YOUR PATIENTS, YOUR PRACTICE | Dr. Lawrence D. Komer Medical Professional Corporation

Dr. Lawrence D. Komer Medical Professional Corporation

Diagnostic Tools and Treatment Options for Andropause

Re-defining clinical goals of treatment, striving for optimal patient response

About The Author:

Lawrence D. Komer, MD, FRCSC is Medical Director of the Masters Men’s Clinic in Burlington, Ontario, a clinic “Dedicated to the Science of Andropause”. He is an Assistant Clinical Professor at the McMaster University Faculty of Health Sciences. He has worked extensively in the field of Reproductive Endocrinology. Dr. Komer is presently focused on research, diagnosis, treatment and education of men and women in the area of testosterone deficiency.

Overview; Normal vs. Optimal:

The diagnosis of andropause or Androgen Deficiency in the Aging Male is not as straight forward as it may seem. If the physician simply relies on blood tests to make the diagnosis, a very high percentage of cases will be missed. Clinicians have found total and free testosterone levels to be the least helpful. Bio-available testosterone done between 8:00 and 9:00 in the morning, when testosterone levels peak, while probably the best clinical indicator, can still be misleading. Part of the problem lies in the wide range of so-called normal values.

In a typical Lab, a bio-available testosterone value between 3.5 and 12.0 nmol/L is designated normal. While this may have been adopted as a de-facto standard, we have found that this is not true clinically. As opposed to being satisfied with normal we feel that it is important to develop the concept of optimal, with a therapeutic goal of getting our patients into that optimal range. Our feeling is that optimal testosterone ranges are probably in the upper quartile of normal. Experience with our large patient cohort bears this out.

The majority of our patients have presented in the range of between 3.5 and 7 and yet have responded extremely well to testosterone replacement therapy. However, by the strict criteria of blood tests alone, they would not have had the diagnosis of andropause made.

What we have found much more helpful is a detailed questionnaire, developed by our Clinic, called The Masters Andropause Screening IndexÓ (MASIÓ ). This is a 50-question survey, which allows the patient to quantify his symptoms of andropause resulting in a score between 0 and 250, with 250 being the most symptomatic.

Therefore, diagnosis of andropause in our clinic is made with a combination of clinical symptoms of andropause and blood values. We have also found that following treatment with testosterone, blood tests have not necessarily reflected the improvement in patients and we administer the MASIÓ after treatment to show the degree of improvement.

Case Presentation #1:

Mr. C. W. is a 63 year old farmer who was referred to The Masters Men’s Clinic for low libido and fatigue. When he filled out the MASIÓ survey we found that he had to nap before dinner, felt inappropriately tired, had a decreased range of motion accompanied by increased stiffness and was losing muscle size and strength. He felt very sore after a heavy day of labour and also had unexpected episodes of hot flashes and sweating. His skin was dry, his overall feeling of well-being was poor, he was easily frustrated and angry, was less enthusiastic towards his work, and had withdrawn from social gatherings. Mr. C. W. had moderate erectile dysfunction, a decreased interest in sex, and finally, felt his concentration and memory were not as good as in the past.

Findings:

His MASIÓ score was 180 out of 250 suggesting fairly severe symptoms of andropause. At the same time, we had him fill out The Beck Depression InventoryÓ and he scored 27 which correlates with severe depression. His initial blood work was not remarkable. His bio-available testosterone done at 8 o’clock in the morning was 4.6. (normal range 3.5 to 12.0 nmol/litre.) Total testosterone 17.2 (normal 7 to 38 nmol/L). His PSA was only 0.56 (normal range 0 to 4.00 m g/L). Estradiol 75 (normal range 50 to 218 pmol/L). LH 2 ( normal range 1 to 10 iu/L)and DHEA 4.4 (normal 2.6 to 7.7 m mol/L).

Treatment Approach:

We discussed our findings and the diagnosis with the patient and his wife who had accompanied him. She noted how withdrawn he had become and this was very different from his usual outgoing personality.

A bio-available testosterone of 4.6 is felt to be within the normal range but we pointed out this is far from optimal, and how, when he was a younger man, his bio-available testosterone may have been many times this level. After our discussion with the couple we elected to start treatment with intramuscular injections of Delatestryl™ (testosterone enanthate). Our usual starting therapy is either oral testosterone in the form of Andriol® (testosterone undecanoate) or transdermal testosterone using a compounded cream, however, as a self-employed farmer, not on a drug plan, injectible testosterone is the most in-expensive form of treatment. In addition, we have found that Delatestryl™ has been very helpful for the initial treatment of severe patients to get them feeling very well, very quickly although it can give somewhat fluctuating levels. Once we have established a new ‘high-water mark’ for the patient in terms of feeling well, our usual practice is then to switch them to more easily administered therapy.

We have found that intramuscular injections of 1 cc., 200 mg. of Delatestryl™ every two weeks works very well. We started off the injections in our Clinic and administered them to C. W. every two weeks.

Follow-up:

There was a steady improvement and within 8 weeks he was feeling his old self. We have not found it particularly helpful clinically to follow bio-available testosterone after treatment has begun. In addition, in Ontario, the patient is required to pay for this test. A total testosterone was taken 48 hours after an injection and this was 25 nmol/litre, which is close to optimal. Estrogen levels stayed normal. There was no change in liver enzymes, PSA or other blood tests. After 8 weeks of treatment period he looked like a completely different person, once again outgoing and happy. We had him fill out the MASIÓ and his score fell from his pre-treatment score of 180 to a score of 72. His Beck Depression Index fell from 27 to 0. Mr. C.W. wife said, “…I’ve got my old husband back again!”

Next Steps:

It would be our usual practice after 10 weeks to switch this patient to either oral or transdermal testosterone after this degree of clinical improvement. If there were any deterioration in his mood he certainly could identify it so that we could adjust the dose appropriately. However, with C. W. we were reluctant to change his therapy at this stage since he was doing so well. In order to reduce patient frequency of visits to the Clinic, we do have some of our patients give themselves intramuscular injections or we can teach the partner to do this. We also have had patients give themselves their own subcutaneous injections with Delatestryl™. This seems to work well using the standard IM dose or a slightly reduced amount.

Case Presentation #2:

Mr. A. B. is a 60-year-old man who was referred to the Clinic for developing erectile dysfunction and fatigue. However, he had a number of other symptoms and we had him fill out The Masters Andropause Screening IndexÓ (MASIÓ ). The MASIÓ showed that he fell asleep after dinner, felt inappropriately tired, experienced substantial joint and muscle ache, and felt sore for several days after any physical activity. A. B. was experiencing frequent headaches and was aware of palpitations. He had frequent episodes of hot flashes and sweating, his skin was dry and he woke up at least four to six times at night. His overall feeling of well-being was poor, he was frustrated and irritable and he found changes in his memory, mood and concentration. In addition, he had fairly severe erectile dysfunction with the loss of morning erections, decreased ejaculatory force and decreased libido. He found sex non-fulfilling and in general felt many years older than his age.

Findings:

He scored 197 out of 250 on The MASIÓ survey, a score that is very positive for andropause. His bio-available testosterone was in the so-called normal range at 3.6. His PSA was only 0.54 and the remainder of his blood work was normal.

Treatment Approach:

Our usual preference would be to start A. B. on oral medication; however, this man did not have the best eating habits and often had only coffee and dry toast for breakfast. Optimum absorption of Andriol® occurs 20 – 30 minutes after meals that contain between 15 and 20 grams of fat and although most normal meals include this, this gentleman’s eating pattern precluded the use of Andriol® (testosterone). He also did not like the idea of using a cream or a gel and felt that injections every 2 weeks would fit into his busy lifestyle much better.

Follow-Up:

Mr. A. B. was started on Delatestryl™ 1cc. every 2 weeks intramuscularly and noticed improvements within 2 weeks, particularly sleeping through the night, waking only once. During further follow up visits in the first two or three months he noticed his erections improved, his joint and muscle ache went away and his mood was very much better. After 10 weeks of treatment his MASIÓ score fell from 197 to 82 and the score on The Beck Depression InventoryÓ fell from 18 (moderate depression) to 4, which is normal mood.

Looking Ahead:

Because the patient has done so well he is very reluctant to change to other forms of testosterone therapy, and so to for added ease-of-use, he will be taught to self-administer his injections. This case once again represents a man whose bio-available testosterone was in the so-called normal range but his symptoms were very obviously not and responded excellently to treatment.

Discussion Points:

Historically, injections of large doses (400 – 600mg every 4 weeks) of testosterone could occasionally lead to polycythemia and liver damage. Today we know to administer smaller doses of bio-identical testosterone using Testosterone-Enanthate (Delatestryl™) at 200mg every 2 weeks or 100mg every week. This technique is clinically effective, safe and for some patients these injections represent a very convenient form of treatment.

As with any form of testosterone, continued follow up is necessary. While we have not seen alterations in liver enzymes or significant changes in blood values, we continue to measure these. PSA’s and digital rectal examinations on an ongoing basis are necessary.

We have also found that a percentage of men bio-transform testosterone to estrogen and this can decrease the effectiveness of the treatment or lead to other symptoms. Therefore, we do follow blood levels of Estradiol. If these are elevated, treatment with aromatase inhibitors is very successful.

Key Clinical Take-Away Points for …

YOUR PATIENTS, YOUR PRACTICE:

  • Blood tests alone are not enough to diagnose andropause. As clinicians we need to adopt the concept of Optimal and work with our patients to restore this feeling as much as possible.
  • Detailed symptom surveys such as the MASIÓ are very useful tools to aid in the diagnosis of andropause and the subsequent measuring of patient improvement.
  • It is very helpful to outline the various treatment options available to our patients. We know that allowing the patient to actively participate in the treatment decision results in improved patient compliance with therapy.
  • To work effectively, all testosterone therapies presently available have some degree of impact on the patient’s lifestyle, be it eating habits, showering/dressing habits, frequency of office visits, or cost. The most clinically effective therapeutic strategy will be the one that most easily integrates into the individual patients existing lifestyle, requiring the least amount of alteration to their daily activities and habits.
  • Delatestryl™ resolves symptoms of androgen deficiency quickly and reliably. To further aid in patient convenience, we have successfully trained patients to self-administer their Delatestryl™, either IM, or increasingly subcutaneously.
  • As with other therapeutic areas, clinical experience and medical advancement shifts the paradigms of what is considered acceptable or ‘normal’.
  • In all areas of our practices, we need to embrace the concept of optimal health as opposed to normal health.

Note: The subcutaneous use of Delatestryl™ is investigational, and has not been approved by Health Canada. The information and opinions presented in this report are those of the author, and do not necessarily represent the views of, and are completely independent of Theramed Corporation. Supplying and accuracy of references is solely the responsibility of the author. Any questions or comments should be communicated directly to the author. Before prescribing any medication please consult the complete prescribing information, including indications, contraindications, warnings, precautions and adverse effects. No claims or endorsements are made for any products, indications, or dosages not approved in Canada or presently under investigation. No endorsement is made or implied by the reporting of any unapproved use. Delatestryl™ is trademark of Theramed Corporation. Andriol® is a registered trademark of Organon Canada.

Your Patients, Your Practice™ is a case study reporting service of Landmark Medical Communications. The intent is to provide a peer-to-peer opinion-sharing vehicle for medical educational purposes. This report has been provided by an unrestricted educational grant from Theramed Corporation. Copyright © 2005 Landmark Medical Communications. Published by Landmark Medical Communications. LandmarkMedical@cogeco.ca

Contributed by:

Lawrence Komer MD, Assistant Clinical Professor, McMaster University, Hamilton, Ontario.
Email doc@drkomer.com
Website: www.mastersmensclinic.com