Journal List > Korean J Urol > v.47(3) > 1069848

Yang and Kim: The Influence of Treatment-emergent Adverse Reactions on Selecting Phosphodiesterase Type 5 Inhibitors

Abstract

Purpose

This study was conducted to determine how treatment-emergent adverse reactions (ARs) of each of the phosphodiesterase type 5 inhibitors (PDE5Is) influenced the patient when selecting a drug.

Materials and Methods

For our study, we recruited a total of 123 patients who were suffering with erectile dysfunction and they randomly took 3 different PDE5Is (sildenafil, tadalnafil, and vardenafil), at least 4 times each and then had successful intercourse after using each PDE5I. We investigated the influence of the treatment-emergent ARs on the patients selecting a PDE5I.

Results

Sixty eight out of 123 patients (55.3%) showed more than one AR. Five patients (4.1%) did not select any of the PDE5Is due to their treatment-emergent ARs, and 15 patients (12.2%) did not select the PDE5Is due to the severity and/or duration of the AR. Facial flushing was the most common cause of non-selection; this was followed by headache. Fifteen patients (12.2%) selected one specific PDE5I because they experienced a less severe AR with that drug. The severity and duration of the ARs increased in the group of elderly men and the group of men who took larger doses of the drug.

Conclusions

ARs had an important effect on the patients' selection of a PDE5I, although the impact was quite low compared with its overall occurrence rate. The severity and/or duration of the AR were so variable, depending on the patient, that no PDE5I was better than the others in terms of attributing the selection of a PDE5I to its reduced AR.

Figures and Tables

Table 1
Treatment-emergent adverse reactions
kju-47-272-i001
Table 2
Severity and duration (minutes) of the adverse reactions that had an influenced on the selection of the PDE5I
kju-47-272-i002

+: mild, ++: moderate, +++: severe

Table 3-1
Severity of the treatment-emergent adverse reactions according to the drug dose
kju-47-272-i003

+: mild, ++: moderate, +++: severe, Group A: sildenafil 50mg, tadalafil 10mg, vardenafil 10mg, Group B: sildenafil 100mg, tadalafil 20mg, vardenafil 20mg

Table 3-2
Duration (minutes) of the treatment-emergent adverse reactions according to the drug dose
kju-47-272-i004

Group A: sildenafil 50mg, tadalafil 10mg, vardenafil 10mg, Group B: sildenafil 100mg, tadalafil 20mg, vardenafil 20mg, *: p<0.05

Table 4-1
Severity of the treatment-emergent adverse reactions according to the patient's age
kju-47-272-i005

+: mild, ++: moderate, +++: severe

Table 4-2
Duration (minutes) of the treatment-emergent adverse reactions according to the patient's age
kju-47-272-i006

*: p<0.05

References

1. Lee U, Lee MH, Kim SY, Ji YH, Hong JH, Ahn TY. Clinical efficacy and safety of sildenafil in the men with erectile dysfunction in Korea. Korean J Urol. 2001. 42:435–440.
2. Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res. 1998. 10:69–73.
3. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med. 1998. 338:1397–1404.
4. Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000. 12:305–311.
5. Oh SY, Jun HJ, Kim SC. Changin trends in the treatment of erectile dysfunction in the era of oral sildenafil. Korean J Urol. 2002. 43:69–74.
6. Moreira SG Jr, Brannigan RE, Spitz A, Orejuela FJ, Lipshultz LI, Kim ED. Side-effect profile of sildenafil citrate (Viagra) in clinical practice. Urology. 2000. 56:474–476.
7. McMahon CG, Samali R, Johnson H. Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. J Urol. 2000. 164:1192–1196.
8. Marks LS, Duda C, Dorey FJ, Macairan ML, Santos PB. Treatment of erectile dysfunction with sildenafil. Urology. 1999. 53:19–24.
9. Jarow JP, Burnett AL, Geringer AM. Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. J Urol. 1999. 162:722–725.
10. Saenz de Tejada I, Glina S, Becher E, Ulbrich E. Vardenafil Study Group. Long-term efficay and safety of vardenafil: a 12 month double-blind study. Int J Impot Res. 2002. 14:Suppl 13. S35.
11. Giuliano F, Porst H, Shen W, Chan S. Safety and efficacy of Cialis taken daily for the treatment of erectile dysfunction. Int J Impot Res. 2002. 14:Suppl 4. PS4–PS6.
12. Padma-Nathan H, Steers WD, Wicker PA. Sildenafil Study Group. Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Int J Clin Pract. 1998. 52:375–379.
13. Porst H, Rosen R, Padma-Nathan H, Goldstein I, Giuliano F, Ulbrich E, et al. The efficacy and tolerability of vardenafil, a new, oral, selective posphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res. 2001. 13:192–199.
14. Porst H, Giuliano F, Liyanage N. 6 month study shows sustained efficacy of vardenafil in treating ED. Int J Impot Res. 2002. 14:Suppl 4. PS4–PS5.
15. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins V, et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002. 168:1332–1336.
16. Padma-Nathan H, Brock G, McMahon C, Chen KK, Anglin G, Costigan T, et al. Efficacy and safety of tadalafil in men with erectile dysfunction with and without hypertension. Am J Hypertens. 2002. 15:Suppl 1. A143–A144.
17. Giuliano F. Phosphodiesterase type 5 inhibition in erectile dysfunction: an overview. Eur Heart J. 2002. 4:Suppl. H7–H12.
18. Virag R. Indications and early results of sildenafil (Viagra) in erectile dysfunction. Urology. 1999. 54:1073–1077.
19. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med. 1998. 338:1397–1404.
20. Lowentritt BH, Scardino PT, Miles BJ, Orejuela FJ, Schatte EC, Slawin KM, et al. Sildenafil citrate after radical retropubic prostatectomy. J Urol. 1999. 162:1614–1617.
21. Zippe CD, Jhaveri FM, Klein EA, Kedia S, Pasqualotto FF, Kedia A, et al. Role of Viagra after radical prostatectomy. Urology. 2000. 55:241–245.
22. Rendell MS, Rajfer J, Wicker PA, Smith MD. Sildenafil Diabetes Study Group. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. JAMA. 1999. 281:421–426.
23. Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical safety of oral sildenafil citrate (VIAGRA) in the treatment of erectile dysfunction. Int J Impot Res. 1998. 10:69–73.
24. Dinsmore WW, Hodges M, Hargreaves C, Osterloh IH, Smith MD, Rosen RC. Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Urology. 1999. 53:800–805.
25. Eardley I, Gentile V, Austoni E, Hackett G, Lembo D, Wang C, et al. Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction. BJU Int. 2004. 94:871–877.
26. Fonseca V, Seftel A, Denna J, Fredlund P. Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: analysis of data from tadalafil clinical trials. Diabetologia. 2004. 47:1914–1923.
27. Markou S, Perimenis P, Gyftopoulos K, Athanasopoulos A, Barbalias G. Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports. Int J Impot Res. 2004. 16:470–478.
28. Nagao K, Ishii N, Kamidono S, Osada T. Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan. Int J Urol. 2004. 11:515–524.
29. Padma-Nathan H, Giuliano F. Oral drug therapy for erectile dysfunction. Urol Clin North Am. 2001. 28:321–334.
30. Nichols DJ, Muirhead G, Harness JA. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. Br J Clin Pharmacol. 2002. 53:Suppl 1. S5–S12.
TOOLS
Similar articles