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In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. [See DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS and Use In Specific Populations ] Renal Impairment. In male volunteers with CL cr = 50.80 mL/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min. In male volunteers with CL cr = 30.50 mL/min or CL cr 80 mL/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. [See DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS and Use In Specific Populations ]. LEVITRA was evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of LEVITRA in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general erectile dysfunction (ED) population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). LEVITRA was dosed without regard to meals on an as needed basis in men with ED, many of whom had multiple other medical conditions. Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability purchase maxifort zimax 100mg to maintain an erection long enough for successful intercourse (SEP3). In all four fixed-dose efficacy trials, LEVITRA showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). LEVITRA (5 mg, 10 mg, and 20 mg) was effective in all age categories ( PATIENT INFORMATION. Read the Patient Information about LEVITRA before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about LEVITRA when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT LEVITRA? LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke. Do not take LEVITRA if you: Take any medicines called “nitrates” (often used to control chest pain, also known as angina). Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. Take riociguat (Adempas ® ), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. (See "Who Should Not Take LEVITRA?") Tell all your healthcare providers that you take LEVITRA . If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA. LEVITRA is a prescription medicine taken by mouth for the treatment of erectile dysfunction cialis 100mg real (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. LEVITRA may help a man with ED get and keep an erection when he is sexually excited. LEVITRA does not: Cure ED Increase a man’s sexual desire Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about ways to guard against sexually transmitted diseases. When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Talk to your doctor to decide if LEVITRA is right for you. LEVITRA has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy. Do not take LEVITRA if you: Take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”). Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension. Have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING LEVITRA? Before taking LEVITRA, tell your doctor about all your medical problems, including if you: Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your doctor if it is safe for you to have sexual activity. Have low blood pressure or have high blood pressure that is not controlled. Or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome). Have retinitis pigmentosa, a rare genetic (runs in families) eye disease Have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). Have had an erection that lasted more than 4 hours. Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following: Medicines called nitrates (see “What important information should you know about LEVITRA?”). Ketoconazole or itraconazole (such as Nizoral ® or Sporanox ® ). Ritonavir (Norvir ® ) or indinavir sulfate (Crixivan ® ) saquinavir (Fortavase ® or Invirase ® ) or atazanavir (Reyataz ® ). These include Hytrin ® (terazosin HCl), Flomax ® (tamsulosin HCl), Cardura ® (doxazosin mesylate), Minipress ® (prazosin HCl), Rapaflo ® (silodosin) or Uroxatral ® (alfuzosin HCl). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to fainting. You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider. These include quinidine, procainamide, amiodarone and sotalol. Some men can only take a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you. If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA. If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA. If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period. Take 1 LEVITRA tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with LEVITRA. Do not change your dose of LEVITRA without talking to your doctor. Your doctor may lower your dose or raise your dose, depending on how your body reacts to LEVITRA. Call your doctor or emergency room immediately if you accidentally took more LEVITRA than prescribed. The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will purchase maxifort zimax 100mg not go away. LEVITRA may uncommonly cause: An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections. Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including LEVITRA. It purchase maxifort zimax 100mg is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking LEVITRA and contact a doctor right away. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088. Store LEVITRA at room temperature between 59–86° F (15–30° C). Keep LEVITRA and all medicines out of the reach of children. Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use LEVITRA for a condition for which it was not prescribed. Do not give LEVITRA to other people, even if they have the same symptoms that you have. This leaflet summarizes the most important information about LEVITRA. If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about LEVITRA that is written for health professionals. For more information you can also visit www.LEVITRA.com, or call 1-866-LEVITRA. 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, 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?’ is limited, as it does provides no context to the answer. 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 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 Sildenafil AND clinical trial AND erectile dysfunction’ combined with ‘drug preference OR drug choice OR patient preference OR patient attitude OR patient satisfaction’ and limited to articles in English and referring to humans. The studies identified were stringently assessed according to the Mulhall criteria. 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. GAQ, global assessment question; PDE5I, PDE5 inhibitor; PP, patient preference; PPPQ, physician?rated patient?treatment preference questionnaire; SEP, Sexual Encounter Profile; SIL, sildenafil TAD, tadalafil; TEAE, treatment emergent adverse events; TP, treatment preference; TSS, Treatment Satisfaction Scale; VAR, vardenafil; ITT, intent?to?treat. In the light of the considerations above, the six interventional trials are good, but not ideal, studies, as all of them meet most, but not all of Mulhall’s criteria. Three of the five interventional studies [ 6, 8, 9 ] were open?label studies because of the difficulty in conducting a blind study with these compounds, as there are major differences in their instructions on use. [ 5 ] is reduced by several other shortcomings; it included patients who were not naive to PDE5 inhibitor use, and the comparison of the two compounds was unfair, as tadalafil was given at its regular dose, whereas only the starting dose of sildenafil (50 mg) was given to patients, without the option of titrating to the maximum dose of 100 mg; moreover, the duration of treatment was too short (4 weeks). Thus, the two pivotal patient?preference studies are the double?blind studies by Keitz et al. [ 7 ], which compared tadalafil and sildenafil, and by Rubio?Aurioles et al. In these two studies elaborate measures were taken that put patients in conditions that differed considerably from usual clinical practice. [ 5 ] had an elaborate crossover design; patients were randomized to one of 4 arms (i) tadalafil + tadalafil instructions vs sildenafil + sildenafil instructions; (ii) sildenafil + sildenafil instructions vs tadalafil + tadalafil instructions; (iii) tadalafil + tadalafil instructions vs tadalafil + sildenafil instructions; (iv) tadalafil + sildenafil instructions vs tadalafil + tadalafil instructions. The comparison between arm 1 and 2 was between drugs, whereas the comparison between arm 3 and 4 was between instructions. This design enabled the study to also address the key issue of the difference in instruction sets by comparing these while always giving the same drug, tadalafil. The only pitfall of this study is that 66% of the patients were not naive to PDE5 inhibitor. Double?blind conditions were achieved in the study by Rubio?Aurioles et al. [ 10 ] by encapsulating sildenafil tablets, creating a formulation that does not exist on the market.
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