Is low-dose tadalafil better than tamsulosin? A randomized controlled trial in shockwave lithotripsy for solitary upper tract calculi.
extracorporeal shockwave lithotripsy
medical expulsive treatment
tadalafil
tamsulosin
urolithiasis
Journal
BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
medline:
23
10
2023
pubmed:
2
5
2023
entrez:
2
5
2023
Statut:
ppublish
Résumé
To ascertain whether low-dose tadalafil (5 mg) is more efficient than tamsulosin (0.4 mg) in facilitating calculus expulsion in those receiving extracorporeal shockwave lithotripsy for solitary upper urinary tract calculi. This was a triple-blinded, prospective, superiority, randomized controlled, single-centre trial. A total of 250 patients with solitary renal or ureteric calculus measuring 6-24 mm were randomized (1:1) to receive either 0.4 mg tamsulosin or 5 mg tadalafil daily for 30 days or until calculus clearance, whichever was earlier. There was no difference in the primary outcome, namely, calculus expulsion rate at 30 days (tamsulosin vs tadalafil, n (%) 99 [81.1%] vs 98 [80.3%] respectively, 95% confidence interval = 0.8% [-9.0, 10.7], P = 0.874). Similarly, a lack of difference was also noted in the secondary outcome, number of days to expulsion (tamsulosin vs tadalafil, geometric mean [SD] 13.59 [2.39] vs 13.74 [2.39] respectively, P = 0.928). Four patients discontinued the drug due to adverse drug reactions in the tadalafil group. Low-dose tadalafil is not superior to tamsulosin in improving calculus expulsion when used as an adjunct to shockwave lithotripsy. In this study, we also noted that tadalafil was less tolerated.
Substances chimiques
Tamsulosin
G3P28OML5I
Tadalafil
742SXX0ICT
Sulfonamides
0
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
314-320Informations de copyright
© 2023 BJU International.
Références
Pickard R, Starr K, MacLennan G et al. Use of drug therapy in the management of symptomatic ureteric stones in hospitalised adults: a multicentre, placebo-controlled, randomised controlled trial and cost-effectiveness analysis of a calcium channel blocker (nifedipine) and an alpha-blocker (tamsulosin) (the SUSPEND trial). Health Technol Assess 2015; 19: vii-viii, 1-171
Li M, Wang Z, Yang J et al. Adjunctive medical therapy with α-blocker after extracorporeal shock wave lithotripsy of renal and ureteral stones: a meta-analysis. PLoS One 2015; 10: e0122497
Naja V, Agarwal MM, Mandal AK et al. Tamsulosin facilitates earlier clearance of stone fragments and reduces pain after shockwave lithotripsy for renal calculi: results from an open-label randomized study. Urology 2008; 72: 1006-11
Bhagat SK, Chacko NK, Kekre NS, Gopalakrishnan G, Antonisamy B, Devasia A. Is there a role for tamsulosin in shock wave lithotripsy for renal and ureteral calculi? J Urol 2007; 177: 2185-8
Chen K, Mi H, Xu G et al. The efficacy and safety of tamsulosin combined with extracorporeal shockwave lithotripsy for urolithiasis: a systematic review and meta-analysis of randomized controlled trials. J Endourol 2015; 29: 1166-76
Skolarikos A, Grivas N, Kallidonis P et al. The efficacy of medical expulsive therapy (MET) in improving stone-free rate and stone expulsion time, after extracorporeal shock wave lithotripsy (SWL) for upper urinary stones: a systematic review and meta-analysis. Urology 2015; 86: 1057-64
Professionals SO. EAU guidelines: urolithiasis [internet]. Uroweb. Available at: https://uroweb.org/guideline/urolithiasis/#3. Accessed July 2021
Gratzke C, Uckert S, Kedia G et al. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res 2007; 35: 49-54
Goyal SK, Singh V, Pandey H, Chhabra MK, Aggarwal SP, Bhat A. Comparative efficacy of tamsulosin versus tadalafil as medical expulsive therapy for distal ureteric stones. Urol Ann 2018; 10: 82-6
Rahman MJ, Faridi MS, Mibang N, Singh RS. Comparing tamsulosin, silodosin versus silodosin plus tadalafil as medical expulsive therapy for lower ureteric stones: a randomised trial. Arab J Urol 2018; 16: 245-9
Neeli S. Effect of tamsulosin versus tamsulosin plus tadalafil on renal calculus clearance after shock wave lithotripsy: an open-labelled, randomised, prospective study. Asian J Urol 2021; 8: 430-5
Montes Cardona CE, García-Perdomo HA. Efficacy of phosphodiesterase type 5 inhibitors for the treatment of distal ureteral calculi: a systematic review and meta-analysis. Investig Clin Urol 2017; 58: 82-9
Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology 2015; 85: 59-63
Çelik S, Akdeniz F, Afsar Yildirim M et al. Tadalafil versus alpha blockers (alfuzosin, doxazosin, tamsulosin and silodosin) as medical expulsive therapy for <10 mm distal and proximal ureteral stones. Arch Ital Urol Androl 2018; 90: 117-22
Washington SL, Shindel AW. A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy. Drug Des Devel Ther 2010; 4: 159-71
Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol 2008; 180: 1228-34
Pandey A, Aggarwal A, Maulik M, Gupta J, Juneja A. Challenges in administering a clinical trials registry: lessons from the clinical trials registry-India. Pharm Med 2013; 27: 83-93
Delvecchio FC, Preminger GM. Management of residual stones. Urol Clin North Am 2000; 27: 347-54
Coptcoat MJ, Webb DR, Keilet MJ, Whitfield HN, Wickham JEA. The steinstrasse: a legacy of extracorporeal lithotripsy? EUR 1988; 14: 93-5
World Health Organization. Quality Assurance and Safety of Medicines Team. Safety of medicines: a guide to detecting and reporting adverse drug reactions: why health professionals need to take action [Internet]. World Health Organization, 2002. Report No.: WHO/EDM/QSM/2002.2. Available at: https://apps.who.int/iris/handle/10665/67378. Accessed June 2022
Serious Adverse Event [Internet]. Available at: https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/SAE/. Accessed July 2021
Clayman RV, McClennan BL, Garvin TJ, Denstedt JD, Andriole GL. Lithostar: an electromagnetic, acoustic shock wave unit for extracorporeal lithotripsy. In Lingeman JE, Newman DM eds, Shock Wave Lithotripsy 2 [Internet]. Boston, MA: Springer US, 1989: 403-9
Puvvada S, Mylarappa P, Aggarwal K, Patil A, Joshi P, Desigowda R. Comparative efficacy of tadalafil versus tamsulosin as the medical expulsive therapy in lower ureteric stone: a prospective randomized trial. Cent Eur J Urol 2016; 69: 178-82
Nabi G, Baldo O, Cartledge J, Cross W, Joyce AD, Lloyd SN. The impact of the Dornier Compact Delta lithotriptor on the management of primary ureteric calculi. Eur Urol 2003; 44: 482-6
EAU-Guidelines-on-Urolithiasis_2017_10-05V2.pdf [Internet]. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-on-Urolithiasis_2017_10-05V2.pdf. Accessed July 2021
De Nunzio C, Brassetti A, Bellangino M et al. Tamsulosin or silodosin adjuvant treatment is ineffective in improving shockwave lithotripsy outcome: a short-term follow-up randomized, placebo-controlled study. J Endourol 2016; 30: 817-21