Label: TADALAFIL tablet, coated

Tadalafil tablet was taken once daily at doses ranging from 2.5 mg to 10 mg.

Comparing the Mechanism of Action

Food and alcohol intake were not restricted.

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Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.Results in General ED Population - The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hispanic, and 2% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease.

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Most (>96%) patients reported ED of at least 1-year duration.The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). The population was 86% White, 3% Black, 0.4% Hispanic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration.In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17).

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Tadalafil tablet was taken once daily at doses ranging from 2.5 mg to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.Results in General ED Population - The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hispanic, and 2% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>96%) patients reported ED of at least 1-year duration.The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years).

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The population was 86% White, 3% Black, 0.4% Hispanic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration.In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17). When taken as directed, tadalafil tablets were effective at improving erectile function.In the 6 month double-blind study, the treatment effect of tadalafil tablet did not diminish over time.Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil Tablet for Once Daily Use Studiesa Twenty-four-week study conducted in the US.b Twelve-week study conducted outside the US.c Statistically significantly different from placebo.Efficacy Results in ED Patients with Diabetes Mellitus - Tadalafil tablet for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298).

Tadalafil: the science

In this third trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil Tablet for Once Daily Use Study in ED Patients with Diabetesa Statistically significantly different from placebo.14.3 Tadalafil Tablet 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)The efficacy and safety of tadalafil tablet for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see Clinical Studies (14.4)]. The first study (Study J) randomized 1058 patients to receive either tadalafil tablet 2.5 mg, 5 mg, 10 mg cialis wholesale prices or 20 mg for once daily use or placebo. The second study (Study K) randomized 325 patients to receive either tadalafil tablet 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. When taken as directed, tadalafil tablets were effective at improving erectile function.In the 6 month double-blind study, the treatment effect of tadalafil tablet did not diminish over time.Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil Tablet for Once Daily Use Studiesa Twenty-four-week study conducted in the US.b Twelve-week study conducted outside the US.c Statistically significantly different from placebo.Efficacy Results in ED Patients with Diabetes Mellitus - Tadalafil tablet for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). In this third trial, tadalafil tablets demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil Tablet for Once Daily Use Study in ED Patients with Diabetesa Statistically significantly different from placebo.14.3 Tadalafil Tablet 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)The efficacy and safety of tadalafil tablet for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see Clinical Studies (14.4)].

STRONGER ERECTIONS, BETTER SEX

Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four 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. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping buy cialis uk cheap and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablet 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablet 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablet for Once Daily Use StudiesIn Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.

Use in women

Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.Efficacy Results in Patients with BPH initiating Tadalafil Tablets and Finasteride – Tadalafil tablet for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either tadalafil tablets 5 mg with finasteride 5 mg or placebo with finasteride 5 mg. The study population had a mean age of 64 years (range 46 to 86). Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (tadalafil tablets -4, placebo -2.3: p<0.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=0.022).

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However, cialis 5 price the magnitude of the treatment difference between placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at Week 4 to 1 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablet for Once Daily Use Study Together with FinasterideaOverall ITT population.bMixed model for repeated measurements.cUnadjusted mean.In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Tadalafil tablets with finasteride (N=203) was compared to placebo with finasteride (N=201). A statistically significant improvement from baseline (tadalafil tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001).14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of tadalafil tablet for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablet 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The first study (Study J) randomized 1058 patients to receive either tadalafil tablet 2.5 mg, 5 mg, 10 mg cialis wholesale prices or 20 mg for once daily use or placebo.

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The second study (Study K) randomized 325 patients to receive either tadalafil tablet 5 mg for once daily use or placebo.

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The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil tablets for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four 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. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping buy cialis uk cheap and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity.

17.2 Guanylate Cyclase (GC) Stimulators

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Maximum urinary flow rate (Qmax), an objective measure of urine flow, was assessed as a secondary efficacy endpoint in Study J and as a safety endpoint in Study K.The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil tablet 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively.In each of these 2 trials, tadalafil tablet 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil Tablet for Once Daily Use StudiesIn Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.In Study K, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups.Efficacy Results in Patients with BPH initiating Tadalafil Tablets and Finasteride – Tadalafil tablet for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (>30 cc) for up to 26 weeks. This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either tadalafil tablets 5 mg with finasteride 5 mg or placebo with finasteride 5 mg. The study population had a mean age of 64 years (range 46 to 86). Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included.Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (tadalafil tablets -4, placebo -2.3: p<0.001) and the score remained decreased through 26 weeks (tadalafil tablets -5.5, placebo -4.5; p=0.022). However, cialis 5 price the magnitude of the treatment difference between placebo/finasteride and tadalafil tablets/finasteride decreased from 1.7 points at Week 4 to 1 point at Week 26, as shown in Table 20 and in Figure 7.

Ingredient	Amount per Dose	Purpose	Notes
Tadalafil	20 mg	Active ingredient, vasodilator	Main component for ED
Microcrystalline Cellulose	-	Filler	Binds ingredients
Magnesium Stearate	-	Excipient	Improves pill stability
Titanium Dioxide	-	Coloring agent	Provides yellow color

The incremental benefit of tadalafil tablets beyond 26 weeks is unknown.Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablet for Once Daily Use Study Together with FinasterideaOverall ITT population.bMixed model for repeated measurements.cUnadjusted mean.In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Tadalafil tablets with finasteride (N=203) was compared to placebo with finasteride (N=201).

8. Cialis can treat more than erectile dysfunction

The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.The efficacy results for patients with both ED and BPH, who received either tadalafil tablet 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablet 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablet 5 mg for once daily use also resulted in statistically significant improvement in SEP3.

For Erectile Dysfunction

Tadalafil tablets 2.5 mg did not result in statistically significant improvement in the total IPSS.Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTable 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTadalafil tablet for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).In this study, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.

Effectiveness by condition:

A statistically significant improvement from baseline (tadalafil tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001).14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPHThe efficacy and safety of tadalafil tablet for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil tablet 2.5 mg, 5 mg, for once daily use or placebo.

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ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil tablets.The efficacy results for patients with both ED and BPH, who received either tadalafil tablet 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.Tadalafil tablet 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil tablet 5 mg for once daily use also resulted in statistically significant improvement in SEP3.

2.7 Concomitant Medications

Tadalafil tablets 2.5 mg did not result in statistically significant improvement in the total IPSS.Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTable 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPHTadalafil tablet for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).In this study, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.