ED+BPH

CIALIS 5 mg for once daily use

Significant reduction in urinary symptom severity in Study L1

Mean changes in total International Prostate Symptom Score (IPSS)* by visit in patients with ED+BPH

Study L
  • Total IPSS at baseline: placebo (N=193): 18.2; CIALIS 5 mg (N=206): 18.5
  • CIALIS 5 mg for once daily use resulted in statistically significant improvement in total IPSS at 12 weeks compared to placebo

*The IPSS is a 4-week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. It assesses the severity of irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with scores ranging from 0 to 35. Higher numeric scores represent greater severity.

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Significantly improved erectile function1

Mean change in International Index of Erectile Function-Erectile Function (IIEF-EF)* domain score in patients with ED+BPH

IIEF-EF
  • IIEF-EF domain score at baseline: placebo: 15.6; CIALIS 5 mg: 16.5
  • CIALIS 5 mg for once daily use resulted in greater improvement in erectile function compared with patients treated with placebo

*The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The EF domain of the IIEF has a 30-point total score. Higher numeric scores reflect better erectile function.

Select Important Safety Information Related to Warnings and Precautions

  • 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.

Mean change in Sexual Encounter Profile, question 3 (SEP 3) in patients with ED+BPH

SEP 3
  • SEP 3 values at baseline: placebo: 36%; CIALIS 5 mg: 43%
  • CIALIS 5 mg for once daily use showed greater improvement in the percentage of successful intercourse attempts at week 12 compared with patients receiving placebo

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

Select Important Safety Information Related to Warnings and Precautions

  • 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.

Treatment-emergent adverse reactions1

Studies J, K, and L

Treatment-emergent adverse reactions reported by ≥1% of patients treated with CIALIS 5 mg for once daily use and more frequent on drug than placebo

Studies J, K, and L
  • Data from studies J, K, and L: 3 placebo-controlled clinical studies of 12 weeks' duration (2 studies for BPH and 1 study for ED+BPH)
  • The discontinuation rate due to adverse reactions in patients treated with CIALIS for once daily use was 3.6% compared with 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with CIALIS included headache, upper abdominal pain, and myalgia

ED+BPH clinical trial design1,2

Study L

A placebo-controlled, double-blind, parallel-design, 12-week study that assessed the efficacy and safety of CIALIS 5 mg for once daily use in men with both ED and BPH

  • Patients with both ED and BPH (N=408) received either CIALIS 5 mg for once daily use or placebo
  • Timing of sexual activity was not restricted relative to when patients took CIALIS 5 mg for once daily use
Study L
Eligibility criteria

Eligibility criteria:

  • Patients (N=408) were ≥45 years of age
  • Clinical diagnosis of BPH >6 months
  • BPH symptom severity ranged from moderate to severe (IPSS ≥13 at start of placebo lead-in period)*
  • ED severity ranged from mild to severe
Efficacy parameters

Efficacy parameters:

  • Total IPSS (co-primary endpoint)
  • IIEF-EF domain score (co-primary endpoint)
  • SEP 3 (key secondary endpoint)
Safety measures

Safety measures:

  • Analyzed treatment-emergent adverse reactions, laboratory measures, postvoid residual volume, and maximum urinary flow rate

*Moderate BPH symptoms are defined as total IPSS ≥8 to <20; severe symptoms as total IPSS ≥20.


References

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

  2. Egerdie RB, Auerbach S, Roehrborn CG, et al. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. J Sex Med. 2012;9:271-281.