EFTA00625099Set 9
30p10,397w
double-blind study, 144 patients with erectile dysfunction and chronic stable angina limited
by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or
VIAGRA ... hour prior to exercise testing. The primary endpoint was time to limiting
angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina
were ... hypertension (BP >170/110);
• Patients with cardiac failure or coronary artery disease causing unstable angina;
• Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of
retinal phosphodiesterases);
• Patients
https://www.justice.gov/epstein/files/DataSet%209/EFTA00625099.pdf
EFTA00625051Set 9
40p15,170w
high cholesterol, or are obese
• Have or have had clotting disorders, heart attack, stroke, angina pectoris
(severe chest pains), cancer of the breast or sex organs, jaundice, or
malignant ... brain (stroke), blockage of blood vessels in the heart
(heart attack or angina pectoris), or other organs of the body. As mentioned above,
smoking increases the risk of heart attacks ... history of blood clots in the deep veins of your legs
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus,
cervix, vagina
https://www.justice.gov/epstein/files/DataSet%209/EFTA00625051.pdf
EFTA00447987Set 9
2017-03-244p1,054w
major cardiovascular events
(composite of cardiovascular death, myocardial infarction (MI),
stroke, hospitalization for unstable angina, or coronary
revascularization). Key secondary efficacy endpoints included a
composite of cardiovascular death ... risk for
the primary composite endpoint of cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary
revascularization. Also observed was a significant reduction in the risk for the secondary ... coronary revascularizafion. but there remained no observed effects on hospitalization rates
for unstable angina, cardiovascular death or hospitalization for worsening heart failure, or death from any cause. There
were
https://www.justice.gov/epstein/files/DataSet%209/EFTA00447987.pdf
EFTA00315715Set 9
3p2,447w
penury«. of Ike Canna Apemen heplayleop. fee ibe angina et neat Ile.. Teeny aJ Conlettain dull fa any tuna he hat be he ended. ~pl. n onanaveable. Ik amain ... anal, a w1 nin rsoniab niseks. nibs, spknaliR”. nIS,Paia,n• ad angina`
aveinneciIKton 'lull* omeloane ad nn Inman, cubiene. angina:abeam he allulla mane and rencelnythnon pep amnia
https://www.justice.gov/epstein/files/DataSet%209/EFTA00315715.pdf
EFTA00447984Set 9
2017-03-243p1,043w
major cardiovascular events
(composite of cardiovascular death, myocardial infarction (MI),
stroke, hospitalization for unstable angina, or coronary
revascularization). Key secondary efficacy endpoints included a
composite of cardiovascular death ... risk for
the primary composite endpoint of cardiovascular death, MI, stroke, hospitalization for unstable angina, or coronary
revascularization. Also observed was a significant reduction in the risk for the secondary ... coronary revascularization, but there remained no
observed effects on hospitalization rates for unstable angina,
cardiovascular death or hospitalization for worsening heart failure,
or death from any cause. There were
https://www.justice.gov/epstein/files/DataSet%209/EFTA00447984.pdf
EFTA00447981Set 9
2017-03-243p1,031w
major cardiovascular events
(composite of cardiovascular death. myocardial infarction (MI).
stroke, hospitalization for unstable angina, or coronary
revascularization). Key secondary efficacy endpoints included a
composite of cardiovascular death ... risk for
the primary composite endpoint of cardiovascular death. MI, stroke, hospitalization for unstable angina, or coronary
revascularization. Also observed was a significant reduction in the risk for the secondary ... coronary revascularization, but there remained no
observed effects on hospitalization rates for unstable angina,
cardiovascular death or hospitalization for worsening heart failure,
or death from any cause. There were
https://www.justice.gov/epstein/files/DataSet%209/EFTA00447981.pdf