Hormone therapy (ADT), using luteinizing hormone releasing hormone (LHRH) agonists or gonadatropin releasing hormone or GnRH agonists (Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel ) have been known to have many side effects, some severe and potentially life threatening. Many of us believe that ADT is associated with cardiovascular disease and diabetes along with a myriad other morbidity issues. During the last few years the relationship of ADT and these potentially life threatening diseases has become become a bigger question.

The Food & Drug Administration (FDA) has announced that it will be evaluating the role these drugs have in increasing the risk for diabetes and cardiovascular disease. The FDA safety announcement (05-03-2010), “FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases” states that (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

The safety announcement asserts that in six published reports the use of ADT appears to cause a slight increase risk for diabetes and cardiovascular disease. However, they also state that these studies do have design limitations that make it unclear if there is an actual cause and effect relationship.

Until ADT is better evaluated the FDA has published the following recommendations:

• Healthcare professionals should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment.

• Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease.

• Health care professionals should manage cardiovascular risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight, according to current clinical practice.

• Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Based on the FDA guidelines you should continue ADT to treat advanced prostate cancer. However, if you have any family or personal history with diabetes and cardiovascular diseases make sure that your oncologist is made aware. Additionally, if you are under the care of a cardiologist or endocrinologist, speak to them prior to starting or continuing ADT.

Additionally, ask your doctor about intermittent ADT as opposed to continuous treatment. There is no evidence that intermittent therapy might have a better outcome in the prevention of diabetes and cardiovascular diseases, but it is worth a conversation with your doctor. Additionally, the FDA has not determined that ADT does increase the risk for developing diabetes and cardiovascular diseases, but there is also no evidence that ADT will extend life, especially in men with PSA only increases.

Again, we are faced the yet another prostate cancer dilemma, when to start ADT, if at all. What are the relative risks and rewards? Decisions about this can only be made with careful consultations with your doctors topped with some additional prayers.

Report a Serious Problem with ADT or any drug contact your doctor and the FDA at:

• 1-800-332-1088

• 1-800-FDA-0178 Fax

MedWatch on-line

Regular Mail: Use postage-paid FDA Form 35004
and to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

Joel T Nowak, MA, MSW