Agent for premature ejaculation shows no interactions with PDE-5 inhibitors

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.

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[] Lastly, penile implantation surgery remains a viable therapeutic option where medical management of ED is not possible.[] Besides ED, the use of Dapoxetine, a selective serotonin reuptake inhibitor, has been widely reported for the treatment of premature ejaculation in men. Dapoxetine is the first oral pharmacological agent indicated for the treatment of men aged 18–64 years with premature ejaculation. [] In addition, the Sildenafil + Dapoxetine combination therapy has been reported to significantly improve the intravaginal ejaculation latency time values with mild and transient side effects. [] Moreover, Dapoxetine has no clinically relevant pharmacokinetic interactions with Tadalafil or Sildenafil, and the drug combinations (Tadalafil + Dapoxetine or Sildenafil + Dapoxetine) are well-tolerated.[] This manuscript discusses the effect of physiological and metabolic parameters on sexual dysfunction, particularly ED in male T2DM subjects. The purpose of such retrospective analysis was to evaluate the effect of parameters such as body mass index (BMI), HbA1c, testosterone, VitB12 and lipid profile parameters such as cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) on ED in men due to T2DM.

High blood pressure or prostate drugs (alpha-blockers)

The efficacy of Tadalafil alone and in combination with Dapoxetine in managing ED was evaluated and discussed. And the effect of comorbidities in individuals suffering from T2DM and ED was evaluated separately based on their BMI and the treatment groups. This was a bicentric, prospective, open-labelled, cross-sectional, observational study. Study centers were RIMS Super Specialty Hospital, Ahmedabad, and Rudraksha Multi-specialty Hospital, Bareja, situated in the state of Gujarat, India. Ethical approval for this study was provided by the Rudraksha Hospital Ethical Committee, on 16 December 2021.

Therapeutic Categories

All willing males with age between 30 and 65 years, having any duration of T2DM, with or without hypertension, and having a complaint relevant to sexual desire as diagnosed by the IIEF questionnaire were included in the study. IIEF questionnaire is used by physicians to diagnose the presence and severity of ED. [] The five items are based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health’s definition of ED. The following five items are included: erectile function (EF); orgasmic function (OF); sexual desire (SD); intercourse satisfaction (IS); and overall satisfaction (OS). Individuals with type-1 diabetes, chronic kidney disease, and those taking PDE-5 inhibitors were excluded from the study. [] 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 dapoxetine 60mg tablet price 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. 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.

MATERIALS AND METHODS

Participants in the study were recruited from December 1, 2021 until March 31, 2022. Examination, history taking, anthropometric data, laboratory parameters, and questionnaire surveys were undertaken as a part of routine protocol. At the end of the demographic questionnaire, participants were requested to provide informed consent. Prospective data collection for metabolic disorders was done at priligy dapoxetine canada tertiary care centers. The Tadalafil drug belongs to the class of PDE-5 inhibitors and Dapoxetine is a selective serotonin reuptake inhibitor.

Molecular Weight

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.

Depression and anxiety

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. The study investigated the frequency of IIEF scores in 216 men suffering from T2DM.

• 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.

Approximately 41% of the subjects included in this study reported lower than normal SD scores which is a clear indication of ED.

• Tadalafil is effective for up to 36 hours, offering flexibility.
• Dapoxetine provides quick relief from pre-ejaculation symptoms.
• Both medications may be part of a comprehensive sexual health plan.
• Regular dosing of tadalafil can help in managing chronic erectile issues.
• Dapoxetine should be used exactly as prescribed, not more frequently.
• Patients should monitor their response and report adverse 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.

Warnings & Precautions

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 domains of IIEF except SD [Figure 3]B.

Male pelvic floor muscles

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. [,] Thus, low SD is a clear indicator of ED in individuals with DM.

Uses of Tadalafil and Dapoxetine

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.

Eligibility criteria

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 tadalafil with dapoxetine tablets 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.

What is tadalafil used for?

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. 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.

• 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.