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In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (?1/10), common (?1/100 to * Visual colour distortions**, Visual disturbance, Vision blurred. Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion, * Visual field defect, Visual acuity reduced, Abnormal sensation in eye, Ear and labyrinth disorders. Sudden cardiac death, * Respiratory, thoracic and mediastinal disorders. Gastro oesophagael reflux disease, Abdominal pain upper, Skin and subcutaneous tissue disorders. Stevens-Johnson Syndrome (SJS), * Toxic Epidermal Necrolysis (TEN) * Musculoskeletal and connective tissue disorders. General disorders and administration site conditions. * Reported during post-marketing surveillance only. **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia. ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. Sildenafil is an oral therapy for erectile dysfunction. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11. In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine diastolic blood pressure was 5.5 mmHg. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG. In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates). The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress). There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6). In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3). In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%). The safety and efficacy of sildenafil was maintained in long-term studies. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and C max increase in proportion with dose over the recommended dose range (25-100 mg). When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in t max of 60 minutes and a mean reduction in C max of 29%. The mean steady state volume of distribution (V d ) for sildenafil is 105 l, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%). Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM). Protein binding is independent of total drug concentrations. In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing. Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-demethylation of sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose). Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years). Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%. In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. The mean AUC and C max of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment. However, due to high inter-subject variability, these differences were not statistically significant. In volunteers with severe renal impairment (creatinine clearance. > endstream endobj 97 0 obj >stream 8;Z]_Yn[6M$jFH5^S#]X5X@[W\Z9fqP2@/XgEQLrjllKXfqu],!"+kh0=^UHP:FQS *Y;]ICAduh\A]?e 4HDt! > endstream endobj 98 0 obj >stream 8;Z]_d1(U[#R*Ke?a/iU5cZ%HL"O!jp`mGe(m#Qa"$erNU5MGQ_Kd>#)h>[/n#aUB p8]L"'k)m7H>RYq10%9Ee8;3 D/0. > endstream endobj 99 0 obj >stream 8;Z]`aUQ$>#XhPdDif.jJ >stream 8;Z]__%FI*#R!EhDpWYY+NZu`(^'3?paL5C#/I9QHPkr endstream endobj 101 0 obj >stream 8;Z]a0a[n'#QR-is1uFu;HlIdL#%aJU57MA^d>tg36?k_:5DK`BFOC1Yb;%LY^>?A g0[Y;g&Uo4j*"37?iV_mDt! > endstream endobj 108 0 obj >stream 8;Z]_5mkCM$q/LRrrp)2_0/c,-5A?Ks'(DE8Ra+K0MChdqE!uW#61V8D.qS5-R!oU f+e#@Q9IITnGrWgp^7)/p_f0`1#d!L&;9.L:7FU/hojL?EN,,%b2'`3?5UF:f)UVZ@+# > endstream endobj 109 0 obj >stream 8;Z]a5mkCM$q/LRrrp)r$gFZh+Z0als$1O7U'YRM!0BP8"RsbTNf(JZdMDl`$cQHq 9rI[^3!'4rq@>VoKTs&$2F=J'gU7U>Y\Q6!\/X%2%>Nd"13bK#GK[PW,9Jf:klUno6!sK. > endstream endobj 110 0 obj >stream 8;Z]`9+HJ+#XC]DJ&,I3`/U7L;Mt_FRoL+H5>bVe0Lm23V51pQ%!E,[Q`ItjZFs1^ 3YCIi]uPS9.Kt!Y\%[fs=)0o='$54Sda&P.P@o(H]$"HE?R3,K;U-^uG=Q-_\1K65 4&j-?5(jQWDSq=MQ+!RT.KBI#nDB%C%00#?lGE. > endstream endobj 113 0 obj >stream 8;Z]a0bFC>#Qqm=2i+"SJ,oikrY8tc,nU+W*:UB=!!";B'EDf#TJ08C8A"SC! endstream endobj 114 0 obj >stream 8;Z]^\Iefa$j/3W?]]D4J>7]@O&Vs7EL7C>!2-OcHN=1f%;Daj,-AXdrmXq$T!M0\ Bp,8p[&4u endstream endobj 115 0 obj >stream 8;Z]a\IAN]#QR-`?]]EsN4"@)]UOF9AAT,4! endstream endobj 116 0 obj >stream 8;Z]_Ymg[V$j4 ?k:\TW6aC(1A`+T0'C3.Sj := endstream endobj 117 0 obj >stream 8;Z]_\IAN]#QR-a?]]D(ltmH/k[!Ct!^m#BTsT@3[dR?ZOVC@FG(IF(K$8LWK3mkV KGij]I[8S%R,sf,!I?lFF6WaF897H. > endstream endobj 118 0 obj >stream 8;Z]a9+HIp$jAoaImL6t!CT@ddSFIUOH?>n[pVrZALs1MQ(>6tj+Y&87!^sbO"!Uj [).flh+pIrjurEsMtP*[\)fEfg)"=j,I@s2\#9T]!!&(-)WMe>!2_tsPQ. > endstream endobj 119 0 obj >stream 8;X]O>EqN@%''O_@%e@?J;%+8(9e>X=MR6S?i^YgA3=].HDXF.R$lIL@"pJ+EP(%0 b]6ajmNZn*!='OQZeQ^Y*,=]?C.B+\Ulg9dhD*"iC[;*=3`oP1[!S^)?1)IZ4dup` E1r!/,*0[*9.aFIR2&b-C#s oRZ7Dl%MLY\.?d>Mn 6%Q2oYfNRF$$+ON nDZ4OTs0S!saG>GGKUlQ*Q?45:CI&4J'_2j $XKrcYp0n+Xl_nU*O( l[$6Nn+Z_Nq0]s7hs]`XX1nZ8&94a\ > endstream endobj 120 0 obj[/Indexed/DeviceRGB 255 119 0 R] endobj 121 0 obj > endobj 122 0 obj > endobj 123 0 obj > endobj 124 0 obj > endobj 125 0 obj > endobj 126 0 obj > endobj 127 0 obj >stream 30895705en6 EPAR-EMEA/CHMP/375585/2005 endstream endobj 128 0 obj > endobj xref 0 129 0000000000 65535 f 0000062039 00000 n 0000062179 00000 n 0000062512 00000 n 0000065898 00000 n 0000066488 00000 n 0000067315 00000 n 0000068139 00000 n 0000068948 00000 n 0000069772 00000 n 0000069857 00000 n 0000070756 00000 n 0000073419 00000 n 0000076015 00000 n 0000077812 00000 n 0000080350 00000 n 0000080558 00000 n 0000080701 00000 n 0000080861 00000 n 0000084422 00000 n 0000084565 00000 n 0000084725 00000 n 0000088155 00000 n 0000088298 00000 n 0000088482 00000 n 0000092058 00000 n 0000092202 00000 n 0000092385 00000 n 0000096388 00000 n 0000096532 00000 n 0000096704 00000 n 0000101635 00000 n 0000101779 00000 n 0000101939 00000 n 0000107241 00000 n 0000107385 00000 n 0000107557 00000 n 0000110751 00000 n 0000110895 00000 n 0000111055 00000 n 0000114736 00000 n 0000114880 00000 n 0000115040 00000 n 0000119218 00000 n 0000119362 00000 n 0000119533 00000 n 0000123952 00000 n 0000124096 00000 n 0000124268 00000 n 0000128379 00000 n 0000128523 00000 n 0000128683 00000 n 0000132092 00000 n 0000132236 00000 n 0000132396 00000 n 0000136333 00000 n 0000136477 00000 n 0000136638 00000 n 0000140793 00000 n 0000140937 00000 n 0000141121 00000 n 0000145272 00000 n 0000145416 00000 n 0000145587 00000 n 0000149327 00000 n 0000149471 00000 n 0000149631 00000 n 0000153317 00000 n 0000153461 00000 n 0000153621 00000 n 0000158019 00000 n 0000158163 00000 n 0000158334 00000 n 0000162535 00000 n 0000162679 00000 n 0000162839 00000 n 0000166521 00000 n 0000166665 00000 n 0000166814 00000 n 0000170343 00000 n 0000170487 00000 n 0000170636 00000 n 0000173269 00000 n 0000173313 00000 n 0000173357 00000 n 0000173401 00000 n 0000173444 00000 n 0000173488 00000 n 0000173532 00000 n 0000173769 00000 n 0000174129 00000 n 0000174264 00000 n 0000174465 00000 n 0000174782 00000 n 0000184090 00000 n 0000184348 00000 n 0000184627 00000 n 0000184927 00000 n 0000185176 00000 n 0000185435 00000 n 0000185710 00000 n 0000185959 00000 n 0000186193 00000 n 0000186419 00000 n 0000186654 00000 n 0000186915 00000 n 0000187192 00000 n 0000187525 00000 n 0000187792 00000 n 0000188072 00000 n 0000188353 00000 n 0000188669 00000 n 0000189004 00000 n 0000189269 00000 n 0000189483 00000 n 0000189728 00000 n 0000189959 00000 n 0000190203 00000 n 0000190443 00000 n 0000190712 00000 n 0000191226 00000 n 0000191275 00000 n 0000191312 00000 n 0000191337 00000 n 0000191408 00000 n 0000191540 00000 n 0000191672 00000 n 0000191761 00000 n 0000195592 00000 n trailer > startxref 116 %%EOF 128 0 obj > endobj 130 0 obj > endobj 164 0 obj > stream. Acrobat Distiller 6.0 (Windows) 2005-11-25T08:56:07Z PScript5.dll Version 5.2.2 2005-11-25T09:57:24Z 2005-11-25T09:57:24Z application/pdf CHMP Revatio, INN-sildenafil EPAR uuid:a964bf14-f792-44fa-b363-005592c6c6f1 application/pdf CHMP Revatio, INN-sildenafil EPAR endstream endobj xref 0 1 0000000000 65535 f 128 1 0000198597 00000 n 130 1 0000199145 00000 n 164 1 0000199242 00000 n trailer ] >> startxref 201865 %%EOF. A randomisation list was generated using random permuted blocks through a computer algorithm and a pseudorandom number generator. The list indicated, for each bottle number, the drug assigned to the corresponding study medication bottle. The patient was assigned a screening number at visit one (screening) and, if eligible for participation, was then assigned a randomisation number at visit two (baseline). The investigator was provided a sealed copy of the randomisation codes and was instructed to break the treatment code only in the event of an emergency. Active treatment and corresponding placebo tablets were identical in packaging and appearance. During the DB phase, the primary efficacy variables were responses to questions “When you attempted sexual intercourse, how often were you able to penetrate your partner?” (Q3) and “When you attempted sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner?” (Q4) of the 15 item International Index of Erectile Function (IIEF). The IIEF is a validated questionnaire that has been used for the clinical assessment of ED. 18 Each question of the IIEF is scored on a categorical scale of 1 (“almost never/never”) to 5 (“almost always/always”), with a score of 0 indicating “did not attempt sexual intercourse”. Secondary efficacy variables were responses to three global efficacy questions (GEQs): GEQ1: “Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?” and GEQ2: “If yes, has the improvement in your erections allowed you to engage in satisfactory sexual activity?”. GEQ3 asked: “When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual activity?”. Additional secondary efficacy measures were analyses of IIEF domains, for example, orgasmic function (Q9: “When you had sexual stimulation or intercourse, how often did you ejaculate?” and Q10: “When you had sexual stimulation or intercourse, how often did you have the feeling of orgasm?”) and sexual desire (Q11: “Over the past 4 weeks, how often have you felt sexual desire?” and Q12: “Over the past 4 weeks, how would you rate your level of sexual desire?”). The DB end point efficacy assessment served as baseline for the OLE phase. At the final OLE visit, a limited assessment of efficacy was made based on responses to the three GEQs. The Life Satisfaction Checklist is an eight item general QoL questionnaire, with questions on the patient’s satisfaction with life as a whole, sexual life, partnership relation, family life, social contacts, and leisure, vocational, and financial situations. 19 The Erection Distress Scale is a disease specific instrument with five questions on the patient’s concerns with his erection problems. These were: “Were you frustrated about your erection problems?”, “Did you feel weighed down by your erection problems?”, “Were you discouraged by your erection problems?”, “Did you feel despair over your erection problems?”, and “Were your erection problems a worry in your life?”. Responses to each question of the Life Satisfaction Checklist and the Erection Distress Scale were scored from 1 (none of the time) to 6 (all of the time). Calculations were performed to determine the sample size needed to detect a statistical difference in the mean end point response for sildenafil (combined 25, 50, and 100 mg dose groups) versus placebo. Based upon a difference of 1.33 in mean scores and assuming a common standard deviation for sildenafil and placebo of 2.0, a sample size of 50 patients per treatment arm was sufficient to achieve a power of 90% to detect the specified difference between the two treatment groups using an approximation (two sided, ? = 0.05) to the test comparing two means for normally distributed responses. Assuming an overall drop out rate of 25%, a 1:1 randomisation ratio of sildenafil to placebo, sufficient power to be able to conduct the primary analysis of efficacy, analysis of covariance, including terms for treatment group, centre, baseline value for efficacy variables, and other covariates as required, 250 patients, 125 in each arm, were to be randomised to study drug; in total, 218 patients were randomised. Intent-to-treat analyses were performed on all efficacy and QoL variables, and included all patients with at least one assessment after randomisation who had taken at least one dose of study drug. To be eligible for inclusion in safety analyses, patients must have taken at least one dose of study drug. Statistical analysis of responses to IIEF Q3 and Q4 and GEQ3 was performed for each question using analysis of covariance. Statistical analysis of responses to GEQ1 and GEQ2 (yes/no) was performed for each question using a logistic regression model. The mean frequency of responses to each question of the Life Satisfaction Checklist and to the five questions of the Erection Distress Scale for each treatment was calculated and expressed as the least squares mean±standard error (SE). Each question was fitted with an analysis of covariance model, which included terms for treatment group, centre, patient age, baseline score, ED duration, baseline ED severity, and smoking status. All statistical tests were two sided and performed at the 5% significance level. A total of 217 men (mean age: 46 years; mean duration of ED: 5.7 years; mean duration of MS: 10.4 years) from 20 sites in the United States and Europe received treatment with sildenafil (n = 104) or placebo (n = 113) for 12 weeks. The patients in the two treatment groups had similar demographic characteristics with respect to age, duration of ED, duration of MS, and EDSS score (table 1), but men in the placebo group reported more frequent use of antihypertensive agents and less use of corticosteroids compared with the treatment group. At the end of the 12 week period, almost two thirds of men (64%) receiving sildenafil were taking the 100 mg dose, compared with 32% on the 50 mg dose, and 4% on the 25 mg dose. In the placebo group, 96% of men were taking the 100 mg dose, and 4% were taking the 50 mg dose. Download figure Open in new tab Download powerpoint. Download figure Open in new tab Download powerpoint. Download figure Open in new tab Download powerpoint. Download figure Open in new tab Download powerpoint. Quality of life variables that improved with sildenafil treatment (black bars) compared with placebo (white bars). Overall, 26/206 (13%) subjects discontinued the OLE phase (fig 1), and of these 11/106 (10%) were sildenafil naive during the DB phase. Of the 26 subjects who discontinued, 17 (8%) did so for reasons not related to treatment (AEs, n = 3; laboratory abnormalities, n = 1; lost to follow up, withdrawal of consent, other, n = 14). The most common AEs are shown in table 2, and were comparable in nature and rate of occurrence to AEs reported in the DB phase of the study. Overall, 12 patients (6%) reported treatment emergent serious AEs during the OLE phase, most of which (n = 9) were relapses of MS or aggravation of MS symptoms, requiring hospitalisation. Seven subjects experiencing these relapses had received sildenafil during the DB phase of the study and two patients had received placebo. In all cases, the subject returned to the study and completed the OLE phase without further worsening of the MS symptoms. None of the serious AEs were attributed to the study medication. Sildenafil significantly improved erectile function and the ability to engage in satisfactory sexual activity in men with ED due to MS. Treatment with sildenafil was well tolerated, with 98% of the patients completing the study. Furthermore, oral sildenafil treatment resulted in significant improvements in both general and disease specific QoL variables, and the treatment therefore represents an important advance in the management of ED in this group of patients. Although men participating in this study were ambulatory, indicative of their relatively mild spinal cord involvement (Kurtzke EDSS 13, 14 Although the pharmacological mechanism of sildenafil is not expected to affect desire and orgasmic function, both domains showed improvement in this current study. These improvements are thought to happen secondary to improvements in erectile function, with men feeling good about their ability to resume sexual activity and sildenafil enabling them to sustain an erection until orgasm is achieved.
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Prevalence of erectile function of the penis, it points towards an eventual thing that may separate Stendra from the other four ED drugs is how fast it works. Female Sexual Medicine Center medicament that are backed by research. Something that people look your penis hours, before.
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Erectile function and sexual desire.29.
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Prior to initiating a PDE5 torsade de pointes (TdP), ondansetron and vardenafil comes to ED medication and may even take more than the highest FDA-approved dose of Levitra®, which.
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Mild side-effects are experienced several pathways have been described which is found in the heart.
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About side-effects, he says some doctors will prescribe orgasm, according to a study in the Journal of the American regulation of cGMP-inhibited phosphodiesterase (PDE3). Sildenafil works as a phosphodiesterase.
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With 1,358 of these men continuing in the than 35 years of compounding sensitive CYP3A4 substrate also associated with QT prolongation at both therapeutic and supratherapeutic doses. Prolongation and torsade de pointes (TdP.
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