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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): PHARMACODYNAMICS

Mechanism of Action

Duodart (Dutasteride, Tamsulosin Hydrochloride) is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with BPH: dutasteride, a dual 5-alpha-reductase inhibitor (5-ARI) and tamsulosin hydrochloride, an antagonist of alpha1a-adrenoreceptors.

Dutasteride inhibits both type 1 and type 2, 5-alpha-reductase isoenzymes, which are responsible for the conversion of testosterone to 5 alpha-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for hyperplasia of glandular prostatic tissue.

Tamsulosin inhibits alpha1a adrenergic receptors in the stromal prostatic smooth muscle and bladder neck. Approximately 75% of the alpha1-receptors in the prostate are of the alpha1a subtype.

Pharmacodynamic Effects

The pharmacodynamic effects of Dutasteride, Tamsulosin (Duodart) have not been studied; however, the effects of the combination would not be expected to be different from those of dutasteride and tamsulosin administered separately.

Dutasteride

Dutasteride lowers DHT levels, reduces prostate volume, improves lower urinary tract symptoms and urine flow and reduces the risk of AUR and BPH-related surgery.

The maximum effect of daily doses of dutasteride on the reduction on DHT is dose-dependent and is observed within one to two weeks. After one week and two weeks of daily dosing of dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively.

In BPH patients treated with 0.5 mg of dutasteride daily, the median decrease in DHT was 94% at one year and 93% at two years, and the median increase in serum testosterone was 19% at both one and two years. This is an expected consequence of 5-alpha-reductase inhibition and did not result in any known adverse events.

Tamsulosin

Tamsulosin increases maximum urinary flow rate by reducing smooth muscle tension in the prostate and urethra, thereby relieving obstruction. It also improves the complex of irritative and obstructive symptoms in which bladder instability and tension of the smooth muscles of the lower urinary tract play an important role. Alpha-1 adrenergic blockers can reduce blood pressure by lowering peripheral resistance.

The Tamsulosin HCl component in Duodart has not been shown to be bioequivalent to the Tamsulosin HCl product currently available in Australia. The clinical efficacy of the two tamsulosin formulations has been shown to be similar. Due to differences in pharmacokinetics, small differences in some adverse event rates have been reported. When the Australian formulation of tamsulosin (tamsulosin OCAS 0.4 mg) was compared to a tamsulosin formulation equivalent to Duodart (Tamsulosin-MR 0.4 mg), the incidences of all treatment emergent adverse events attributable to alpha1 adrenergic blockade were 6.9% (non-cardiovascular 4.4% and cardiovascular 2.5%) for the OCAS formulation and 7.8% (non-cardiovascular 5.1% and cardiovascular 3.2%) for the MR formulation.

Non-cardiovascular events included all abnormal ejaculation-related events, asthenia, headache, fatigue, rhinitis, somnolence, nasal dryness, nasal congestion and nasal obstruction. Cardiovascular events included all dizziness-related events, tachycardia, palpitations, hypotension, dizziness postural, orthostatic hypotension, syncope, orthostatic/circulatory collapse and depressed level of/loss of consciousness. The most common treatment emergent adverse events were dizziness (1.4% vs 1.3%) and retrograde ejaculation (1.7% vs 1.4%). If switching between tamsulosin formulations, patients should be advised of these differences and monitored accordingly. Patients should also be reminded to adhere to the dosage and administration requirements for each product.


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