Levitra (vardenafil, Bayer, GlaxoSmithKline)
A phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED), the second oral impotence therapy approved. The first was Viagra (sildenafil), also a PDE-5 inhibitor, approved in 1998.
Recommended Dosage: 10 mg taken about 1 hour before sexual activity, increasing to 20 mg or decreasing to 5 mg, depending on effectiveness and side effects. Taken no more than once per day. Less frequent and/or lower dosing (2.5 mg or 5 mg) for men on drugs such as some HIV protease inhibitors or erythromycin that can reduce Levitra metabolism.
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Special Considerations: Contraindicated with any use of nitrates or [alpha]-blockers (can produce hypotension). QT-interval prolongations in a study of healthy men were not considered clinically significant by an expert panel convened by the Food and Drug Administration in May, but the drug should be avoided in men who have congenital QT prolongation or are on antiarrhythmics such as quinidine or amiodarone. Not studied or recommended for certain populations, including men with unstable angina, a history of an MI or stroke in the past 6 months, significantly low or uncontrolled blood pressure, or unstable angina. In trials, headache, flushing, rhinitis, and indigestion were among the most common side effects; 2% of patients reported dizziness, and a “small number” reported abnormal vision, as expected for a PDE-5 inhibitor.
Comment: Levitra enhances the smooth muscle relaxant effects of nitric oxide in the corpus cavernosum, normally released in response to sexual stimulation, and increases penile blood flow. In 50 studies of 5,700 men with ED, up to 91% who took Levitra reported significant improvements in ability to achieve and maintain an erection, said one of the principal investigators, Dr. Marc Gittelman, director of the Miami Center for Sexual Health, Aventura, Fla.
Men taking 10 mg or 20 mg reported improved satisfaction with erection hardness, orgasm, and overall sexual experience. About three-quarters of men who had diabetes or a radical, bilateral nerve-sparing prostatectomy reported improved erections with 20 mg of Levitra, added Dr. Gittelman, who has been a principal investigator in studies of Levitra, Viagra, and other ED therapies, and has served as a speaker and consultant to those companies.
No statements can be made on the relative effectiveness of Levitra and Viagra because they have not been compared directly in a study, he said. But unlike Viagra, which is absorbed more slowly after a fatty meal, Levitra can be taken after a fatty meal.
Enbrel (etanercept, Amgen)
A blocker of tumor necrosis factor (TNF), an inflammatory cytokine, for treating active ankylosing spondylitis (AS). Previously approved for treating rheumatoid arthritis (RA), psoriatic arthritis, and juvenile RA.
Recommended Dosage: 25 mg subcutaneous injection twice a week.
Special Considerations: The safety profile in trials was similar to that seen in trials of Enbrel for other indications, including a greater rate of upper respiratory infections in treated patients. Serious infections and serious nervous system disorders have been reported in patients treated with Enbrel.
Comment: Elevated TNF levels have been found in the serum and synovial tissue of people with AS. This prompted testing of Enbrel, which binds to and inactivates TNF, as a treatment for AS. naprosyn. Approval was based on three studies, including a trial of 277 patients in which 60% of those treated with Enbrel achieved at 12 weeks at least a 20% improvement in response criteria (physical function, pain, spinal stiffness and inflammation, and patient’s global assessment), vs. 27% of those on placebo. The significantly greater benefits persisted through 24 weeks of treatment. Spinal mobility also improved in all three studies.
About 350,000 people in the United States have been diagnosed with AS, a chronic, inflammatory rheumatologic disease primarily affecting the sacroiliac joints and axial skeleton. The true incidence is probably much higher since many people are relatively asymptomatic. A member of an FDA advisory panel that unanimously recommended approval of Enbrel for AS in June emphasized that Enbrel should be reserved for patients with active AS, and that the risks would outweigh the benefits for patients who are essentially asymptomatic. Prior to this approval, various nonsteroidal anti-inflammatory drugs were the only treatments approved for AS.
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