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Inactive Ingredients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide. Tadalafil and vardenafil vs sildenafil: a review of patient?preference studies. Volume 107 Issue 7 BJU International pages: 1166-1166 First Published online: March 25, 2011.

Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and.

Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and. Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and. Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and.

Department of Urology, University Vita Salute San Raffaele, Milan, Italy.

Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and.

Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and.

Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and. Department of Urology, University Federico II of Naples, Ely Lilly Italy, Florence, and.

Department of Urology, University Vita Salute San Raffaele, Milan, Italy. The immediate objective of phosphodiesterase type 5 (PDE5) inhibitor treatment is to restore the ability of a man to achieve and/or maintain an erection adequate for sexual intercourse.

As erectile dysfunction (ED) generally develops in the second half of life, the ultimate objective generally is not procreation, but quality of sexual life. Indeed, ED is known to impair quality of life considerably; two?thirds of men report that ED has impaired their self?esteem and nearly a third claim that it has damaged the relationship with their partner. It follows that the therapeutic success of PDE5 inhibition has an important subjective component, which is compounded by the subjective nature and complexity of sexual life in humans.

This makes it very difficult for physicians to be certain that they have selected the optimal therapy for a couple, even after a thorough evaluation.

The 2007 European Association of Urology Guidelines stress the importance of educating the patient and claim that ‘the patient will choose the final drug after his own experience’. However, PDE5 inhibitors are typically used twice a week, so a patient would have to spend ?3 months trying the various compounds and dosages to achieve adequate exposure to all three PDE5 inhibitors; this would seem an unrealistic strategy in normal clinical practice.

The acknowledgement that the patient has an important role in therapeutic decisions for ED has fuelled interest in the concept of patient preference. It has been established that patient preference depends on three factors, i.e.

age, duration of ED, frequency and dynamics of sexual relations, and the characteristics of their partners, e.g.

age, menopausal status and level of interest in sexual activity and medication profile.

Medication features of interest include efficacy in terms of quality of erection, consistency of effects, rapid onset of action, long duration of action, side?effect profile and route of administration; drug costs must also be considered if the medicinal product is not reimbursed. After explaining why patient preference is an important endpoint for assessing a phosphodiesterase type 5 (PDE5) inhibitor, we review the quality of published patient?preference studies and the data related to the reasons for the preference of one compound over another. The immediate objective of PDE5 inhibitor treatment is to restore the ability of a man to achieve and/or maintain an erection adequate for sexual intercourse.

As erectile dysfunction (ED) generally develops in the second half of life, the ultimate objective generally is not procreation, but quality of sexual life.

Indeed, ED is known to impair quality of life considerably: two?thirds of men report that ED has impaired their self?esteem and nearly a third claim that it has damaged the relationship with their partner [ 1 ].

It follows that the therapeutic success of PDE5 inhibition has an important subjective component, which is compounded by the subjective nature and complexity of sexual life in humans. This makes it very difficult for physicians to be certain that they have selected the optimum therapy for a couple, even after a thorough evaluation [ 1 ]. The 2007 European Association of Urology Guidelines [ 2 ] stress the importance of educating the patient and claim that ‘the patient will choose the final drug after his own experience’.

However, Hatzimouratidis and Hatzichristou [ 3 ] point out that PDE5 inhibitors are typically used twice a week, free viagra no prescription so a patient would have to spend ?3 months trying the various compounds and dosages to achieve adequate exposure to all three PDE5 inhibitors; this would seem an unrealistic strategy in normal clinical practice. The acknowledgement that the patient has an important role in therapeutic decisions for ED has fuelled interest in the concept of patient preference. It has been established that patient preference depends on three factors, i.e. personal characteristics, such as age, duration of ED, frequency and dynamics of sexual relations, and the characteristics of their partners, such as age, menopausal status and level of interest in sexual activity and medication profile. Medication features of interest include efficacy in terms of quality of erection, consistency of effects, rapid onset of action, long duration of action, side?effect profile and route of administration; drug costs have to be considered, too, if the medicinal product is not reimbursed [ 1 ]. Three PDE5 inhibitors are currently commercially available; each one is characterized by particular pharmacokinetic features. In the attempt to evaluate which is the most favoured drug, several preference studies have been conducted in the last few years.

Unfortunately, several of them have proved to be severely flawed because of methodological pitfalls. Mulhall [ 4 ] made the point that patient preference studies are not the same as the classical efficacy and safety studies, and set forth detailed recommendations for their conduct.

The ideal study for preference evaluation should: (i) be randomized, double?blind, crossover; (ii) not include bias by pre?selection of patients (e.g. only nonresponders to previous treatment); (iii) make fair comparisons, adopting equivalent doses of each drug and giving each drug for equal periods; (iv) be based on an intent?to?treat analysis.

He also indicated several pitfalls: drug instructions might differ considerably, e.g.

because of differences in duration of action, and invalidate the blinding, or might even condition patient preference; period effects might produce improvements over time that bias results in studies with medications that require an adaptation period or training; carry?over effects might produce an overlap in the effects of medications, jeopardizing their comparison, when the wash?out interval between periods is too short.

He also raised the issue of how patient preference should be assessed. A single question, such as ‘Which treatment did you

prefer

A multi?question preference questionnaire, including questions that are related to putative contributing factors, such as time to onset of action, duration of action, quality of erection and side?effects, is preferable. Several published studies are available that evaluated patient preference for tadalafil or vardenafil vs sildenafil and that meet some, but not all, the requirements listed above. The aim of this review is to free viagra no prescription establish whether current knowledge enables any conclusive judgement. We electronically searched Medline (from 1966 to 2007 week 18) and EMBASE (from 1988 to 2007 week 18) using the search string ‘(tadalafil or vardenafil)

AND

We identified seven patient?preference studies (Table 1) [ 5-12 ], comprising six interventional trials [ 5-10, 12 ] and one observational trial [ 11 ]. All of them compared tadalafil with sildenafil, except two, i.e. a large double?blind study by Rubio?Aurioles et al.

[ 10 ] that compared vardenafil with sildenafil, and a small open?label study by Tolra et al.

[ 9 ] that compared sildenafil with vardenafil and tadalafil.

Three of the studies were declared as sponsored by Lilly ICOS LLC [ 7, 8, 11 ] and one jointly by Bayer and Glaxo?SmithKline [ 10 ].

Ref Design Population, n inclusion criteria Treatment Questionnaires [ 5 ] Randomized, double?blind Crossover Fixed dose 1–2 week washout SIL vs TAD 191 completers 18–65 years ?3 months ED Heterosexual TAD naive SIL naive/insufficient therapy SIL 50 mg 30 min up to 4 h before sex TAD 20 mg 30 min up to 24 h before sex ?4 weeks TP question SEP diary TEAE [ 6 ] Open?label, fixed dose, 1?way cross over, 1?week screening3?week SIL assess 1 week treatment?free washout 6?week TAD initiation 3?week TAD assess 6?month extension 147 completers ?18 years ?3?month history of ED on SIL treatment at stable dose for 6–24 weeks Stable heterosexual relationship SIL continue 25–100 mg as before (100 mg max 35%) TAD 20 mg % choosing TAD for extension SEP diary TEAE [ 7 ] Randomized, Double?blind, crossover 4?armed study drug preference TAD – SIL or SIL – TAD DIP TAD – SIL (drug was always TAD) Drug comparison, 219 Instructions comparison, 46 18–65 years Heterosexual ?3?month history of ED SIL 50 mg (up to 35% 100 mg) TAD 20 mg ? 12 weeks + 12?week extension Instructions SIL take 30 min up to 4 h before sex; TAD take 30 min up to 24 h before sex TP question DIP question Time from dosing to sex TEAE [ 8 ] Randomized 291 completers SIL 25–100 mg TP question [ 12 ] Open?label Crossover SIL vs TAD 4?week run?in 7–10 day washout 8?week titration 8?week extension ?18 years Steady relationship PDE5I?naive 30 min to 4 h before sex TAD 10–20 mg 30 min to 12 h before sex ? 12 weeks IIEF SEP diary PAIRS Correlate baseline, IIEF, SEP and PAIRS with PP TEAE [ 9 ] Randomized, Open?label Crossover Fixed dose 7?day washout SIL vs TAD vs VAR 90 completers ?18 years Heterosexual ?6 months ED Mild to moderate according to IIEF PDE5 naive SIL 100 mg TAD 20 mg VAR 20 mg ?6 times over 45–60 days IIEF EDITS TP questions TEAE [ 10 ] Pooled data from two randomized, double?blind, crossover with 1 week wash?out SIL vs VAR 931 patients (ITT population) ?18 years 4?week treatment periods Stable heterosexual relationship ?6 months ED History/diagnosis of diabetes mellitus, hypertension and/or hyperlipidaemia SIL, 100 mg VAR 20 mg TP questions IIEF SEP GAQ TSS [ 11 ] Non?interventional observational previous 8 weeks 2425 Use of SIL or TAD within the Need to change to other medication data collected on SIL, TAD PPPQ TP question 4, to patient 5, to partner 6, GAQ N (%) patients Accompanied by partner Who informed partner about PDE5I treatment, EDITS.