Addressing Psychological Aspects with Pharmacological Aid

Amol Chaudhari is also a part of the scientific department at Neovation Consultancy Services Pte.

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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. 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. However, no clear advantage of combination of the two drugs was observed. Dr. Vipul Chavda conceived the idea and design for the study and overlooked the entire study until completion. Dr. Santosh Jha made major contributions in drafting the manuscript and statistical analysis. Dr. Tejal Gandhi and Anjali Patel conducted manuscript editing and reviewing.

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This study lays the foundation of long-term prospective clinical studies to validate the efficacy of using Tadalafil + Dapoxetine drug combination in managing ED in individuals with T2DM. The findings of this study also outline the pressing need of careful examination of sexual dysfunction in healthcare clinics for diabetic individuals. Increased awareness through routine screening for ED can contribute to the timely diagnosis and effective treatment of ED especially in elderly population. The authors of this study do not have any conflicts of interest with publication of the manuscript or an institution or product that is mentioned in the manuscript and/or is important to the outcome of the study presented. Dr. Literature search and clinical data collection was done by Hiren Raninga. Dr. Amol Chaudhari and Dr. Dhruvi Hasnani performed statistical analysis on the collected data, wrote and reviewed the manuscript. Vibhuti Jain Rana, Nishtha Singh, and Pusala Lakshmi Prasanna from Neovation Consultancy Services Pte. Ltd., Singapore, for assisting with statistical analysis and manuscript revision. Sexual dysfunction in men with type II diabetes Caspian J Intern Med. Al-Saeed AH, Constantino MI, Molyneaux L, D’Souza M, Limacher-Gisler F, Luo C, et al An inverse relationship between age of type 2 diabetes onset and complication risk and mortality: The impact of youth-onset type 2 diabetes Diabetes Care. Redrow GP, Thompson CM, Wang R. Treatment strategies for diabetic patients suffering from erectile dysfunction: An update Expert Opin Pharmacother. Hatzimouratidis K, Hatzichristou D. How to treat erectile dysfunction in men with diabetes: From pathophysiology to treatment Curr Diab Rep. 2014;14:545. The effectiveness of psychological interventions for the treatment of erectile dysfunction: Systematic review and meta-analysis, including comparisons to sildenafil treatment, intracavernosal injection, and vacuum devices J Sex Med. Etiology of erectile dysfunction and duration of symptoms in patients undergoing penile prosthesis: A systematic review Sex Med Rev. Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED study Int J Impot Res. Dresser M, Desai D, Gidwani S, Seftel A, Modi N. Dapoxetine, a novel treatment for premature ejaculation, does not have pharmacokinetic interactions with phosphodiesterase-5 inhibitors Int J Impot Res. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction Int J Impot Res. Evidence-based multiple action points for public awareness, screening, and treatment: An extension of Asian-Pacific recommendations Asia Pac J Clin Nutr. Nehra A. Erectile dysfunction and cardiovascular disease: Efficacy and safety of phosphodiesterase type 5 inhibitors in men with both conditions Mayo Clin Proc. The association between erectile dysfunction and cardiovascular risk in men with Type 2 diabetes in primary care: It is a matter of age J Diabetes Complications.

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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. Seftel AD, Sun P, Swindle R. The prevalence of hypertension, hyperlipidemia, diabetes mellitus and depression in men with erectile dysfunction J Urol. Nakanishi S, Yamane K, Kamei N, Okubo M, Kohno N. Erectile dysfunction is strongly linked with decreased libido in diabetic men Aging Male. Fedele D, Coscelli C, Santeusanio F, Bortolotti A, Chatenoud L, Colli E, et al Erectile dysfunction in diabetic subjects in Italy. Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. [6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant. Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of PE in 2004. [8] Dapoxetine is sold in several European and Asian countries, and in Mexico. In the US, dapoxetine has been in phase III development. In May 2012, US-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceuticals to market dapoxetine in the United States, Japan, and Canada, while selling the rights to market the drug in Europe, most of Asia, Africa, Latin America, and the Middle East to Menarini. Randomized, double-blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. [10] Different dosages have different impacts on different types of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compared to that of dapoxetine 30 mg in men with lifelong PE, but no difference is seen in men with acquired PE. [11] Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Since PE is associated with personal distress and interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition. With no drug approved specifically for treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used off-label to treat PE. Waldinger's meta-analysis shows that the use of these conventional antidepressants increases IELT two- to nine-fold above baseline, compared to three- to eight-fold when dapoxetine is used. [11] However, these SSRIs may need to be taken daily to achieve meaningful efficacy, and their comparatively longer half-lives increase the risk of drug accumulation and a corresponding increase of adverse effects such as reduced libido. [13] Dapoxetine, though, is generally categorized as a fast-acting SSRI. It is more rapidly absorbed and mostly eliminated from the body within a few hours. These pharmacokinetics are more favorable in that they might minimize drug accumulation in the body, habituation, and side effects.

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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. Dapoxetine was initially considered unsuccessful in its intended use as an antidepressant; however, it has since been investigated as a possible aid to an approach to depression treatment focused on stress reduction, based on an animal model of depression. Dapoxetine should not be used in men with moderate to severe hepatic impairment and in those receiving CYP3A4 inhibitors such as ketoconazole, ritonavir, and telithromycin. Dapoxetine also cannot be used in patients with heart failure, permanent pacemaker, or other significant ischemic heart disease. Caution is advised in men receiving thioridazine, monoamine oxidase inhibitors, SSRIs, serotonin-norepinephrine reuptake inhibitors, or tricyclic antidepressants. If a patient stops taking one of these drugs, he should wait for 14 days before taking dapoxetine. If a patient stops taking dapoxetine, he should wait for 7 days before receiving these drugs. The most common effects when taking dapoxetine are nausea, dizziness, dry mouth, headache, diarrhea, and insomnia. [16][17] Discontinuation rates due to adverse effects and costs are very high, as demonstrated in a study in Asia which showed that cumulative discontinuation rates within one year are as high as 87%. [18] Unlike other SSRIs used to treat depression, which have been associated with high incidences of sexual dysfunction,[19] dapoxetine is associated with low rates of sexual dysfunction.