Evaluating patient risk status

Prognostic implications of NYHA functional class

REVEAL Registry observational analysis: FC III patients who improved to FC I-II within 1 year of enrollment had a significantly better prognosis than patients who remained in FC III or worsened to FC IV.1*

Reveal FC III Patients1 12 months post-enrollment (N=982)
Improved FC FC Unchanged Worsened FC
27% 66% 8%

Lack of improvement in key clinical indicators correlated with poorer prognosis compared with patients whose indicators improved.2

REVEAL: Nearly 7 in 10 patients may be at risk of a poor prognosis, compared to patients with improving indicators2

*Only patients who obtained a follow-up FC assessment within 1 year of enrollment were included. The first follow-up FC assessment was performed at a mean ± SD of 4 ± 3 months.1

Download the Risk Assessment Sheets to learn more about the ESC/ERS or REVEAL risk criteria.

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Consider the consistent treatment guidelines for patients in FC III and FC IV

High Risk
per key indicators3-6
FC IV, FC III with
evidence of rapid
progression or
other markers of
poor prognosis4
Worsening Disease
despite treatment3-6
FC III with
evidence of disease
progression4
Inadequate Clinical Response
to current treatment3-6
FC III with evidence of poor prognosis despite treatment4
The Guidelines Agree: Consider Parenteral Therapy
2009 ACCF/AHA
Consensus3		 2013 5th World
Symposium6		 2014 CHEST Treatment
Recommendations4
 2015 ESC/ERS
Treatment
Guidelines5

ACCF=American College of Cardiology Foundation; AHA=American Heart Association; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=functional class; NYHA=New York Heart Association; PAH=pulmonary arterial hypertension; REVEAL=Registry to Evaluate Early and Long-Term PAH Disease Management; SD=standard deviation.

STARTING PATIENTS ON REMODULIN

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).

References: 1. Barst RJ, Chung L, Zamanian RT, et al. Functional class improvement and 3-year survival outcomes in patients with pulmonary arterial hypertension in the REVEAL Registry. Chest. 2013;144(1):160-168. 2. Benza RL, Miller DP, Foreman AJ, et al. Prognostic implications of serial risk score assessments in patients with pulmonary arterial hypertension: a Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL) analysis. J Heart Lung Transplant. 2015;34(3):356-361. 3. McLaughlin VV, Archer SL, Badesch DB, et al; ACCF/AHA. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009;119(16):2250-2294. 4. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-475. 5. Galiè N, Humbert M, Vachiery JL, et al; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2016;37(1):67-119. 6. Galiè N, Corris PA, Frost A, et al. Updated treatment algorithm of pulmonary arterial hypertension. J Am Coll Cardiol. 2013;62(25 Suppl):D60-D72.