Erectile Dysfunction

CIALIS for once daily use (2.5 mg, 5 mg)

Significantly improved erectile function1

CIALIS for once daily use improved Sexual Encounter Profile, question 3 (SEP 3)* values in ED patients at 24 weeks1,2

Mild ED

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

Data from a randomized, double-blind, placebo-controlled, parallel-design, multicenter study. Patients (N=287) were randomized to 24 weeks of treatment with fixed doses of CIALIS 2.5 mg, CIALIS 5 mg, or placebo, stratified by baseline ED severity (mild, moderate, or severe) as defined by the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

The efficacy of CIALIS for once daily use was maintained throughout a 6-month, double-blind, placebo-controlled trial.

  • Mean per-patient percentage of successful intercourse attempts (SEP 3) in all patients
    • Endpoint: placebo 31%, CIALIS 2.5 mg 50%, CIALIS 5 mg 57%
    • Change from baseline: placebo 10%, CIALIS 2.5 mg 31%, CIALIS 5 mg 35%

CIALIS for once daily use provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)3,4

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.

CIALIS for once daily use improved Sexual Encounter Profile, question 3 (SEP 3)* values in ED patients at 24 weeks1,2

Moderate ED

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

Data from a randomized, double-blind, placebo-controlled, parallel-design, multicenter study. Patients (N=287) were randomized to 24 weeks of treatment with fixed doses of CIALIS 2.5 mg, CIALIS 5 mg, or placebo, stratified by baseline ED severity (mild, moderate, or severe) as defined by the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

The efficacy of CIALIS for once daily use was maintained throughout a 6-month, double-blind, placebo-controlled trial.

  • Mean per-patient percentage of successful intercourse attempts (SEP 3) in all patients
    • Endpoint: placebo 31%, CIALIS 2.5 mg 50%, CIALIS 5 mg 57%
    • Change from baseline: placebo 10%, CIALIS 2.5 mg 31%, CIALIS 5 mg 35%

CIALIS for once daily use provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)3,4

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.

CIALIS for once daily use improved Sexual Encounter Profile, question 3 (SEP 3)* values in ED patients at 24 weeks1,2

Severe ED

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

Data from a randomized, double-blind, placebo-controlled, parallel-design, multicenter study. Patients (N=287) were randomized to 24 weeks of treatment with fixed doses of CIALIS 2.5 mg, CIALIS 5 mg, or placebo, stratified by baseline ED severity (mild, moderate, or severe) as defined by the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). Per protocol, patients with "mild" or "mild-moderate" ED were combined into a single category of "mild" ED.

The efficacy of CIALIS for once daily use was maintained throughout a 6-month, double-blind, placebo-controlled trial.

  • Mean per-patient percentage of successful intercourse attempts (SEP 3) in all patients
    • Endpoint: placebo 31%, CIALIS 2.5 mg 50%, CIALIS 5 mg 57%
    • Change from baseline: placebo 10%, CIALIS 2.5 mg 31%, CIALIS 5 mg 35%

CIALIS for once daily use provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD)3,4

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.

Improved erection confidence5

CIALIS for once daily use improved International Index of Erectile Function question 15 (IIEF 15)* scores in patients with ED

Improved International Index

Results from a retrospective analysis of 2 clinical trials 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=148; CIALIS 2.5 mg, N=96; CIALIS 5 mg, N=206) as denominator.

  • Mean IIEF 15 scores at baseline and endpoint: placebo, 1.73 and 2.06; CIALIS 2.5 mg, 1.76 and 2.73; CIALIS 5 mg, 1.89 and 3.26

Treatment-emergent adverse reactions6

Treatment-emergent adverse reactions reported by ≥2% of patients treated with CIALIS for once daily use (2.5 mg or 5 mg) for ED and more frequent on drug than placebo in 3 primary, placebo-controlled, phase 3 studies (including a study in patients with diabetes)

Adverse Reactions
  • Discontinuation rate due to adverse reactions for patients taking CIALIS for once daily use for ED was 4.1% vs 2.8% for placebo

References

  1. Rajfer J, Aliotta PJ, Steidle CP, Fitch WP III, Zhao Y, Yu A. Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res. 2007;19:95-103.

  2. Data on file. Lilly USA, LLC. CIA20110110A.

  3. Data on file. Lilly USA, LLC. CIA20080501B.

  4. Data on file. Lilly USA, LLC. CIA20080501C.

  5. Data on file. Lilly USA, LLC. CIA20080411E.

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