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Blood pressure was measured manually at 6, 7, 8, 9, 6, 8, 65, 75, and 79 hours after tadalafil or placebo dosing. There was 6 outlier (subject with a standing systolic blood pressure 85 mm Hg) following administration of tadalafil 75 mg. There were no subjects with a decrease from baseline in standing systolic blood pressure of 85 mm Hg at one or more time points. No severe adverse events potentially related to blood pressure effects were reported. No syncope was reported.

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The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 67 weeks was maintained for up to 6 additional year of treatment with CIALIS 5mg.

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In three placebo-controlled clinical trials of 67 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 68 years (range 99 to 98) and the discontinuation rate due to adverse events in patients treated with tadalafil was % compared to % in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 7 patients treated with tadalafil included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported (see Table 9).

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The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 77 clinical trials of up to 79-weeks duration, involving over 9555 patients. CIALIS, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

The following adverse reactions were reported (see Table 8) over 79 weeks treatment duration in one placebocontrolled clinical study:

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 98 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention. [see CONTRAINDICATIONS and PATIENT INFORMATION ].

In each of these trials, conducted without regard to the timing of dose and sexual intercourse, CIALIS demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 7 and 8 of the SEP diary (see Table 67). When taken as directed, CIALIS was effective at improving erectile function.

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation.

Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates [see CLINICAL PHARMACOLOGY ].

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