Effect of tadalafil on erectile dysfunction in male patients with diabetes mellitus

Popovic, Srdjan; Nale, Djordje; Dabetic, Marija; Matanović, Dragana; Dimitrijević-Srećković, V.; Milic, Gordana; Gostiljac, D.; Vujovic, Svetlana; Antonijević, Nebojša; Nisic, Tanja; Djordjević, Predrag

doi:10.2298/vsp0706399p

Cited by 6 publications

(5 citation statements)

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“…The proportion of subjects with IIEF‐EF domain scores ≥26 was 23.3% (2.5 mg) and 22.1% (5 mg) [24]. On demand treatment of tadalafil in diabetic male patients improved ED by 58% and 60% towards SEP2 and SEP3, respectively [25]. Another study by Goldstein et al., who investigated tadalafil 20 mg administrated as needed prior to sexual activities in men with ED and multiple comorbidities including diabetes, for 12 weeks, demonstrated a significant mean change of 7.6 from baseline in EF domain score.…”

Section: Discussionmentioning

confidence: 98%

Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Park

Choi

Ahn

et al. 2010

The Journal of Sexual Medicine

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Introduction Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). Aim To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Main Outcome Measures Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). Results After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P <0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P <0.0001) and Q4 (1.7 vs. 0.3, P <0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P <0.0001). Difference in GAQ “YES” responses was also significant (76.9% vs. 19.1%, P <0.0001). Normal EF domain scores (≥26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Conclusions Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.

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Section: Discussionmentioning

confidence: 98%

Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Park

Choi

Ahn

et al. 2010

The Journal of Sexual Medicine

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“… 26 In addition, Popovic et al reported that combination of antidiabetic drugs and tadalafil can even improve the bioavailability and efficacy of tadalafil. 27 Repaglinide ( Fig. 1b ), a BCS class II drug with poor aqueous solubility, is an oral antidiabetic drug for clinical treatment of type II diabetes mellitus by stimulating insulin release from pancreatic β-cells.…”

Section: Introductionmentioning

confidence: 99%

A novel drug–drug coamorphous system without molecular interactions: improve the physicochemical properties of tadalafil and repaglinide

Xia

Shen

et al. 2020

RSC Adv.

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“…The proportion of subjects with IIEF-EF domain scores ≥ 26 (normal erectile function) was 23.3% (2.5 mg) and 22.1% (5 mg) [10]. On-demand treatment with tadalafil in patients with DM improved ED by 58% and 60% for SEP2 and SEP3, respectively [11]. The Scheduled Use vs. On-demand Regimen Evaluation study in 14 European countries showed that >40% of patients with DM and ED had a normal IIEF-EF domain score (≥26), and the proportion of "yes" responses was 73% for SEP2 and ≥58% for SEP3 after on-demand or three-times-per-week administration of 20 mg tadalafil [12].…”

Section: Discussionmentioning

confidence: 99%

Serum High-Sensitivity C-Reactive Protein Levels and Response to 5 mg Tadalafil Once Daily in Patients With Erectile Dysfunction and Diabetes

Lee

Park

2013

Korean J Urol

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PurposeWe studied the relative importance of high-sensitivity C-reactive protein (hs-CRP) concentrations in patients with erectile dysfunction (ED) and diabetes and determined whether the hs-CRP level predicts the response to treatment with 5 mg tadalafil once daily.Materials and MethodsWe enrolled 102 men (aged 40-60 years) with diabetes and ED. All patients completed the International Index of Erectile Function (IIEF) questionnaire and were given 5 mg tadalafil daily. The IIEF and serum hs-CRP levels in patients and healthy controls and in patient responders and nonresponders to 5 mg tadalafil once daily were compared.ResultsMedian age was 53.2 years (range, 45 to 62 years) in patients and 55.6 years (range, 47 to 64 years) in healthy controls (p=0.158). The median duration of diabetes was 54.3 months (range, 34 to 70 months). The median IIEF and hs-CRP level were 12.1 (range, 5 to 20) and 0.21 mg/dL (range, 0.05 to 0.6 mg/dL) in patients and 28.2 (range, 13 to 31) and 0.09 mg/dL (range, 0.04 to 0.2 mg/dL) in the controls, respectively (pIIEF=0.000, pCRP=0.031). After tadalafil treatment, 71 patients (69.6%) achieved an erection sufficient for sexual intercourse, whereas 31 (30.4%) did not. The median age of the tadalafil nonresponders was 56.2 years (range, 45 to 64 years) and that of the responders was 51.3 years (range, 42 to 62 years; p=0.065). Median hs-CRP levels were 0.31 mg/dL (range, 0.18 to 0.62 mg/dL) in nonresponders and 0.14 mg/dL (range, 0.09 to 0.4 mg/dL) in responders, respectively (p=0.028).ConclusionsSerum hs-CRP was significantly higher in patients with ED and diabetes mellitus than in patients without ED. A significant correlation was observed between serum hs-CRP levels, the degree of ED, and responsiveness to tadalafil.

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Effect of tadalafil on erectile dysfunction in male patients with diabetes mellitus

Abstract: Tadalafil is an effective tool for treating ED in diabetes patients. In some situations tadalafil application could replace prostaglandin test. The sexual sphere motivation leads to the improvement of glucoregulation in DM patients.

Cited by 6 publications

References 11 publications

Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

A novel drug–drug coamorphous system without molecular interactions: improve the physicochemical properties of tadalafil and repaglinide

Serum High-Sensitivity C-Reactive Protein Levels and Response to 5 mg Tadalafil Once Daily in Patients With Erectile Dysfunction and Diabetes

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