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Nova Southeastern University

2024

Frances M. Colón Pratts

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benign prostatic hyperplasia integrated disease management pharmacotherapy

Summary

This document provides an overview of benign prostatic hyperplasia (BPH), including lecture objectives, introduction, signs and symptoms, evaluation and assessment, complications, goals of therapy, and management strategies. It also discusses various treatment options, including pharmacological strategies like alpha-adrenergic antagonists, 5 Alpha reductase inhibitors (5ARIs), and phosphodiesterase 5 inhibitors (PDE5Is), and non-pharmacological alternatives, as well as important points to consider.

Full Transcript

Benign Prostatic Hyperplasia Integrated Disease Management I Winter 2024 Frances M. Colón Pratts; Pharm D. CDCES Clinical Assistant Professor Pharmacy Practice Department NOVA Southeastern University College of Pharmacy- Puerto Rico [email protected] Lecture Objectives After the lecture, the student sh...

Benign Prostatic Hyperplasia Integrated Disease Management I Winter 2024 Frances M. Colón Pratts; Pharm D. CDCES Clinical Assistant Professor Pharmacy Practice Department NOVA Southeastern University College of Pharmacy- Puerto Rico [email protected] Lecture Objectives After the lecture, the student should be able to: Recognize the signs and symptoms related to BPH. Mention drugs that may exacerbate symptoms related to BPH. Recommend appropriate therapy for BPH based on patient specific characteristics. Design an appropriate pharmacotherapy plan based on patient-specific characteristics, ensuring indication, efficacy, safety, and convenience, thus preventing or managing drugrelated problems. Appropriately counsel a patient regarding medication and nonpharmacological therapies for the management of BPH. Introduction  Benign prostatic hyperplasia (BPH)  Common urologic condition in aging men  Can be a progressive condition: Producing and worsening lower urinary tract signs and symptoms (LUTS) Impacting in a negative manner the quality of life (QOL) of the patient Developing complications  Characterized by a non-malignant growth of some components of the prostate Signs and Symptoms Obstructive/Voiding Symptoms: Early in the disease course Hesitancy Weak stream Sensation of incomplete emptying Straining Dribbling Intermittent flow Irritative/ Storage Symptoms: Occurs after several years of untreated BPH Dysuria Urinary Frequency Nocturia Urgency Urinary Incontinence (UI) Evaluation/ Assessment  Patient perception of the severity (bothersome) of symptoms.  American Urological Association Symptom Scoring Index (AUA-SI) Validated tool that quantifies patient 7 subjective symptoms severity on a scale from 0 to 5. The resultant score can help guide the need for intervention Evaluate baseline symptoms and monitoring the evolution and treatment of BPH. Changes in AUA-SI of ≥ 3 points considered clinically significant http://www.urologymatch.com/book/export/html/86 Complications  Decrease quality of life (QOL)  Recurrent urinary tract infections (UTIs)  Bladder stones or calculi  Renal impairment  Acute urinary retention (AUR)  Inability to void resulting in painful dilation of the bladder and/or lower abdominal discomfort  Urinary incontinence (UI)  Hematuria  Surgery Goals of Therapy  Goals of Therapy:  Reduce bothersome LUTS (lower urinary tract symptoms)  Prevention of disease progression  Prevention of complications  Decreasing the need for surgery  Minimizing adverse drug effects  Improving QOL BPH Management  Patients are classified into 3 groups based on bothersome symptoms and/or severity, to assist deciding treatment approach. Severity Mild AUA –SI Score ≤7 Moderate 8-19 Severe ≥20 Usual Symptoms and Signs (s/s) Asymptomatic or mildly symptomatic All the above s/s plus obstructive voiding symptoms and irritative voiding symptoms All the above plus one or more complications of BPH Lee M. Chapter 93. BPH. In: DiPiro JT, et al. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: McGraw-Hill; 2011. Management Strategies Watchful Waiting Pharmacotherapy Surgery No pharmacological or surgical management is implemented but, the patient s/s are monitored. Alpha Adrenergic Antagonist 5 Alpha Reductase Inhibitors (5ARIs) Phosphodiesterase 5 Inhibitors (PDE5I) Antimuscarinics or B3 agonist for those experiencing irritative symptoms. Recommended: When complications are present In moderate to severe s/s of BPH in patients who don’t respond to or don’t tolerate drug therapy Non-Pharmacological Alternatives  Lifestyle Modification (always) Limit fluid intake close to bedtime Minimize caffeine and alcohol intake Educate patient to take time to empty their bladder completely and often Avoid medications that can exacerbate symptoms Avoiding medications that can exacerbate BPH symptoms  Avoid or modifying drug therapy that can exacerbate BPH may offer some relief or prevent BPH symptoms.  Assess Medications that the patient is using:  Anticholinergics→ ↓ detrusor bladder muscle contractibility→ ↓ ability of bladder to contract and to force urine out→ urinary retention Antihistamines Diphenhydramine and chlorpheniramine Tricyclic antidepressants (TCAs) May be used in those patients with BPH and irritative symptoms. To minimize the risk of acute urinary retention, should be used with caution if postvoid residual urine volume (PVR) is > 100 to 150 mL Urinary Anticholinergics: oxybutinin, solifenacin, darifenacin, trospium chloride, and tolterodine Avoiding medications that can exacerbate BPH symptoms  Medication History:  α1 adrenergic agonist (e.g., decongestants-pseudoephedrine) → stimulating α1 adrenergic receptors in prostate and urethra → increasing obstruction and urine retention  Diuretics→ increase urinary frequency  Testosterone→ can stimulate prostate growth Management Alternatives  Watchful Waiting (or active surveillance)  Recommended for patients with mild symptoms of LUTS secondary to BPH (AUA-SI score 1.5ng/ml, according to AUA 2021). Predominantly used in combination with alpha blockers Could also be use alone in those who cannot tolerate side effects of alpha blockers  The onset of action is slow (e.g., 3 to 6 months), may take months to ↓prostate size. Maximal reductions in prostate volume or symptom improvement may not be evident for 12 months 5 Alpha Reductase Inhibitors (5ARIs)  Efficacy:  Efficacy appears to be greater in those with large prostates (e.g., > 30g or a PSA ≥ 1.4 ng/ml).  Dosing Information:  Finasteride: 5mg tablet daily  Dutasteride: 0.5mg capsule daily 5 Alpha Reductase Inhibitors (5ARIs)  Side Effect Profile:  Ejaculatory disorders (reduced semen during ejaculation or delayed ejaculation) Higher risk when compared with α adrenergic receptor antagonist  Decreases Libido(3 -8%)  Erectile Dysfunction (ED) (3-16%)  Gynecomastia and breast tenderness (1.0%)  Others: nausea, abdominal pain, flatulence, headache, muscle weakness, etc.  Counseling Points:  Pregnant females should be careful when handling these agents (pregnancy category X).  Take with or without food Question 4 Test your knowledge!  Which of the following patient is the best candidate for 5ARI? a) A 61-year-old male patient with a prostate size of 25g, who is not bothered by the mild LUTS s/s. b) A 75-year-old male patient with an AUA-SI score of 21, a prostate size of 25g, who expresses cannot tolerate the urine dribbling and the sensation of incomplete emptying. c) A 70-year-old male patient with a prostate size of 45g, an AUA-SI score of 18, who comes to his physician complaining of needing to push to initiate urination, urinary dribbling, and sensation of incomplete emptying after urination, and states this is impacting his quality of life negatively. Phosphodiesterase 5 Inhibitor (PDE5I)  Agents:  Tadalafil (Cialis®)- the only PDE5I approved by the FDA for BPH  General Information:  Could offer another alternative for the treatment of BPH, especially those patients with BPH and ED.  Tadalafil could be given with: α1 antagonist [usually uroselective agents (α1A adrenergic antagonist) to avoid risk of hypotension]. However, the AUA 2021 guidelines states this combination offers no advantages in symptom improvement over either agent alone. 5ARIs  MOA: Relax smooth muscle in the prostate, urethra and bladder neck Phosphodiesterase 5 Inhibitor (PDE5I)  Dosing: 5mg tablet daily  If patient is using strong CYP3A4 Inhibitors dose should be 2.5mg daily  If the CrCl is 30-50 ml/min, initiate with 2.5mg daily, max 5mg/day  If CrCl30g or PSA ≥1.4ng/ml), they have slower onset of action when compare with α1 adrenergic antagonist.  PDE5I could be consider in patients with BPH and ED. Selected References         Lee M, Sharifi R. Benign Prostatic Hyperplasia. In: DiPiro JT, Yee GC, Haines ST, Nolin TD, Ellingrod VL, Posey L. eds. DiPiro’s Pharmacotherapy: A Pathophysiologic Approach, 12th Edition. McGraw Hill; 2023. Accessed July 20, 2023. https://accesspharmacy-mhmedicalcom.ezproxylocal.library.nova.edu/content.aspx?bookid=3097&sectionid=268554059 Michelle Moseley, (2022), "Chapter 39: Men’s Health," The APhA Complete Review for Pharmacy, 13th Edition https://doi-org.ezproxylocal.library.nova.edu/10.21019/9781582123615.ch39 Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline part II, surgical evaluation and treatment. J Urol 2021; 206: 818. Benign Prostatic Hyperplasia. In: Schwinghammer TL, DiPiro JT, Ellingrod VL, DiPiro CV. eds. Pharmacotherapy Handbook, 11e. McGraw Hill; Accessed August 16, 2021. https://accesspharmacy-mhmedicalcom.ezproxylocal.library.nova.edu/content.aspx?bookid=3012&sectionid=253437590 Lee M, Sharifi R. Benign Prostatic Hyperplasia. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e. New York, NY: McGraw-Hill; 2016.http://accesspharmacy.mhmedical.com.ezproxylocal.library.nova.edu/content.aspx?bookid=1861&Sectionid=1 33892664. Accessed September 8, 2019. McVary KT, Roehrborn CG, Avins AL, et al. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010, reviewed and validity confirmed 2014. Esherick JS, Clark DS, Slater ED. Disease Management. In: Esherick JS, Clark DS, Slater ED. eds. CURRENT Practice Guidelines in Primary Care 2015. New York, NY: McGraw-Hill; 2015 Fode M, Sonksen J, Ohl DA, McPhee SJ. Chapter 23. Disorders of the Male Reproductive Tract. In: Fode M, Sonksen J, Ohl DA, McPhee SJ, eds. Pathophysiology of Disease: An Introduction to Clinical Medicine. 6th ed. New York: McGraw-Hill; 2010. http://www.accesspharmacy.com/content.aspx?aID=5372334. Accessed July 12, 2014.

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