Dapoxetine (International)

Among all study participants, 61.9% were found to have a low level of testosterone.

Conflict of interest statement

The drugs were prescribed based on participant’s discretion. At baseline, the medical history of subjects including any previous medical conditions and other concomitant medication was recorded in a case record form followed by a general and systemic examination. Participants on either medication were followed up after 1 month of medication. The individual domain scores of IIEF were represented as boxplots to evaluate the effect of measured parameter such as BMI, HbA1c, testosterone, VitB12, cholesterol, triglyceride, HDL, and LDL. Similarly, the effect of treatments on IIEF scores was also represented.

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The statistical analysis was carried out using Microsoft Excel (Microsoft 365). For comparison of categorical variables, the χ2 test was used. For comparison of two groups, 2 tailed t-test with unequal variance was carried out. A significance level of 5% was used for considering the differences to be significant. Out of the 240 male T2DM subjects screened, 216 satisfied the inclusion criteria and were enrolled in the study.

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Subjects with age more than 40 years experienced ED almost two times as compared to those in the age groups of 30–39 years. In general, the prevalence of ED increased with age among subjects having T2DM. Among the selected group, 53 individuals were prescribed either Tadalafil or Tadalafil + Dapoxetine drug combination as per their demand. The following effects were studied: (I) relationship between ED and BMI, HbA1c, testosterone, and VitB12; (II) effect of lipid profile parameters on ED; (III) effect of treatment on IIEF; (IV) role of BMI on the treatment efficacy; and (V) effect of co-morbidities on treatment outcome. The effect of imbalance in parameters such as BMI, HbA1c, testosterone, and VitB12 caused by T2DM on ED was evaluated. Furthermore, the effect of hypogonadism on reduced libido and DM is supported by several studies.

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[,] Besides, conditions such as metabolic syndrome and atherogenic dyslipidemia are also associated with ED among diabetic men.

Side Effect	Tadalafil	Dapoxetine	Both Medications
Headache	Yes	Yes	Yes
Flushing	Yes	No	Yes
Dizziness	Sometimes	Sometimes	Sometimes
Nasal Congestion	Rare	No	Rare
Gastrointestinal upset	Rare	Yes	Sometimes

[] Among the study participants, 57.8% had high triglyceride levels and 25.4% of subjects had low levels of HDL.

Side Effects

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. [,] 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. [] Secondly, obesity is also one of the risk factors for developing ED.

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[] 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. 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.

27 May – 1 June 2026

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%). Higher HbA1c levels are associated with ED which was also observed in another study. [] In addition, testosterone hormone is responsible for normal sexual functioning such as erection and for sexual desire or libido. 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.

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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. [] Subjects having high (>7.5%) compared to normal HbA1c reported reduced SD and OS scores.

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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. 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.

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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. 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 tab dapoxetine 30 mg domains of IIEF except SD [Figure 3]B. Both Tadalafil and Tadalafil + Dapoxetine improved most of the IIEF parameters.

• Tadalafil is marketed under brand names like Cialis.
• Dapoxetine is available in various countries, often as brand Priligy.
• Tadalafil can also help in the treatment of pulmonary hypertension.
• Dapoxetine reduces the urgency and frequency of premature ejaculation.
• Missed doses of tadalafil should be taken as soon as remembered.
• Do not exceed the recommended dose to avoid severe side effects.

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.

• Always consult a healthcare provider before starting these medications.
• Do not drink alcohol when taking tadalafil or dapoxetine, to reduce risks.
• Tadalafil can be used by men with diabetes or prostate issues.
• Dapoxetine is intended for men aged 18-64 with premature ejaculation.
• Patients should report any prolonged erections exceeding 4 hours.
• These drugs are not suitable for women or children.

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.

• Tadalafil is generally well-tolerated but requires medical supervision.
• Dapoxetine's side effects often diminish with continued use.
• Combining medications may increase the risk of adverse reactions.
• Tadalafil can cause flushing and nasal congestion as side effects.
• Patients should avoid grapefruit juice, which can interact with tadalafil.
• Regular medical check-ups are recommended during treatment.

The findings of the present study highlight the high prevalence of ED in men suffering from T2DM. 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.

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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. BMI has a significant effect on the IIEF parameters as seen from this study [Figure 1] as well as previous reports. [] 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. 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.

Warnings for other groups

Tadalafil and Tadalafil + Dapoxetine combination treatment improved all the IIEF scores for individuals with above cut-off BMI except for SD values. 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. [] 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.

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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. [] 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. [] 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 dapoxetine sildenafil online in this study reported lower than normal SD scores which is a clear indication of ED. In addition to this, the presence of comorbidities such as hypertension, dyslipidemia, and coronary artery disease further elevates the odds of developing ED. The treatment of individuals with T2DM with Tadalafil and Tadalafil + Dapoxetine drug combination shows promising results in improving ED, as analyzed using the IIEF questionnaires.