it significantly influenced their choice. Owners who opted for surgery reported better QOL scores for their pets post-treatment, suggesting that if QOL is a primary concern, surgery should be highly considered. The risk of cancer and the remaining time with the pet were the next most influential factors. Most NTH cases are due to malignancy, with splenic hemangiosarcoma being the most common. Given the poor prognosis of these cases, owners should be well-informed about the likelihood of cancer before deciding on surgery. The study also found that preoperative imaging to screen for metastasis could improve confidence in diagnosing malignant pathology and aid in the decision-making process. Other factors such as finances, comorbidities, and pet age also played a role, demonstrating that an individualized approach to owner counseling is necessary. About 25% of respondents had second thoughts about their decision, regardless of the treatment choice. This finding underscores the need for further educational and emotional support for pet owners during this challenging decision-making process. Therefore, a standardized approach to discussing treatment options, potential outcomes, and factors that are most important to an individual pet owner is recommended to guide the treatment of patients with NTH. 

Menard, J. V., Sylvester, S. R., & Lopez, D. J. (2023). Assessing major influences on decision-making and outcome for dogs presenting emergently with nontraumatic hemoabdomen, Journal of the American Veterinary Medical Association https://doi.org/10.2460/javma.23.01.0014  

Bottom line — A nice reminder of ways to advise folks facing this problem

Just putting things in perspective …

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