Vardenafil

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Vardenafil on Prescriptsy

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Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor prescribed in the United Kingdom for the treatment of erectile dysfunction (ED) in adult men.

It is the generic form of Levitra, which was originally developed by Bayer and has been available in the UK since 2003.

Vardenafil works by enhancing the natural erectile response to sexual stimulation, increasing blood flow to the penis and enabling the achievement and maintenance of a satisfactory erection.

It is available as film-coated tablets in strengths of 5 mg, 10 mg, and 20 mg.

Erectile dysfunction is a common condition that affects an estimated 4.3 million men in the UK.

Its prevalence increases with age, affecting approximately 40% of men aged 40 and rising to over 70% of men aged 70 and above.

ED can have a significant impact on quality of life, self-confidence, intimate relationships, and mental health.

While ED has traditionally been under-reported, growing awareness and the availability of effective treatments have encouraged more men to seek help.

This page provides a comprehensive clinical overview of vardenafil, covering its mechanism of action, clinical evidence, dosing, side effects, contraindications, safety warnings, and how to obtain a prescription in the UK.

Important safety information about vardenafil

Before reading further, note the following key safety points about vardenafil.

• Never take vardenafil with nitrate medications (including GTN spray, isosorbide mononitrate, and recreational "poppers"). This combination can cause a dangerous drop in blood pressure.
• If you develop chest pain during or after sexual activity, call 999. Do not use GTN spray or any nitrate.
• If an erection lasts more than 4 hours, attend A&E immediately. This is a medical emergency called priapism.
• Vardenafil does not work without sexual stimulation and does not protect against sexually transmitted infections or pregnancy.

What is erectile dysfunction

Erectile dysfunction is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse.

It may be primary (lifelong) or acquired (developing after a period of normal function), and may be situational (occurring only in certain contexts) or generalised.

ED is not an inevitable consequence of ageing, although its prevalence increases with age due to the accumulation of vascular, hormonal, neurological, and psychological risk factors.

The causes of ED are broadly classified as organic (physical), psychogenic (psychological), or mixed.

Organic causes account for approximately 80% of cases in men over 40 and include vascular disease (atherosclerosis, hypertension, dyslipidaemia), diabetes mellitus, neurological conditions (multiple sclerosis, spinal cord injury, Parkinson disease), hormonal disorders (hypogonadism, hyperprolactinaemia, thyroid disease), medication side effects (antihypertensives, antidepressants, antiandrogens), pelvic surgery or radiotherapy, and Peyronie disease.

Psychogenic factors include performance anxiety, relationship difficulties, stress, depression, and body image concerns. In many men, organic and psychogenic factors coexist.

ED is increasingly recognised as an early marker of cardiovascular disease. Endothelial dysfunction in the penile arteries may precede symptomatic coronary artery disease by 2 to 5 years.

A diagnosis of ED in a man without known cardiovascular disease should prompt assessment of cardiovascular risk factors, including blood pressure, lipid profile, fasting glucose, and HbA1c.

How vardenafil works: mechanism of action

Penile erection is a haemodynamic event initiated by neurological signals and mediated by the local release of nitric oxide (NO).

During sexual arousal, parasympathetic nerve fibres and endothelial cells in the corpus cavernosum release NO, which activates the enzyme soluble guanylate cyclase.

This enzyme catalyses the conversion of guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP), a second messenger that triggers smooth muscle relaxation through protein kinase G-mediated calcium desensitisation and potassium channel activation.

Smooth muscle relaxation within the corpus cavernosum increases arterial inflow via the helicine arteries, distends the sinusoidal spaces, compresses the subtunical venular plexus against the tunica albuginea (the veno-occlusive mechanism), and produces a rigid erection.

The erection is terminated when cGMP is hydrolysed by phosphodiesterase type 5 (PDE5), the predominant phosphodiesterase isoform in penile tissue.

Vardenafil selectively and potently inhibits PDE5, preventing the degradation of cGMP and thereby prolonging and amplifying the erectile response to sexual stimulation.

It is approximately 10-fold more potent than sildenafil in vitro at inhibiting PDE5, and has greater selectivity over PDE6 (the retinal isoform) compared with sildenafil, which may account for the lower incidence of visual side effects.

Vardenafil does not initiate erection in the absence of sexual arousal, as the initial release of NO is required to generate the cGMP that the drug preserves.

Clinical evidence for vardenafil

Vardenafil has been extensively studied in randomised controlled trials involving thousands of men with ED of varying aetiology and severity.

In pooled analyses of phase III trials, vardenafil 20 mg improved the International Index of Erectile Function (IIEF) erectile function domain score by approximately 8 to 9 points from baseline, compared with approximately 2 points for placebo.

Success rates for vaginal penetration (SEP2) were approximately 80% with vardenafil 20 mg compared with 50% for placebo, and success rates for maintenance of erection to completion (SEP3) were approximately 65% compared with 30% for placebo.

Vardenafil has demonstrated efficacy across a broad range of patient populations, including men with diabetes mellitus, men who have undergone bilateral nerve-sparing radical prostatectomy, men with spinal cord injury, and elderly men.

A specific study in men with type 2 diabetes, a population known to have more treatment-resistant ED, showed that vardenafil 20 mg significantly improved erectile function compared with placebo, with 72% of attempts at intercourse being successful compared with 28% for placebo.

Head-to-head studies comparing vardenafil with other PDE5 inhibitors are limited, but available data and clinical experience suggest broadly similar efficacy among sildenafil, vardenafil, and tadalafil.

The choice between agents is typically guided by patient preference, onset and duration of action, side effect profile, and interaction potential.

Dosage and administration

Vardenafil is taken on an as-needed basis, approximately 25 to 60 minutes before anticipated sexual activity.

It should be swallowed whole with water and can be taken with or without food. A high-fat meal may delay the time to onset of action.

Starting dose

The recommended starting dose for most men is 10 mg.

Based on individual efficacy and tolerability, the dose may be adjusted to 20 mg (if 10 mg is insufficient) or 5 mg (if side effects are troublesome or the patient is elderly).

The maximum recommended dose is 20 mg in any 24-hour period. Vardenafil should not be taken more than once a day.

Dose adjustments

A lower starting dose of 5 mg is recommended for men aged 65 and over, men with moderate hepatic impairment (Child-Pugh B), men with severe renal impairment (creatinine clearance below 30 mL/min), and men taking moderate CYP3A4 inhibitors such as erythromycin.

Vardenafil is contraindicated in severe hepatic impairment and should not be co-administered with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir without specific dose limitations.

Side effects of vardenafil

Common side effects

The most frequently reported side effects reflect the systemic vasodilatory action of PDE5 inhibition and include headache (10 to 15%), facial flushing (approximately 10%), nasal congestion (approximately 9%), and dyspepsia (3 to 4%).

These are usually mild to moderate, self-limiting, and diminish with repeated use in many men.

Uncommon side effects

Less frequently reported effects include dizziness, visual disturbances (blurred vision, photosensitivity, chromatopsia with a blue-green tinge), palpitations, tachycardia, nausea, myalgia, back pain, and a sensation of warmth. These effects resolve without treatment once the drug is eliminated from the body.

Rare but serious side effects

Priapism (a painful erection lasting more than 4 hours without ongoing sexual stimulation) is a rare but serious complication that requires immediate medical intervention at A&E to prevent permanent ischaemic damage to the corpora cavernosa.

Non-arteritic anterior ischaemic optic neuropathy (NAION) has been reported very rarely with PDE5 inhibitors, presenting as sudden painless vision loss in one eye.

Sudden sensorineural hearing loss, with or without tinnitus and dizziness, has also been reported very rarely. These events require immediate cessation of the drug and urgent specialist assessment.

When to seek medical help

Contact your GP or NHS 111 if side effects are persistent, troublesome, or affecting your quality of life.

Seek emergency care by calling 999 or attending A&E if you experience chest pain during or after sexual activity, an erection lasting more than 4 hours, sudden visual loss, or sudden hearing loss.

Do not take GTN spray or any nitrate medication if you have taken vardenafil in the past 24 hours.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and contraindications

Absolute contraindications

Vardenafil must not be taken by men who are using organic nitrates in any form, including sublingual glyceryl trinitrate (GTN), isosorbide mononitrate, isosorbide dinitrate, and recreational nitrite inhalants (poppers).

The concurrent use of PDE5 inhibitors and nitrates causes profound, potentially fatal hypotension.

Men with severe hepatic impairment (Child-Pugh C), men on dialysis, men with recent myocardial infarction or stroke (within 6 months), men with unstable angina, severe heart failure (NYHA class III or IV), or uncontrolled hypertension or hypotension should not take vardenafil.

Cardiovascular considerations

Sexual activity itself carries a degree of cardiac risk.

Men with ED should undergo cardiovascular risk assessment before starting PDE5 inhibitor therapy, particularly those with known coronary artery disease, heart failure, or multiple cardiovascular risk factors.

Vardenafil causes a modest reduction in blood pressure (typically 5 to 10 mmHg systolic) and should be used with caution in men with pre-existing hypotension or those taking antihypertensive medications.

Alpha-blockers and vardenafil can interact to produce symptomatic postural hypotension; if both are required, the alpha-blocker should be stabilised first and vardenafil introduced at the lowest dose.

QT prolongation

Vardenafil has been shown to cause a modest prolongation of the QT interval at supratherapeutic doses (40 mg).

It should be avoided in men with congenital or acquired QT prolongation and those taking class IA or class III antiarrhythmic medications.

An electrocardiogram may be appropriate before prescribing in men with relevant cardiac history.

How to get a vardenafil prescription in the UK

Vardenafil is classified as a prescription-only medicine (POM) in the UK.

It can be prescribed by GPs, sexual health clinic physicians, urologists, or authorised online prescribers following a clinical assessment of the patient's medical history, cardiovascular risk factors, and current medications.

Unlike sildenafil 50 mg, which is available from pharmacies without prescription under the brand name Viagra Connect, vardenafil requires a prescription in all cases.

PDE5 inhibitors are available on NHS prescription for men with erectile dysfunction, subject to clinical assessment.

Sildenafil is the most commonly NHS-prescribed PDE5 inhibitor due to its low generic cost, but vardenafil may be prescribed when sildenafil has been tried and found to be ineffective or poorly tolerated.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

When to seek medical advice about erectile dysfunction

If you are experiencing persistent difficulty achieving or maintaining erections, consult your GP or a sexual health professional. ED is common, treatable, and nothing to be embarrassed about.

Early assessment is important not only for improving sexual function and quality of life but also for detecting underlying cardiovascular disease, diabetes, hormonal disorders, or psychological conditions that may require treatment.

Your GP can offer a confidential consultation, perform relevant investigations, and discuss the most appropriate treatment option for your circumstances.

Sources

• Vardenafil film-coated tablets, Summary of Product Characteristics (EMC)
• Vardenafil, British National Formulary (BNF)
• Erectile dysfunction, NICE Clinical Knowledge Summaries
• Erectile dysfunction (impotence), NHS
• MHRA Yellow Card Scheme