Research: effectiveness and safety of Levitra are measured

1. Long-term use among patients who were treated according to a “three-drug regime

STUDY OBJECTIVES

To study long-term use among patients who were treated according to a “three-drug regime”. There are three PDE5 inhibitors marketed, Viagra, Levitra and Cialis. Although oral treatment is simple and mostly effective, approximately fifty percent of men stop using the medication within two years. It was hypothesised that compliance would improve if the patient was allowed to try all three PDE5 inhibitors and to prescribe the drug(s) he and his partner found most effective.

DESIGN

A non-intervention survey.

PATIENTS

127 men with an average age of sixty years who had all participated in treatment regimes in 2003 that allowed them to test all three drugs

METHODS

The patients were interviewed by telephone between two and three years after completing their treatment program.

RESULTS

The reason given for discontinuing use was that erections were achieved without drug support. Just over 85% were still using PDE5 inhibitors. The usage varied between one and eight tablets per month. Three-quarters polled used only one drug. The others switched between a short- and slow-acting drug as required. One quarter had changed their drug preference through their experience over three years.

CONCLUSIONS

That patients were more inclined to continue drug use if they were given control over the type of drug and dosage they were allowed to take.

2. The effect of Levitra on kidney function in rabbits with induced Diabetes

STUDY OBJECTIVES

A pilot study of the effect of Levitra on kidney function in rabbits with induced Diabetes.

METHODS

Blood and urine samples were analysed from two groups: a group of rabbits with induced diabetes given Levitra and a control group.

RESULTS

Serum creatinine concentration significantly increased after six months Diabetes, was significantly reduced by Levitra. As compared to control animals, TP/C from diabetic rabbit spot urine samples at six months were elevated significantly, demonstrating that proteinuria was present. TP/C was also normalised. Diabetic animals receiving Levitra showed a significant improvement in CrCl when compared with diabetic animals given vehicle.

CONCLUSION

There is a potential role for Levitra in the treatment of kidney damage caused by long-term exposure to high blood glucose levels.

Further reports

A short research exercise has recently confirmed that the Erection Quality Scale is responsive and internally consistent, and more useful than the International Index of Erectile Function. This study provides strong evidence supporting the use of the Erection Quality Scale in clinical trials. It was assumed that sexual symptoms can be evidence of underlying disease. Thus, sexual enquiry should be an integral component of diagnostic methodology.

A number of other research trials are under way to assess the evidence of effectiveness and safety over time. One of the most important is the investigation of the appearance of vision problems in a very small number of users. Other than this, the PDE5 inhibitors are mature products in a well-established market so the focus of research is shifting to measure other factors.

3. The effectiveness and safety of Levitra

STUDY OBJECTIVES

To study the effectiveness and safety of Levitra, and to assess the effect of treating erectile dysfunction on the female partner’s sexual quality of life.

DESIGN

A randomised, double-blind, parallel group study of Levitra with a placebo control.

PATIENTS

350 male patients suffering from ED and their partners.

INTERVENTIONS

In the first four weeks, patients were allocated either 10mg Levitra or placebo. In a second eight week period, the dosage of Levitraeither stayed the same, or was adjusted to 5mg or 20mg. Diary records, global confidence questions and partnership questionnaires assessed effectiveness and measured the self-esteem of the male patients.

RESULTS

Pending

CONCLUSIONS

Awaited.

4. The effectiveness and safety in the use of Levitra in routine treatment of ED

STUDY OBJECTIVES

To obtain data on effectiveness and safety in the use of Levitra in routine treatment of ED and to assess the effect of the treatment on self-esteem in men with ED.

DESIGN

An open, uncontrolled, prospective, non-interventional post-marketing surveillance study.

RESULTS

Pending

CONCLUSIONS

Awaited.