Posted on 06-07-2012
Filed Under (Levitra) by admin

Levitra is the market/brand name of the drug Vardenafil hydrochloride-a newer phosphodiesterase-5 (PDE5) inhibitor, which is prescribed to treat male erectile dysfunction. It is available in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage round tablets which need to be taken 1-2 hours before sexual intercourse to attain and maintain penile erection in men. Commonly prescribed start-up dose is 10 mg. As compared to the traditional drug Viagra (Sildenafil), it has a longer half-life (therefore longer duration of action) and similar efficacy (effectiveness).

Levitra- Clinical trials to study effect on blood cholesterol levels: A double blind clinical trial study was conducted to observe all the clinical effects of Levitra when compared to a placebo. In this study, about 400 men participated that were suffering from erectile dysfunction and high levels of blood cholesterol. After the study was over, it was observed from the results that erectile dysfunction in these men showed significant improvement as compared to a placebo, while no significant effects were seen on their blood cholesterol levels.

In this study group, all the participants were taking cholesterol-controlling agents, more specifically statins for their dyslipidemia. The trial was conducted for 12 weeks with random selection of patients and physicians. It showed the success rate of penetration of Levitra was significantly higher than a placebo and resulted in sustained erection.

Clinically, there are many cases seen about the same scenario in which patients who suffer from hyperlipidemias also end up suffering from erectile dysfunction later on. Due to this particular finding, this study was conducted to see effects of drugs given for erectile dysfunction on patients with concurrent hyperlipidemias. It has been proved now that men who take Levitra while having high blood cholesterol levels, show positive response in terms of erectile dysfunction improvement.

Levitra-recent studies:
Recent studies done on Levitra show a very rare reporting of development of short-term amnesia or short-term memory loss in men taking this drug. In such patients, short bouts of decreased memory or frank amnesia (complete memory loss) have been reported that do not last longer than a day, and there are no associated symptoms seen. Due to extreme rarity of this finding, no warnings or precautions will be added to the labels. Instead, amnesia will be added to the rarely reported side effects from taking Levitra. However, FDA (Food and Drug Administration) and Bayer Pharmaceuticals (manufacturers of Levitra) have agreed to change the wordings on Levitra. Cialis and Viagra have yet not decided the same.

Yet another study has indicated its effects on heart in terms of a certain degree of cardiac protection. The results were published in the March issue of the Journal of Molecular and Cellular Cardiology. It has been reported that in patients suffering from myocardial infarction (Heart attacks), pretreatment with Levitra in clinically relevant doses produces a protective effect against heart attack injury. Following the results of this study, it has been stated that giving phosphodiesterase inhibitors (specifically PDE5 such as Levitra) for one day to patients who are at high risk of acute myocardial infarction or those undergoing coronary artery bypass surgery, might improve cardiac protection.
Levitra-Use in elderly: Elderly men with age 65 years or more tend to have higher plasma/blood concentration of Vardenafil when compared to younger men in the age group of 18 to 45 years. Therefore, the drug dosage for elderly is generally kept lower than adult males. In a Phase 3, (double blind) clinical trial conducted on more than 834 elderly men showed that the safety and efficacy of Vardenafil were not different in them when compared to young males. However, due to the finding of higher blood concentrations, a start up dose of 5 mg Levitra is generally prescribed in men more than 65 years of age.

Patients Subgroups with No Clinical Trials Done:
Following are the patient subgroups where still no clinical studies have been performed to state the safety of Levitra with the following diseases or disorders: 1. Patients with high blood pressure (hypertension) 2. Hypotensive patients ( resting systolic blood pressure of <90 mmHg) 3. Unstable angina 4. Recent stroke 5. Recent history of myocardial infarction (within last 6 months) 6. Life-threatening arrhythmias 7. End-stage renal failure (requiring dialysis) 8. Hereditary degenerative retinal diseases/disorders e.g. retinitis pigmentosa 9. Severe liver impairment/failure 10. Severe cardiac failure Its use in these patients is not recommended until further clinical information and data is not available. Studies on Carcinogenesis and Fertility Impairment:
In vitro studies of use of Levitra have shown that it is not carcinogenic when given for 24 months to experimental rats and mice. In vitro bacterial Ames assay has shown that the Maximum Recommended Human Dose (MRHD) of 20 mg is not mutagenic (mutation inducing). In addition, studies conducted on Chinese hamster V79 cells have proved this observation.
Studies conducted on healthy volunteers with a single dose of 20 mg Levitra have shown that there was no effect on either sperm motility or its morphology. This supports that use of Levitra does not affect fertility adversely.

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