Table 22: Mean SEP Question 3 Changes in the TADALISTA 5 mg for Once Daily Use Study in Patients with ED and BPH. Table 21: Mean IPSS and IIEF EF Domain Changes in the TADALISTA 5 mg for Once Daily Use Study in Patients with ED and BPH. The efficacy results for patients with both ED and BPH, who received either TADALISTA 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.
Table 20: Mean Total IPSS Changes in BPH Patients in a TADALISTA for Once Daily Use Study Together with Finasteride. Table 19: Mean IPSS Changes in BPH Patients in Two TADALISTA for Once Daily Use Studies. The second study (Study K) randomized 325 patients to receive either TADALISTA 5 mg for once daily use or placebo.

In each of these trials, conducted without regard to the timing of dose and sexual intercourse, TADALISTA 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, TADALISTA was effective at improving erectile function. In the first of these studies, 348 patients with ED were randomized to placebo or TADALISTA 20 mg. Patients were encouraged to make 4 total attempts at intercourse; 2 attempts were to occur at 24 hours after dosing and 2 completely separate attempts were to occur at 36 hours after dosing. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound Tadalista exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound Tadalista exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg. In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound Tadalista exposures of approximately 14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment.

The mean change in QTc (Fridericia QT correction) for Tadalista, relative to placebo, was 3.5 milliseconds (two-sided 90% CI=1.9, 5.1). The mean change in QTc (Individual QT correction) for Tadalista, relative to placebo, was 2.8 milliseconds (two-sided 90% CI=1.2, 4.4). A 100-mg dose of Tadalista (5 times the highest recommended dose) was chosen because this dose yields exposures covering those observed upon coadministration of Tadalista with potent CYP3A4 inhibitors or those observed in renal impairment. Metoprolol — A study was conducted to assess the interaction of sustained-release metoprolol (25 to 200 mg daily) and Tadalista 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to Tadalista 10 mg in subjects taking metoprolol was 5/3 mm Hg, compared to placebo.
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