REST ASSURED —
VETMEDIN has proven safety in 10 years of worldwide use
Rigorous licensing studies demonstrated VETMEDIN is safe and well-tolerated1,2
- A 56-day field study involving 355 dogs confirmed the safety of VETMEDIN
in dogs with congestive heart failure (CHF) due to atrioventricular valvular insufficiency (AVVI) or dilated cardiomyopathy (DCM) over a 2-month treatment period.
- The most commonly reported side effects of VETMEDIN were poor
appetite, lethargy, diarrhea, dyspnea, azotemia, weakness, and ataxia.
The prevalence of side effects was similar in the active control group
(enalapril, an angiotensin-converting enzyme [ACE] inhibitor).
- The incidence of new arrhythmias was also similar between the group treated with VETMEDIN and the enalapril-treated active control. Only 39.4% of dogs treated with VETMEDIN developed new arrhythmias
versus 45% of active control dogs treated with the ACE inhibitor
enalapril.
- An extended-use field study provided further evidence of VETMEDIN safety
in dogs with CHF resulting from AVVI or DCM when used in combination with
other appropriate CHF therapy for periods of at least 6 months.2
- A laboratory toxicity study at 3 to 5 times the recommended dosage
confirmed a wide safety margin for VETMEDIN.1,2
QUEST study confirms VETMEDIN safety3
- The international QUEST study was the largest study of its kind
to be conducted in dogs with CHF. It studied 260 dogs in 11 countries over 3
years.
- VETMEDIN was well-tolerated and caused few adverse events.3
- Observed adverse events in both the VETMEDIN (n=18) and ACE inhibitor (n=17) groups were very similar.3
- Gastrointestinal disorders were most common (n=6 and 4, respectively), followed by abnormal behavior, such as lethargy, confusion, or uneasiness (n=3 and 4, respectively). Three dogs treated with VETMEDIN were reported to have had a seizure.
For more information about the design and results of the QUEST trial, go to
www.questtrial.com.
Adverse events reported in VetSCOPE study were minimal
In the VetSCOPE trial, there were 3 adverse events in the VETMEDIN group and 1 in the ACE inhibitor group. Diarrhea, soft stool, and vomiting occurred in the VETMEDIN group (1 dog each) and colitis occurred in the ACE inhibitor group.
Proven track record of successful use worldwide
Veterinarians around the world have demonstrated safe, effective use of VETMEDIN
in their practices for nearly 10 years. VETMEDIN was first licensed for use in dogs
with CHF in 1999 in Europe.4
Since then, more than 300 million doses of VETMEDIN have been sold in the USA,
Europe, Australia, New Zealand, Canada, Mexico, South Africa, and Japan.4
In addition to proven use by practicing veterinarians in the US and around the
world, positive experiences with VETMEDIN in clinical trials have been reported in
peer-reviewed journals.3,5,6
Important safety information
In foreign, post-approval drug experience reporting, the following additional suspected adverse reactions were reported in dogs treated with a capsule formulation of VETMEDIN:
- Hemorrhage
- Petechia
- Anemia
- Hyperactivity
- Excited behavior
- Erythema
- Rash
- Drooling
- Constipation
- Diabetes mellitus
References:
1. VETMEDIN® (pimobendan) Chewable Tablets [package insert]. St. Joseph, MO:
Boehringer Ingelheim Vetmedica, Inc.; 2007.
2. VETMEDIN® (pimobendan) Chewable Tablets [Freedom of Information Summary]. St.
Joseph, MO: Boehringer Ingelheim Vetmedica, Inc.; 2007.
3. Häggström J, Boswood A, O’Grady M, et al. Effect of pimobendan or benazepril
hydrochloride on survival times in dogs with congestive heart failure caused by naturally
occurring myxomatous mitral valve disease: the QUEST study. J Vet Intern Med.
2008;22(5):1124–1135.
4.Data on file, Boehringer Ingelheim Vetmedica, Inc.
5. Lombard CW, Jöns O, Bussadori CM; for the VetSCOPE Study. Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs. J Am Anim Hosp Assoc. 2006;42(4):249–261.
6. Luis Fuentes V, Corcoran B, French A, Schober KE, Kleemann R, Justus C. A double-
blind, randomized, placebo-controlled study of pimobendan in dogs with dilated
cardiomyopathy. J Vet Intern Med. 2002;16(3):255–261.