Erectile Dysfunction Medical Treatment
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2 Erectile Dysfunction Medical Treatment Alireza Ghoreifi Assistant of Urology Mashhad University of Medical Sciences March
3 Treatment of ED Unknown cases of ED First-line therapy Second-line therapy Third-line therapy Three lines 3
4 Treatment of ED First-line therapy Oral pharmacotherapy Topical pharmacotherapy Vacuum constriction devices VCD 4
5 Treatment of ED Second-line therapy 1. Intracavernous injections 2. Intraurethral alprostadil PGE 1 5
6 Treatment of ED Third-line therapy Penile prothesis 6
7 First line Treatment of ED Oral pharmacotherapy PDE5 inhibitors The PDE5 enzyme hydrolyses cyclic guanosine monophosphate (cgmp) in the cavernosum tissue of the penis. 7
8 PDE 5 inhibitors Mechanism of action Inhibition of PDE5 reduce the degradation of cgmp that effect on nitric oxide Vasodilatation Smooth muscle relaxation Penile erection 8
9 PDE 5 inhibitors - Sildenafil * - Tadalafil * - Vardenafil * * European Medicines Agency EMEA Approval 9
10 PDE 5 inhibitors new generation Avanafil: currently has no trademarked Lodenafil: (Helleva), not FDA approved Mirodenafil: (Mvix), not FDA approved Udenafil:( Zydena), not FDA approved 10
11 Sildenafil Iaunched in 1998 First PDE5 inhibitor erection and rigidity sufficient for vaginal penetration Effective: min after administration and T max = 0.8 to 1 hour Heavy meal prolonged absorption reduce of efficacy 11
12 Sildenafil Starting dose = 50 mg and then adapt according to the: - Patients response - Side-effects Efficacy maintain for up to 12h 12
13 Sildenafil After 24 weeks of treatment and in a dose-response study Pre-market ; improved erections: mg = 56% mg = 77% mg = 84% 4. Placebo = 25% In diabetics: - Improved erection= 66.6% / 28.6% - Successful intercourse= 63% / 33% 13
14 Tadalafil Licensed for the treatment of ED = Feb 2003 Effective = 30 min with peak efficacy = 2h Efficacy is maintained for up to 36h and is not affected by food. Recommended starting dose = 10 mg and then adapt 14
15 Tadalafil After 12 weeks of treatment and in a dose - response study, Pre-market improved erections: 1-10 mg = 67% 2-20 mg = 81% 3- Placebo = 35% Diabetic = 64% / 25% 15
16 Vardenafil Commercially available as of March 2003 Effective = 30 min, reduce effect by a heavy fatty meal (>57%) and Tmax = 0.9h Recommended starting dose = 10 mg ( mg) Improved erections in difficult-to-treat subgroups. 16
17 Vardenafil 5 mg = 66% 10 mg = 76% 20 mg = 80% Placebo = 30% Diabetic patients =72% / 13% 17
18 PDE5 inhibitors : Not 100% effective to everyone, every time 18
19 Choice or preference between the different PDE5 inhibitor To date, no data are available Choice of drug will depend on: - The frequency of intercourse (occasional use or regular therapy, 3-4 times weekly) - Patients personal experience Patients need to know whether a drug is short or longacting, possible disadvantages and how to use it 19
20 On-demand or continuous therapy (daily) of PDE5 inhibitors? Tadalafil 5 mg once daily is an alternative to on-demand for couples who prefer spontaneous rather than scheduled sexual activities or who anticipate frequent sexual activity Tadalafil 2.5 and 5 mg/daily is efficacious and well tolerate However, when patients have the choice, it seems that they prefer on-demand rather than continuous therapy. 20
21 Safety issues for PDE5 inhibitors In patients receiving PDE5 inhibitors, myocardial infarction rates does not increase. PDE5 inhibitors may improve exercise tests, and dose not alter cardiac contractility, and cardiac out-put 21
22 Absolute contraindications with the use of PDE5 inhibitors Agents used to treat angina: - Organic nitrates: nitroglycerine isosorbide mononitrate isosorbide dinitrate - Other nitrate preparations Agents used for recreation: - Amyl nitrite or amyl nitrate 22
23 If a PDE5 inhibitors is taken and the patients develops: Chest pain = nitroglycerine must be withheld for at least 24h for use of sildenafil and vardenafil and 48h for use of tadalafil Angina = other agents may be given instead of nitroglycerine until the appropriate time has (above) passed. 23
24 Alpha-blocker interactions All PDE5 inhibitors show some interaction with alpha-blockers orthostatic hypotension. 24
25 Alpha-blocker interactions Sildenafil (50 or 100mg ) should not be taken within 4h following treatment with an alpha-blocker 25
26 Alpha-blocker interactions Co-administration of vardenafil with tamsulosin is not associated with clinically significant hypotension 26
27 Alpha-blocker interactions In the USA, vardenafil is absolutely contraindicated with alpha-blocker 27
28 Alpha-blocker interactions Tadalafil is contraindicated in patients taking alpha-blockers, except for tamsulosin, 0/4mg 28
29 Dosage adjustment Lower doses Ketoconazole, itraconazole, erythromycine, clarythromycin increase blood levels of PDE5 inhibitors so that lower doses of PDE5 inhibitors are necessary. 29
30 Dosage adjustment higher doses Rifampin, phenobarbital, phenytoin and carbamazepine enhance the breakdown of PDE5 inhibitors so that higher doses of PDE5 inhibitors are required 30
31 Dosage adjustment Severe kidney or hepatic dysfunction may require dose adjustments or warnings 31
32 Ways of improving efficacy 1- Medication of associated risk factors. 2- Treatment of associated hypogonadisem. 3- Changing to another PDE5 inhibitor. 4- Continuous use daily of a PDE5 inhibitor. 32
33 Non-responders to PDE5 inhibitors Reasons 1- Incorrect drug use= the main reason is inadequate counseling from his physician. 2- Inefficacy of the drug 33
34 Management of non-responders to PDE5 inhibitors Check by physician Using a licensed medication (black market) The main ways in which a drug may be incorrectly used are: - Failure to use adequate sexual stimulation - Failure to use an adequate dose - Failure to wait an adequate amount of time between taking the medication and attempting sexual intercourse 34
35 PDE5 inhibitors Time between taking and intercourse All three drugs have an onset of action in some patients within 30 min of oral ingestion, most patients require a longer time with at least: 60 min for sildenafil and vardenafil 2h for tadalafil 35
36 PDE5 inhibitors food and delay of absorption Sildenafil = Heavy meal Vardenafil = Fatty meal Tadalafil = Is less affected 36
37 Side effects of PDE5 inhibitors Flushing and headache (mild to moderate in severity) Myalgia, back pain, leg pain, vision disturbances 37
38 ED and dyslipedemia In hypercholesteromic men with erectile dysfunction not initially responsive to sildenafil sildenafil Atorvastatine improves the response to LDL > 120 mg/100cc 40 mg atorvastatin 100 mg On-demand sildenafil for 12 weeks. 27 Nov
39 Treatment of ED First-line therapy Apomorphine sublingual is a centrally acting dopamine agonist Enhancing the natural central erectile signals that occur during sexual stimulation improve erectile erection 39
40 Apomorphine Has been approved in several countries but not in the USA 40
41 Apomorphine Dose = 2 or 3 mg sublingually Efficacy rate = 28.5% to 55%. Due to rapid absorption, 71% of erections are achieved within 20 min 41
42 Apomorphine Most common adverse effects Nausea 7% Headache 6.8% Dizziness 4.4% Are generally mild in nature and self-limited. Severe events such as syncope, are extremely rare = < 0.2% 42
43 Apomorphine Apomorphine is not contraindicated in patients that taking nitrates or antihypertensive drugs (of all classes) and is a first-line treatment in patients, who use nitrates. Does not effect on vital signs. 43
44 Apomorphine It is use is limited to patients with mild to moderate ED or psychogenic causes of sexual dysfunction due to reduce efficacy rates. 44
45 Treatment of ED Other oral treatment Yohimbine and Trazodone Randomized trials have shown that yohimbine and trazodone have a similar efficacy to placebo in patients with organic causes of ED. 45
46 Other oral agents Red korea ginseng Is a formulation with an unknown mechanism of action (though it may possibly act as a nitric oxide donor) Efficacy data on red korea ginseng suggested it might have a role in treatment of ED 46
47 Other oral agents Phentolamine Oral formulation of phentolamine (non selective alpha-adrenergic antagonist) had efficacy rates (erections sufficient for intercourse) of about 50%, but possible carcinogenesis in animal models stopped further development. 47
48 Other oral agents l-argenine is a nitric oxide donor Nalmefene / naltrexone is an opioid-receptor antagonist Limaprost is an alprostadil derivative for oral use There are no efficacy data on these drugs 48
49 Treatment of ED First-line therapy Topical pharmacotherapy No topical therapy has been approved and currently these agents have no role in treatment of ED. 49
50 Treatment of ED First-line therapy Vacuum therapy More acceptable to older patients with infrequent sexual intercourses Efficacy is as high as 90% Satisfactory rate range = 27% and 94% Long-term use decreases to 50% - 64% after 2 years Most men who discontinue use of VCDs do so within 3 months 50
51 Vacuum therapy The commonest adverse events Occur in less than 30% of patients: Penis pain, petechiae, bruising, numbness, inability to ejaculate, and delayed ejaculation 51
52 Treatment of ED Second-line therapy 1. Intracavernous injections - Monotherapy Alprostadil PGE 1 - Combination therapy: * Papaverine + Phentolamine * Papaverine + Phentolamine + PGE 1 2. Intraurethral alprostadil PGE 1 52
53 Treatment of ED Second-line monotherapy therapy Alprostadil PGE1 Is the first and only approved for intracavernous ED treatment in general ED papulation and patients subgroups diabetes, cardiovascular disease. 53
54 Alprostadil Efficacy rate > 70 % Satisfaction rate = 87% % in patients and 86% -90.3% in partners Doses : 5-4µg and erection appears after 5-15 min Drop-out rate : 41% - 68% particularly within the first 2-3 months 54
55 Alprostadil Complications: * Pain 50% after 11% of injections * Prolonged erection 5% * Priapism 1% * Fibrosis 2% * Hypotension is uncommon 55
56 Alprostadil Contraindications History of hypersensitivity to alprostadil Men at risk of priapism Men with bleeding disorders 56
57 Intracavernous injections Combination therapy 1) Papaverine mg + Phentolamine mg 2) Papaverine 8-16mg + Phentolamine mg+ Alprostadil 10-20µg Penile pain due to decrease of dose of Alprostadil and fibrosis for Phentolamine and mild hepatotoxicity with Papaverine 57
58 Intracavernous injections Combination therapy Efficacy rate = 92% If not respond to combination therapy sildenafil + triple combination regimen 58
59 Treatment of ED Second-line therapy Intraurethral alprostadil µg in a medicated pellet Erection sufficient for intercourse = 30% % Adverse events: * Local pain 29% - 41% * Dizziness 1.9% - 14% * Penile fibrosis and priapism < 1% * Urethral bleeding 5% * Urinary tract infections 0.2% 59
60 Third-line therapy Penile prothesis Do not respond to pharmacotherapy Who prefer a permanent solution to their problem Malleable (semi-rigid) and inflatable: - Two piece - Three piece 60
61 Penile prothesis Complications Mechanical failures < 5% at 5 years fallow up Infection = 2-3% but with antibiotic -impregnated prothesis or hydrophilic coated prothesis = 1% In spinal cord injuries : infection and erosions = 9% 61
62 when infection occurred: 1) Removed the prothesis, antibiotic administration and re-implantation after 6-12 months. 2) Removed and re-implantation at the same time, after copious irrigation of the corpora with multi-drug solutions, had an 82% success rate. 62
63 63
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