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Treatment of Erectile Dysfunction. Gregory Harochaw Robin Coulter Tache Pharmacy 400 Tache Avenue Winnipeg, MB R2H 3C3 Phone: (204) 233-3469. What is Erectile Dysfunction?. The persistent or recurrent inability to obtain or maintain an erection sufficient for sexual activity 1
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Treatment of Erectile Dysfunction Gregory Harochaw Robin Coulter Tache Pharmacy 400 Tache Avenue Winnipeg, MB R2H 3C3 Phone: (204) 233-3469
What is Erectile Dysfunction? • The persistent or recurrent inability to obtain or maintain an erection sufficient for sexual activity1 • > 50% of men aged 40 – 70 will have fairly marked erectile problems2,3 • Incidence is on the rise due to aging population & and prevalence of conditions that are the root of the problem (i.e. diabetes, cardiovascular disease)2 • Hatzimouratidis K, and Hatzichristou D. Sexual dysfunctions: Classifications and definitions. Journal of Sexual Medicine 2007;4:241-250. • Fazio L, Brock G. Erectile dysfunction: management update. CMAJ 2004;170(9):1429-1437 • Feldman HA, Goldstein I, Hatzichristou D, et al. Impotence and its medical and psychosocialcorrelates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61
Men With ED • ED can have a major impact on the quality of life and self-esteem of men who suffer from it • Men often draw a link between their masculinity and their ability to have an erection • Some men with ED may begin to think that they are no longer a “real” man • This can lead also to affected relationships with partners
Pathophysiology: Mechanism of an erection • A normal erection relies on the coordination: • Vascular • Neurological • Hormonal • Psychological • An erection can occur following direct genital stimulation or auditory or visual stimulation, aspects that contribute to the influx of blood to the penis
Pathophysiology: Mechanism of an erection • An erection occurs when the amount of blood rushing to the penis is greater than the amount of blood flowing from it • A massive influx of blood accumulates in the sinusoidal spaces due to relaxation of smooth muscle & dilatation of arteries corpora cavernosa to swell (tumescence) • Tumescence compresses the veins that normally drain the penis prevents blood outflow & maintains penile rigidity
Pathophysiology: Mechanism of an erection • Usually following ejaculation: • A reduction in arterial inflow due to contraction of the smooth muscle cells • Combination of increased venous return • loss of erection (detumescence)
Erectile Dysfunction • ED is most often an organic origin (up to 80%) • Can also have psychogenic causes • In several cases, it is both organic/psychogenic in origin mixed-type ED Anatomy and physiology of erection: pathophysiology of erectile dysfunction. Int J Impot Res 2003;15 Suppl 7:S5-S8.
Main Organic Causes • Vascular • Roughly 40% of cases of ED in men over 50 • Vascular problems can impede arterial blood flow into the penis • Examples: diabetes, cardiovascular disease (hypertension ,dyslipidemia), Peyronie’s disease, smoking, and trauma affecting blood circulation Feldman HA, Goldstein I, Hatzichristou D, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61
Main Organic Causes • Neurological conditions • Can lead to interruption in nerve impulse transmission or the failure to conduct nerve impulses • Examples: diabetic or alcoholic neuropathy, MS, stroke, trauma or surgical procedures involving the spinal cord or pelvis Brock G. Issues in the assessment and treatment of erectile dysfunction: Individualizing and optimizing treatment for the “silent majority”. www.medscape.com/viewprogram/1826 Accessed January 20, 2009
Main Organic Causes • Hormone disorders • ED that is hormonal in origin can be related to low circulation blood levels of testosterone (hypogonadism), hyperprolactinemia (drug-related or non-drug related), hypothyroidism, adrenal insufficiency or glucocorticoid excess Brock G. Issues in the assessment and treatment of erectile dysfunction: Individualizing and optimizing treatment for the “silent majority”. www.medscape.com/viewprogram/1826 Accessed January 20, 2009
Psychogenic Origin • Can be cause by: • Anxiety • Depression or psychosis • Possibly with a loss of self-esteem • If causes of erectile dysfunction are completely psychological, the patient will continue to have nocturnal erections • Men with psychogenic ED often lose interest in sex Anatomy and physiology of erection: pathophysiology of erectile dysfunction. Int J Impot Res 2003;15 Suppl 7:S5-S8.
Risk Factors1,2,3 • Aging • Diabetes (vascular or neurological problems) • Cardiovascular disease (vascular issues) • Stress, anxiety & depression (low libido or self-esteem) • Medications or illicit substances • Prostatectomy (neurological problems) • Smoking (exacerbates vascular problem) • Hatzimouratidis K, and Hatzichristou D. Sexual dysfunctions: Classifications and definitions. Journal of Sexual Medicine 2007;4:241-250. • Fazio L, Brock G. Erectile dysfunction: management update. CMAJ 2004;170(9):1429-1437 • Feldman HA, Goldstein I, Hatzichristou D, et al. Impotence and its medical and psychosocialcorrelates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61
Diabetes ED • About 35 – 75% of men with diabetes will experience at least some degree of ED (impotence) during their lifetime • Men with diabetes develop ED 10 – 15 years earlier than men without diabetes • Often 1st symptom men notice even before they are diagnosed as a diabetic • Above age of 50, the likelihood of having difficulties with an erection occurs in approximately 50 – 60% of men • Above the age of 70, there is a 95% likelihood of having some difficulty with erection function www.WebMD.com
Diabetes ED • To get an erection, men need healthy: • Blood vessels • Nerves • Muscle function • Desire to be sexually stimulated • Elevated blood glucose levels can cause damage to blood vessels & nerves to the penis • Men with coronary artery disease (CAD) & diabetes will be 9 times more likely to develop ED than men with just diabetes www.diabetes..about.com
Diabetes ED • Longer a man has diabetes with poor blood glucose levels, complications of accompanying heart disease such as high blood pressure & high cholesterol can also affect ED • Diabetic men who smoke also have increased risk of developing ED www.diabetes..about.com
Drug-induced male sexual dysfunction.Pharmacist’s Letter/Prescriber’s Letter 2006; 22(9):220907.
Treatment Options • PDE5 Inhibitors • Sildenafil - Viagra® • Varedenafil - Levitra® • Tadalafil - Cialis® • Intraurethral suppositories • Alprostadil - MUSE® • Intraurethal gel • Penile injections • Vacuum devices
Intraurethral Suppository • MUSE® • 250ug, 500ug, 1000ug • Medicated Urethral System for Erection • A choice for people: • Who do not respond to oral pills • Are afraid of injections • Suppository (about the size of a grain of rice) which is placed about 1” inside the urethra using a special applicator
Advantages with MUSE® • Fool proof and low incidence of SE’s • Gives an erection similar to penile injection therapy • Gives the most normal looking erection. The head of the penis doesn’t swell in penile injections/PDE5 inhibitors but does with MUSE®
Disadvantages with MUSE® • 50 – 75% of men don’t respond well • 50- 60% of men don’t respond consistently • May get good erection one time but not the next • May develop a lack of confidence because 1 out of every 2 or 3 uses doesn’t work well • 2% of men may have dizziness on 1st administration with 1000µg strength. May need to do the 1st dose in the Dr’s office • Not with 250µg or 500µg dose
Intraurethal Gels • Fool proof and low incidence of SE’s • Gives an erection similar to penile injection therapy • Possibly stronger than using MUSE® • Must be kept in the fridge and has a 30 day expiry date
Intraurethral Gels • Many combinations • Dispense in 0.2ml single use syringes • Expiry date 30 days • Dose 0.2 intraurethrally 10 – 15 minutes prior to sexual intercourse • Hold penis upright for 30 seconds to allow medication to absorb • Rub any excess cream over the forehead of the penis
Penile Injections • Intracavernosal injection therapy • Very safe & highly effective • Around since 1983. • In 1982, a French surgeon injected a vasodilator into the pelvic artery & the patient obtained an erection • Shortly after, a British physician injected a drug directly into the penis
Caverject • Alprostadil 20µg/0.5ml • Prefilled syringe • Dosage range 5 – 20µg • Works in 60% with all men with ED • Will work better with milder erection problems • Can cause an aching or burning penile pain in some men with cavernous nerve injury
Penile Injections • Alprostadil • Prostaglandin E -1 cAMP • Vasodilator & muscle relaxant of corpus cavernosum & trabecular smooth muscle • Papaverine • Inhibits phosphodiesterase in smooth muscle cells, which cAMP & cGMP relaxation of vascular smooth muscles • Phentolamine • Blocks -adrenergic receptors in penile blood vessels relaxation of trabecular cavernous smooth muscles & dilatation of the penile arteries • Weak erectile-promoting effect when used alone. • Potentiates the effect of papaverine or PGE-1 • Atropine • Smooth muscle relaxation • Chlorpromazine • blocker activity • 1:1 mg interchangeability with phentolamine
Penile Injections • Products require refrigeration • Caverject® is kept at room temperature • After 18 months of radical prostatectomy more than 70% of people will the dose of their injection • Duration of injection will be a sign for this i.e. 30 minutes 45 minutes 60 minutes
Price Comparison Prices January 2013
BD Inject-Ease Will inject needle into the skin but you still need to push the plunger to dispense injection $45.00
Autoject 2 Does a complete injection $69.95
Vacuum Devices • Have been used for more than a century • 1874 by Dr. John King • 1917 Dr. Otto Lederer developed constriction rings for maintenance of erections • 1960’s Geddings Osborn developed his version of vacuum device • 1974 Osborn’s product became commercially available • 1976 FDA withdrew it’s approval • 1982 FDA reapproved product
Vacuum Devices • Erect penis (especially Caucasian) appears blue or grey • 50% of blood from arteries oxygenated • 50% of blood from veins non-oxygenated • Arterial blood is warmer than venous blood • Penis may not be as warm (1º-2º F lower) • Most common complaint of partners • Touch penis • Upon penetration
Vacuum Devices • Takes 2-10 minutes to obtain a functional erection • Take on average 4 attempts to use pumps to become proficient • Need to place constriction ring as close as possible to base of penis. Penis will be hard on one side of ring and soft on the other side • Only wear for maximum 30 minutes
Vacuum Pumps • 80-90%of men can obtain an erection • Overall patient satisfaction 60-80% • In order to achieve enough pressure in the vacuum device, gel will have to be applied to the open end of the device • Some men will also have to trim the pubic hair to maximize seal
Vacuum Devices • Certain groups of men should avoid using these devices • Blood thinners or history of bleeding disorders • Coumadin® - Warfarin • Plavix® - Clopidogrel • Diminshed penile sensation • Spinal cord injury • Significant penile curvature • History of priapism Not ASA 81mg
Automatic $495.00 OsbonErecaid Classic OTC $395.00 5 Year Warranty 30 day Warranty
Vacuum Devices • Bonro Medical • Vacurect® Retails $195.00
Beige = Regular fit OsbonErecaidConstriction Rings Pink = firm fit Each colour comes in 2 sizes small and large
Actis Adjustable constriction loop
Peenuts® • Acronym for “Power to Empty Every time while Never Urinating Too Soon” • Contains: • Vitamin C, E, B6, Selenium, Zinc, Echinacea, Glycine, Alanine, Glutamic Acid, Saw Palmetto (Beta-Sitosterol), Pygrum, Pumpkin Seed, Nettle, Garlic & Ginkgo Biloba • Antioxidants, antiinflammatories, beta-sitosterol& immune boosters • EPS & WBC & improved PSA
Neo 40 Daily • ED is may be an early warning sign of CVD • 80% of men who had ED in beginning of a study were more likely to develop CVD by the end of the 10 year study • Neo40 Daily helps restore nitric oxide (NO) levels • Safer and more effective than L-arginine