Male hypogonadism is a condition in which the body does not produce enough testosterone, the hormone that plays a key role in masculine growth and development during puberty. Hypogonadism can occur at all ages. Signs and symptoms depend on when the condition develops and in adults include erectile dysfunction, infertility, decrease in beard and body hair growth, decrease in muscle mass, development of breast tissue and loss of bone mass. Testosterone therapy is considered standard treatment in men with hypogonadism. Most middle-aged and older men, who are treated with testosterone are likely to present with sexual dysfunction, a feature not related to hormone deficiency or to advancing age, but rather to the presence of underlying cardiovascular (heart) disease risk factors, such as obesity, diabetes and atherosclerotic cardiovascular diseases. Adverse cardiovascular effects such as myocardial infarction and stroke during long-term testosterone therapy are of increasing clinical significance in view of the ongoing epidemic of testosterone over-prescribing. Recent observational studies have shown conflicting findings regarding adverse cardiovascular effects during testosterone therapy. Preferential testosterone use in patients at increased cardiovascular risk could explain discrepancies of previous studies and this study could be be fundamental in overcoming the limitations of previous observational studies on testosterone use and cardiovascular events.
This study aims to describe the association between the prevalence of cardiovascular risk factors and new use of testosterone in a population-based nested case-control study in a cohort of men with a GP consultation between January 2001 and the latest data available in the CPRD-HES link. Patients with an initial testosterone prescription at a GP consultation will be defined as cases. Patients matched on year of birth, history of hypogonadism and on the day of initial testosterone prescription (index day) but without a history of testosterone prescription use as of the index day will be selected as controls. Potential cardiovascular risk factors of interest will include high BMI, smoking, hypercholesterolemia, history of stroke/transient ischaemic attack, atrial fibrillation, myocardial infarction, ischaemic heart disease, heart failure, hypertension and diabetes. Adjusted odds ratios of the association between cardiovascular risk factors and initiation of testosterone therapy will be estimated using conditional logistic regression for matched case-control data.
Post-stroke dementia/cognitive impairment.
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
HES Admitted Patient Care;Patient Level Index of Multiple Deprivation