| Adapted from the updated clinical classification of WHO Group I PAH (JACC 2009)1 |
Prevalence rates2 |
| 1.1. Idiopathic | 6 per million2 |
1.2. Heritable
1.2.1. BMPR2
1.2.2. ALK1, endoglin*
1.2.3. Unknown
|
BMPR2 mutations detected in 11% to 40% of IPAH cases with no family history1
|
| 1.3. Drug- and toxin-induced |
29% of IPAH patients reported stimulant use in a retrospective study of 340 PAH and PH patients in a single center3
In an epidemiologic study of 579 PH patients, 13% reported anorexigen use4
|
1.4. Associated with:
1.4.1. Connective tissue disease
1.4.2. HIV infection
1.4.3. Portal hypertension
1.4.4. Congenital heart disease
1.4.5. Schistosomiasis
1.4.6. Chronic hemolytic anemia
|
8% to 27% of systemic sclerosis patients may develop PAH2
0.5% of HIV patients may develop PAH2
12% to 34% of congenital heart disease patients may develop PAH5
|
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.
- Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009;54(suppl 1):S43-S54.
- 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.
- Chin KM, Channick RN, Rubin LJ. Is methamphetamine use associated with idiopathic pulmonary arterial hypertension? Chest. 2006;130:1657-1663.
- Rich S, Rubin L, Walker AL, et al. Anorexigens and pulmonary hypertension in the United States: results from the Surveillance of North American Pulmonary Hypertension. Chest. 2000;117:870-874.
- Engelfriet PM, Duffels MGJ, Möller T, et al. Pulmonary arterial hypertension in adults born with a heart septal defect: the Euro Heart Survey on adult congenital heart disease. Heart. 2007;93:682-687.