Table 1.
Condition | Pivotal trials supporting treatment efficacy* |
Relevant USA clinical practice guidelines that include drug treatments available during BACH baseline data collection (April 2002–June 2005)† |
---|---|---|
BPH | Doxazosin [7,8] | AUA guideline [10] ‘Alfuzosin, doxazosin, tamsulosin, and terazosin are appropriate treatment options for patients with LUTS secondary to BPH.’ |
Terazosin [9] | AUA guideline [10] | |
Alfuzosin [11,12] | AUA guideline [10] | |
Tamsulosin [13] | AUA guideline [10] | |
Prazosin [14,15] | AUA guideline [10] ‘Data are insufficient to support a recommendation for the use of prazosin…’ |
|
Dutasteride [16,17] | AUA guideline [10] | |
‘The 5α-reductase inhibitors finasteride and dutasteride are appropriate and effective treatments for patients with LUTS associated with demonstrable prostatic enlargement.’ |
||
Finasteride [18,19] | AUA guideline [10] | |
ED | Sildenafil [20] | AUA guideline [21]. ‘Oral PDE 5 inhibitors, unless contraindicated, should be offered as a first-line of therapy for erectile dysfunction (based on review of data and Panel consensus).’ |
Vardenafil [22] | AUA guideline [21] | |
Tadalafil [23] | AUA guideline [21] | |
Alprostadil [24–26], | ||
papaverine | AUA guideline [21] ‘Recommendation: Patients who have failed a trial with PDE5 inhibitor therapy should be informed of the benefits and risks of other therapies, including the use of a different PDE5 inhibitor, alprostadil intraurethral suppositories, intracavernous drug injection, vacuum constriction devices, and penile prostheses (based on Panel consensus).’ |
|
OAB | Oxybutynin [27,28] | No clinical guidelines found for data collection period. |
Tolterodine tartrate [27,28] | No clinical guidelines found for data collection period. | |
UI | Oxybutynin [29] | Agency for Health Care Policy and Research [30]‡ ‘Anticholinergic agents are the first-line pharmacologic therapy for patients with detrusor instability (DI)’ |
Propantheline bromide [31] | Agency for Health Care Policy and Research [30]; ‘Propantheline is the second- line anticholinergic agent in the treatment of patients with DI who can tolerate the full dosage.’ |
|
Hyoscyamine sulphate | Agency for Health Care Policy and Research [30]; ‘Hyoscyamine and other oral anticholinergics are known to be used in clinical practice in the treatment of DI; however, no scientific literature that met the panel’s criteria addressed the use of these agents for patients with UI. The panel therefore is not making recommendations regarding these drugs.’ |
|
Flavoxate hydrochloride | Agency for Health Care Policy and Research [30]; Trials summarized; ‘Flavoxate is not recommended for the treatment of patients with DI.’ |
|
PBlS/IC | Pentosan polysulphate [32] | No guidelines from medical organizations found. Drug reviewed in [33]§ |
Amitriptyline [34] | Drug reviewed in [33] |
Trials listed are cited in review papers as pivotal and/or that the Food and Drug Administration (FDA) used for basis of approval. Trials were not found for all drugs. Some UI/OAB treatments used currently were FDA-approved during or after the baseline BACH data collection period and thus are not included above (solifenacin succinate; trospium chloride, darifenacin).
Treatment guidelines cited are specific to the USA and published before or during the baseline BACH data collection period, and might not reflect current treatment guidelines or practices. The recommendations without the supporting text have been excerpted from the guideline. For full context, please refer to the original guideline document.
Other medications listed in this guideline were considered nonspecific for UI and were not included in our treatment estimate (e.g. calcium-channel blockers, NSAIDS) or no BACH participants used them (dicyclomine hydrochloride).
Other medications listed in this guideline were considered nonspecific for PBlS (e.g. corticosteroids) and were not included in our treatment estimate.