LITTLE BLUE PILL. SIGNIFICANT EFFICACY.

In a retrospective analysis of data pooled from 5 flexible-dose studies of men with ED,

Men with ED taking VIAGRA saw significant improvement in penetration
and erection maintenance vs placebo

Patients were asked (IIEF Q3): When you attempted sexual intercourse, how often were
you able to penetrate (enter)
your partner?”
Patients were asked (IIEF Q4): During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?”
IIEF=International Index of Erectile Function.
*Based on Group Mean ([Subject-Level End of Treatment Value minus
Group Baseline Mean]/Group Baseline Mean x 100).
Data on file.1
Efficacy data. Ability to penetrate (IIEF Q3). Ability to maintain (IIEF Q4).

INDICATION

VIAGRA® (sildenafil citrate) is indicated for the treatment of erectile dysfunction (ED).

IMPORTANT SAFETY INFORMATION

  • Nitrates: Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is contraindicated. VIAGRA was shown to potentiate the hypotensive effect of nitrates.
  • Concomitant Guanylate Cyclase (GC) Stimulators: Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.
  • Hypersensitivity Reactions: VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria.
  • Cardiovascular: Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status. Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by the vasodilatory effects of VIAGRA, especially in combination with sexual activity. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with the following characteristics: recent serious cardiovascular events, hypotension, or uncontrolled hypertension; if prescribed, this should be done with caution.
  • Prolonged Erection: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Use VIAGRA with caution in patients predisposed to priapism.
  • Effects on the Eye: Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa; if prescribed, this should be done with caution.
  • Hearing Loss: Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. (It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.) Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
  • Potential Drug Interactions: VIAGRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. Initiate VIAGRA at 25 mg with concomitant use of alpha-blockers.
    CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole, erythromycin) increase VIAGRA plasma exposure. Do not exceed 25 mg of VIAGRA in a 48-hour period with ritonavir. Consider a starting dose of 25 mg of VIAGRA with erythromycin or strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, saquinavir).
    Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
  • Specific Populations: Consider a starting dose of 25 mg of VIAGRA for patients age >65, patients with hepatic impairment or severe renal impairment.
  • Sexually Transmitted Diseases: Use of VIAGRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.
  • Adverse Reactions: The most common adverse reactions (≥2%) with VIAGRA 25 mg, 50 mg, 100 mg vs placebo, respectively, include headache (16%, 21%, 28% vs 7%), flushing (10%, 19%, 18% vs 2%), dyspepsia (3%, 9%, 17% vs 2%), abnormal vision (1%, 2%, 11% vs 1%), nasal congestion (4%, 4%, 9% vs 2%), back pain (3%, 4%, 4% vs 2%), myalgia (2%, 2%, 4% vs 1%), nausea (2%, 3%, 3% vs 1%), dizziness (3%, 4%, 3% vs 2%), and rash (1%, 2%, 3% vs 1%).

Study description:
Data on file, Pfizer Inc; efficacy improvement: Results from a retrospective analysis of data pooled from one phase 2 and four phase 3 double-blind, flexible-dose, placebo-controlled studies with 1370 patients with ED who took at least one dose of VIAGRA and/or placebo study medication. The primary efficacy end points included Questions 3 and 4 of the 15-question International Index of Erectile Function (IIEF) questionnaire. Patients (n=1238) responded to Q3: “Over the past 4 weeks, when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?” Patients (n=1233) responded to IIEF Q4: “Over the past 4 weeks, during sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?” Responses were rated on a scale of 0 (did not attempt intercourse) to 5 (almost always or always). For Q3, the Group Baseline Mean for VIAGRA was 1.90 and the Group Baseline Mean for placebo was 1.89. At the End of Treatment (EOT), the Group EOT Mean for men taking VIAGRA (n=631) was 3.61 vs 2.05 for men taking placebo (n=607). For Q4, the Group Baseline Mean was 1.54 for men taking VIAGRA (n=629), and 1.49 for men taking placebo (n=604). At EOT, the Group EOT Mean for men taking VIAGRA was 3.44 vs 1.68 for men taking placebo. At EOT, men with ED taking VIAGRA demonstrated a 90% change from Baseline for IIEF Q3 vs an 8% change from Baseline for placebo (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo). For Q4, men with ED taking VIAGRA demonstrated a 122% change from Baseline vs a 14% change from Baseline for placebo, (P<.0001, based on Least Squares Mean of percent change from Group Baseline Mean for VIAGRA vs placebo).

Percent change from Baseline was calculated: ([Subject-Level End of Treatment Value minus Group Baseline Mean]/Group Baseline Mean x 100).

Reference:
1. Data on file. Pfizer Inc, New York, NY.

Please scroll for Important Safety Information and Indication

IMPORTANT SAFETY INFORMATION

  • Nitrates: Administration of VIAGRA® (sildenafil citrate) to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is contraindicated. VIAGRA was shown to potentiate the hypotensive effect of nitrates.
  • Concomitant Guanylate Cyclase (GC) Stimulators: Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.
  • Hypersensitivity Reactions: VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported, including rash and urticaria.
  • Cardiovascular: Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status. Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by the vasodilatory effects of VIAGRA, especially in combination with sexual activity. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with the following characteristics: recent serious cardiovascular events, hypotension, or uncontrolled hypertension; if prescribed, this should be done with caution.
  • Prolonged Erection: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Use VIAGRA with caution in patients predisposed to priapism.
  • Effects on the Eye: Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa; if prescribed, this should be done with caution.
  • Hearing Loss: Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. (It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.) Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
  • Potential Drug Interactions: VIAGRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. Initiate VIAGRA at 25 mg with concomitant use of alpha-blockers.
    CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole, erythromycin) increase VIAGRA plasma exposure. Do not exceed 25 mg of VIAGRA in a 48-hour period with ritonavir. Consider a starting dose of 25 mg of VIAGRA with erythromycin or strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, saquinavir).
    Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
  • Specific Populations: Consider a starting dose of 25 mg of VIAGRA for patients age >65, patients with hepatic impairment or severe renal impairment.
  • Sexually Transmitted Diseases: Use of VIAGRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.
  • Adverse Reactions: The most common adverse reactions (≥2%) with VIAGRA 25 mg, 50 mg, 100 mg vs placebo, respectively, include headache (16%, 21%, 28% vs 7%), flushing (10%, 19%, 18% vs 2%), dyspepsia (3%, 9%, 17% vs 2%), abnormal vision (1%, 2%, 11% vs 1%), nasal congestion (4%, 4%, 9% vs 2%), back pain (3%, 4%, 4% vs 2%), myalgia (2%, 2%, 4% vs 1%), nausea (2%, 3%, 3% vs 1%), dizziness (3%, 4%, 3% vs 2%), and rash (1%, 2%, 3% vs 1%).

INDICATION

VIAGRA is indicated for the treatment of erectile dysfunction (ED).