Examining Health Outcomes with Testosterone Therapies in British Columbia from 1997-2013
We have already been granted ethics and access to the MSP, DAD and PharmaNet databases for this project through the British Columbia Ministry of Health.
Laboratory data (LifeLabs, VCH, SPH): We are also hoping to attain access to patients' serum testosterone (bioavailable, free, SHBG), PSA, creatinine, CRP, HgA1c, HDL, LDL, total cholesterol and triglycerides levels. We are now applying for access to patients' serum tests through the laboratories as these will be useful to better characterize the relationships between testosterone therapies and health outcomes. In particular, testosterone therapies are approved by the FDA for symptomatic hypogonadism in various disorders such as Klinefelters syndrome and pituitary injury. Despite a lack of efficacy and safety data off-label testosterone supplementation is common in men without these disorders. It is not known if the men receiving off-label testosterone have low serum levels of testosterone (bioavailable, free, SHBG) warranting supplementation or if they are supplemented testosterone therapies for symptoms only. Furthermore, it is not known if patients with hypogonadism respond to supplemented testosterone (bioavailable, free, SHBG) with rising serum testosterone levels or not. The associations between testosterone therapies and co-morbidities such as cardiovascular disease and diabetes in relation to pre-, intra and post- testosterone (bioavailable, free, SHBG), PSA, creatinine, CRP, HgA1c, HDL, LDL, total cholesterol and triglycerides serum levels will be important to evaluate in this study.
Specific Laboratory data request:
Laboratory data for the following data fields for years 1997-2013 (when available; it is recognized that data may be incomplete or unavailable in the early years):
1) Lab tests and results as follows: serum testosterone (bioavailable, free, SHBG), PSA, creatinine, CRP, HgA1c, HDL, LDL, total cholesterol and triglycerides levels
2) Date of Service
3) Ordering Physician Speciality (if available)
4) Project-specific ID: to be included for linkage to the MSP, DAD, and PNet data.