Initial combination therapy with ambrisentan (AMB) and tadalafil (TAD) in treatment naïve patients with pulmonary arterial hypertension (PAH): Efficacy and safety in the AMBITION study intent to treat (ITT) population

Hoeper, Marius M.; Galiè, Nazzareno; Barberà, Joan Albert; Frost, Adaani E.; Ghofrani, Ardeschir; McLaughlin, V.V.; Peacock, Andrew J.; Simonneau, Gérald; Vachiéry, Jean‐Luc; Blair, Christiana; Gillies, Hunter; Harris, Julia; Langley, Jon; Rubin, Lewis J.

doi:10.1183/13993003.congress-2015.oa4994

Cited by 2 publications

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“…In the AMBITION study, the PH-DM cohort has a worse 6-minute walk distance (a surrogate for RV function in patients with PAH) compared to a matched PH cohort, despite a trend toward lower pulmonary arterial pressures [ 22 ]. These results have led to acceptance that patients with PH-DM and other features of the metabolic syndrome behave differently than patients with PH alone, and recent clinical studies have amended their exclusion criteria so that these patients are excluded from participation [ 23 ]. While further research is needed, the above radiographic and hemodynamic data suggests that the right ventricle is adversely impacted by diabetes in patients with PH and that RV dysfunction leads to fundamental differences between cohorts of patients with pulmonary arterial hypertension.…”

Section: Right Ventricular Failure and Diabetes Mellitusmentioning

confidence: 99%

The Role of Hyperglycemia and Insulin Resistance in the Development and Progression of Pulmonary Arterial Hypertension

Grinnan

Farr

Fox

et al. 2016

Journal of Diabetes Research

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Pulmonary hypertension is a progressive disorder which often leads to right ventricular failure and death. While the existing classification system for pulmonary hypertension does not account for the impact of diabetes mellitus, evidence is emerging that suggests that diabetes is associated with pulmonary hypertension and that diabetes modifies the course of pulmonary hypertension. There is also growing radiographic, hemodynamic, biochemical, and pathologic data supporting an association between diabetes and pulmonary hypertension. More robust epidemiologic studies are needed to confirm an association between diabetes and pulmonary hypertension and to show that diabetes is a disease modifier in pulmonary hypertension. In addition, evaluating the effects of glucose control in animals with pulmonary hypertension and diabetes (as well as in humans) is warranted.

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Section: Right Ventricular Failure and Diabetes Mellitusmentioning

confidence: 99%

The Role of Hyperglycemia and Insulin Resistance in the Development and Progression of Pulmonary Arterial Hypertension

Grinnan

Farr

Fox

et al. 2016

Journal of Diabetes Research

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“…Diastolic LVD may be associated with PAH in patients with CTD [ 1 ], and it is frequently found in an elderly population [ 45 ]; as the median age was 66.5 years in our sample, the likelihood of finding PAH without diastolic LVD was low. An overlap between PAH and LVD has been described as a pathophysiological continuum [ 46 ] with a significant heterogeneity, also in clinical studies [ 47 ]. In our cohort, our observation of an acute improvement of RV and pulmonary vascular functional reserve after sildenafil administration does not seem to be affected by this heterogeneity.…”

Section: Discussionmentioning

confidence: 99%

Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease

Rieth¹,

Richter²,

Berkowitsch³

et al. 2018

PLoS ONE

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BackgroundHemodynamic assessment during exercise may unmask an impaired functional reserve of the right ventricle and the pulmonary vasculature in patients with connective tissue disease. We assessed the effect of intravenous sildenafil on the hemodynamic response to exercise in patients with connective tissue disease.MethodsIn this proof-of-concept study, patients with connective tissue disease and mean pulmonary arterial pressure (mPAP) >20 mm Hg were subjected to a supine exercise hemodynamic evaluation before and after administration of intravenous sildenafil 10 mg.ResultsTen patients (four with moderately elevated mPAP 21–24 mm Hg; six with mPAP >25 mm Hg) underwent hemodynamic assessment. All of them showed markedly abnormal exercise hemodynamics. Intravenous sildenafil was well tolerated and had significant hemodynamic effects at rest and during exercise, although without pulmonary selectivity. Sildenafil reduced median total pulmonary resistance during exercise from 6.22 (IQR 4.61–8.54) to 5.24 (3.95–6.96) mm Hg·min·L-1 (p = 0.005) and increased median pulmonary arterial capacitance during exercise from 1.59 (0.93–2.28) to 1.74 (1.12–2.69) mL/mm Hg (p = 0.005).ConclusionsIn patients with connective tissue disease who have an abnormal hemodynamic response to exercise, intravenous sildenafil improved adaption of the right ventricular-pulmonary vascular unit to exercise independent of resting mPAP. The impact of acute pharmacological interventions on exercise hemodynamics in patients with pulmonary vascular disease warrants further investigation.Trial registrationClinicaltrials.gov NCT01889966.

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Initial combination therapy with ambrisentan (AMB) and tadalafil (TAD) in treatment naïve patients with pulmonary arterial hypertension (PAH): Efficacy and safety in the AMBITION study intent to treat (ITT) population

Cited by 2 publications

References 0 publications

The Role of Hyperglycemia and Insulin Resistance in the Development and Progression of Pulmonary Arterial Hypertension

The Role of Hyperglycemia and Insulin Resistance in the Development and Progression of Pulmonary Arterial Hypertension

Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease

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