Long-Term Testosterone Therapy: Effects on Hypogonadal Men with Type 1 Diabetes
APRIL 01, 2017
Farid Saad, DVM, PhD, Bayer Pharma AG explained to MD Magazine, at ENDO 2017 that he and his team conducted an effectiveness and safety study nearly 13 years ago on a long acting testosterone injection launched in Germany. They observed several patients visiting a urology office in the north of Germany with various complaints who were screened for testosterone therapy. If a patient was testosterone deficient, he was offered testosterone therapy, but he was required to complete at least 1 year of continuous treatment before entering the registry.
Saad was quite surprised with what they could learn from this registry. It was interesting, he said, that while testosterone, which had been available for medical treatment for more than 70 years, there were only 3 placebo-controlled trials each with a duration of 3 years.
Since their observation study went beyond the traditional 3 years, they noticed several comorbidities in these hypogonadal men. Saad explained that hypogonadism is not an isolated disease, it usually comes in men who are obese, in men who have type 2 diabetes, and in men who are hypertensive – all the features of the metabolic syndrome.
Based on sub-analyses of these different conditions, one of the comorbidities they found was actually a relatively small number of patients with 1 diabetes. Since this is a disease, which is difficult to treat, Saad and team decided to run a separate analysis on these patients.
Saad learned that the men with type 1 diabetes did experience benefits of long-term testosterone therapy – they showed improvements in their underlying diseases. “We found, after many years of studying these patients, that these patients were continuously and progressively improving. For instance, the HP1C protein, which they measured routinely in the urology office, came down from a mean 7.9 to 5.9. They improved a lot,” Saad said.