Other Medical Options
Dutasteride
Dutasteride (Avodart®), a second-generation 5 alpha-reductase inhibitor, is the first and only medicine to inhibit both the type 1 and type 2 enzymes responsible for the conversion of testosterone to DHT (dihydrotestosterone)the primary cause of prostate growth. Dutasteride’s dual inhibition decreases levels of DHT by 90 percent at two weeks and 93 percent at two years.
By reducing DHT levels, dutasteride reduces the size of an enlarged prostate. This reduction in prostate volume was seen as early as one month with reductions continuing through treatment. Shrinking the enlarged prostate relieves urinary obstruction and improves urinary flow. Dutasteride also improves urinary symptoms and reduces the risk of AUR (the sudden complete inability to urinate) and BPH-related surgery, two potential long-term serious consequences of BPH. The pivotal phase III study data were published in this month’s edition of the journal Urology.1
“With dutasteride, we now have a medicine that reduces the production of DHT by more than 90 percent, helping to shrink the prostate,” said Claus Roehrborn, MD, a principal trial investigator and professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas, Texas. “By taking dutasteride, patients can improve urinary symptoms and reduce their risk of suffering from acute urinary retention – where you suddenly can’t urinate at all – or needing BPH-related prostate surgery.”
Dutasteride was approved by the Swedish regulatory authority (MPA) on July 24th 2002. It will be marketed in Sweden by the trade name Avolve. The MPA agreed to act as the Reference Member State for the Mutual Recognition procedure within Europe and GSK plan to market the drug in all major European markets once approvals are finalized during 2003. The European trade name (Avolve) is to be confirmed.
Background on BPH
BPH is one of the most common health problems in older men.2 BPH often begins after age 50 and can progress and worsen as men age. More than half of men over age 60 experience BPH,3 and by age 80, nearly 80 percent of men have the disease.3,4 In the United States alone, 375,000 hospital stays each year involve a diagnosis of BPH.5
BPH is a progressive disease in which the prostate gland surrounding the urethra enlarges.6 As it grows, the prostate obstructs the urethra, the tube through which urine flows, causing urinary difficulties. BPH symptoms interfere with normal activities and reduce the sense of well being.7 Symptoms of BPH vary, but the most common involve urinary problems, such as a hesitant, interrupted weak stream; urgency and leaking or dribbling; and more frequent urination, especially at night.5 In severe cases, the bladder and the kidney may become damaged.5
An enlarged prostate can continue to increase in size and may in severe cases lead to AUR and the need for BPH-related surgery.6 A 60-year-old man with a 20-year life expectancy has a 23 percent risk of developing acute urinary retention.8 Among men 60 years or older, with prostatic enlargement and obstructive symptoms, the 20-year probability of needing BPH-related surgery is 39 percent.9
To diagnose BPH, a physician will discuss urinary symptoms with a patient and conduct a digital rectal exam. A physician may also use a simple blood test that measures a protein called “prostate-specific antigen,” or PSA. PSA is produced by the prostate, and an increase in levels is associated with prostate growth.6 While PSA is primarily used as a screening tool for prostate cancer, it can also be used to determine prostate enlargement.
Clinical Trial Results
Dutasteride was investigated in three large, well-controlled multi-center studies involving 4,325 men aged 50 and above with a serum PSA level 1.5 ng/mL and 10 ng/mL, and BPH diagnosed by medical history and physical examination, including enlarged prostate (greater than or equal to 30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index.
Data from these two-year clinical trials demonstrated that treatment with dutasteride (0.5 mg once daily) reduced the risk of both AUR and BPH-related surgical intervention relative to placebo, improved BPH-related symptoms, decreased prostate volume, and increased maximum urinary flow rates.
Dutasteride should not be used in women and children. Women who are pregnant or may become pregnant should not handle dutasteride because of possibility of absorption of dutasteride and subsequent potential risk to a male fetus.
Men treated with dutasteride should not donate blood until at least six months after their final dose to prevent giving dutasteride to a pregnant woman through a blood transfusion. Men with an allergic reaction to dutasteride or its ingredients should not take it. Men with liver disease should talk to their doctor before taking dutasteride.
Clinical trials of dutasteride showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the dutasteride and placebo groups.
Drug-related side effects during the first six months were as follows: impotence (4.7 percent vs. 1.7 percent for placebo), decreased libido (3 percent vs. 1.4 percent), breast tenderness and breast enlargement (gynecomastia; 0.5 percent vs. 0.2 percent) and ejaculation disorders (1.4 percent vs. 0.5 percent).
The incidence of most drug-related sexual adverse events decreased with duration of treatment. The incidence of drug-related breast tenderness and breast enlargement remained constant over the treatment period. Ejaculate volume may be decreased in some patients with continued treatment. This decrease did not appear to interfere with normal sexual function.
Dutasteride will reduce the amount of PSA measured in the blood. A physician will be aware of this effect and can still use PSA to detect prostate cancer.
Although improvement in urinary symptoms was seen in some patients by three months, a therapeutic trial of at least six months is usually necessary to assess whether a beneficial response in symptom relief is achieved with dutasteride.
GraftCyte
GraftCyte is a new product containing copper-peptide manufactured by ProCyte Corporation, that has been shown to facilitate wound healing in well controlled scientific studies. Our clinical experience with these products has been the same.
We supply GraftCyte shampoo to our patients as part of their routine post-operative care. In addition, our patients have the option of using a more intensive 7-day course with a variety of products containing copper-peptide. We do not routinely use the 7-day course of GraftCyte in our practice since we have found that GraftCyte has not offered any significant benefit in Follicular Unit Transplantation where the very small wounds already permit extremely rapid healing.
There has been speculation that copper-peptide solutions may also hasten the growth of newly transplanted hair. This later claim has not yet been proven and, at this point in time, we do not prescribe GraftCyte for this purpose. We do, however, strongly recommend its use for wound healing.
The following copper-peptide products are recommended for post-op care:
GraftCyte Moist Dressing Packets, GraftCyte Post-surgical Shampoo, GraftCyte Post-surgical Conditioner, GraftCyte Concentrated Spray, and GraftCyte Iamin-hydrating Gel.
The protocol that we use at our clinic is as follows:
Moist Dressings -7 foiled packages of three sheets each
The first dressings (three sheets) will be applied after your procedure before you leave the office. The dressings should be placed to cover the entire grafted area using occasional gentle pressure to keep the area saturated. Apply all three sheets to the transplanted area. For best results leave the dressings in place 30 to 60 minutes. Apply dressings twice per day, AM and PM for the following three days, until all packets are used up.
Concentrated Spray – 1 bottle
Beginning the day after surgery, spray the transplanted area liberally every hour or two in order to keep the transplanted area moist. This should be continued even after the dressings are stopped. Use a minimum of 15 spays per application and 5-10 applications per day. Use until the bottle is finished.
Post-surgical Shampoo and Conditioner – 1 bottle each
Use the GraftCyte shampoo and conditioner in place of other shampoos. Use shampoo and conditioner every day until the shampoo and conditioner are completely used up. When GraftCyte shampoo and conditioner are used up, resume your regular shampoo.
Iamin-hydrating Gel – 1 tube
Apply a continuous layer to the entire suture line 3 times a day (AM, after work, PM). Use this in place of the other ointments for the suture line, as discussed in your post-operative instructions. When you shower, shampoo out any existing gel from previous applications.
Cloning Hair
The thought of being able to culture hair follicles and have an unlimited donor supply has been a long-time dream of patients with hair loss and hair restoration surgeons alike. The obstacles, however, have seemed enormous since the hair follicle is a very complex structure of skin cells, blood vessels, nerves, muscles, and glands. (As an analogy, culturing a hair follicle would be more like culturing an entire eyeball rather than just the cells of the cornea.) Now there is hope that not only is cloning possible, but that this hair may not even need to be your own.
Dr. Colin Jahoda, a British scientist recently reported that he took dermal sheath cells (cells from the lowest part of the hair follicle) from his own scalp and transplanted them into his wife’s forearm. These implanted cells then stimulated his wife’s skin to grow new hair. The hair was analyzed by Dr. Angela Christiano at Columbia University in New York and was show to be composed of cells with Dr. Jahoda’s XY chromosomes at the bottom and his wife’s XX chromosomes at the top.
This clever experiment shows that the hair follicle’s dermal sheaths cells are one of the bodies “immune privileged” organs, enabling them to be transplanted from one person to another without rejection. More importantly, this study suggests that all one might need to do is to transplant these “inducer” cells to stimulate new hair growth, rather than having to transplant the entire follicle itself. The great significance, for those that are balding, is that these cells may some day be cultured in the lab, to produce a potentially unlimited supply of hair.
Although, this was just one preliminary study, the work provides a clear direction for further cloning research and gives considerable hope that the technology may be available in the not too distant future. Stay tuned!
