Oral solution approved by the FDA for canine heart failure

Photo: Fukume/Adobe Stock

A new drug for the management of signs of congestive heart failure (CHF) in dogs has been approved by FDA officials. The drug, pimobendan oral solution (Vetmedin Solution; Boehringer Ingelheim [BI]), is indicated for treatment of CHF caused by myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM) and is the first oral solution approved by the FDA for this use, according to a news release.¹

Heart disease affects approximately 10% of dogs in their lifetime, and MMVD accounts for about 75% of these cases presented at veterinary practices in North America.² Both MMVD and DCM may progress to CHF, according to BI.

The Vetmedin brand of pimobendan therapies has been on the market for 25 years. The product line includes Vetmedin Chewable Tablets for management of signs of mild, moderate or severe canine CHF caused by MMVD or DCM. These tablets and Vetmedin Solution are indicated for concurrent therapy use in treating CHF, on a case-by-case basis. Additionally, Vetmedin-CA1 may delay the onset of heart failure symptoms in dogs and is conditionally approved by the FDA for canines with stage B2 preclinical MMVD.¹

"We continue to deliver new innovations rooted in robust clinical evidence to help more pets," Daniel Watkins, vice president of US Pet Business for Boehringer Ingelheim, said in the release.¹ "We know some dogs and pet owners may prefer a liquid medication, especially for smaller dogs. With Vetmedin Solution, an easy-to-use liquid formulation, we can help more dogs with heart disease have longer survival and live better lives."

The safety and effectiveness of pimobendan oral solution for its indicated use was established by demonstrating the bioequivalence of Vetmedin Chewable Tablets.³ In dogs with MMVD or DCM, previous studies have demonstrated that pimobendan could help increase the survival time and quality of life.^4,5

In a 2013 study comparing pimobendan vs benazepril hydrochloride on quality of life variables, 124 dogs were randomized to receive treatment. Although the incidence of arrhythmia was similar in both treatment groups, dogs administered pimobendan were shown to have smaller heart size, higher body temperature and less water retention.⁴

Another study, published in 2006, compared the clinical efficacy of pimobendan vs benazepril hydrochloride for acquired atrioventricular valvular disease in dogs. This randomized, positive-controlled, multicenter investigation enrolled 76 canines with clinical acquired atrioventricular valvular disease. The study found that dogs receiving pimobendan had a long-term median survival of 415 days vs 128 days for dogs that did not receive pimobendan.⁵

Adverse effects of pimobendan were reported in a clinical study prior to the approval of Vetmedin Chewable Tablets. In the 56-day study, common adverse effects in 175 dogs with CHF and MMVD or DCM receiving the Vetmedin tablets included poor appetite, lethargy, diarrhea, and dyspnea. Additionally, azotemia, weakness and atxia, pleural effusion, syncope, and cough were reported. In 6% of these studied dogs, sudden death was reported. The prevalence of adverse effects was similar in the study’s active control group of 180 dogs receiving enalapril maleate.³

The safety of the pimobendan oral solution product has not been established in dogs with asymptomatic heart disease and heart failure caused by conditions other than MMVD or DCM. This product has also not been evaluated in dogs young than 6 months with congenital heart defects, those with diabetes or other serious metabolic diseases, or in dogs used for breeding, or are pregnant or lactating.³

References

1. Boehringer Ingelheim launches Vetmedin Solution (pimobendane oral solution), first oral solution approved by the FDA for congestive heart failure in dogs. News release. Boehringer Ingelheim. November 22, 2024. Accessed November 22, 2024. https://www.prnewswire.com/news-releases/boehringer-ingelheim-launches-vetmedin-solution-pimobendan-oral-solution-first-oral-solution-approved-by-the-fda-for-congestive-heart-failure-in-dogs-302314386.html?tc=eml_cleartime
2. Keene BW, Atkins, CE, Bonagura JD, et al. ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs. J Vet Intern Med. 2019;33(3):1127-1140. doi:10.1111/jvim.15488
3. Vetmedin Solution. Product label. Boehringer Ingelheim. 2023. Accessed November 22, 2024. https://docs.boehringer-ingelheim.com/VetmedinSolutionPI_2024.pdf
4. Häggström J, Boswood A, O’Grady M, et al. Longitudinal analysis of quality of life, clinical, radiographic, echocardiographic, and laboratory variables in dogs with myxomatous mitral valve disease receiving pimobendan or benazepril: the QUEST study. J Vet Intern Med. 2013;27(6):1441-1451. doi:10.1111/jvim.12181
5. Lombard, Christophe W et al. Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs. J Am Anim Hosp Assoc. 2006;42(4):249-61. doi:10.5326/0420249