Background

Levitra (generic name vardenafil) was the second of the PDE5 drugs to be introduced, with FDA approval in August 2003. Approved five years after Viagra had begun to help men with erectile dysfunction, Levitra attempted to help even more.

Manufacturers Bayer and GlaxoSmithKline launched the drug with a heavy advertising campaign. Sports celebrity Mike Ditka stood by the product, and the bold-print slogan read “When you’re in the zone, it’s all good.”

Levitra Dosage and usage

Levitra’s unique status among PDE5 agents is its biochemical potency, meaning that very few milligrams are needed to produce the desired effect. The drug is supplied as round orange tablets, with the dose stamped on one side. Levitra is available in strengths of 5mg, 10mg and 20mg.

The normal starting dose is 10mg. A starting dose of 5mg is appropriate for men older than 65 years, or who have moderate hepatic impairment. No dose adjustment is needed for renal impairment, or mild hepatic impairment [Ref]. If Levitra is not working at the starting dose, higher doses may be needed to achieve results. Difficult-to-treat erectile dysfunction should be titrated more rapidly.

Like Viagra, Levitra is taken 25 to 60 minutes before anticipated sexual intercourse. Also, sexual stimulation is required for Levitra to produce a satisfactory erection.

Levitra is vaunted to reach its maximum plasma concentration within a relatively short time, and for some people, the first clinical effect may be seen as soon as 10 minutes after ingesting Levitra. Maximum plasma concentrations vary among individuals from 30 minutes to 120 minutes. Review of the product monograph shows the median time to maximum concentration to be 60 minutes, which is similar to Viagra.

Levitra has a mildly delayed absorption following a high-fat meal. A meal with greater than 30% fat will reduce maximum plasma concentration by 18-50% and delay the time at which maximum concentration occurs by 1 extra hour [Ref]. This delay is somewhat less than with Viagra. Users of Levitra should avoid meals with over 30% fat within 2 hours prior to taking Levitra. There is no noted negative effect on absorption with low-fat meals.

Levitra is usually recommended not to be taken more than once a day.

Levitra Side-effects

Levitra, like other PDE5 inhibitor medications in its class, is well tolerated overall.

Many of the side-effects are ones that also occur with other PDE5 inhibitor drugs. These include headache (13%), flushing (12%), rhinitis (9%) and dyspepsia (3%). Rare side-effects of accidental injury, flu syndrome and increased creatine kinase were all 2%, and similar to rates seen in placebo.

Notably, Levitra has a reduced incidence of blue-tinted vision versus Viagra, likely due to its reduced affinity to the PDE6 enzyme in the retina. In the commonly cited studies, only 0.7% of patients reported any type of visual abnormality with Levitra.

Virtually all adverse events diminish with discontinuation with the medication.

The PDE5 class of medications has had case reports of priapism, and erections over 4 hours in duration should be treated medically to avoid damage to the penis.

The mildness of adverse events with Levitra is quantified by the fact that only 3.5% of patients stop taking Levitra as a result of the side-effects (versus 1.2% for placebo)

Levitra Contraindications, drug interactions and cautions

Levitra should not be used by men who are taking any form of nitrates or nitric oxide donors. Nitrates are medications that have an effect of lowering blood pressure. Levitra causes a drop in blood pressure when taken in isolation, but when used together with nitrates, that drop in blood pressure can be enough to endanger life.

The FDA approval mandates that Levitra is also contraindicated in patients taking an alpha-adrenergic blocker medication. Alpha-blocker medications include such agents as Uroxatral (alfuzosin), Cardura (doxazosin), Flomax (tamsulosin), Hytrin (terazosin), and prazosin. They are used in the treatment of benign prostate hypertrophy (BPH) and, less commonly, for reducing blood pressure. Similar to nitrates, the combination of Levitra and an alpha-blocker can lead to dangerous hypotension, as well as priapism or other adverse events.

Levitra is metabolized in the liver, primarily by an enzyme called P450 34A. Other drugs, including anti-infection agents erythromycin, ketoconazole, itraconazole, saquinavir and ritonavir inhibit this liver enzyme. With the liver enzyme inhibited, less Levitra is broken down, and the levels in the plasma can rise unwantedly high. Thus, Levitra is either contraindicated with concurrent use of these drugs, or else the dose of Levitra is adjusted downward accordingly.

Levitra is not recommended to be used together with other erectile dysfunction drugs, such as penile injections, since it may increase the likelihood of priapism.

Since there are not clinically controlled trials to prove otherwise, warnings should be considered in certain groups of patients. These warning groups include patients with: unstable angina, acute myocardial infarction, blood pressure less than 90/50, blood pressure over 170/110, or a stroke/myocardial infarction/symptomatic postural hypertension within 6 months.

Similar to the studies on Viagra, Levitra does not significantly alter cardiac status nor increase the exercise time on a stress test, as compared to placebo.

Strengths and weaknesses

Levitra has advocates that describe a faster onset of action as compared to Viagra, though comprehensive comparator trials are still pending.

There is an increased selectivity versus Viagra for some PDE enzymes in the body, including the retina, so there is lessened visual side-effects.

Another advantage is that some men with erectile dysfunction that is not responding to Viagra may have some effect with Levitra. One such trial shown that, among men who were nonresponders to Viagra, Levitra was effective in over 60% of these patients. It is important to note that men with the most severe forms of erectile dysfunction are less likely to respond to any type of PDE5 inhibitor medication.

There is still the inconvenience of avoiding high-fat meals before using Levitra, although the effect is not as bad as with Viagra.

The duration of action of Levitra is much less than that of Cialis.

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Levitra vs viagra and cialis

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