Important Drug Interactions to Consider

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.

Satisfaction scores

Prospective data collection for metabolic disorders was done at tertiary care centers. The Tadalafil drug belongs to the class of PDE-5 inhibitors and Dapoxetine is a selective serotonin reuptake inhibitor. The drugs were prescribed based on dapoxetine 30mg tablet 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.

What should I know about tadalafil before using it?

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. 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. Lipid profile parameters and their effect on IIEF scores.

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:

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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. 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.

Study Record Updates

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. 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). 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.

Study Overview

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. 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. [19] 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.

Dosage Adjustments

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. 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. 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.

• Tadalafil with dapoxetine is available in tablet form and is taken orally.
• A typical dose is one tablet 30-60 minutes before sexual activity.
• The medication is designed for use as needed, not daily use.
• Patients should avoid heavy or fatty meals close to taking the medication.
• Dapoxetine works best when taken with a full glass of water.
• Tadalafil helps sustain an erection for longer periods.

In addition, individuals on Tadalafil + Dapoxetine reported significant improvement in all domains of IIEF except SD [Figure 3]B.

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[14] 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. [16] 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. [17] Moreover, Dapoxetine has no clinically relevant pharmacokinetic interactions with Tadalafil or Sildenafil, and the drug combinations (Tadalafil + Dapoxetine or Sildenafil + Dapoxetine) are well-tolerated.

Study Major Dates

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. 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. 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.

• Tadalafil and dapoxetine are combined to treat premature ejaculation and erectile dysfunction.
• Tadalafil prolongs erection, while dapoxetine delays ejaculation for better sexual control.
• The medication is usually taken prior to sexual activity for optimal results.
• Tadalafil has a long half-life, providing up to 36 hours of effectiveness.
• Dapoxetine is a fast-acting SSRI that helps reduce the urgency associated with ejaculation.
• Combining these drugs can enhance sexual performance and satisfaction.

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.

Adverse effects

Decreased NO production by the penile arteries leads to decreased levels of cGMP, which is responsible for relaxation of the corpus cavernosum. [7] Furthermore, low testosterone levels are commonly found in men with T2DM with clinical symptoms of hypogonadism, including ED and decreased libido. Clearly, one cannot render any single molecular target treatment to be effective for managing the broad spectrum of cases that present ED-related complications. Moreover, early-stage targeted treatments are recommended for best results before irreversible changes occur. [8] The multifactorial etiology of ED calls for a multi-faceted approach for its treatment as well.

Q8: Can women take Dapoxetine + Tadalafil?

The immediate action requires working on modifiable risk factors and lifestyle changes. The first line of pharmacologic therapy involves the use of phosphodiesterase 5 (PDE-5) inhibitors. [8] Sildenafil and vardenafil are the most-commonly used drugs to treat the ED but Tadalafil is more potent than other PDE-5 inhibitors. [9,10] Intracavernous injections, intraurethral suppositories, and vacuum erection devices comprise the second line of available treatment approaches for ED. [11,12,13] Thirdly, hormonal replacement therapy is also available for the individuals suffering from ED who do not respond to pharmacological therapies. (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.

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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. 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.

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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. Relationship between ED and BMI, HbA1c, testosterone, and VitB12 The effect of imbalance in parameters such as BMI, HbA1c, testosterone, and VitB12 caused by T2DM on ED was evaluated. 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).