New drug for BPH to contain dutasteride; will affect PSA assessment

Earlier today, GlaxoSmithKline received approval from the US Food & Drug Administration to market Jalyn® — a fixed dose combination of dutasteride (Avodart) with tamulosin (Flomax) — for the treatment of benign prostatic hyperplasia (BPH). We expect GlaxoSmiothKline to initiate marketing of Jalyn later in 2010.

Men and their doctors need to be aware that Jalyn contains a fixed dose of dutasteride, because men being treated with Jalyn for symptoms of BPH may have abnormally low levels of PSA, which may affect their perceived risk for prostate cancer.

Both of the approved 5α-reductase inhibitors (finasteride and dutasteride) have the ability to drive down a man’s PSA level, making it look as though his PSA level is well within the normal range, although the patient’s actual PSA level if he were not receiving a 5α-reductase inhibitor his PSA might actually be twice as high as the level measured.

Men who use the drug Propecia to manage hair loss are at a similar risk because Propecia contains finasteride, which can also drive down a patient’s PSA level to lower than normal levels.

4 Responses

  1. Why would anyone want to change to Jalyn, if it gives a much lower than actual PSA, thus distorting the results of the standard blood work, identifying one’s PSA thus giving the patient the thought that no problem exists in regard to a potential cancer being harbored in the prostate gland? This does not square with common sense, does it?

    Thank you.

  2. Dear Mr. Noble:

    Change to Jalyn from what, and why? Jalyn is a treatment for BPH. It may manage BPH extremely well for some patients. It is well understood that when assessing the PSA levels of men who receive any drug that contains dutasteride or finasteride (Avodart, Proscar, Propecia, Jalyn, or just generic finasteride), one has to allow for the fact that their PSA will be lower than the norm, and make decisions accordingly. BPH is far more common than prostate cancer. Men with BPH need to get appropriate treatment for that as a priority.

  3. Why would this drug reflect a faulty reading (1/2 of true result)? Seems disingenuous of the pharmaceutical company as well as the urologist who prescribes it. I became curious when my PSA dropped from 16 to 8 after being prescribed.

  4. Dear Tom:

    The use of drugs like dutasteride and finasteride do not cause “faulty readings” of PSA levels. Such drugs are designed to treat benign prostatic hyperplasia. In doing this, they affect the ways that prostate cells and tissues grow, and this affects patients’ PSA levels. This effect is well understood by the drugs’ manufacturers and by urologists.

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