May 16, 2007
FDA Approves New Drug for Heart Failure in Dogs
The Food and Drug Administration announced today the approval of Vetmedin (pimobendan), a new drug for the management of the signs of mild, moderate, or severe (modified New York Heart Association Class II, III, or IV) congestive heart failure in dogs due to atrioventricular valvular insufficiency or dilated cardiomyopathy. Vetmedin, a new molecular entity, is the first drug approved to treat congestive heart failure in dogs, in over ten years. Vetmedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Congestive heart failure is one of the more common heart problems seen in dogs, especially older smaller breeds. It is a complex and serious condition defined as the heart's inability to function normally, leading to excessive retention of water and salt causing fluid build-up in the lungs. Signs of congestive heart failure include fatigue and weakness, decreased ability to exercise, shortness of breath (fluid build up in the chest), increased respiratory rate, coughing, weak or irregular pulses, rapid or irregular heart beats and distended abdomen (fluid build up in the abdomen).
Vetmedin helps alleviate signs of heart failure by increasing contractility (the force of heart muscle contraction) and by dilating blood vessels (decreasing resistance to blood flow).
Congestive heart failure is classified by a veterinarian according to clinical signs (Class II through Class IV). Class II is mild (fatigue, shortness of breath, coughing, etc. apparent when ordinary exercise is exceeded); Class III, moderate (comfortable at rest, but exercise capacity is minimal), and Class IV, severe (no capacity for exercise and disabling clinical signs are present even at rest).
The effectiveness and safety of Vetmedin were evaluated in a 56-day, multi-site, active controlled field study with pivotal success determined at Day 29. Three hundred fifty-five (355) dogs with modified New York Heart Association Class II, III, or IV congestive heart failure in dogs due to atrioventricular valvular insufficiency or dilated cardiomyopathy were randomly assigned to either the Vetmedin treatment group or the active control Enacard (enalapril maleate) treatment group. Treatment success at Day 29 in the Vetmedin group (80.7%) was determined to be non-inferior to the treatment success in the Enacard group (76.1%).
Adverse reactions associated with Vetmedin (and Enacard) were potentially related to congestive heart failure, the therapy of congestive heart failure, or both and included poor appetite, lethargy, diarrhea, worsening signs of heart failure, heart failure death, azotemia (increase in the blood urea nitrogen), and mild increases in serum liver enzymes.
Pimobendan is not for use in cats and is only for use in dogs with clinical evidence of heart failure due to atrioventricular valvular insufficiency or dilated cardiomyopathy. Pimobendan acts to alleviate the clinical signs of congestive heart failure, rather than to reverse the underlying cardiac pathology, and it does not replace the need for other appropriate concurrent heart failure therapy (diuretics, antiarrhythmic drugs, etc.).
Vetmedin is manufactured by MEDA Manufacturing GmbH, Cologne, Germany for Boehringer Ingelheim Vetmedica, Inc. of St. Joseph, Missouri.
For more information on Vetmedin, please see http://www.fda.gov/OHRMS/DOCKETS/98fr/2007-141-273-fois001.pdf.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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