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Cited by 195

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Effects of Tadalafil on Erectile Dysfunction in Men With Diabetes

Sáenz de Tejada, Iñigo, Anglin, Greg, Knight, James R., Emmick, Jeffrey T.·2002·Diabetes Care

Abstract

OBJECTIVE—To evaluate the efficacy and safety of tadalafil taken as needed before sexual activity by men with diabetes and erectile dysfunction (ED). RESEARCH DESIGN AND METHODS—Men with type 1 or type 2 diabetes and a minimum 3-month history of ED were randomly allocated to one of three groups: placebo (n = 71), tadalafil 10 mg (n = 73), or tadalafil 20 mg (n = 72) taken up to once daily for 12 weeks. Changes from baseline in mean scores on the erectile function domain of the International Index of Erectile Function (IIEF) and changes from baseline in the proportion of “yes” responses to question 2, “Were you able to penetrate?,” and 3, “Were you able to complete intercourse?,” of the Sexual Encounter Profile were coprimary outcome measures. RESULTS—A total of 191 (88%) of 216 patients completed the study. Treatment with tadalafil significantly improved all primary efficacy variables, regardless of baseline HbA1c level. Therapy with tadalafil also significantly improved a number of secondary outcome measures, including changes in other IIEF domains, individual IIEF questions, and percentage of positive responses to a global assessment question measuring erection improvement. Treatment with tadalafil did not alter mean HbA1c levels. Tadalafil was well tolerated, with headache and dyspepsia being the most frequent adverse events with active treatment. CONCLUSIONS—Tadalafil therapy significantly enhanced erectile function and was well tolerated by men with diabetes and ED.

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Citations

Cites

Research works printed but not linked: 18

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  2. Lehman TP, Jacobs JA: Etiology of diabetic impotence. J Urol 129:291–294, 1983 · DOI
  3. Klein R, Klein BE, Lee KE, Moss SE, Cruickshanks KJ: Prevalence of self-reported erectile dysfunction in people with long-term IDDM. Diabetes Care 19:135–141, 1996 · DOI
  4. Buvat J, Lemaire A, Buvat-Herbaut M, Fourlinnie JC, Racadot A, Fossati P: Hyperprolactinemia and sexual function in men. Horm Res 22:196–203, 1985 · DOI
  5. McCulloch DK, Young RJ, Prescott RJ, Campbell IW, Clarke BF: The natural history of impotence in diabetic men. Diabetologia 26:437–440, 1984 · DOI
  6. McKinlay JB: The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res 12 (Suppl. 4):S6–S11, 2000 · DOI · Paper page
  7. Aytac IA, McKinlay JB, Krane RJ: The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 84:50–56, 1999 · DOI · Paper page
  8. Rendell MS, Rajfer J, Wicker PA, Smith MD: Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial: Sildenafil Diabetes Study Group. JAMA 281:421–426, 1999 · DOI
  9. Price DE, Gingell JC, Gepi-Attee S, Wareham K, Yates P, Boolell M: Sildenafil: study of a novel oral treatment for erectile dysfunction in diabetic men. Diabet Med 15:821–825, 1998 · DOI
  10. Ignarro LJ, Bush PA, Buga GM, Wood KS, Fukuto JM, Rajfer J: Nitric oxide and cyclic GMP formation upon electrical field stimulation cause relaxation of corpus cavernosum smooth muscle. Biochem Biophys Res Commun 170:843–850, 1990 · DOI · Paper page
  11. Burnett AL: Nitric oxide in the penis: physiology and pathology. J Urol 157:320–324, 1997 · DOI
  12. Sáenz de Tejada I, Goldstein I, Azadzoi K, Krane RJ, Cohen RA: Impaired neurogenic and endothelium-mediated relaxation of penile smooth muscle from diabetic men with impotence. N Engl J Med 320:1025–1030, 1989 · DOI
  13. Padma-Nathan H, McMurray JG, Pullman WE, Whitaker JS, Saoud JB, Ferguson KM, Rosen RC: On-demand IC351 (Cialis) enhances erectile function in patients with erectile dysfunction. Int J Impot Res 13:2–9, 2001 · DOI
  14. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A: The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile function. Urology 49:822–830, 1997 · DOI · Paper page
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  16. Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB: Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts Male Aging Study. J Urol 163:460–463, 2000 · DOI · Paper page
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Cited by

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Metadata

Authors
Sáenz de Tejada, I., Anglin, G., Knight, J. R., & Emmick, J. T.
Affiliations
  • Fundacíon para la Investigacíon y el Desarrollo en Andrología, Madrid, Spain
  • Eli Lilly Canada, Toronto, Ontario, Canada
  • Eli Lilly and Company, Indianapolis, Indiana
Venue
Diabetes Care
Published
2002-12-01
Volume
25
Issue
12
Pages
2159-2164
ISSN
  • 0149-5992
  • 1935-5548
Cited by
195
References
3
Language
en

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