These findings suggest a
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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. 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. direct correlation between an unbalanced
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glycometabolic profile and sexual
Aim of the study
Additionally, the presence of co-morbidities further elevates the odds of ED prevalence. The treatment with Tadalafil and Tadalafil + Dapoxetine drug combination shows promising results in improving the ED but a study with larger pool of subjects is needed to determine the additional benefits of Dapoxetine. Type-2 diabetes mellitus (T2DM) is one of the most common endocrine and metabolic disorders threatening global fitness. [1] Genetic predisposition, obesity, sedentary lifestyle, and an unhealthy diet are major risk factors for the development of T2DM and associated metabolic abnormalities resulting in insulin resistance. It manifests as hyperglycemia that occurs due to impaired insulin secretion or impaired insulin action or both.
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[2] The resulting metabolic imbalance often leads to the development of various micro- and macro-vascular complications. Micro-vascular complications comprise retinopathy, neuropathy, and nephropathy while macro-vascular complications can lead to coronary heart disease, stroke, and peripheral vascular disease. [3] In addition, sexual dysfunction is another common complication of T2DM in both men and women. Erectile dysfunction (ED) is the well-established diabetes-related sexual dysfunction in men. In various studies, the prevalence of ED in men with diabetes is reported to lie between 20% and 67.4%.
Neurocognitive safety
[4] However, it is important to note that the multifactorial pathophysiology of diabetes-induced ED and the need to consider multiple etiologies while addressing issues such as ED. The proposed mechanisms of ED in diabetic males include elevated advanced glycation end-products (AGEs), raised oxygen-free radicals, impaired nitric oxide (NO) synthesis, more endothelin B receptor binding sites, up-regulated RhoA/Rho-kinase pathway, neuropathic damage, and impaired cyclic guanosine monophosphate (cGMP)-dependent protein kinase-1. [5] AGEs accumulation result in vascular thickening, decreased elasticity, and atherosclerosis. Neuropathy plays a major role in the pathophysiology of ED in diabetes mellitus (DM). Next, neurophysiological tests such as nerve conduction studies, anal sphincter electromyography, heart rate variability testing, and quantitative sensory testing, have indicated abnormalities in men with diabetic ED with at least similar frequency as in men with neuropathic ED. dysfunction in individuals with T2DM.
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[6] In addition, endothelial dysfunction leads to impaired activity of endothelial NO synthase (eNOS) and reduction in released NO. 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.
Getting Started Is Easy
[8] The multifactorial etiology of ED calls for a multi-faceted approach for its treatment as well. 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.
Monitor for Side Effects
[11,12,13] Thirdly, hormonal replacement therapy is also available for the individuals suffering from ED who do not respond to pharmacological therapies. [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. Glycometabolic parameters and their effect on IIEF scores.
- 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.
The effect of BMI (cut-off: 23 kg/m2, above cut-off: >23
Patients and methods
[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. 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.
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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. 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.
Cardiovascular safety
[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. 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 dapoxetine over counter March 31, 2022. Examination, history taking, anthropometric data, laboratory parameters, and questionnaire surveys were undertaken as a part of routine protocol. kg/m2), HbA1c (normal: <7.5%, high:
| Storage Aspect | Details |
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| Temperature | Store below 30°C |
| Light Exposure | Keep in a cool, dark place |
| Humidity | Avoid excessive moisture |
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>7.5%), testosterone (low: 0–400 ng/dL; normal:
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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. 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. 400–1000 ng/dL), and VitB12 (low:
- Common side effects include lightheadedness, nasal congestion, or stomach upset.
- Serious side effects, though rare, include vision changes or allergic reactions.
- Do not use if you have a history of severe hypotension or stroke.
- Alcohol consumption may impair the effectiveness and increase side effects.
- Use this medication only under medical supervision and guidance.
- Always read the patient leaflet for detailed instructions and warnings.
0–300 pg/mL; normal: 300–2000 pg/mL) on
Shipping Information
At the end of the demographic questionnaire, participants were requested to provide informed consent. 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 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.
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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. The statistical analysis was carried out using Microsoft Excel (Microsoft 365). For comparison of categorical variables, the χ2 test was used.
Phosphodiesterase 5 inhibitors
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. 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. sexual dysfunction in the subjects was measured based on IIEF scores.
| Condition | Tadalafil Dapoxetine Tablet Caution |
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| Heart Disease | Consult doctor before use |
| Liver Impairment | Use with caution |
| Use of Nitrates | Contraindicated |
| Severe Psychiatric Disorders | Discuss with healthcare provider |
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