Table 2.

Long-term, Placebo-Controlled Studies in Patients with Heart Failure and Pulmonary Hypertension

Study	Drug	Duration	Population	N	Results
Lewis et al. 200767	Sildenafil (25 to 75 mg t.i.d.)	12 weeks	NYHA class II–IV, LVEF <40%, mPAP >25 mmHg	34	Sildenafil increased peak VO2 and cardiac output and reduced PVR with exercise; no effect on PCWP, blood pressure, or heart rate; improved 6-MWT distance and reduced HF admissions; higher incidence of headache
Kaluski et al. 200868	Bosentan (8–125 mg b.i.d.)	20 weeks	NYHA class IIIB-IV, LVEF <35%, RVSP ≥40 mmHg (echo), supine SBP ≥100 mmHg	94	No difference from baseline to week 20 in RVSP (0.1±11.5 mm Hg, p = 0.97) or other echocardiographic parameter; more SAEs in the bosentan arm
Guazzi et al. 201169	Sildenafil (50 mg t.i.d.)	1 year	LVEF ≥50%, RVSP ≥40 mmHg (echo)	44	Sildenafil reduced mean PAP by 42.0±13.0%, improved right ventricular function, and reduced right atrial pressure by 54.0±7.2% and PCWP by 15.7±3.1%
Guazzi et al. 201270	Sildenafil (50 mg t.i.d.)	1 year	LVEF <45%, mean PAP 25–35mmHg	32	Sildenafil increased peak VO2 and exercise ventilation efficiency, and decreased PCWP, mean PAP, and pulmonary vascular resistance

LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; PAP: pulmonary arterial pressure; PCWP: pulmonary capillary wedge pressure; RVSP: right ventricular systolic pressure; SAE: serious adverse event; SBP: systolic blood pressure