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Individuals treated with Tadalafil + Dapoxetine who were also having cut-off or below cut-off BMI showed no significant improvement in any of the IIEF scores. Tadalafil and Tadalafil + Dapoxetine combination treatment improved all the IIEF scores for individuals with above cut-off BMI except for SD values. Effect of BMI and treatment on IIEF scores at baseline and follow-up of treated subjects. At normal BMI (cut-off or below cut-off), the effect of (A) Tadalafil, and (B) Tadalafil + Dapoxetine on IIEF scores. At high BMI (above cut-off), the effect of (C) Tadalafil, and (D) Tadalafil + Dapoxetine on IIEF scores. p < 0.05 was considered statistically significant and indicated with a horizontal bracket Effect of co-morbidities on treatment outcome The effect of comorbidities on ED is not well understood because co-morbidities such as hypertension, dyslipidemia, and coronary artery disease can lead to other health problems that can also impact erectile function. [22] Therefore, the effect of comorbidities at baseline was compared with the follow-up values of IIEF parameters of all the treated subjects. [Figure 5] depicts that except for the SD values in individuals without co-morbidities (C–), all other IIEF values significantly improved after the treatment (Tadalafil or Tadalafil + Dapoxetine). On the other hand, in individuals with comorbidities (C+), the effect of both the medications was positive on treatment of ED as seen by the significant improvement of all the IIEF scores. Evaluation of changes in IIEF scores at baseline versus at follow-up in individuals with (C+) and without (C–) comorbidities, who were treated with either Tadalafil or Tadalafil + Dapoxetine drug combination. p < 0.05 was considered statistically significant and indicated with a horizontal bracket DM is considered a possibly life-threatening metabolic disorder with mortalities reported to be associated with complications such as cardiovascular diseases, kidney failure, retinopathy, nephropathy, and neuropathy. [3] Additionally, ED, reduced sexual desire, orgasmic disorder, and retrograde ejaculation are also a sub-set of complications of variable incidence in men suffering from DM. [1] The objective of the present study was to characterize the major sexual dysfunctions in a single diabetic population, and their inter-associations with other clinical variables and comorbidities. The study investigated the frequency of IIEF scores in 216 men suffering from T2DM. Approximately 41% of the subjects included in this study reported lower than normal SD scores which is a clear indication of ED. This finding resonated with reports published in several previous studies. Two studies, one from the Netherlands and another from the United States indicated that 41.3% and more than 50% of the subjects respectively reported prevalence of ED. [23,24] Thus, low SD is a clear indicator of ED in individuals with DM. The findings of the current study showed that age is significantly associated with ED in individuals with T2DM which is known from the fact that the prevalence of severe ED increases with age.

Tolerability and acute toxicity studies

Subjects with low (<400 ng/dL) compared to normal testosterone levels reported reduced OF and SD scores. Subjects having low (<300 pg/mL) compared to normal VitB12 reported a significant reduction in SD scores. These findings suggest a direct correlation between an unbalanced glycometabolic profile and sexual dysfunction in individuals with T2DM. Glycometabolic parameters and their effect on IIEF scores. The effect of BMI (cut-off: 23 kg/m2, above cut-off: >23 kg/m2), HbA1c (normal: <7.5%, high: >7.5%), testosterone (low: 0–400 ng/dL; normal: 400–1000 ng/dL), and VitB12 (low: 0–300 pg/mL; normal: 300–2000 pg/mL) on sexual dysfunction in the subjects was measured based on IIEF scores. [25] Secondly, obesity is also one of the risk factors for developing ED. [26] Among all subjects enrolled in the current study, 187 (86.6%) had a BMI of more than cut-off of 23 kg/m2 and these subjects showed significantly lower SD values as compared to the individuals with cut-off or lower than cut-off BMI.

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p < 0.05 was considered statistically significant and indicated with a horizontal bracket The effects of lipid profile parameters of the subjects on sexual dysfunction were evaluated. [Figure 2] depicts that there was no significant difference in IIEF parameters when compared at normal (0–200 mg/dL) or high (200–400 mg/dL) cholesterol levels. In terms of elevated triglyceride levels (>150 mg/dL), SD score was reported to be significantly reduced as compared to the subjects with triglyceride levels in the normal range (0–150 mg/dL). The subjects with low levels of HDL (0–40 mg/dL) compared to normal as well as high levels of LDL (100–220 mg/dL) compared to normal reported a significant reduction in SD and OS scores. Lipid profile parameters and their effect on IIEF scores. A similar observation was also made for other clinical parameters except cholesterol. Reported SD values are significantly lower in subjects who also exhibit imbalanced metabolic profile with high HbA1c, low testosterone, low VitB12, high triglyceride, low HDL, and high LDL. The lipid profile is also a pressing cause of concern in aggravating ED. Findings in this study demonstrate that an imbalance in triglycerides, HDL, and LDL affect the OS scores significantly. Interesting to note is the fact that a raised cholesterol level does not by itself have a direct adverse effect on any of the five domains of the IIEF scores. Next, the investigation demonstrates that the prevalence of ED using the IIEF is (more than 50%) higher in men with DM as observed from the HbA1c results. Among 216 participants with sexual dysfunction enrolled in this study, 136 (62.9%) had a higher HbA1c level (7.6–16%).

Patients undergoing vagotomy or gastrectomy

The effect of cholesterol (normal: 0–200 mg/dL; high: 200–400 mg/dL), triglyceride (normal: 0–150 mg/dL; high: >150 mg/dL), HDL (low: 0–40 mg/dL; normal: 40–60 mg/dL), and LDL (normal: 0–100 mg/dL; high: 100–220 mg/dL) on sexual dysfunction in subjects was measured based on reported IIEF scores. p < 0.05 was considered statistically significant and indicated with a horizontal bracket The subjects, who were on Tadalafil or the combination of Tadalafil + Dapoxetine, were counselled with the validated IIEF questionnaire for ED at baseline and at follow-up. It was seen that the individuals on Tadalafil reported significant improvement in all the IIEF parameters at the follow-up with respect to the baseline [Figure 3]A. In addition, individuals on Tadalafil + Dapoxetine reported significant improvement in all domains of IIEF except SD [Figure 3]B. Thus, if we compare the effects of both, Tadalafil versus Tadalafil + Dapoxetine drug combination on change in IIEF scores at the follow-up, both groups had similar effect on ED and there was no significant difference in the IIEF parameters when compared at follow-up [Figure 3]C. Higher HbA1c levels are associated with ED which was also observed in another study. [25] In addition, testosterone hormone is responsible for normal sexual functioning such as erection and for sexual desire or libido.

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The effect of these parameters was assessed by means of five domains of the IIEF questionnaire namely EF, OF, SD, IS, and OS. The significant differences (p < 0.05) are shown by horizontal brackets. Analysis of the participant responses to the IIEF questionnaire, as shown in [Figure 1], indicates that SD and OS scores were significantly low in subjects with BMI higher than cut-off (>23 kg/m2) with respect to subjects with BMI less than or equal to cut-off (≤23 kg/m2). A cut-off BMI of 23 kg/m2 was considered according to the Asian standards. [20] Subjects having high (>7.5%) compared to normal HbA1c reported reduced SD and OS scores. Among all study participants, 61.9% were found to have a low level of testosterone. Furthermore, the effect of hypogonadism on reduced libido and DM is supported by several studies. [27,28] Besides, conditions such as metabolic syndrome and atherogenic dyslipidemia are also associated with ED among diabetic men. [29] Among the study participants, 57.8% had high triglyceride levels and 25.4% of subjects had low levels of HDL. This study also presents noteworthy findings when the participants were subjected to Tadalafil or the combination of Tadalafil + Dapoxetine. There was no indication of superiority of either. Both Tadalafil and Tadalafil + Dapoxetine improved most of the IIEF parameters. Thus, there appears to be no masking effect on the efficacy of Tadalafil when it is used in combination with Dapoxetine. Moreover, the Tadalafil + Dapoxetine combination improved all the IIEF parameters for subjects with high BMI except for SD. In subjects with co-morbidities, the use of either Tadalafil or Tadalafil + Dapoxetine drug combination was shown to significantly enhance all the IIEF scores, suggesting a strong correlation between comorbidities and ED. The findings of the present study highlight the high prevalence of ED in men suffering from T2DM.

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Efficacy of (A) Tadalafil or (B) the combination of Tadalafil + Dapoxetine in the treated individuals based on IIEF scores at baseline and at follow-up. (C) A comparison of change in IIEF scores at follow-up with either Tadalafil or Tadalafil + Dapoxetine drug combination. p < 0.05 was considered statistically significant and indicated with a horizontal bracket Role of BMI on the treatment efficacy BMI has a significant effect on the IIEF parameters as seen from this study [Figure 1] as well as previous reports. [21] Therefore, the effect of BMI at cut-off and above cut-off was evaluated for treated individuals at the baseline and at follow-up. Figure 4 shows that Tadalafil-treated individuals having cut-off or below cut-off BMI showed significant improvement only in OS score. An imbalanced physiological profile, such as higher BMI, higher HbA1c, lower testosterone, disturbed lipid profile, and a lower VitB12 level is reported to be major contributors to ED.