Symptoms of Benign Prostatic Hyperplasia

CIALIS 5 mg for once daily use

Significant reduction in urinary symptom severity1

Mean changes in total International Prostate Symptom Score (IPSS)* by visit in patients with BPH in Study J1

Study J
  • Total IPSS at baseline: placebo (N=205): 17.1; CIALIS 5 mg (N=205): 17.31
  • CIALIS 5 mg for once daily use resulted in a statistically significant improvement in total IPSS at week 12 compared to placebo1

*The IPSS is a 4-week recall questionnaire 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.1 Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms.3

Select Important Safety Information Related to Potential Drug Interactions

  • CIALIS can potentiate the hypotensive effects of alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units). CIALIS is not recommended in combination with alpha-blockers for the treatment of benign prostatic hyperplasia (BPH) symptoms because efficacy of the combination has not been adequately studied and due to the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. CIALIS for once daily use provides continuous plasma tadalafil levels. Physicians should consider this when evaluating the potential for interactions.

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Mean changes in total IPSS* by visit in patients with BPH in Study K1

Study K
  • Total IPSS at baseline: placebo (N=164): 16.6; CIALIS 5 mg (N=160): 17.11
  • CIALIS 5 mg for once daily use resulted in a decrease in mean total IPSS starting at week 1 and throughout the 12 weeks of treatment1

*The IPSS is a 4-week recall questionnaire 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. Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms.3

Select Important Safety Information Related to Patient Counseling

  • Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

Watch a video on CIALIS efficacy

Mean changes in total IPSS* by visit in patients with moderate to severe BPH symptoms and enlarged prostate (>30 cc) in Study LVIW1,2

Study LVIW
  • Total IPSS at baseline: placebo + finasteride (N=350): 17.4; CIALIS 5 mg + finasteride 5 mg (N=345): 17.11
  • CIALIS 5 mg for once daily use + finasteride resulted in improvement in total IPSS compared to placebo + finasteride at all time points measured1

*The IPSS is a 4-week recall questionnaire. 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 scores represent greater severity.1 Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms.3

Limitation of use:

If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown

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Treatment-emergent adverse reactions

Studies J, K, and L1

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

  • 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)
Studies JKL
  • 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

Study LVIW4

Treatment-emergent adverse reactions reported by ≥1% of patients treated with CIALIS 5 mg for once daily use + finasteride 5 mg or placebo + finasteride 5 mg

  • Data from Study LVIW: a placebo-controlled clinical study of 26 weeks’ duration in men with BPH and enlarged prostate (>30 cc)
Study LVIW
  • The discontinuation rate due to adverse reactions in patients treated with CIALIS 5 mg for once daily use + finasteride 5 mg was 1.2% compared with 2.9% in patients treated with placebo + finasteride 5 mg

Limitation of use:

If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown.


BPH clinical trial designs

Studies J and K1,5,6

Two placebo-controlled, double-blind, parallel-design, 12-week studies assessed the efficacy and safety of CIALIS 5 mg for once daily use in men with BPH

  • Patients with BPH (N=410 in Study J and N=325 in Study K) received either CIALIS 5 mg for once daily use or placebo
  • Patients had moderate to severe BPH symptoms and mean age was 63.2 years (range 44 to 87)
Studies J and K

*Study K had an additional visit at week 1.

Eligibility criteria

Eligibility criteria:

  • Patients (N=410 in Study J and N=325 in Study K) 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)
  • Maximum urinary flow rate (Qmax) 4-15 mL/sec at start of placebo lead-in period
Efficacy parameter

Efficacy parameter:

  • Total IPSS (primary endpoint)
Safety measures

Safety measures:

  • Analyzed treatment-emergent adverse reactions, laboratory measures, postvoid residual volume, and Qmax

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

Study LVIW1,2

A placebo-controlled, double-blind, parallel-design, 26-week study that assessed the efficacy and safety of CIALIS 5 mg with finasteride 5 mg vs placebo with finasteride 5 mg in men with moderate to severe BPH symptoms

  • 696 patients with symptoms of BPH and an enlarged prostate (>30 cc) were randomized to receive either CIALIS 5 mg for once daily use + finasteride 5 mg or placebo + finasteride 5 mg
Study LVIW
Eligibility criteria

Eligibility criteria:

  • Patients (N=696) 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)*
  • Qmax 4-15 mL/sec
  • Enlarged prostate (>30 cc)
  • Patients were naive to 5-alpha reductase inhibitor therapy, such as finasteride
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Efficacy parameters:

  • Total IPSS at week 12 (primary endpoint)
  • Total IPSS at week 4 and week 26 (key secondary endpoints)
  • Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) in 404 men with erectile dysfunction at baseline (key secondary endpoint)
asd

Safety measures:

  • Treatment-emergent adverse reactions, vital signs, and clinical laboratory values

Limitation of use:

If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown.

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

The IIEF is a 4-week recall questionnaire. The EF domain of the IIEF score ranges from 0 to 30. Higher IIEF-EF scores reflect better erectile function.


References

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

  2. Casabé A, Roehrborn CG, Da Pozzo LF, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191:727-733.

  3. Barry MJ, Fowler FJ Jr, O’Leary MP, et al; and The Measurement Committee of the American Urological Association. The American Urological Association symptom index for benign prostatic hyperplasia. J Urol. 1992;148:1549-1557.

  4. Data on file. Lilly USA, LLC. CIA20131017A.

  5. Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008;180:1228-1234.

  6. Porst H, Kim ED, Casabé AR, et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60:1105-1113.