Sponsored by an educational grant from Schering
Participation in this presentation will enable the attendee to become familiar with the fundamental concepts
necessary for the safe and effective monitoring of adult men receiving testosterone.
The administration of any testosterone preparation requires that the treating physician, as well as the patient, be committed to regular follow-up Recommendations exist from several societies for the monitoring of these men. They apply equally to all testosterone preparations, including Nebido®. Some basic issues regarding watchful supervision of treatment are consistent across different sets of recommendations, as follows:
1) Monitoring should take place quarterly for the 1st year. If the situation is stable, yearly follow-up is sufficient. These visits should assess both the safety and effectiveness of treatment. This schedule fits remarkably well with the known PK efficacy period of Nebido® as shown by Dr. Schubert in this symposium.
2) Each visit should include an assessment of efficacy. This, of course, depends on the individual's most
prominent manifestations. For instance, improvement in sexual performance may be evident within 12 to 24
weeks; not so for sarcopenia or osteoporosis. "Placebo effect" may be observed for several months with any testosterone delivery form.
3) Safety, undoubtedly, remains the highest priority for Nebido® or any other testosterone formulation. What
are the mandatory assessments?
a) Patient's report of adverse effects (e.g.: acne, oedema, LUTS, etc.)
b) Prostate health (assessed by DRE, PSA and, if indicated, by residual urine, etc.)
c) Lipid profile*
d) Haematology*
e) Liver function*(in part for legal considerations)
f) Sleep disturbances
g) Negative behavioural alterations
The presentation will include illustrative information of the most relevant situations facing the clinician.
This presentation will also emphasize that there is no place, in any practice that offers testosterone therapy, for the uninterested or uninformed physician. Equally, the patient must devote the necessary time to attend and participate in a regular follow-up program. Monitoring is not onerous. Following the recommendations listed above makes testosterone replacement safe and ensures that these men truly need it and benefit from it.
*It is understood that baseline determinations were carried out prior to the onset of therapy.
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