These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• Rosuvastatin (Crestor) by AstraZeneca. The FDA has approved rosuvastatin (Crestor), a statin in the class of drugs called HMG-CoA reductase inhibitors, to lower cholesterol.
Rosuvastatin was approved based on multiple trials of at least six weeks’ duration in which rosuvastatin treatment was compared to placebo and other marketed statins. In these trials, rosuvastatin reduced total-C, LDL-C, and TG, and increased HDL-C, with therapeutic response occurring within one week and maximum response seen at four weeks.
The most frequent side effects seen in patients treated with rosuvastatin included muscle aches, stomach pain, constipation, nausea, and weakness. In rare instances, severe muscle pain and muscle weakness resulting in kidney damage have been associated with statin drugs.
Patients should be monitored for abnormalities of liver function before treatment, at 12 weeks following initial therapy, and with any elevation of dose. Monitoring is recommended periodically thereafter.
Rosuvastatin is available in 5 mg, 10 mg, 20 mg, and 40 mg tablets. In the clinical trials, the majority of patients reached target LDL-C levels as recommended by the National Cholesterol Education Program on either the 5 mg or 10 mg starting dose. The 20 mg dose can be the starting dose for patients who have very high cholesterol levels, while the 40 mg dose should be reserved only for those individuals who are not adequately treated with the 20 mg dose.
• Vardenafil (Levitra), manufactured by Bayer Corp. in Germany and distributed by GlaxoSmithKline. The FDA has approved vardenafil (Levitra), an oral medication, to treat erectile dysfunction in men. This is the second oral product approved for this indication.
The recommended dose is 10 mg taken one hour before sexual activity. A higher dose of 20 mg is available for patients whose response to the 10 mg dose is not adequate. Two lower doses (2.5 mg and 5 mg) also are available and may be necessary for patients who are taking other medicines or have medical conditions that may decrease the body’s ability to metabolize vardenafil. Vardenafil should not be used more than once a day.
Vardenafil should not be used with nitrates or with alpha-blockers. Currently, there is no information available to support the safety of even the lower doses of vardenafil taken together with alpha-blockers. In addition, vardenafil should not be used in patients who have prolongation of the QT interval because of the possibility of producing abnormal heart rhythm.
Vardenafil is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, end stage renal disease requiring dialysis, or retinitis pigmentosa.
The most common side effects reported in clinical trials included headache, flushing, rhinitis, and indigestion. Dizziness was reported in about 2% of patients. A small number of patients taking vardenafil also reported abnormal vision.
• Levonorgestrel and ethinyl estradiol (Season-ale) tablets by Barr Laboratories. The FDA has approved levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg tablets (Seasonale), an extended-cycle oral contraceptive for the prevention of pregnancy. Levonorgestrel and ethinyl estradiol tablets, the first and only FDA-approved extended-cycle oral contraceptive, will be available by prescription to women at the end of this month.
The drug regimen is designed to reduce the number of periods from 13 to four per year. The levonorgestrel and ethinyl estradiol tablet is a 91-day regimen taken daily as 84 active tablets of 0.15 mg levonorgestrel/0.03 mg ethinyl estradiol, followed by seven inactive tablets. In contrast, oral contraceptive products currently available in the United States are based on a 28-day regimen.
• New indication for etanercept (Enbrel) by Amgen and Wyeth Pharmaceuticals. The FDA has approved an expanded indication for etanercept (Enbrel) to inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis. Etanercept is the only approved therapy for both the inhibition of structural damage and the reduction in signs and symptoms of patients with psoriatic arthritis.
Adverse events were similar to those reported in previous clinical trials of etanercept in patients with rheumatoid arthritis. There was no increase in the number of serious adverse events occurring in patients treated with etanercept compared to those receiving placebo. Only the rate of injection site reactions in patients receiving etanercept was statistically different compared to those receiving placebo (36% with etanercept vs. 9% in placebo-treated patients).