Duodart may be prescribed at general hospitals in Korea

Duodart (Avodart+Harnal)

Passed DCs of Sinchon Severance Hospital, etc…. landing in progress at major medical institutions

Listed for insurance benefit in March… combination therapy recommended by American Urological Association and others

The combination drug ‘Duodart’ that contains ‘dutasteride’ and ‘tamsulosin’ may be prescribed in general hospitals in Korea.

 

According to industry sources, Duodart, GSK Korea’s fixed-dose combination drug for benign prostatic hyperplasia (BPH), has recently passed the drug committee (DC) review of Sinchon Severance Hospital and is undergoing landing procedures at major medical institutions across the country.

 

The drug was granted insurance benefits starting in March this year.

 

Duodart is reimbursed for ??

 

patients with ‘benign prostatic hyperplasia (BPH)’ who satisfy both of the following conditions: International Prostate Symptom Score (IPSS) of 8 or higher and ▲ Ultrasonography shows a prostate size of 30ml or larger, or Digital rectal examination shows moderate or higher BPH or the patient’s prostate-specific antigen (PSA) level is 1.5ng/ml or higher.

 

Duodart is the first fixed-dose combination of dutasteride and tamsulosin introduced for BPH in Korea and can be administered orally once daily in a capsule form to treat moderate-to-severe symptoms of BPH.

 

The drug was approved by the EU and the US FDA in 2010 and approved in May last year in Korea.

 

The combination of the 5α-reductase inhibitor (dutasteride) and antagonist of α1a-adrenoreceptors (tamsulosin hydrochloride) is recommended in global clinical practice guidelines.

 

Rapid symptom improvement and long-term disease progression control were expected through the combination of the two drugs with complementary mechanisms of action.

 

In real-world data, patients using Duodart showed statistically significantly higher compliance compared with those using 5α-reductase inhibitor/ Alpha1-adrenergic antagonist free-combination therapy.

 

The European Association of Urology (EAU) currently recommends introducing the 5α-reductase inhibitor (5-ARI) and Alpha1-adrenergic antagonist combination therapy in the early stages of treatment in patients with BPH with accompanying lower urinary tract symptoms (LUTS).

 

The American Urological Association (AUA) also recommends using combination therapy in the early stages of BPH treatment.

 

According to the CombAT study, the clinical trial that became the basis for Duodart’s approval, patients in the dutasteride-tamsulosin combination therapy group showed rapid symptom improvement at Month 3 like the tamsulosin monotherapy group.

 

Also, the combination demonstrated superior symptom improvement over either monotherapy from Month 9, which lasted until Month 48.

 

In addition, the combination therapy reduced the risk of BPH symptom progression and risk of AUR-related surgery than either monotherapy.