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Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
Date:6/9/2009

tments are required. Certain populations of PAH patients such as those with mild-to-moderate renal or hepatic impairment or those taking the drug ritonavir should use a dose of 20 mg daily when beginning therapy with ADCIRCA. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided. The safety and efficacy of combinations of ADCIRCA with CIALIS or other PDE5 inhibitors have not been studied. Therefore, the use of such combinations is not recommended.

The most common side effects with ADCIRCA seen in the PHIRST-1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion.

In rare instances, patients taking PDE5 inhibitors (including tadalafil) reported a sudden decrease or loss of vision or hearing, or in men, an erection lasting more than four hours. A patient who experiences a decrease or loss in vision or hearing or prolonged erection should seek immediate medical attention.

For full patient information and/or full prescribing information, visit http://www.ADCIRCA.com or call 1-800-545-5979 (1-800-LILLY-RX).

Important Safety Information for CIALIS (tadalafil)

CIALIS is available by prescription only and is not for everyone. Men should discuss their medical conditions and all medications with their doctors to ensure CIALIS is right for them and that they are healthy enough for sexual activity.

Men taking nitrates, often used for chest pain, should not take CIALIS. Such a combination could cause a sudden, unsafe drop in blood pressure.

CIALIS for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with certain medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors
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SOURCE United Therapeutics Corporation
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