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The site is secure. Canine pulmonary hypertension PH is associated with increased morbidity and mortality. Tadalafil, a phosphodiesterase-5 inhibitor used commonly in humans with PH, has not been evaluated in a clinical trial in dogs with naturally-occurring PH. Our objectives were to compare the efficacy of tadalafil and sildenafil on PH assessed by peak tricuspid regurgitant flow velocity, estimated systolic pulmonary arterial pressure gradient, voluntary activity, quality of life, and safety profiles in dogs with moderate-to-severe PH.
Twenty-three dogs with echocardiographic evidence of moderate-to-severe PH. Prospective short-term, randomized, double-blinded pilot study. Dogs with PH were randomly allocated to receive sildenafil or tadalafil for 2 weeks and assessed via echocardiography, activity monitors, and owner-reported outcomes.
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In this pilot study, phosphodiesterase-5 inhibition led to apparent improvement in quality of life scores without documenting superiority of tadalafil over sildenafil. Pulmonary hypertension PH is characterized by persistently increased pulmonary arterial pressure PAP which can lead to pulmonary arterial remodeling, right ventricular failure, and death [ 1 ]. In dogs, PH can be primary idiopathic or secondary to left-sided heart disease [ 3 — 5 ], respiratory disease [ 6 — 10 ], left-to-right cardiovascular shunts [ 6 — 9 ], heartworm disease [ 6 , 7 , 11 ], and pulmonary thromboembolism [ 6 — 8 ].
Pulmonary vascular pathology and disease progression are shared sequela regardless of disease etiology [ 12 ]. The nitric oxide pathway is impaired by upregulated phosphodiesterase-5 PDE5 in pulmonary vessels which decreases cyclic guanosine monophosphate contributing to endothelial dysfunction and smooth muscle cell proliferation [ 12 ].
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Phosphodiesterase-5 inhibitors prevent cyclic guanosine monophosphate metabolism, prolonging protein kinase G activation. This decreases pulmonary artery smooth muscle cell calcium concentration causing pulmonary artery vasodilation and decreased smooth muscle cell proliferation [ 13 ].
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While sildenafil improves clinical signs related to PH [ 8 , 14 ], its short half-life in dogs 3—4 hours [ 15 , 16 ] requires dosing three times daily which can compromise treatment compliance and owner-dog relationship.
Additionally, its long-term costs may preclude treatment. Tadalafil is a newer oral PDE5I for treatment of pulmonary arterial hypertension in people [ 17 ].
Tadalafil and sildenafil have similar efficacy and safety profiles in people with pulmonary arterial hypertension [ 18 — 20 ]. Several pharmacokinetic and pharmacodynamic differences between these drugs could make tadalafil a better alternative. For example, tadalafil in people has a long plasma half-life Tadalafil is markedly more selective for PDE5 than sildenafil and may have fewer adverse effects from a lower proclivity to inhibit unintended PDE isoenzymes [ 12 ].
While tadalafil attenuates PAP following a single dose in experimentally-induced PH in dogs [ 23 ], clinical use for naturally-occurring PH in dogs is limited to a single case report [ 24 ]. The study objective was to compare efficacy of tadalafil with sildenafil on peak tricuspid regurgitant flow velocity TRFV , estimated systolic pulmonary arterial pressure sPAP , voluntary activity, quality of life QOL , and safety profiles in moderate-to-severe canine PH. We hypothesized that dogs with moderate-to-severe PH treated with tadalafil would exhibit significantly greater decreases in peak TRFV and estimated sPAP, and significantly greater increases in voluntary activity, QOL, and fewer adverse events AE compared to sildenafil.
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Dogs of any age, breed, or sex were eligible for enrollment in this prospective, randomized, double-blinded pilot study between August to February Dogs were examined days 0 and 15 and questionnaires and visual analog scores VAS assessed days 0, 8, and A power calculation a priori was performed utilizing data extrapolated from the only clinical trial directly comparing the effect i. The difference between means in that study 1. We increased the number to 23 to account for disease etiology variation and potential drop-out.
Client-owned dogs with clinical signs of chronic cough, tachypnea, respiratory distress, cyanosis, syncope, or in which thoracic auscultation revealed abnormal sounds i.
Stratification of dogs into these groups was based on diagnostics performed by attending clinicians and subject to owner approval and finances. Not all dogs received the same diagnostic tests. Dogs were grouped within those aforementioned constraints. Previous treatment with sildenafil was permitted provided there was a washout of 7 days and echocardiographic evidence of moderate-to-severe PH persisted after the washout.
If these clinical signs occurred, sildenafil was to be restarted and the primary clinician contacted immediately.
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Dogs were randomized via a computer-generated schedule into one of 2 treatments Figure 1. Randomization, drug compounding, and dispensation were performed by a pharmacist or a technician under the direct supervision of a pharmacist blinded to the dog characteristics other than body weight.
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Dogs receiving tadalafil group had a compounded suspension allocated into a bottle labeled MB and placebo suspension allocated into a bottle labeled AEB. Treatment in both groups was started the morning after PH diagnosis day 1.
Flowchart documenting the numbers of dogs recruited to each treatment and their progress through the trial.
Sildenafil, tadalafil, and placebo were matched with regard to suspension consistency, color, and volume. Owners, veterinarians, and all clinic personnel participating in evaluations were masked to treatment.
Treatment code was known only to the pharmacist treatment dispenser. All owners were requested to return medication bottles at the treatment period end.
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Dosing compliance was evaluated by measuring residual volume from MB and AEB when available for each dog at the study end and comparing it with what was dispensed.
Echocardiography was performed using a conventional echocardiographic system and phased-array transducers with nominal frequencies ranging from 2. Sonographers were blinded to treatment group but not to time point i. Tricuspid and pulmonic valves were imaged in multiple planes to optimize alignment for Doppler interrogation of regurgitant jets and to evaluate pulmonary artery systolic flow velocity and profile.
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Estimated systolic and mean pressure gradients were calculated by applying the modified Bernoulli equation to maximal velocity of tricuspid and pulmonic regurgitant jets, respectively. Right atrial pressure was estimated at 5 mmHg with subjectively normal right atrial size, 10 mmHg with a subjectively enlarged right atrium without evidence of right-sided CHF, and 15 mmHg with right-sided CHF [ 29 , 30 ].
Estimated systolic pulmonary arterial pressure was calculated by adding estimated right atrial pressure to systolic right ventricular to right atrial pressure gradient. Eisenmenger physiology was diagnosed if right-to-left intra- or extra-cardiac shunting was documented with agitated saline contrast study. Right pulmonary artery distensibility index was measured as previously described [ 26 ].
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Briefly, maximum systolic and minimum diastolic internal diameter of the right branch of the pulmonary artery were measured using a trailing edge to leading edge technique in either long or short axis the view giving the clearest image was utilized. Acceleration time was measured from onset of Doppler flow to peak flow velocity.
Ejection time was measured from onset of Doppler pulmonary artery flow signal to end of signal. An AT:ET ratio was calculated. Indirect blood pressures were measured on days 0 and 15 using an ultrasonic blood flow monitor f sphygmomanometer, and pneumatic cuff as previously described [ 31 , 32 ].
Owners used a previously validated QOL scoring system, functional evaluation of cardiac health FETCH questionnaire [ 33 ] reflective of 7 days before each assessment i. Five possible scores for each question ranged from 1 poor to 5 excellent.
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Responses for each question were summed to obtain an overall score for each dog at each time point. Owners performed a VAS assessment on days 0, 8, and Distance from 0 to the patient score was measured providing a quantifiable VAS score. Voluntary activity was measured using a canine-specific activity monitor AM g that continuously measured magnitude, frequency, and duration of movement that was converted to a raw activity value.
This AM was placed ventrally on the neck collar of each dog at baseline evaluation and worn through the study duration. Data were downloaded at the second evaluation.
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Short-term AE occurring throughout the 14 days of dosing were recorded. An AE was defined as any observation, unwanted experience, or reaction that was unfavorable, unintended, and occurred after initiating PDE5I treatment.
Statistical analysis was performed using commercial software.
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Descriptive continuous data of dogs in each group were summarized using median, Q1, Q3, and range for non-normally distributed data and mean and standard deviation SD or standard error SE for normally distributed data.
Continuous baseline descriptive characteristics i. Univariate logistic regression analysis investigated association between treatment and PH group classification with the dependent variable being treatment type sildenafil or tadalafil and the independent variables being groups i.
For between-treatment group comparisons over three time points i. Only dogs with a complete questionnaire and VAS at each time point were included in these analyses.
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For between-group comparisons of change in voluntary activity during treatment week 1 i. Change in peak TRFV and estimated sPAP from baseline before treatment; day 0 to second evaluation after 14 days of treatment; day 15 was only performed in dogs where this data was available for both time points and was evaluated with a two-way repeated measures ANOVA and with post-hoc Bonferroni t-test making pairwise multiple comparisons.
Incidence of AE and frequency of returned residual drug between treatments were compared using a Fisher Exact test. Dogs were stratified into four subgroups to assess if differences in the change in peak TRFV from baseline to second evaluation existed between dogs that did or did not have residual drug returned. These subgroups included tadalafil residual returned A , tadalafil residual not returned B , sildenafil residual returned C , and sildenafil residual not returned D. Twenty-three dogs were enrolled Figure 1.
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Two dogs were excluded for 1 each of the following: death from primary respiratory disease shortly after study commencement and pacemaker lead migration with sick sinus syndrome. The dog that died received 3 doses of tadalafil.
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Baseline demographics Table 1 did not significantly differ between treatments. There was no significant association between PH classification group and treatment Supplementary Table 1. At least one medication was administered to Five dogs had previously been treated with sildenafil and received a 7-day washout before enrollment.
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One dog required other medications trimethoprim-sulfa and trazadone concomitantly with study treatment because of diagnosis of pneumocystis pneumonia. Comparison of hemodynamic outcome parameters measured at baseline are reported in Table 2.
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Eight dogs had unchanged type III pulmonary flow profiles from baseline to second evaluation. One dog had resolution of notching at second evaluation and another dog had notching first identified at second evaluation. There was no significant difference in estimated sPAP between dogs treated with sildenafil or tadalafil at baseline compared to second evaluation Figure 2.
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A descriptive summary of hemodynamic parameters measured in dogs at baseline and final evaluation are reported in Table 3. The black circles represent the mean and the bars the SE. Comparison of selected hemodynamic and quality of life results at baseline day 0 in dogs treated with sildenafil or tadalafil. Comparison of selected hemodynamic results at baseline day 0 and final evaluation day 15 in dogs treated with sildenafil or tadalafil in which the echocardiographic parameter was measured at both time points using a two-way repeated measures analysis of variance.
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A: comparison of variable means for treatment regardless of time; B: comparison of variable means for time regardless of treatment; C: interaction between treatment and time; AT:ET: acceleration time AT indexed to the ejection time ET of pulmonary artery flow; time PRPV: pulmonary regurgitation peak velocity; RPAD: right pulmonary artery dispensability index; PRPV: pulmonary regurgitation peak velocity; m: meter; mmHg: millimeter of mercury; mm: millimeter; n: number; sPAP: systolic pulmonary arterial pressure; s: second; TRFV: tricuspid regurgitant flow velocity.
Mean SABP in dogs receiving sildenafil was Mean SABP in dogs receiving tadalafil at baseline was
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