New Patient Research Shows Importance Of Early Success In Treating Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Sexual Health / STDs;  Men's health
Article Date: 29 Nov 2007 - 2:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

A UK study, made available at the 10th Congress of the European Society of Sexual Medicine in Lisbon, has warned healthcare professionals who treat erectile dysfunction (ED) of the importance of their first patient consultation. Authors observed that the success of the first consultation and treatment is important both directly - on measures of patient well being - and indirectly - in terms of not losing patients from a management pathway and the opportunity to monitor important co-morbidities. The study was supported by a research grant from Bayer Schering Pharma.

Study authors analysed retrospective data from 630 men with ED, all of whom had received treatment with at least one PDE5 inhibitor. Results showed that when unable to have satisfactory sex with their first dose a third of men did not return to their prescriber to try an alternative treatment. Analysis showed that first dose failure impacted on overall confidence (58%), relationships (47%) and self-esteem (68%). Additionally 77% were worried that their ED was permanent and 32% reported feelings of depression.

Oxfordshire GP David Edwards, a study author, emphasized: "Primary care has yet to fully realise the importance of early treatment success in ED. The first consultation and subsequent treatment can be critical in determining the success of longer term management. This study is a first step towards highlighting the importance of this critical phase."

Authors concluded that when prescribing a treatment for ED, patient desired attributes should be taken into consideration as many do not re-consult if the treatment is unsuccessful. The research showed that 89% of patients reported that, prior to taking their first PDE5 inhibitor, 'high success rate with first tablet' and 'works quickly' were the most important attributes for an ED treatment. Furthermore, 87% reported being willing to consider switching their current therapy if they were offered alternative treatment options by their GP.

Data revealed that 72% of respondents preferred to speak to a GP about their ED in the first instance. Even so, less than half (49%) made an appointment specifically to discuss their ED. Dr Mike Callander, Chair of the Primary Care ED Society, commented, "More can be done within primary care to screen men for ED as part of a general health check. These new data show men with ED continue to 17 months on average before seeking help. How many GPs would turn down the opportunity of an early warning signal for vascular disease, or choose to have patients suffer in silence for this long? GPs and practice nurses should ask their patients about erection problems."

Study methodology

The research was conducted amongst 630 men with ED:

- Men had been suffering with ED for an average of 4.65 years
- The average age was 55 years old
- All men had taken an oral treatment for ED at some stage
- 70% of men were still taking an oral medication
- 23% were not taking a treatment for a specific reason - the most commonly cited reason was a lack of effect (32%)

References

1. ICM. ED Patient Research. Attitudes towards Erectile Dysfunction (ED) and Treatment. Commissioned by Bayer HealthCare, May 2007

LEVITRA 5 mg / 10 mg / 20 mg film-coated tablets.
(Refer to SmPC before prescribing.)

Presentation: Each tablet contains 5 mg / 10 mg / 20 mg vardenafil (as hydrochloride trihydrate).

Indications: Treatment of erectile dysfunction. To be effective, sexual stimulation is required. Not for use by women.

Dosage: Adult men: 10 mg approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg once per day. Can be taken with or without food, onset of activity may be delayed if taken with a high fat meal. Elderly men: a first dose of 5 mg should be used. Mild and moderate hepatic impairment, severe renal impairment: A starting dose of 5 mg should be considered. With other medicinal products: In combination with erythromycin, the dose of LEVITRA should not exceed 5 mg. Children and adolescents: not indicated.

Contraindications: Coadministration with nitrates or nitric oxide donors (such as amyl nitrite) in any form; patients who have loss of vision in one eye because of NAION; men for whom sexual activity is inadvisable (e.g. severe cardiovascular disorders); severe hepatic impairment; endstage renal disease requiring dialysis; hypotension; recent stroke or myocardial infarction; unstable angina; known hereditary retinal degenerative disorders; concomitant use of potent HIV protease inhibitors such as ritonavir and indinavir, concomitant use of potent CYP3A4 inhibitors (ketoconazole and itraconazole (oral form)) in men older than 75 years; hypersensitivity to vardenafil or to any of the excipients.

Warnings and Precautions: Medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes. Consider cardiovascular status, since there is a degree of cardiac risk associated with sexual activity. Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Use with caution in patients with anatomical deformation of the penis or conditions which predispose to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Combination with other treatments for erectile dysfunction is not recommended. Concomitant use with potent CYP 3A4 inhibitors (itraconazole and ketoconazole (oral form)) should be avoided. A dose of 5mg vardenafil must not be exceeded when given concomitantly with erythromycin. Patients on stable alpha-blocker therapy: initiate vardenafil therapy at a starting dose of 5mg and consider a time separation of dosing. Prolongation of QTc interval - avoid use in patients with relevant risk factors. Advise patients that in the case of sudden visual defect to stop taking Levitra and consult a physician. Avoid grapefruit juice. Administration to patients with bleeding disorders or active peptic ulceration only after careful benefit-risk-assessment.

Undesirable Effects: Most common: flushing, headache, dizziness, nasal congestion, dyspepsia, nausea. Serious side effects include: tachycardia, palpitations, angina pectoris, hypersensitivity, laryngeal oedema, priapism, intraocular pressure increased, NAION, retinal vascular occlusion, visual field defect, myocardial infarction. Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia reported post marketing in temporal association with another medicinal product in this class. Prescribers should consult the SmPC in relation to other side effects.

Legal Category: POM

Marketing Authorisation Numbers: EU/1/03/248/001-012.

Marketing Authorisation Holder: Bayer AG, D-51368 Leverkusen, Germany.

Package Quantities and Costs: Packs of 4, 5mg tablets £16.59; Packs of 8, 5mg tablets £33.19; Packs of 4, 10mg tablets £22.24; Packs of 8, 10mg tablets £44.47; Packs of 4, 20mg tablets £23.50; Packs of 8, 20mg tablets £46.99.

Further information available from: Bayer plc, Pharmaceutical Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom. Version: 008 Date of preparation: July 2006

- Agents for the treatment of ED should not be used in men for whom sexual activity is inadvisable

- The co administration of Levitra or any PDE5 inhibitor with nitrates or nitric oxide donors is contraindicated

- Concomitant use of Levitra with ritonavir and indinavir is contraindicated. Concomitant use with potent CYP3A4 inhibitors such as itraconazole and ketoconazole should be avoided. A dose of 5mg Levitra must not be exceeded when given concomitantly with erythromycin

- The recommended starting dose of Levitra is 10mg. In elderly men or men with mild-moderate hepatic or severe renal impairment, or in men on stable alpha blocker therapy a first dose of 5mg should be used.

- The maximum recommended dosing frequency is once per day

- The use of PDE5 inhibitors including Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION).

http://www.levitra.com