Erectile Dysfunction

CIALIS for use as needed (5 mg, 10 mg, 20 mg)

Improved erectile function1

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Mild ED

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men2†
  • Efficacy for up to 36 hours2‡§
  • Mean SEP 3 scores in all patients3
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

*SEP 3 is a yes/no question: "Did your erection last long enough for you to have successful intercourse?"1

Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse).2,4

Individual results may vary. Not studied for multiple attempts per dose.

§In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS. CIALIS was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)1

Select Important Safety Information Related to Cardiovascular Considerations

  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Moderate ED

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men2†
  • Efficacy for up to 36 hours2‡§
  • Mean SEP 3 scores in all patients3
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

*SEP 3 is a yes/no question: "Did your erection last long enough for you to have successful intercourse?"1

Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse).2,4

Individual results may vary. Not studied for multiple attempts per dose.

§In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS. CIALIS was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)1

Select Important Safety Information Related to Cardiovascular Considerations

  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Severe ED

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men2†
  • Efficacy for up to 36 hours2‡§
  • Mean SEP 3 scores in all patients3
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

*SEP 3 is a yes/no question: "Did your erection last long enough for you to have successful intercourse?"1

Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse).2,4

Individual results may vary. Not studied for multiple attempts per dose.

§In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS. CIALIS was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for once use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)1

Select Important Safety Information Related to Cardiovascular Considerations

  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

Improved erection confidence5

CIALIS for use as needed improved International Index of Erectile Function question 15 (IIEF 15)* scores in ED patients vs placebo

Improved erection confidence

Results from a retrospective analysis of 17 placebo-controlled studies in the general ED population with a range of ED severity based on responses to the IIEF questionnaire.

*Patient response to IIEF 15: "How do you rate your confidence that you could get and keep an erection?" Percentage based on total cohort population (placebo, N=1002; CIALIS 10 mg, N=527; CIALIS 20 mg, N=1816) as denominator.

  • Mean IIEF 15 scores at baseline and endpoint: placebo, 1.94 and 2.24; CIALIS 10 mg, 1.90 and 3.05; CIALIS 20 mg, 1.98 and 3.44

Treatment-emergent adverse reactions2

Treatment-emergent adverse reactions reported by ≥2% of patients treated with CIALIS for use as needed (10 mg or 20 mg) and more frequent on drug than placebo in 8 primary, placebo-controlled, phase 3 studies (including a study in patients with diabetes)

Adverse reactions
  • Overall discontinuation rates in clinical trials were 3.1% for CIALIS 10 mg and 20 mg vs 1.4% for placebo

References

  1. Lewis RW, Sadovsky R, Eardley I, et al. The efficacy of tadalafil in clinical populations. J Sex Med. 2005;2:517-531.

  2. Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.

  3. Carson CC, Rajfer J, Eardley I, et al. The efficacy and safety of tadalafil: an update. BJU Int. 2004;93:1276-1281.

  4. Rosen RC, Padma-Nathan H, Shabsigh R, Saikali K, Watkins V, Pullman W. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med. 2004;1:193-200.

  5. Data on file. Lilly USA, LLC. CIA20110217A.