Long-term Open-Label Study

Patients in the pivotal phase 3 studies who received either RAPAFLO® or placebo were allowed to continue in a 40-week open-label extension study.10

Objective:

To evaluate the long-term safety and efficacy of RAPAFLO® 8 mg administered chronically over a 40-week period.10

Study Design:

Open-label study of RAPAFLO® 8 mg administered daily with a meal for 40 weeks.10

Study Endpoints:

  • Primary: Safety of RAPAFLO® 8 mg once daily for 40 weeks, as measured by AEs, vital signs, ECGs, clinical laboratory tests, and physical examinations10
  • Secondary: Sustained efficacy of RAPAFLO® 8 mg once daily, as measured by changes in the IPSS10

Patient Population:

A total of 661 patients were included in this open-label extension (safety population), of whom 435 (65.8%) completed the 40-week open-label study.10

Safety Results:

  • Side effect profile during the open-label phase was consistent with that observed in the double-blind phase of the trials9
  • No apparent differences in adverse events between patients taking antihypertensive medications or PDE5 inhibitors and those not taking these medications.10

Conclusion:

RAPAFLO® was shown to have sustained safety when chronically administered for up to 1 year.9

References
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  2. RAPAFLO® (silodosin) Capsules full Prescribing Information, November 2009.
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RAPAFLO® is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO® is not indicated for the treatment of hypertension.

Important Safety Information

RAPAFLO® is contraindicated in patients with severe renal impairment (CCr <30 mL/min), severe hepatic impairment (Child-Pugh score ≥10), and with use of strong CYP3A4 inhibitors. Postural hypotension with or without symptoms (eg, dizziness) may develop when beginning treatment with RAPAFLO®. As with all alpha-blockers, there is a potential for syncope. Patients should be warned of the possible occurrences of such events and should avoid situations where injury could result. RAPAFLO® should be used with caution in patients with moderate renal impairment. Patients should be assessed to rule out the presence of prostate cancer prior to starting treatment with RAPAFLO®. Patients planning cataract surgery should inform their ophthalmologist that they are taking RAPAFLO®.

The most common side effects are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.