Effectiveness of Spedra

What is erectile dysfunction?

The International Society for Sexual Medicine defines erectile dysfunction as a man’s inability to achieve or maintain an erection suitable for satisfactory sex. When a man is sexually aroused, nerves and chemicals work together to relax smooth muscle tissue and widen arteries so that the penis can fill with blood. Veins constrict to keep the blood inside the penis, forming the erection. Once the man ejaculates, the blood is released back into the body.

Erectile dysfunction can happen for many reasons, both physical and psychological. The most common causes of erectile dysfunction are poor blood flow to the penis, nerve damage, hormonal issues, medication side effects, Peyronie’s disease and psychological and emotional issues. Also, your lifestyle can interfere with this erectile function. Smoking, obesity, drug and alcohol abuse, an unhealthy diet and poor exercise habits can contribute to other health conditions associated with erectile dysfunction.

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The incidence of erectile dysfunction

The incidence of erectile dysfunction increases with increasing age. Men aged 18-59 years have an incidence of erectile dysfunction of 10%.

Other data looking at similar groups divided the age groups into 10-year sections and found that, by setting individuals aged 18-29 years as a reference group, individuals aged 50-59 years had a 3.5 times higher incidence of erectile dysfunction. Another survey found that males older than 70 years had a 61% incidence of erectile dysfunction.

 

When does erectile dysfunction occur?

Erectile dysfunction becomes more common as men get older. It’s also associated with some medical conditions, like heart disease and diabetes. In fact, diabetic men are 4 times more likely to develop erectile dysfunction than those without diabetes. They also tend to develop erectile dysfunction 10 to 15 years earlier and have more severe cases.

 

What Spedra is and what it is used for?

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors and is a treatment for adult men suffering from erectile dysfunction (also known as impotence).

It works by helping the blood vessels in your penis to relax, which increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra is not a cure for your condition however it is a treatment.³

Spedra is commercialised and promoted in over 40 European countries plus Australia and New Zealand. It is a new phosphodiesterase-5 inhibitor (PDE5-i) approved by the European Commission (EC) in June 2013 for the treatment of erectile dysfunction.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction.

Spedra is not intended for women.

 

Mechanism of action

Spedra is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by Spedra produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Spedra has no effect in the absence of sexual stimulation.³

 

How to take Spedra?

The recommended dose of Spedra is a 100 mg tablet, once a day.

You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking medicines such as erythromycin (a drug to treat infections), amprenavir, fosamprenavir (antiviral drugs), aprepitant (a drug that prevents vomiting), diltiazem (a drug to treat angina pectoris and high blood pressure), fluconazole (a drug to treat mycosis) or verapamil (a medication used for the treatment of high blood pressure, angina, and supraventricular tachycardia), the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

Dose adjustments are not required in patients aged 65 years and older. However, the available data on patients aged ≥ 70 years old is limited. Similarly, dose adjustments are not required in patients with diabetes mellitus or mild-to-moderate renal impairment. 4

You should take Spedra about 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated.

Spedra can be taken with or without food. However, if taken with large meals, it may take longer to work.

 

Is Spedra simple to use?

Yes. Spedra is an oral treatment which is taken on demand. You simply take a pill roughly 30 minutes before you plan to have sex. It doesn’t need to be taken at specific times on any given day, or with meals, so it’s not possible to “forget” to take it.

Spedra is also taken on a one-tablet basis, so the user does not have to remember how many tablets to take or worry about reducing or increasing their dose in increments.

Compared to other medication forms such as injections or urethral devices, Spedra tablets are a discreet and convenient way of administering treatment for erectile dysfunction.

 

Effectiveness of Spedra

In clinical trials, avanafil was assessed for its effect on the ability of men with erectile dysfunction to achieve and maintain an erection sufficient for satisfactory sexual activity.

Avanafil was evaluated in 4 randomised, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration in the general population with erectile dysfunction, in patients with type 1 or type 2 diabetes and erectile dysfunction, and in patients with erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

The fourth study investigated the onset of action of avanafil at 2 doses (100 and 200 mg) in terms of the per-subject proportion of sexual attempts resulting in the satisfactory completion of sexual intercourse. A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (4 studies), respectively. Patients were instructed to take 1 dose of study medicinal product approximately 30 minutes prior to initiation of sexual activity. In the fourth study, patients were encouraged to attempt sexual intercourse approximately 15 minutes post-dosing, to assess the onset of the erectogenic effect of avanafil, taken on an as-needed basis, at 100 and 200 mg dose.

In addition, a subset of patients was enrolled in an open-label extension trial with 493 patients receiving avanafil for at least 6 months and 153 patients for at least 12 months. Patients were initially assigned to avanafil 100 mg and at any point during the trial, they could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual response to treatment.

In all trials, statistically significant improvement in all primary efficacy measures was observed for all 3 doses of avanafil compared to placebo. These differences were maintained with long-term treatment (as per studies in the general ED population, in diabetics with ED and in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial).

The percentages of successful intercourse attempts after taking each dose were as follows:³

  • The 50 mg dose had a 47% success rate;
  • The 100 mg dose had a 58% success rate;
  • The 200 mg dose had a 59% success rate.

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In men with either type 1 or type 2 diabetes mellitus, the mean percentage of attempts resulting in successful intercourse was approximately 34% and 40% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 21% for the placebo group.

In the time to onset study, avanafil demonstrated statistically significant improvement in the primary efficacy variable as compared with placebo, resulting in successful intercourse in 24.71% of the attempts for the 100 mg dose and 28.18% for the 200 mg dose at approximately 15 minutes after dosing compared to 13.78% for placebo.

Across all the pivotal trials of avanafil, the percentage of successful intercourse attempts was significantly higher for all doses of avanafil compared to placebo for attempts at all post-dosing time intervals examined.

 

What are the benefits of Spedra?

It is well known the speed at which Spedra works. Whereas most other oral drugs taken on demand may take between 30-60 minutes to produce noticeable results in erectile dysfunction patients, Spedra is often reported to get to work within 15-30 minutes.

However, this is not the only advantage of using Spedra:

  • Spedra was proven efficient in many trials and all its doses had an over 50% success rate;
  • Its price is in most of the cases lower than Viagra or Cialis;
  • It is a patented, innovative medication which means there is only one version of the treatment and it is, in some cases, easier to ensure you’re getting a genuine item.

 

How do I know if I need Spedra?

Having erection problems does not immediately mean you need to be taking a male sexual enhancement drug such as Spedra. Erectile dysfunction or impotence can be caused by a variety of reasons. Examine the reasons for your problems before taking Spedra.

Remember that Spedra is a treatment for erectile dysfunction, which is a symptom. Don’t buy the medication before talking with your doctor first. Determine if you have the desire to have sex with your partner. If the problem is psychological, Spedra may not work. Stress, anxiety and low self-esteem may be psychological factors that cause impotence. If your problem is not physical, a therapist can help you and your partner have a satisfactory sex life.

Consider the times when you desired to have sexual intercourse. The inability to maintain an erection for sex at least 25% of the time, may indicate erectile dysfunction.5

Visit your doctor for a physical examination. Your doctor can rule out any underlying problems that could be causing erection difficulties.

 

Do not take Spedra:

  • If you are allergic to avanafil or any of the other ingredients of this medicine;
  • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure;
  • If you are taking drugs for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir;
  • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin;
  • If you have a serious cardiac problem;
  • If you have had a stroke or heart attack in the last 6 months;
  • If you have low blood pressure or high blood pressure not controlled by medicines;
  • If you have chest pain (angina) or you get chest pain during sexual intercourse;
  • If you have a serious liver or kidney problem;
  • If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischaemic optic neuropathy);
  • If certain serious eye problems run in your family (such as retinitis pigmentosa);
  • If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.³

 

Does Spedra interact with other medicines?

Yes, it does. Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Alpha-blockers – for prostate problems or for lowering your high blood pressure;
  • Medicines for an irregular heartbeat („arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol;
  • Antibiotics for infections such as erythromycin;
  • Phenobarbital or primidone – for epilepsy;
  • Carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain;
  • Other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4 inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil;³
  • Riociguat.

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil. If any of the above applies to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

 

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects:

  • An erection that will not go away (“priapism”). If you get an erection that lasts more than 4 hours, this must be treated as soon as possible, because this is a serious side-effect and will affect your penis for a long time (including not being able to get erections);³
  • Blurred vision;
  • Sudden decrease or loss of vision in one or both eyes;
  • Sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).

 

The use of avanafil is contraindicated in:

  • Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
  • Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg);³
  • Patients with unstable angina, angina with sexual intercourse, or congestive heart failure, categorised as class 2 or greater.

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Take home messages

  • Erectile dysfunction is considered a disease of vascular origins in many patients and affects approximately 52% of men between the ages of 40 and 70
  • Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists), lifestyle (tobacco, alcohol use, drug use), diseases (diabetes, vascular conditions, metabolic syndrome, obesity), and spinal cord injuries.
  • Left untreated, erectile dysfunction can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt.
  • However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with treatment.
  • The market opportunity for ED medical treatments continues to grow, with worldwide sales exceeding $5.5 billion.
  • Spedra, the trade name for avanafil in the EU, after proving its efficacy and safety in numerous clinical trials, was approved by the European Medicines Agency for the treatment of erectile dysfunction in the EU.

 

References

https://www.issm.info/sexual-health-qa/what-is-erectile-dysfunction1/;
Ryan M Burke, Jeffery D Evans. Avanafil for the treatment of erectile dysfunction: a review of its potential. Vasc Health Risk Manag. 2012; 8: 517–523. PMCID: PMC3433322. PMID: 22973106. DOI: 10.2147/VHRM.S26712
https://www.ema.europa.eu/documents/product-information/spedra-epar-product information_en.pdf;
Giovanni Corona, Mario Maggi, Emmanuele A. Avanafil: The second-generation treatment of erectile dysfunction. https://emj.europeanmedical-group.com/wp-content/uploads/sites/2/2018/01/Avanafil-The-Second-Generation-Treatment-of-Erectile-Dysfunction.pdf
https://www.treated.com/erectile-dysfunction/spedra/advantages-of-spedra;

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