Today's Veterinary Practice

MAY-JUN 2018

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6. An 11-year-old small-breed dog presents with an increased respiratory rate and effort. The dog has had a left apical systolic murmur for years that has increased in intensity to a grade 4. The heart rate is 120 beats/min with normal femoral pulses. The best method to evaluate the cause of this dog's clinical signs is: a. Echocardiography b. Electrocardiography c. Thoracic radiography d. Blood testing troponin and a proBNP assay e. Blood pressure measurement 7. A 10-year-old Shih Tzu presents with a 2-week history of coughing. Clinical examination reveals the presence of a grade 4 left apical systolic murmur and pulmonary crackles. The heart rate is 130 beats/min with normal pulses, and the respiratory rate is 28 breaths/min. Based on these findings, a likely diagnosis is a. CHF requiring furosemide IV and pimobendan PO. b. Respiratory disease that warrants further investigation. c. Respiratory tract infection requiring antibiotics. d. Heartworm disease. e. Impossible to narrow down without further investigation. 8. A 10-year-old German shepherd with stable compensated congestive heart represents with dyspnea. Examination reveals a heart rate of 220 bpm with an irregularly irregular rhythm. This is most likely caused by: a. Supraventricular premature complexes b. Supraventricular tachycardia c. Ventricular tachycardia d. Atrial fibrillation e. Ventricular premature complexes 9. Which statement about spironolactone is correct? a. It is a powerful potassium-sparing diuretic. b. It can be used to replace the loop diuretic furosemide in the control of CHF. c. There is evidence it may delay the onset of heart failure, so it can be used in asymptomatic patients. d. It is not helpful as an aldosterone antagonist, as ACE inhibitors prevent the angiotensin II mediated release of aldosterone. e. There is evidence it may prolong life in patients with CHF secondary to DMVD. 10. When dogs become resistant to the loop diuretic furosemide, which of the following measures is not appropriate: a. Increase the frequency of administration to 3 or 4 times daily. b. Add a thiazide diuretic such as hydrochlorothiazide. c. Switch to the more potent loop diuretic, torsemide. d. Limit the water intake of the patient. e. Ensure that all the other cardiac medications are optimally dosed. 090340591/0 NADA 141-273, Approved by FDA Vetmedin ® (pimobendan) Chewable Tablets Cardiac drug for oral use in dogs only Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Description: Vetmedin (pimobendan) is supplied as oblong half-scored chewable tablets containing 1.25, 2.5, 5 or 10 mg pimobendan per tablet. Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic drug with vasodilatative properties. Pimobendan exerts a stimulatory myocardial effect by a dual mechanism of action consisting of an increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (Type III). Pimobendan exhibits vasodilating activity by inhibiting phosphodiesterase III activity. The chemical name of pimobendan is 4,5-dihydro-6-[2-(4-methoxyphenyl)-1H-benzimidazole-5-yl]-5-methyl- 3(2H)-pyridazinone. Indications: Vetmedin (pimobendan) is indicated for the management of the signs of mild, moderate, or severe (modified NYHA Class II a , III b , or IV c ) congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI) or dilated cardiomyopathy (DCM). Vetmedin is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis. a A dog with modified New York Heart Association (NYHA) Class II heart failure has fatigue, shortness of breath, coughing, etc. apparent when ordinary exercise is exceeded. b A dog with modified NYHA Class III heart failure is comfortable at rest, but exercise capacity is minimal. c A dog with modified NYHA Class IV heart failure has no capacity for exercise and disabling clinical signs are present even at rest. Contraindications: Vetmedin should not be given in cases of hypertrophic cardiomyopathy, aortic stenosis, or any other clinical condition where an augmentation of cardiac output is inappropriate for functional or anatomical reasons. Warnings: Only for use in dogs with clinical evidence of heart failure. At 3 and 5 times the recommended dosage, administered over a 6-month period of time, pimobendan caused an exaggerated hemodynamic response in the normal dog heart, which was associated with cardiac pathology. Human Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. Precautions: The safety of Vetmedin has not been established in dogs with asymptomatic heart disease or in heart failure caused by etiologies other than AVVI or DCM. The safe use of Vetmedin has not been evaluated in dogs younger than 6 months of age, dogs with congenital heart defects, dogs with diabetes mellitus or other serious metabolic diseases, dogs used for breeding, or pregnant or lactating bitches. Adverse Reactions: Clinical findings/adverse reactions were recorded in a 56-day field study of dogs with congestive heart failure (CHF) due to AVVI (256 dogs) or DCM (99 dogs). Dogs were treated with either Vetmedin (175 dogs) or the active control enalapril maleate (180 dogs). Dogs in both treatment groups received additional background cardiac therapy. The Vetmedin group had the following prevalence (percent of dogs with at least one occurrence) of common adverse reactions/new clinical findings (not present in a dog prior to beginning study treatments): poor appetite (38%), lethargy (33%), diarrhea (30%), dyspnea (29%), azotemia (14%), weakness and ataxia (13%), pleural effusion (10%), syncope (9%), cough (7%), sudden death (6%), ascites (6%), and heart murmur (3%). Prevalence was similar in the active control group. The prevalence of renal failure was higher in the active control group (4%) compared to the Vetmedin group (1%). Adverse reactions/new clinical findings were seen in both treatment groups and were potentially related to CHF, the therapy of CHF, or both. The following adverse reactions/new clinical findings are listed according to body system and are not in order of prevalence: CHF death, sudden death, chordae tendineae rupture, left atrial tear, arrhythmias overall, tachycardia, syncope, weak pulses, irregular pulses, increased pulmonary edema, dyspnea, increased respiratory rate, coughing, gagging, pleural effusion, ascites, hepatic congestion, decreased appetite, vomiting, diarrhea, melena, weight loss, lethargy, depression, weakness, collapse, shaking, trembling, ataxia, seizures, restlessness, agitation, pruritus, increased water consumption, increased urination, urinary accidents, azotemia, dehydration, abnormal serum electrolyte, protein, and glucose values, mild increases in serum hepatic enzyme levels, and mildly decreased platelet counts. Following the 56-day masked field study, 137 dogs in the Vetmedin group were allowed to continue on Vetmedin in an open-label extended-use study without restrictions on concurrent therapy. The adverse reactions/new clinical findings in the extended-use study were consistent with those reported in the 56-day study, with the following exception: One dog in the extended-use study developed acute cholestatic liver failure after 140 days on Vetmedin and furosemide. In foreign post-approval drug experience reporting, the following additional suspected adverse reactions were reported in dogs treated with a capsule formulation of pimobendan: hemorrhage, petechia, anemia, hyperactivity, excited behavior, erythema, rash, drooling, constipation, and diabetes mellitus. Effectiveness: In a double-masked, multi-site, 56-day field study, 355 dogs with modified NYHA Class II, III, or IV CHF due to AVVI or DCM were randomly assigned to either the active control (enalapril maleate) or the Vetmedin (pimobendan) treatment group. Of the 355 dogs, 52% were male and 48% were female; 72% were diagnosed with AVVI and 28% were diagnosed with DCM; 34% had Class II, 47% had Class III, and 19% had Class IV CHF. Dogs ranged in age and weight from 1 to 17 years and 3.3 to 191 lb, respectively. The most common breeds were mixed breed, Doberman Pinscher, Cocker Spaniel, Miniature/Toy Poodle, Maltese, Chihuahua, Miniature Schnauzer, Dachshund, and Cavalier King Charles Spaniel. The 180 dogs (130 AVVI, 50 DCM) in the active control group received enalapril maleate (0.5 mg/kg once or twice daily), and all but 2 received furosemide. Per protocol, all dogs with DCM in the active control group received digoxin. The 175 dogs (126 AVVI, 49 DCM) in the Vetmedin group received pimobendan (0.5 mg/kg/day divided into 2 portions that were not necessarily equal, and the portions were administered approximately 12 hours apart), and all but 4 received furosemide. Digoxin was optional for treating supraventricular tachyarrhythmia in either treatment group, as was the addition of a β-adrenergic blocker if digoxin was ineffective in controlling heart rate. After initial treatment at the clinic on Day 1, dog owners were to administer the assigned product and concurrent medications for up to 56±4 days. The determination of effectiveness (treatment success) for each case was based on improvement in at least 2 of the 3 following primary variables: modified NYHA classification, pulmonary edema score by a masked veterinary radiologist, and the investigator's overall clinical effectiveness score (based on physical examination, radiography, electrocardiography, and clinical pathology). Attitude, pleural effusion, coughing, activity level, furosemide dosage change, cardiac size, body weight, survival, and owner observations were secondary evaluations contributing information supportive to product effectiveness and safety. Based on protocol compliance and individual case integrity, 265 cases (134 Vetmedin, 131 active control) were evaluated for treatment success on Day 29. At the end of the 56-day study, dogs in the Vetmedin group were enrolled in an unmasked field study to monitor safety under extended use, without restrictions on concurrent medications. Vetmedin was used safely in dogs concurrently receiving furosemide, digoxin, enalapril, atenolol, spironolactone, nitroglycerin, hydralazine, diltiazem, antiparasitic products (including heartworm prevention), antibiotics (metronidazole, cephalexin, amoxicillin-clavulanate, fluoroquinolones), topical ophthalmic and otic products, famotidine, theophylline, levothyroxine sodium, diphenhydramine, hydrocodone, metoclopramide, and butorphanol, and in dogs on sodium-restricted diets. Manufactured for: Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO 64506 U.S.A. Vetmedin ® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH licensed to Boehringer Ingelheim Vetmedica, Inc. Copyright © 2017 Boehringer Ingelheim Vetmedica, Inc. or an affiliated company. All Rights Reserved. 448005-00 Revised 01/2017

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