Drugs Log

Schering-Plough said the results of a first prospective trial specifically designed to evaluate erectile function in erectile dysfunction (ED) patients with dyslipidemia showed that Levitra (vardenafil HCl), used in treating ED, significantly improves the ability of men with ED and dyslipidemia to achieve and maintain an erection for successful sexual intercourse.

The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that Levitra significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.

“ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition,” said Dr Martin Miner, clinical associate professor, Family Medicine, Brown University’s Warren Alpert School of Medicine. “This study provides further support that Levitra can successfully treat ED, even in men with a serious common condition like high cholesterol.”

Nearly 70 per cent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of Levitra in men with ED who also have high blood pressure or diabetes.

In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomised to treatment with Levitra or placebo for 12 weeks.

Men treated with Levitra had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1 per cent and 66.7 per cent, respectively, for Levitra, vs. 51.9 per cent and 33.8 per cent, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the Levitra group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.

Treatment-emergent adverse effects (occurring in = 5 per cent of patients) included headaches (9 per cent for Levitra, 1 per cent for placebo) and upper respiratory tract infections (5 per cent for Levitra, 3 per cent for placebo).

Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. ED can be a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. It is estimated that some degree of ED affects up to 30 million men in the United States.

Some of the most common treatments for ED include adjustments to lifestyle and better control of concomitant medical conditions as well as the use of oral medications or other forms of therapy. Treating related health conditions or reducing stress may help maintain erectile function.

Levitra (vardenafil HCl) is a prescription medicine that is indicated to treat erectile dysfunction (ED). Consistent with the effects of PDE5 inhibition, administration of Levitra with nitrates and nitric oxide donors is contraindicated.

In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis. Adverse events were generally transient.

Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including Levitra. Sudden loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including Levitra. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including Levitra, and seek prompt medical attention in the event of sudden loss of vision or hearing.

The recommended starting dose of Levitra is 10 mg. Titrate up to 20 mg or down to 5 mg based on efficacy and side effects.

Consumer Information

Generic Name: vardenafil
Brand Names: Levitra
What is Levitra?

Levitra relaxes muscles and increases blood flow to particular areas of the body.

Levitra is used to treat erectile dysfunction (impotence).

Levitra may also be used for purposes other than those listed in this medication guide.

Important information about Levitra
Do not take Levitra if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (”poppers”). Taking Levitra with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack. If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of Levitra. Do not take this medication more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

A small number of patients have had a sudden loss of eyesight after taking Levitra. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether Levitra is the actual cause of such vision loss. Sudden vision loss with Levitra use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Stop using Levitra and get emergency medical help if you have sudden vision loss.

Before taking Levitra
Do not take Levitra if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (”poppers”). Taking this medication with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

A small number of patients have had a sudden loss of eyesight after taking Levitra. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether Levitra is the actual cause of such vision loss. Sudden vision loss with Levitra use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Before taking this medication, tell your doctor if you have:

• heart disease or heart rhythm problems;
• a recent history (in the past 6 months) of a heart attack, angina (chest pain), or congestive heart failure;
• a history of stroke or blood clots;
• a personal or family history of “Long QT syndrome”;
• high or low blood pressure;
• liver disease;
• kidney disease (or if you are on dialysis);
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a bleeding disorder such as hemophilia;
• a stomach ulcer;
• retinitis pigmentosa (an inherited condition of the eye);
• a physical deformity of the penis (such as Peyronie’s disease); or
• if you have been told you should not have sexual intercourse for health reasons.

Levitra side effects

If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of Levitra. Stop using Levitra and get emergency medical help if you have sudden vision loss. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Levitra and call your doctor at once if you have any of these serious side effects:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• irregular heartbeat;
• swelling in your hands, ankles, or feet;
• shortness of breath;
• vision changes;
• feeling light-headed, fainting; or
  penis erection that is painful or lasts 4 hours or longer.

Continue taking this medication and talk with your doctor if you have any of these less serious side effects:

• warmth or redness in your face, neck, or chest;
• stuffy nose;
• headache;
• upset stomach; or
• back pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Levitra?

Before taking Levitra, tell your doctor if you are using any of the following medications:

• cimetidine (Tagamet, Tagamet HB);
• erythromycin (E-Mycin, Eryc, Ery-Tab) or clarithromycin (Biaxin);
• doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin);
• HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), darunavir (Prezista), efavirenz (Sustiva), nevirapine (Viramune), indinavir (Crixivan), saquinavir (Invirase, Fortovase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);
• itraconazole (Sporanox) or ketoconazole (Nizoral);
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), quinidine(Quinidex, Quinaglute), procainamide (Procan, Pronestyl), or sotalol (Betapace);
• carbamazepine (Tegretol), phenobarbital (Luminal), or phenytoin (Dilantin); or
• rifampin (Rifadin, Rimactane).

If you are using any of these drugs, you may not be able to take Levitra, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Levitra. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.