Investigate and screen for pulmonary arterial
hypertension with echocardiography

Early-stage pulmonary arterial hypertension

In early PAH, there is no evidence of RV failure despite elevations in PASP.1

Progressing pulmonary arterial hypertension

As PAH progresses, the RV and RA enlarge and RVEF may decrease. Signs of RV dysfunction, septal flattening, and/or volume overload manifest.1,2

Late-stage pulmonary arterial hypertension

In late-stage PAH, RV dilation and dysfunction are evident.1

Echocardiography results meriting further evaluation:

	RVSP estimate of >40 mm Hg1
	RV enlargement (normal 2.0-2.8 cm basal; 2.7-3.3 cm mid)1,3
	RA enlargement (normal 2.9-4.5 cm)1,3
	Flattened interventricular septum1

Echocardiogram videos showing signs of PAH

Mild RV dilation		Severe RV dilation
Mild tricuspid regurgitation		Severe tricuspid regurgitation

LV left ventricle; PASP pulmonary arterial systolic pressure; RA right atrium; RHC right heart catheterization; RV right ventricle; RVEF right ventricular ejection fraction; RVSP right ventricular systolic pressure.

Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may preclude future use as their disease progresses.

Important safety information

Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.

Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter.

High potential for major birth defects—Pregnancy must be excluded and prevented through the use of reliable forms of birth control; monthly pregnancy tests should be obtained.

Contraindicated for use with cyclosporine A and glyburide.

Please see full prescribing information including BOXED WARNING.

Review confirmation of PAH using RHC

1. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol. 2009;53:1573-1619.
2. Movahed M-RR, Hepner A, Lizotte P, Milne N. Flattening of the interventricular septum (D-shaped left ventricle) in addition to high right ventricular tracer uptake and increased right ventricular volume found on gated SPECT studies strongly correlates with right ventricular overload. University of California Postprints. http://repositories.cdlib.org/cgi/viewcontent.cgi?article=2869&context=postprints. Accessed February 2, 2010.
3. Connolly HM, Oh JK. Echocardiography. In: Braunwald E, Zipes DP, Libby P, eds. Braunwald's Heart Disease. 2 vols. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:227-325.