고혈압을동반한전립선비대증환자에서 doxazosin 4mg 투여후효과가부족한경우에서 doxazosin 8mg 용량증가와 doxazosin 4mg + tamsulosin 0.2mg 병합요법비교 조인래, 김종구, 이건철 인제대학교일산백병원비뇨기과
고혈압환자에서알파차단제투여시일반적기준 전립선비대증 + 고혈압 합병증이있는고혈압 단순고혈압 α 차단제투여 내과의사 Antihypertensive Medication 복용중 Antihypertensive Medication 복용안함 Stable BP Decrease BP Stable BP Decrease BP α1-blocker 계속투여 항고혈압제용량조절 α1-blocker 계속투여 항고혈압제용량조절
Adjuvant therapy: α-blocker + another α- blocker In men with hypertension and cardiac risk factors -> doxazocin monotherapy was ass. with a higher incidence of congestive heart failure than seen with other antihypertensive agents. α-blocker + α-blocker therapy Useful in some patients (personal experience)
목적 doxazosin 4mg 에충분한효과를보이지 않는혈압강하제복용환자. doxazosin 8mg VS doxazosin 4mg + tamsulosin 0.2mg 효능과안전성을비교
대상및방법 기간 : 2000 년 5월-2004 년 12 월 대상 : 혈압강하제복용중인전립선비대증환자중 Doxazosin 4mg 에효과를보이지않은 361 명중추적관찰된 263 명을대상으로분석
Exclusion criteria 제외대상환자 Neurogenic bladder Prostate cancer, Bladder cancer Urethral stricture Previous 5 α reductase inhibitor Previous TURP Severe hepatic & renal dysfuntion Other α,β blocker(carvedilol(dilatrend ))
대상및방법 Doxazosin 4mg (n=263) Qmax 2ml/s or IPSS 감소율 20% (4weeks) Doxazosin 8mg (n=96) Doxazosin 4mg + tamsulosin 0.2mg (n=167)
평가항목및시기 1. 치료전 2. doxazosin 4mg 투여 1개월후 3. 용량증가 3개월후 IPSS (Total, QoL) UFR+RU (Qmax( Qmax,, PVR) Blood pressure (Sitting) Adverse effects
결과 (baseline) Chracteristics Doxazosin 8mg (n=142) Doxazosin 4mg +Tamsulosin 0.2mg (n=219) p Age(years) 66.9±11.1 67.2±9.9 0.851 P. vol.(cm3) 33.1±15.7 34.4±14.9 0.418 PSA(ng/ml) 2.47±4.64 2.51±4.72 0.929 IPSS 21.7±8.1 21.5±7.3 0.955 QoL 3.6±0.9 3.5±0.8 0.168 Q max(ml/sec) 12.4±5.0 11.5±5.4 0.105 PVR(ml) 40.2±42.3 40.2±37.8 0.998
결과 : IPSS, QoL mean±sd variable DOX 8mg (n=96) DOX 4mg + TAM 0.2mg (n=167) P value IPSS DOX 4mg 21.1±7.4 20.9±6.5 Endpoint 16.2±7.7 14.5±6.5 Change -4.9±4.5-6.4±4.9 0.018 P-value <0.001 * <0.001 * QoL DOX 4mg 3.5±0.8 3.4±0.8 Endpoint 3.0±0.8 2.8±0.8 Change -0.5±0.8-0.6±0.9 0.357 P-value <0.001 * <0.001 * Table 1. Changes in IPSS during treatment with doxazosin 8mg and doxazosin 4mg plus tamsulosin 0.2mg
결과 : UFR, RU mean±sd variable DOX 8mg (n=96) DOX 4mg + TAM 0.2mg (n=167) P value Qmax (ml/s) DOX 4mg 13.0±5.0 12.0±4.4 Endpoint 16.1±5.5 15.9±5.1 Change 3.1±3.0 3.9±2.6 0.030 P-value <0.001 * <0.001 * PVR (ml) DOX 4mg 32.3±35.0 31.9±37.8 Endpoint 23.8±30.0 25.8±25.2 Change -8.5±19.4-6.1±26.3 0.448 P-value <0.001 * 0.004 * Table 2. Changes in Qmax and PVR during treatment with doxazosin 8mg and doxazosin 4mg plus tamsulosin 0.2mg
결과 : 변화량 Doxazosin 8mg (n=96) Doxazosin 4mg +Tamsulosin 0.2mg (n=167) P value Δ IPSS -4.9±4.5-6.4±4.9 0.018 Δ QoL -0.5±0.8-0.6±0.9 0.357 Δ Q max 3.1±3.0 3.9±2.6 0.030 Δ PVR -8.5±19.4-6.1±26.3 0.448
결과 (mean SBP) 140 mmhg 135 133.5 130 125 130.2 123.7 121.5 SBP(DOX8) SBP(DOX4+TAM0.2) 120 115 122 119.6 110 baseline DOX4mg dose increase 3mo.
결과 (mean DBP) 84 82 80 78 76 74 72 70 68 66 81.5 76.5 73.8 77.5 * 72.8 71.6 * base Dox4 용량증가 3mo mmhg DBP(DOX8) DBP(DOX4+TAM0.2)
결과 (mean SBP 의변화량 ) 0 mmhg -2-4 DOX4mg dose increase 3mo -6 ΔSBP(DOX 8mg) -8-10 -12-9.8-8.2 * -8.7 ΔSBP(DOX 4mg+TAM 0.2mg) -14-16 -13.9
결과 (mean DBP 의변화량 ) 0 mmhg -2 DOX4mg dose increase 3mo -4-6 -8-5 -4.7 * -3.7 ΔDBP(DOX 8mg) ΔDBP(DOX 4mg+TAM0.2mg) -10-9.9-12
결과 ( 부작용 ) Adverse effects n (%) DOX 4mg + TAM 0.2mg (n=219) DOX 8mg (n=142) P value Total (n=361) Patients with AEs 55(25.1) 51(35.9) 0.033 106(29.4) Withdrawn due to AEs 9(4.1) 8(5.6) 0.630 17(4.7)
결과 ( 부작용 ) Adverse effects n (%) DOX 4mg +TAM 0.2mg (n=219) DOX 8mg (n=142) P value Total (n=361) vasodilatory TEAEs 33(15.1) 39(27.5) 0.012 72(19.9) dizziness 15(6.8) 18(12.7) 33(9.1) head ache 6(2.7) 8(5.6) 14(3.9) post. hypotension 5(2.3) 5(3.5) 10(2.8) edema 5(2.3) 3(2.1) 8(2.2) palpitation 1(0.5) 3(2.1) 4(1.1) syncope 1(0.5) 2(1.4) 3(0.8)
결과 Adverse effects n (%) DOX 4mg + TAM 0.2mg (n=219 DOX 8mg (n=142 P value Total (n=361) Sexual function AEs 12(5.5) 3(2.1) 0.176 15(4.2) Impotence 3(1.4) 1(0.7) 4(1.1) Decreased libido 1(0.5) 1(0.7) 2(0.6) Ejaculatory disorder 8(3.7) 1(0.7) 0.074 9(2.5) Other AEs 10(4.6) 9(6.3) 0.500 19(5.3) asthenia/fatigue 8(3.7) 5(3.5) 11(3.0) GI trouble 0(0.0) 1(0.7) 1(0.3) nasal stuffness 2(0.9) 2(1.4) 4(1.1) Urticaria 0(0.0) 1(0.7) 1(0.3)
요약 용량증가군, 병합요법군 : IPSS, Qmax,, RU - 호전 평균혈압변화량 : 용량증가군 : -4.1mmHg( 수축기 ), -4.9mmHg( 이완기 ) 로감소 병합요법군 : 혈압변화미미 기타혈관확장성부작용 용량증가군 : 27.5%, 병합요법군 : 15.1% (p=0.012) 성기능관련부작용 용량증가군 : 2.1%, 병합요법군 : 5.5% (p=0.176)
Prescription Drug Information for Consumers & Professionals Home New Drugs Latest News Drug Interactions Pill Identification Images Forum Drugs.com - prescription drug and medicine information available on over 24,000 approved- medications and pharmaceuticals, including side effects and drug interactions. We did not find any drug interactions between the following drugs: tamsulosin,doxazosin
보험급여인정사항 하이트린 (Terazosin): ): BPH, HiBP, NB Chronic prostatitis ( 삭제 ) 카두라 XL (Doxazosin( Doxazosin): BPH, HiBP, NB 4mg 1T/D, 4 주후 8mg 2T/D 증량가능 하루날 (Tamsulosin): BPH 0.2mg 1T/D, NB 자트랄 XL (Alfuzosin( Alfuzosin): BPH, NB 10mg 1T/D 프로스카 (Finasteride): BPH 5mg 1T/D 아보다트 (Dutasteride): BPH 0.5mg 1T/D BPH 에서상기약 2 종류만인정
결론 Doxazosin 4mg +tamsulosin+ 0.2mg 병 합요법은 doxazosin 8mg 에비해 고혈압을동반한전립선비대증환자에 있어서효과적이고 안전한용량증가방법으로생각된다. Thank You for Attentions!