The Role of Dapoxetine in On-Demand PE Pharmacotherapy

All patients were evaluated by filling a detailed documented medical history including the International Index of Erectile Function (IIEF) 5- items questionnaires to exclude those with erectile-dysfunction [Citation14]. All patients were instructed to report in a written diary the correct medication intake in their files.

Special Dietary & Lifestyle Recommendation

Nitric oxide (NO) activates guanylate cyclase which increases the intracellular cGMP in the corpus cavernosum causing smooth muscle relaxation. PDE-5 inhibitors act through increasing nitric oxide which causes relaxation of the smooth muscles of corpus cavernosum and the vas deferens and seminal-vesicles, also they reduce anxiety from sexual performance which is commonly associated with PE [Citation12]. According to several researches, using SSRIs and PDE-5 inhibitors together enhances sexual pleasure and boosts IELT when compared with taking SSRIs alone. PDE-5 may suppress the central sympathetic tone, which causes better erection and increased the time interval for ejaculation [Citation13]. This study aimed to compare the pharmacological effect assessed by IELT in men suffering from PE by using either dapoxetine alone, tadalafil alone, or their combination as a primary outcome and to evaluate the possible side effects of drug therapy as a secondary outcome.

What PRILIGY contains

This was a prospective, randomized work of patients who attended our andrology clinic with PE from May 2021 to September 2022. Patients were randomly allocated into three groups (using a block randomization strategy in Stata, version 13.1, Stata Corp, for Microsoft windows). Participants in group (A) received on- demand tadalafil 5 mg two hours before intercourse; Participants in group (B) received on- demand dapoxetin 30 mg two hours before intercourse; and Participants in group (C) received an on-demand combination of both tadalafil 5 mg and dapoxetin 30 mg two hours before intercourse. Each participant was instructed to engage in sexual activity 2–3 times per week. If an individual met the International Society for Sexual Medicine’s requirements which describes PE as ejaculation that always happens within a minute, following vaginal penetration during the initial sexual encounter (lifetime PE), or a substantial decline in IELT, often within less than 3 minutes (acquired PE), with detrimental personal effects, including anxiety, annoyance, and/or avoiding of sexual intimacy, PE was assumed to be present. Inclusion criteria were heterosexually active men aged more than 20 years with PE (patients with type 1 or lifelong PE were not discriminated from those with acquired type) with IIEF > 22 and at least a three-months period in a stable sexual relationship preceding the research.

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Exclusion criteria were individuals with diabetes mellitus, chronic prostatitis, erectile dysfunction (IIEF <22), neurological disorders, penile implants or deformities, homosexual men and those who were taking medications for neurological or psychiatric disorders and non-compliant patients.

Condition	Contraindicated?	Notes
Heart failure	Yes	Risk of worsening symptoms
Liver impairment	Yes	Metabolized in the liver, caution advised
Use with MAO inhibitors	Yes	Causes severe interactions
History of syncope	Yes	Due to risk of fainting
Allergic reactions to SSRIs	Yes	Allergic response possible

Each patient received a comprehensive pretreatment evaluation that include medical history, clinical assessment, fasting blood glucose level, and hormonal profile (blood glucose and testosterone were measured in the early morning while the patient was fasting).

Satisfaction scores

Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) define PE as a persistent or recurrent ejaculation that occurs within approximately 1 minute after vaginal penetration and before the individual wishes it. The problem must present for at least 6 months and present on almost all (approximately 75–100%) or on all occasions of sexual attempts with clinically significant distress and cannot be explained by a nonsexual mental disorder or as a result tadalafil dapoxetine of severe relationship distress and is not attributable to the effects of a substance/medication or other medical condition [Citation3,Citation4]. A recent comprehensive novel classification of PE was reported by Raveendran A. In this classification, the grading of the severity of reduction of IELT was reported as mild or grade 1 (IELT of 2 to 3 minutes), moderate or grade 2 (IELT of 1 to less than 2 minutes), severe or grade 3 (IELT less than 1 minute), and extreme or grade 4 (ejaculation occurring prior to vaginal penetration) [Citation5]. Premature ejaculation is a frequent male sexual dysfunction, although the real incidence is unclear, 24% to 30% of males may be affected [Citation6,Citation7].

Results of the Pivotal Trial

Several drugs as tricyclic antidepressants (e.g. clomipramine) and tramadol could be used for treatment of PE. Selective serotonin-reuptake-inhibitors (SSRIs), like escitalopram, fluoxetine, serteralin, paroxetine and dapoxetine are the most common medications used for management of PE [Citation8–10]. As SSRI, dapoxetine was the first licenced drug with FDA approval used for on-demand management of PE. Dapoxetin acts by neglecting the effect for the different G protein coupled and ligand gated channels for all 5-hydroxytryptamin (5-HT) receptor subtypes, it inhibits the 5-HT transporter and activate the 5-HT 2C receptor, an action which diminishes the operation of 5-HT 1A receptor, thus reattaining equilibrium between the actions of 5-HT 1A and 5-HT 2C receptors and this leads to increased 5-HT levels in the synaptic clefts which results in delayed ejaculation [Citation11]. Each patient was assessed with measurements of IELT using a stopwatch (held by the partner) at baseline and after treatment.

About dapoxetine

& Giuliano, F. Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries. It presents diseases of the genital organs through detailed text and images. Some content may not be suitable for children or sensitive readers. Many illustrations are available exclusively to Steady members.

Cardiovascular safety

Are you a physician and interested in supporting this project? Join Steady to unlock full access to all images and enjoy an ad-free experience. Try it free for 7 days—no obligation. New release: The first edition of the Urology Textbook as an e-book—ideal for offline reading and quick reference. With over 1300 pages and hundreds of illustrations, it’s the perfect companion for residents and medical students. A full explanation about the measurement of the ILET (beginning with intromission and ending with ejaculation) was done.

• Use of dapoxetine should be discontinued if adverse reactions are severe or persistent.
• Keep track of dosage and frequency to avoid overdose and ensure safety.
• Dapoxetine is not intended for recreational use; misuse can be harmful.
• Always keep medication out of reach of children and pets to prevent accidental ingestion.

The Kim and Paick scale, which ranges from 0 to 5, while 0 denoting severe dissatisfaction and 5 denoting extreme pleasure, was used to evaluate sexual satisfaction in all participants prior to and following therapy [Citation15].

Additional information

After your 7-day trial has ended, you will receive a download link for your exclusive e-book. To compare the efficacy of tadalafil alone, dapoxetine alone, and tadalafil with dapoxetine as a combination therapy for the treatment of premature ejaculation. Eligible patients attended our andrology clinic with premature ejaculation were randomly allocated into three groups: group A (92 participants) received on-demand tadalafil, 5 mg; group B (91 participants) were given on-demand dapoxetine, 30 mg; and group C (89 participants) received on-demand combination of tadalafil, 5 mg, and dapoxetine, 30 mg. We assessed the changes in the intravaginal ejaculatory latency time (IELT) and the satisfaction scores 1, 2, and 3 months after treatment. Highly statistically significant improvements were found in the mean IELT and satisfaction scores 1, 2, and 3 months post-treatment in all groups (P = <0.001).

Getting rid of any unwanted medicine

Post hoc analysis suggested this improvement was more pronounced in group C (P < 0.001). Both tadalafil and dapoxetine are effective in the treatment of patients with premature ejaculation, but the combination of both drugs gives better results. Premature ejaculation (PE) is a male sexual disorder characterized by a brief intra-vaginal ejaculatory latency time (IELT) and lack of ability to properly control ejaculation which has detrimental personal effects [Citation1]. There is no global definition for PE. PE is defined according to the International Society for Sexual Medicine (ISSM) guidelines as ejaculation that always happens in fewer than 1 minute following vaginal penetrating from the initial sexual encounter (lifelong PE), or a decrease in IELT, less than 3 min (acquired PE) with inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences, such as distress, frustration, bother and/or avoidance of sexual intimacy [Citation2]. Patients were also advised to note any side effects following medication delivery in their follow-up sheets both during medication intake and at the end of treatment.

Advice Point	Explanation
Take 1-3 hours before sex	Ensures optimal effectiveness
Do not exceed 1 dose per 24 hrs	Risk of side effects and overdose
Avoid alcohol during use	Can increase side effects
Report adverse effects promptly	E.g., suicidal thoughts, severe dizziness
Use as part of a complete plan	Consult a healthcare provider for best results

Patients were followed up every month for three months.

Storage Condition	Temperature Range	Protect From	Additional Tips
Cool, dry place	20°C - 25°C	Moisture & Light	Keep out of reach of children
Away from heat	Up to 25°C	Sunlight	Store in original container
Humidity control	Avoid bathroom	Humid environments	Ensure proper sealing

The local Ethics Committee approved the study.

• Dapoxetine 30 mg may cause side effects such as nausea, dizziness, or headache.
• Avoid alcohol while taking dapoxetine to reduce the risk of adverse effects.
• It is not recommended for use in individuals with heart conditions or liver issues.
• Store the medication at room temperature away from moisture and children.

The ethical approval code is: SVU-MED-URO 016-1-21-4-183.

Uses of Dapoxetine

Exercise caution when dapoxetine is used with other centrally acting depressants (such as alcohol, sedatives, or opioids) because of the potential for additive sedative effects. Moderate and severe hepatic impairment (Child–Pugh B and C). Severe renal impairment with an estimated glomerular filtration rate of less than 30 mL/min. Significant structural heart disease (such as heart failure New York Heart Association class II–IV, clinically relevant conduction disorders, significant coronary artery disease, or severe valvular heart disease). Mania, major depression, or ongoing psychiatric pharmacotherapy (see above).

International Society of Sexual Medicine

Dapoxetine is not approved for women, children, or adolescents. The recommended starting dose for on-demand use is 30 mg taken orally 1 to 3 hours before anticipated sexual activity. The maximum dosing frequency is once per day. If the response is inadequate and tolerability is good, the dose may be increased to 60 mg. If there is no meaningful improvement or if adverse effects are unacceptable, clinicians should discontinue treatment. The study was performed according to the ethical declaration of Helsinki.

• Dapoxetine 30 mg has a rapid onset, with effects usually felt within 1-3 hours.
• Do not exceed the prescribed dose to reduce the risk of severe side effects.
• Combining dapoxetine with certain medications may cause interactions; always inform your doctor.
• It’s important to follow the prescribed timing for maximum effectiveness.

Every participant signed a written statement of permission.

• Common side effects include nausea, loss of balance, and dry mouth.
• If serious side effects like irregular heartbeat occur, seek medical help immediately.
• Dapoxetine may not be suitable for all men, especially those with cardiovascular issues.
• Regular medical check-ups are important while using this medication long-term.