DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20182093

A comparative study of efficacy of tadalafil and alfuzosin regimens in patients of benign prostate hyperplasia

Supratik Das, Harjinder Singh, Vijay Kumar, Jasbir Singh

Abstract


Background: Aim of the study was to compare efficacy of Tadalafil and Alfuzosin regimens in patients of Benign Prostate Hyperplasia.

Methods: It was a comparative, prospective, observational, non-invasive, parallel and randomised study conducted at the Outpatient Department of Urology, Rajindra Hospital, Patiala. 60 patients diagnosed with Benign Prostate Hyperplasia along with Lower Urinary Tract Symptoms, out which, 30 patients, consuming Tadalafil and 30 patients consuming Alfuzosin were considered. History regarding the concerned disease and the compliance of treatment was taken. Symptom scores were assessed with the help of International Prostate Symptom Score, Quality of Lifestyle Score and Erectile Dysfunction Score. Physical examination consisting of Focused Neurological Examination along with Digital Rectal Examination were conducted. Parameters like Renal Function Test, Urine analysis, Ultrasound of Prostate and uroflowmetry were also considered.

Results: The mean age selected for study was 64 years for Tadalafil and Alfuzosin group. The mean level of IPS Score, Qol Score and ED Score at the first day of inclusion of patients were 23.96±4.49, 4±0.78, and 25.33±4.02 respectively for Tadalafil group and regarding Alfuzosin group they were 25.23±4.84, 3.56±0.81, and 26.1±4.04 respectively. Follow ups were conducted at 15 days, 1 month and 3 months for both the groups which were found to be statistically significant after 3 months and Alfuzosin showed a favourable result.

Conclusions: Alfuzosin 10mg given at daily dose was found to have higher efficacy than Tadalafil (5mg).


Keywords


Alfuzosin, Alpha blockers, Benign prostate hyperplasia, Erectile dysfunction, International Prostate Symptom Score, Phosphodiesterase inhibitors, Tadalafil

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References


Chan SWH. Pathology and Medical Therapy of Benign Prostatic Hyperplasia. The Hong Kong Medical Diary. 2011;16(6):4-8.

Robertson C, Link C, Onel E, Mazzetta C, Keech M, Hobbs R, et al. The impact of lower urinary tract symptoms and comorbidities on quality of life: the BACH and UREPIK studies. BJU Int. 2007;99:347-54.

Rosen R, Altwein J, Boyle P, Kirby R, Lukacs B, Meuleman E, et al. Lower urinary tract symptoms and male sexual dysfunction: The Multinational Survey of the Aging Male (MSAM-7). Eur Urol. 2003;44:637-49.

Auffenberg GB, Helfand BT, McVary KT. Established medical therapy for benign prostatic hyperplasia. Urol Clin North Am. 2009;36:443-59.

Lee C, Kozlowski JM, Grayhack JT. Intrinsic and extrinsic factors controlling benign prostatic growth. Prostate. 1997; 31:131-8.

McNeal JE. Origin and evolution of bening prostatic enlargement. Invest Urol. 1978;15:340.

Price H, McNeal JE, Stamey TA. Evolving patterns of tissue composition in benign prostatic hyperplasia asa a function of specimen size. Human Pathology. 1990;21:578-85.

Lee KL, Peehl DM. Molecular and cellular pathogenesis of benign prostatic hyperplasia. J of Urol. 2004;172:1784-91.

Ishigooka M, Hayami S, Hashimoto T, Suzuki Y, Katoh T, Nakada T. Relative and total volume of histological components in benign prostatic hyperplasia: relationships between histological components and clinical findings. The Prostate. 1996 Aug;29(2):77-82.

Claus S, Berges R, Senge T, Schulze H. Cell kinetic in epithelium and stroma of benign prostatic hyperplasia. The Journal of urology. 1997 Jul 1;158(1):217-21.

Lin VK, Wang D, Lee IL. Myosin heavy chain gene expression in normal and hyperplastic human prostate tissue. Prostate. 2000;44:193-203.

Thomphson TC, Yang G. Regulation of apoptosis in prostatic disease. Prostate Suppl. 2000;9:25-8.

Kyprianuou N, Tu H, Jacobs SC. Apoptotic versus proliferative activities in human benign prostatic hyperplasia. Hum Pathol. 1996;27:668-75.

Siiteri PK, Wilson JD, Dihydrotestosterone in prostatic hypertrophy. I. The formation and content of dihydrotestosterone in the hypertrophic prostate of man. J Clin Invest. 1970;49:1737-45.

Geller J, Albert J, Lopez D. Comparison of androgen metabolites in benign prostatic hypertrophy (BPH) and normal prostate. J Clin Endocrinol Metab. 1976;43:686-8.

O’Malley KJ, Dhir R, Nelson JB. The expression of androgen-responsive gene is up-regulated in the epidthelia of benign prostatic hyperplasia. Prostate. 2009;69:1716-23.

Nickel JC, Roehrborn CG, O’Leary MP. Examination of the relationship between symptoms of prostatitis and histological inflammation: baseline data from the REDUCE chemoprevention trial. J Urol. 2007;178:896-900.

Kramer G, Mitteregger M. Is benign prostatic hyperplasia (BPH) an immune inflammatory disease? Eur Urol. 2007;51:1202-16.

Balkau B, Charles MA. Comment on the provisional report from the WHO consultation. European Group for the Study of Insulin Resistance (EGIR). Diabetes Me. 1999;16:442-3.

Neal DE, Ramsden PD, Sharples L. Outcome of elective prostatectomy. BMJ. 1989;299:762-7.

Caine M, Raz S, Ziegler M. Adrenergic and cholinergic receptors in the human prostate, prostatic capsule and bladder neck. Br J Urol. 1975;27:193-202.

McConnell JD, Roehrborn CG, Bautista OM, Andriole Jr GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. New England Journal of Medicine. 2003 Dec 18;349(25):2387-98.

Roni MA, Kibria G, Jalil R. Formulation and in vitro Evaluation of Alfuzosin Extended Release Tablets Using Directly Compressible Eudragit. Indian J. Pharm. Sci. 2009;71(3):252-8.

Hatzimouratidis K. A review of the use of tadalafil in the treatment of benign prostatic hyperplasia in men with and without erectile dysfunction. Ther Adv Urol. 2014;6(4):135-47.

Sharma HL, Sharma KK. Principles of Pharmacology: Vasoactive Peptides and Nitric Oxide. 2nd ed. Hyderabad: Paras Medical Publisher; 2013.

Sharma HL, Sharma KK. Principles of Pharmacology: Androgens and Drug Treatment of Erectile Dysfunction. 2nd ed. Hyderabad: Paras Medical Publisher; 2013.

Sharma HL, Sharma KK. Principles of Pharmacology: Drugs acting on smooth muscles. 2nd ed. Hyderabad: Paras Medical Publisher; 2013.

Sharma HL, Sharma KK. Principles of Pharmacology: Drugs acting on sympathetic nervous system. 2nd ed. Hyderabad: Paras Medical Publisher; 2013.

Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with Tadalafil or Tamsulosin Similarly Improved Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in an International, Randomised, Parallel, Placebo-Controlled Clinical Trial. European Association of Urology. 2012;61:917-25.

Porst H, Roehrborn C, Secrest R, Esler A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. J Sex Med. 2013;10:2044-52.

Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang and Dale’s Pharmacology: Erectile Dysfunction. 7th ed. Livingstone: Churchill Elsevier; 2012.

Moffat AC, Osselton MD, Widdop B, Watts J, Eds., Clarke’s Analysis of Drugs and Poisons, Pharmaceutical Press, London, UK.

Asseldonk BV, Barkin J, Elterman DS. Medical therapy for Benign Prostatic Hyperplasia: a review. Can J Urol. 2015;22(1):7-17.

Product monograph including patient medication information. 2017;11:1-42.

Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang and Dale’s Pharmacolgy: Effects of Nitric Oxide. 7th ed. Livingstone: Churchill Elsevier; 2012.

Rosselli M, Keller PJ, Dubey RK. Role of nitric oxide in the biology, physiology and pathophysiology of reproduction. Human Reproduction Update. 1998;4(1):3-24.

Pawar DS, Kumar A, Singh SK, Singh R, Yadav L, Mittal S. Comparative Study of Tadalafil and Tamsulosin as Monotherapy for Lower Urinary Tract Symptoms Due to Benign Hyperplasia of Prostate. IOSR-JDMS. 2016;15(6):46-50.

Reddy SVK, Shaik AB. Combination of alfa blocker with low dose tadalafil in benign prostatic hyperplasia with erectile dysfunction management. International Journal of Medical Science and Clinical Invention. 2017;4(1):2581-7.

Kedia G, Uckert S, Kedia M, Kuczyk M. Effects of phosphodiesterase inhibitors on contraction induced by endothelin-1 of isolated human prostatic tissue. Urology. 2009;73:1397-401.

Kirby RS. The natural history of benign prostatic hyperplasia: what have we learned in the last decade? Urology. 2000;56(5):3-6.

Debruyne FMJ. Alpha blockers: are all created equal? Urology. 2000;56:20-2.