Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin
- 140 Downloads
Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life.
The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study.
Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants’ ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase).
Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the ‘Stop Use’ and ‘Directions’ instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported.
Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible.
The study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), Ridgefield, CT, USA. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors received no direct compensation related to the development of the manuscript. Writing, editorial support, and formatting assistance was provided by Michelle Rebello, Ph.D., and Maribeth Bogush, MCI, Ph.D., of Cactus Communications, which was contracted and compensated by BIPI for these services. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Compliance with Ethical Standards
The study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), Ridgefield, CT, USA.
Conflict of interest
CGR, FCL, and MG are consultants/advisors for Boehringer Ingelheim; JMW is an employee of Boehringer Ingelheim. AEV was an employee of Boehringer Ingelheim at the time of the study.
- 3.US Department of Health and Human Services. A profile of older Americans; Administration on Aging, Administration for Community Living. 2015. https://www.acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2015-Profile.pdf. Accessed 26 Mar 2018.
- 4.Williams TE Jr, Satiani B, Thomas A, Ellison EC. The impending shortage and the estimated cost of training the future surgical workforce. Ann Surg. 2009;250(4):590–7.Google Scholar
- 5.American Urological Association Guideline. Management of benign prostatic hyperplasia (BPH). 2010. https://www.auanet.org/education/guidelines/benign-prostatic-hyperplasia.cfm. Accessed 26 Mar 2018.
- 6.Gacci M, Corona G, Salvi M, Vignozzi L, McVary K, Kaplan SA, et al. A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with α-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol. 2012;61(5):994–1003.CrossRefGoogle Scholar
- 15.Jacobs LR. Prescription to over-the-counter drug reclassification. Am Fam Physician. 1998;57(9):2209–14.Google Scholar
- 16.Mansfield JE, Callahan D. Benefits of over-the-counter heartburn medication to consumers and the healthcare system. Nielsen Health. 2008. https://www.chpa.org/01_26_09_NielsenReportHeartburn.aspx. Accessed 26 Mar 2018.
- 21.Keehn A, Lowe FC. Complementary and alternative medications for benign prostatic hyperplasia. Can J Urol. 2015;22(Suppl 1):18–23.Google Scholar
- 22.U.S. Food and Drug Administration. Drug applications for over-the-counter (OTC) drugs. 2015. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/over-the-counterdrugs/default.htm. Accessed 26 Mar 2018.
- 23.U.S. Food and Drug Administration. Nonprescription Drug Advisory Committee Meeting. Executive summary. 2006. https://wayback.archive-it.org/7993/20170405064059/https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4230B1-01-Executive%20Summary.pdf
- 24.U.S. Food and Drug Administration. Regulatory approaches for prescription to OTC switch. 2015. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM454815.pdf. Accessed 26 Mar 2018.
- 25.U.S. Food and Drug Administration. Prescription to over-the-counter (OTC) switch list. 2017. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm. Accessed 26 Mar 2018.
- 28.Murphy PW, Davis TC, Long SW, Jackson RH, Decker BC. Rapid estimate of adult literacy in medicine (REALM): a quick reading test for patients. J Read. 1993;37(2):124–30.Google Scholar
- 30.Flomax [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc./Astellas Pharma; 2016.Google Scholar