How Effective Is Levitra?

Posted by MensPharmacy
Aug.10, 2018 Levitra

Levitra is one of the treatments for erectile dysfunction available for sale here at Mens Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.

This article is about the effectiveness of Levitra. We’ll cover what Levitra is, what it is used for, the mechanism of action and what the results from clinical trials say about the effectiveness of Levitra.

 

What is Levitra?

Levitra is the brand name for a medication known as Vardenafil Hydrochloride. It belongs to the pharmacotherapeutic group known as Urologicals.
Each film−coated tablet of Levitra contains 5mg, 10mg or 20mg Vardenafil.
Levitra is available as round orange tablets marked with the BAYER-cross on one side and “5, 10 or 20” on the other side.

The other substances (excipients) in each film coated Levitra tablet (that are inactive) include:

Tablet core:

  • Crospovidone
  • Magnesium stearate
  • Microcrystalline cellulose
  • Silica, colloidal anhydrous

Film coat:

  • Macrogol 400
  • Hypromellose
  • Titanium dioxide (E171)
  • Ferric oxide yellow (E172)
  • Ferric oxide red (E172)

Levitra is also available as 10mg orodispersible tablets. Each orodispersible tablet contains 10mg of Vardenafil (as the Hydrochloride).
Excipients include:

  • Aspartame (E951)
  • Peppermint flavour
  • Magnesium stearate
  • Crospovidone
  • Mannitol (E421)
  • Silica colloidal hydrated
  • Sorbitol (E420)

There is 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.
Orodispersible Levitra tablets are available as white round tablets.

The legal category for Levitra (Vardenafil) is POM. This means that this medication is a prescription only medicine and it can only be supplied or sold according to the instructions in a prescription issued by a duly qualified and registered doctor or non-medical prescriber.
You should not buy this or any other prescription-only medication without first speaking to a duly qualified and registered healthcare professional like a doctor or non-medical prescriber.

 

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What is Levitra used for?

Levitra (Vardenafil) is indicated for the treatment of erectile dysfunction in adult men aged 18 years and older.
Please note that for Levitra to be effective, sexual stimulation is required.

 

What is the mechanism of action Levitra?

Levitra (Vardenafil) is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural setting, i.e., with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
Penile erection is a haemodynamic process. During sexual stimulation, nitric oxide is released. It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. This, in turn, results in smooth muscle relaxation, allowing increased inflow of blood into the penis. The level of cGMP is regulated by the rate of synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing phosphodiesterases (PDEs).
Levitra (Vardenafil) is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum. Levitra (Vardenafil) potently enhances the effect of endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5. When nitric oxide is released in response to sexual stimulation, inhibition of PDE5 by Levitra (Vardenafil) results in increased corpus cavernosum levels of cGMP. Sexual stimulation is therefore required for Levitra (Vardenafil) to produce its beneficial therapeutic effects.#

 

How effective is Levitra?

According to the Marketing Authorisation holder of Levitra (Vardenafil), In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
In a penile plethysmography (RigiScan) study, Levitra (Vardenafil) 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing. The overall response of these subjects to Levitra (Vardenafil) became statistically significant, compared to placebo, 25 minutes after dosing.
Levitra (Vardenafil) causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure following 20 mg and 40 mg Levitra (Vardenafil) were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of Levitra (Vardenafil), when compared to placebo. These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells. Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
A single dose, double-blind, crossover, randomised trial carried out in 59 healthy males compared the effects on the QT interval of Levitra (Vardenafil) (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo. Moxifloxacin (400 mg) was included as an active internal control. Effects on the QT interval were measured one-hour post-dose (average Tmax for Levitra (Vardenafil)). The primary objective of this study was to rule out a greater than 10 msec effect (i.e., to demonstrate lack of effect) of a single 80 mg oral dose of Levitra (Vardenafil) on QTc interval compared to placebo, as measured by the change in Fridericia’s correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point. The Levitra (Vardenafil) results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose. At Tmax, only the mean change in QTcF for Levitra (Vardenafil) 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11). When using the individual correction formulae, none of the values were out of the limit.
In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg Levitra (Vardenafil) or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect. Both Levitra (Vardenafil) and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone. The actual clinical impact of these QT changes is unknown.
Further information on clinical trials with Levitra (Vardenafil) 10 mg orodispersible tablets
Efficacy and safety of Levitra (Vardenafil) 10 mg orodispersible tablets were separately demonstrated in a broad population in two studies including 701 randomized erectile dysfunction patients who were treated up to 12 weeks. The distribution of patients in the predefined subgroups was covering elderly patients (51%), patients with a history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%).
In pooled data from the two Levitra (Vardenafil) 10 mg orodispersible tablets trials, IIEF-EF domain scores were significantly higher with vardenafil 10 mg orodispersible tablet versus placebo.
A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration compared to 44% of all attempts in the placebo group. These results were also reflected in subgroups, in elderly patients (65%), in patients with a history of diabetes mellitus (63%), patients with a history of dyslipidemia (66%) and hypertension (70%) of all sexual attempts reported had successful penetration.
About 63% of all reported sexual attempts with Levitra (Vardenafil) 10 mg orodispersible tablets were successful in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts. In the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% (patients with a history of dyslipidemia) and 60% (patients with history of hypertension) of all reported attempts with vardenafil 10 mg orodispersible tablets were successful in terms of maintenance of erection.
Further information on clinical trials
In clinical trials, Levitra (Vardenafil) was administered to over 17,000 men with erectile dysfunction (ED) aged 18 – 89 years, many of whom had multiple co-morbid conditions. Over 2,500 patients have been treated with Levitra (Vardenafil) for six months or longer. Of these, 900 patients have been treated for one year or longer.
The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidemia (22%), depression (5%), radical prostatectomy (9%). The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions. No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed.
Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of erectile function compared to placebo. In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.
In fixed-dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period. The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.
In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on Levitra (Vardenafil) were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
In a clinical trial in patients with diabetes mellitus, Levitra (Vardenafil) significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at Levitra (Vardenafil) doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg Levitra (Vardenafil) compared to 36% and 23% on placebo for patients who completed three months treatment.
In a clinical trial in post-prostatectomy patients, Levitra (Vardenafil) significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at Levitra (Vardenafil) doses of 10 mg and 20 mg. The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg Levitra (Vardenafil) compared to 22% and 10% on placebo for patients who completed three months treatment.
In a flexible-dose clinical trial in patients with Spinal Cord Injury, Levitra (Vardenafil) significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo. The number of patients who returned to a normal IIEF domain score (≥26) was 53% on Levitra (Vardenafil) compared to 9% on placebo. The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which was clinically and statistically significant (p<0.001).
The safety and efficacy of Levitra (Vardenafil) were maintained in long-term studies.

 

 

Absorption

In Levitra (Vardenafil) film-coated tablets, Vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration. However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. The mean absolute oral bioavailability is 15%. After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5 – 20 mg).
When Levitra (Vardenafil) film-coated tablets are taken with a high-fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median Tmax of 1 hour and a mean reduction in Cmax of 20%. Vardenafil AUC is not affected. After a meal containing 30% fat, the rate and extent of absorption of vardenafil (Tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.
Levitra (Vardenafil) is rapidly absorbed after administration of Vardenafil 10 mg orodispersible tablets without water. The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets. Mean Vardenafil AUC was increased by 21 to 29% (middle-aged and elderly ED patients) or 44% (young healthy subjects) with 10 mg orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small amount of drug in the oral cavity. There was no consistent difference in mean Cmax between orodispersible tablets and film-coated tablets.
In subjects taking Levitra (Vardenafil) 10 mg orodispersible tablets with a high-fat meal, no effect on Vardenafil AUC and Tmax was observed, while Vardenafil Cmax was reduced by 35% in the fed condition. Based on these results Vardenafil 10 mg orodispersible tablets can be taken with or without food.
If Levitra (Vardenafil) 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax remains unchanged and the median Tmax is shortened by 60 minutes compared to intake without water. Vardenafil 10 mg orodispersible tablets must be taken without liquid.

 

Is there anything else I need to know about Levitra?

Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10 mg film-coated.
A physical examination may be required to diagnose your erectile dysfunction and determine potential underlying causes before pharmacological treatment is considered.
Grapefruit or grapefruit juice should be avoided whilst taking Levitra (Vardenafil). This is because taking both at the same time could lead to an increase in the blood plasma concentration of Levitra (Vardenafil). This increase in blood plasma concentration of Levitra (Vardenafil) could potentially increase the risk and severity of side effects.
If you develop any visual defects suddenly, you should stop taking Levitra (Vardenafil) and consult a doctor immediately.
As no studies have been carried out on the effects of Levitra on the ability to drive and use machines have been performed, patients are advised to be aware of how they react to Levitra (Vardenafil) before driving or operating any machinery due to the reports of dizziness and abnormal vision in clinical trials.

 

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References

  1. https://www.medicines.org.uk/emc/product/7629/smpc
  2. https://www.medicines.org.uk/emc/product/7629/smpc#EXCIPIENTS
  3. https://www.medicines.org.uk/emc/product/4513/smpc
  4. https://www.medicines.org.uk/emc/product/4513/smpc#CLINICAL_PARTS
  5. https://www.medicines.org.uk/emc/product/4513/smpc#POSOLOGY
  6. https://www.medicines.org.uk/emc/product/7629/smpc#POSOLOGY
  7. https://www.medicines.org.uk/emc/product/4513#FORM
  8. https://www.medicines.org.uk/emc/product/7629#MACHINEOPS
  9. https://www.medicines.org.uk/emc/product/7629#PHARMACOLOGICAL_PROPS
  10. https://www.medicines.org.uk/emc/product/7629#PHARMACOKINETIC_PROPS

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