Morgentaler A, Krakowsky Y, Conners W, Davidson E, Rawji A. Initial Clinical Experience with Testosterone Undecanoate Therapy (AVEED (R)) in Testosterone-Deficient Men in the United States. Urology. http://www.goldjournal.net/article/S0090-4295(17)30732-X/abstract
OBJECTIVE: To report our initial experiences with TU 750mg in testosterone-deficient men.
METHODS: All patients receiving TU 750mg at our center between July 1 2014 to August 1 2016 were identified. Clinical response was assessed via structured interviews and laboratory evaluations. Adverse events were documented, including increases in prostate specific antigen (PSA), hematocrit (Hct), and the development of post-injection cough.
RESULTS: More than two injections were received by 147 men, with mean age 63.2 years. Mean baseline total and free T were 305 ng/dL and 0.69 ng/dL, respectively. Nadir mean results during treatment were higher for total and free T, at 413.2 ng/dL and 0.81 ng/dL, respectively (p<0.001 for each).
SYMPTOMATIC IMPROVEMENT WAS REPORTED BY 97/147 PATIENTS (66.0%). THIRTY PATIENTS (20.4%) DISCONTINUED THERAPY. Return of symptoms prior to next injection was noted by 34%, managed by reduced interval between injections and/or supplemental injection of T cypionate.
Three patients (2%) experienced transient cough immediately following TU injection, none requiring intervention. Mean Hct rose from 45.6% to 47.2%. Mean PSA rose from 1.7 ng/ml to 2.0 ng/ml. There were no strokes, myocardial infarctions, or deaths, and no new cases of prostate cancer.
CONCLUSION: This initial clinical experience with TU 750 mg (AVEED(R)) provides evidence for good patient satisfaction and persistence with treatment, together with a favorable safety profile. Optimal dosing may be less than 10 weeks for some individuals.
