Vardenafil (Levitra) — how it works and dosing

Vardenafil is a prescription tablet for erectile dysfunction, authorised across the EU since 2003. It works the same way as sildenafil and tadalafil: it keeps the blood vessels in the penis relaxed so blood can flow in during sexual arousal. It must never be taken with nitrate heart medicines.

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What is vardenafil?

Vardenafil is a PDE5-inhibitor tablet, film-coated or melt-in-the-mouth, for adult men with erectile dysfunction — the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Sexual stimulation is still required for it to work. It is normally taken 25 to 60 minutes before sex, and it also comes as a tablet that dissolves on the tongue.

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How it works

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EU authorisation

Levitra is centrally authorised, so a single EU authorisation covers all 27 member states. It was granted on 6 March 2003 and is held by Bayer AG in Germany. The 10 mg orodispersible tablet is taken without liquid and is a different presentation from the 10 mg film-coated tablet, not an interchangeable one.

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What the studies reported

The EMA product information reports fixed-dose success rates: SEP2 (ability to penetrate) at 68% / 76% / 80% for 5 / 10 / 20 mg versus 49% on placebo, and SEP3 (ability to maintain an erection) at 53% / 63% / 65% versus 29% on placebo, measured over three months. The pivotal at-home trial (Porst et al., Int J Impot Res 2001; PMID 11494074) was a multi-centre, randomised, double-blind, placebo-controlled study in 601 men with mild to severe erectile dysfunction of mixed causes; the intention-to-treat population was 580. Coprimary endpoints were IIEF questions 3 (vaginal penetration) and 4 (maintenance of erection), measured as change from baseline over 12 weeks — a short window relative to the chronic nature of the condition. The trial did not measure patient-reported satisfaction beyond the IIEF domain scores and excluded men with certain cardiovascular conditions, so results do not necessarily generalise to the full primary-care population.

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What has been reported

Vardenafil is contraindicated in men who have already lost vision in one eye from NAION.

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Pharmacology

Vardenafil is predominantly metabolised by CYP3A4, with a minor contribution from CYP2C9. Inhibitors of CYP3A4 (such as ketoconazole, ritonavir, and grapefruit juice) can raise vardenafil plasma concentrations, which the reviewing doctor takes into account. Its PDE5-to-PDE6 selectivity ratio is approximately 15-fold — higher PDE6 binding is associated with colour-vision disturbance, so the relatively low rate of visual effects seen with vardenafil is consistent with this selectivity profile. Vardenafil is contraindicated with any nitrate or nitric-oxide donor because both PDE5 inhibition and nitrates increase cyclic GMP in vascular smooth muscle through different pathways, and their combined effect can produce a precipitous fall in blood pressure.

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How to take it

Vardenafil is taken 25 to 60 minutes before sexual activity. Light meals are fine, but very fatty meals delay onset. At most one dose is taken in 24 hours. The orodispersible tablet is placed on the tongue and dissolves without liquid — it is a different presentation from the film-coated tablet and is not interchangeable.

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Common questions

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Who it is not suitable for

• Anyone taking nitrate medicines or nitric-oxide donors (“poppers”) — blood pressure can fall dangerously
• Men with severe cardiovascular disease, including unstable angina, recent stroke or myocardial infarction (within 6 months), or hypotension
• Patients with severe hepatic impairment (Child-Pugh C) or end-stage renal disease requiring dialysis — the safety database does not cover these populations
• Men taking guanylate cyclase stimulators such as riociguat, because both PDE5 inhibition and guanylate cyclase stimulation raise cGMP through different pathways and the combined effect can produce dangerous hypotension (confirmed in the EMA product information for Levitra, EMEA/H/C/000475)
• Men who have ever lost vision from non-arteritic anterior ischaemic optic neuropathy (NAION)
• Patients with hereditary retinal degenerative disorders such as retinitis pigmentosa — the medicine has not been studied in this group

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How Hi-Doctor handles it

Some people who had side effects with sildenafil tolerate vardenafil well — the doctor weighs which PDE5 inhibitor fits your case best, after screening your cardiovascular history and current medicines. At most one dose is taken in 24 hours. See also tadalafil, sildenafil, and avanafil (Spedra), another PDE5 inhibitor in the same group with a faster onset. For the full eligibility checks, see safety and how a consultation works.

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