Tuesday, November 3, 2009

There is a Guideline for That

Medical and voluntary health organizations as well as governmental organizations and departments of health often propose guidelines for treating specific diseases. The guidelines are meant to offer a treatment outline that is based on the best data available on efficacy and safety. Not all recommendations refer to the use of drugs. There can be guidelines for treating sports conditions for example that physical therapists follow in regards to exercises to prescribe.

I am most versed in the Clinical Practice Guidelines for Treating Tobacco Use and Dependence because it is my job to promote them. They ARE backed by our Department of Health and Human Services and the CDC as well as some medical organizations. Two other guidelines that come to mind are for the treatment of hypertension and the treatment of high cholesterol.

Today I read the Guidelines for Treatment of Erectile Dysfunction. Yup, I am all about promoting penile health. These guidelines are not the official position of any other agency at this time, but they are formed out of research from several random controlled clinical trials and they are offered by the American College of Physicians to whom I give some clout.

In the analysis of existing studies, the scientists have determined that hormonal therapy for erectile dysfunction is not recommended as a first line therapy, but may be applied to individual patients based on their presenting symptoms.

Erectile Dysfunction is defined as not being able to maintain or sustain an erection sufficient for satisfactory sexual performance, consistently over time. Treatment is indicated if the problem exists for three months or more. In other words, if a man cannot get an erection after being out all night drinking, that is not ED. Of course, I like the phrase "satisfactory sexual performance" - is that subjective or does the partner get to offer an opinion??

These guidelines recommend the use of erectile dysfunction medications such as Viagra, Levitra and Cialis as well as two more. Can you believe that there are 5 different medicines for this condition?!

The drug names are sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil. They are Viagra, Levitra, Cialis, no brand name yet - drug under study, and Zydena which is not for sale in the USA (respectively). The class of drugs is referred to as phosphodiesterase type 5 or PDE-5.

I am beginning to doubt my professors who assured us that you have to have a drug that treats an illness more completely or safely then an existing drug or a drug to treat a condition that is not yet treated in order to get an approved new drug application from the FDA. Why are there FIVE or at least THREE in the US.

The research shows that all five are equally as effective and have minimal side effects. The clinical guidelines do NOT recommend one drug over the other and say that the decision should be based on patient and doctor preference, side effect profile and / or cost. [I am going to guess the patient will request the one that had the best commercial]

Here is a link to more info on ED [it does discuss hormonal therapy but the guidelines state that the evidence for benefit is inconclusive]


ED can be associated with age, weight, diabetes, heart disease, depression, prostate cancer, low testosterone levels and smoking.

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