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FDA Says Cialis Can Help Prostatic Hyperplasia

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In late October, Eli Lilly and Company announced that the US Food and Drug Administration (FDA) had approved a new product label addition for the drug Cialis indicating that Cialis administered at a dosage of 5 mg per day used in combination with the drug finasteride accelerated relief of benign prostatic hyperplasia (BPH) symptoms.

BPH is common in men, becoming more prevalent with increasing age.
BPH is common in men, becoming more prevalent with increasing age.

Compared to a placebo-finasteride combination, the Cialis-finasteride combination significantly improved symptoms of BPH in about 4 weeks, rather than the 6 to 12 months it takes for relief in many men who use finasteride alone. The FDA’s recommended label change reflects that trials of the combination of Cialis and finasteride have only been studied for up to 26 weeks, and any incremental benefit of taking Cialis with finasteride after 26 weeks are not yet known.

What Is Benign Prostatic Hyperplasia?

Benign Prostatic Hyperplasia, or BPH, goes by other names as well, including benign prostate enlargement, benign prostatic hypertrophy, and adenofibromyomatous hyperplasia. The condition is enlargement of the prostate gland due to an increase in the number of cells present, rather than due to growth in the size of individual cells. The term “hypertrophy” is technically incorrect, because cells themselves don’t grow, but rather the number of cells increases. However, lay people and doctors often use hypertrophy and hyperplasia interchangeably in the case of BPH.

BPH doesn’t lead to prostate cancer, nor does it increase the risk of cancer of the prostate. However, many men with BPH show elevated levels of prostate specific antigen (PSA), which is sometimes used to screen for prostate cancer. In men with BPH, elevated PSA levels are due to inflammation and increased organ volume rather than cancer. BPH causes the formation of nodules in the region of the prostate surrounding the urethra. Should the prostate enlarge enough, these nodules can compress the urethral canal, causing urinary tract obstruction. The result can be difficulty starting urination, frequent need to urinate, urinary retention, and increased risk of urinary tract infections.

Who Gets BPH?

BPH is a common condition. Growth of the prostate is believed to start around the age of 30, and by age 50, around half of all men have cellular evidence of BPH. By age 80, around 75% of men have cellular evidence of BPH. In men who have cellular evidence of BPH, about half experience clinical symptoms. In other words, many men have BPH without any noticeable symptoms.

What Causes It?

Androgens – male sex hormones – don’t cause BPH, but are believed to be necessary for BPH to occur. This belief is supported by data showing that castrated boys do not develop prostate enlargement as adults. A metabolite of testosterone called dihydrotestosterone, or DHT, is considered critical to development of BPH. DHT is made in the prostate from regular testosterone and an enzyme called 5-alpha reductase. DHT binds to androgen receptors, and when this happens, it initiates growth factors to epithelial and stromal cells in the prostate, which then increase in number, leading to the prostate nodules that can compress the urethral canal.

BPH is due to increased number of prostate cells, not enlargement of existing cells.
BPH is due to increased number of prostate cells, not enlargement of existing cells.

While testosterone also binds to androgen receptors, DHT is more potent in initiating growth of prostate cell numbers, because DHT remains bound to androgen receptors longer than ordinary testosterone does. For many years, therapy with the 5-alpha reductase inhibitor called finasteride has been used to treat BPH. By inhibiting 5-alpha reductase, less testosterone is converted to DHT, and the result over time is reduced prostate volume and relief from BPH symptoms in many cases.

Finasteride is also the active ingredient in treatments for male pattern baldness, which is also accelerated by conversion of testosterone to DHT (but in the scalp rather than the prostate). Finasteride’s ability to halt or reverse male pattern balding was discovered when researchers were looking for a treatment for BPH.

How Is BPH Treated?

While BPH can be treated clinically, symptoms management can be aided by lifestyle adjustments. The overall treatment plan for BPH depends on a man’s age, general health, and the severity of his symptoms. Additionally, BPH symptoms may change over time, so it’s important that men with BPH have regular medical check-ups to monitor the condition’s progression. Managing BPH symptoms can be easier with certain lifestyle changes, such as:

  • Urinating as soon as the urge is apparent rather than waiting
  • Urinating on a schedule regardless of urge
  • Avoiding caffeine and alcohol, particularly in the evening
  • Avoiding drinking anything within two hours of bedtime
  • Avoiding decongestants and antihistamines, which can make BPH symptoms worse
  • Regularly performing Kegel exercises to strengthen the pelvic floor muscles
A glass of wine with dinner could aggravate BPH symptoms.
A glass of wine with dinner could aggravate BPH symptoms.

Finasteride alone, and the finasteride-Cialis combination are not the only ways of treating BPH with drugs. Some men take alpha blockers for BPH. Alpha blockers cause the muscles around the bladder to relax so it’s easier to urinate. Alpha blockers should not be taken with drugs used to treat erectile dysfunction, including Cialis, due to the possibility of dangerously low blood pressure. Alpha blockers include the drugs Hytrin, Cardura, Flomax, and Uroxatral.

Some men require surgery for relief from BPH and its symptoms. In men with BPH who have incontinence, repeated instances of blood in the urine, and recurrent urinary infections, surgery may be recommended. Most men who have prostate surgery for BPH experience improvement in symptoms and in urine flow rates, though there are risks, as there are with any type of surgery.

Cialis Plus Finasteride Accelerates Relief from BPH Symptoms

The study of Cialis plus finasteride was a randomized, double-blind, placebo-controlled trial that took place over 26 weeks. Men were either treated with 5 mg finasteride plus 5 mg Cialis, or 5 mg finasteride plus a placebo. There were 696 men in the study, with a mean age of 64, and the study was carried out at 70 sites in 13 countries. The report on the study was published in The Journal of Urology. The study found that the finasteride-Cialis combination provided relief of BPH symptoms much more quickly than the finasteride-placebo combination.

Additionally, there was a subgroup of BPH patients who were sexually active and who had erection problems. In this subgroup, the men who received the finasteride-Cialis combination found that erection function improved along with improvement in BPH symptoms. Improvement in erection function was evident at 4, 12, and 26 weeks according to a commonly used index of erection health.

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Photo Credits: Tina Phillips / freedigitalphotos.net, Dundee Photographics / freedigitalphotos.net, MConnors / morguefile.com

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