Table 7 Phosphodiesterase type 5 inhibitors: non-randomised studies

Sastry et al 2004130 P R DB Oral sildenafil (weight based regimen 25 –100 mg three times daily) vs placebo Cross over designDuration: 12 weeks	n = 22 (male 10, female 12) IPAH 22		Post 12 weeks (6 week cross over period) 1 death, 1 withdrawal			Backache, headache, constipation and numbness reported more frequently
	Age	16–55
	FC II:III	18:4		Sil	P Value
	Exercise time	440 s	Exercise time	686 s	*
	QoL score		QoL score
	Dyspnoea	22	Dyspnoea	+4	*
	Fatigue	20	Fatigue	+2	**
	Emotional	34	Emotional	+3	ns
	PASP	105	PASP	−7	ns
	CO	2.8	CO	+0.7	*
Mikhail et al 2004129 P NR OL Sildenafil 50 mg three times daily Duration: 3 months	n = 10 (male 2, female 8) IPAH 7, CTD 1, toxins, 1, CTEPH 1		After 3 months: 1 withdrawal			1 withdrawal due to blurred vision “No other serious acute or chronic adverse effects observed”
	n = 10 (male 2, female 8) IPAH 7, CTD 1, toxins, 1, CTEPH 1			Sil	p Value
		Sil	6MWD	395	*
	Age	35	FC I:II:III	1:7:1
	FC II:III	5:5	Vo₂max	15.1	ns
	6MWD	283	RAP	+1	ns
	Vo₂max	14.8	mPAP	−5	**
	RAP	5	PVR	−120	*
	MPAP	56	Svo₂	+4	**
	PVR	880	CO	+0.3	ns
	Svo₂	65	Improvement also noted in PA accel time on echo
	CO	4.7	Improvement also noted in PA accel time on echo