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- 1. MARCH 2022 WWW.ANVOPHARMA.COM pms-IRBESARTAN Thu畛c i畛u tr畛 cao huy畉t 叩p v b畉o v畛 th畉n
- 2. HO畉T CH畉T & TRNH BY pms-IBESARTAN 75 mg 100 vi棚n/chai pms-IBESARTAN 150 mg 100 vi棚n/chai pms-IBESARTAN 300 mg 100 vi棚n/chai Ho畉t ch畉t: Irbesartan (thu畛c 畛i kh叩ng th畛 th畛 Angiotensin II)
- 3. C CH畉 TC 畛NG 3
- 4. D働畛C 畛NG H畛C 4 H畉p thu nhanh qua 畛ng ti棚u h坦a v畛i sinh kh畉 d畛ng t畛 60-80%. Th畛c n kh担ng lm thay 畛i nhi畛u t鱈nh sinh kh畉 d畛ng c畛a thu畛c N畛ng 畛 畛nh trong huy畉t t動董ng 畉t 動畛c kho畉ng 1-2h Li棚n k畉t 96% v畛i protein huy畉t t動董ng. Chuy畛n h坦a m畛t ph畉n 畛 gan Th畉i tr畛 qua m畉t v n動畛c ti畛u. Th畛i gian b叩n hu畛 l 11-15h. 畛 b畛nh nh但n suy th畉n ho畉c ch畉y th畉n nh但n t畉o, b畛nh nh但n x董 gan, c叩c th担ng s畛 d動畛c 畛ng h畛c c畛a Irbesartan kh担ng thay 畛i 叩ng k畛 .
- 5. CH畛 畛NH 1. i畛u tr畛 cao huy畉t 叩p v担 cn 2. i畛u tr畛 cao huy畉t cao 畛 b畛nh nh但n b畛nh th畉n v 叩i th叩o 動畛ng type 2 5 Source: 1 https://www.medicines.org.uk/emc/medicine/27608
- 6. LI畛U DNG BN cao HA 董n thu畉n: 150mg/ngy Li畛u kh畛i 畉u: 150mg/l畉n/ngy Li畛u t畛i a: 300mg/l畉n/ngy hay 150mg+ thu畛c l畛i ti畛u (HCTZ) BN 叩i th叩o 動畛ng type 2 k竪m b畛nh th畉n: 300mg/ngy Li畛u kh畛i 畉u: 150mg x 2l畉n/ngy Li畛u t畛i a: 300mg/l畉n/ngy BN ch畉y th畉n nh但n t畉o v BN > 75 tu畛i: Li畛u kh畛i 畉u : 75mg x 2 l畉n/ngy
- 7. Suy th畉n Kh担ng c畉n i畛u ch畛nh li畛u d湛ng Suy gan Nh畉: Kh担ng c畉n i畛u ch畛nh li畛u d湛ng Trung b狸nh: Kh担ng c畉n i畛u ch畛nh li畛u d湛ng N畉ng: kh担ng c坦 d畛 li畛u l但m sng Ng動畛i gi: Kh担ng c畉n i畛u ch畛nh li畛u d湛ng Tr畉 nh畛: 畛 an ton v hi畛u qu畉 ch動a 動畛c thi畉t l畉p 7 Source: 1 https://www.medicines.org.uk/emc/medicine/27608 LI畛U DNG
- 8. TC D畛NG PH畛 TC D畛NG PH畛 R畉t ph畛 bi畉n: Tng kali huy畉t Ph畛 bi畉n: Tng creatine kinase huy畉t t動董ng, ch坦ng m畉t, ch坦ng m畉t t動 th畉, bu畛n n担n/n担n, au c董 x動董ng, h畉 huy畉t 叩p t動 th畉, m畛t m畛i Kh担ng kh畛 bi畉n: Nh畛p tim nhanh, au ng畛c, ho, ti棚u ch畉y, kh坦 ti棚u, 畛 n坦ng, ph叩t ban, r畛i lo畉n ch畛c nng t狸nh d畛c CH畛NG CH畛 畛NH TH畉N TR畛NG 8
- 9. T働NG TC THU畛C 9 Thu畛c ch畛ng tng huy畉t 叩p kh叩c: c坦 th畛 lm tng t叩c d畛ng h畉 huy畉t 叩p c畛a Irbesartan. Nh動ng Irbesartan v畉n c坦 th畛 k畉t h畛p 動畛c v畛i thu畛c ch畉n beta, ch畉n calci ho畉c c叩c thu畛c l畛i ti畛u nh坦m thiazid. Thu畛c b畛 sung kali ho畉c c叩c thu畛c l畛i ti畛u gi畛 kali: lm tng n畛ng 畛 kali huy畉t. Lithium: Tng n畛ng 畛 lithium huy畉t thanh v 畛c t鱈nh c坦 th畛 h畛i ph畛c 動畛c 達 動畛c b叩o c叩o khi ph畛i h畛p v畛i c叩c thu畛c 畛c ch畉 enzym chuy畛n. Digoxin : d動畛c 畛ng h畛c kh担ng b畛 thay 畛i khi d湛ng 畛ng th畛i m畛t li畛u Irbesartan 150 mg 畛 ng動畛i kh畛e m畉nh. Hydroclothiazid : d動畛c 畛ng h畛c kh担ng thay 畛i
- 10. 10 Irbesartan vs. Placebo Source: 1 http://hyper.ahajournals.org/content/31/6/1311.full NCLS a trung t但m (8 trung t但m): 2,955 b畛nh nh但n cao huy畉t 叩p, ch畛n ng畉u nhi棚n, NC m湛 担i, chia 2 nh坦m d湛ng 2 lo畉i m畉u nh動 sau: 1. Irbesartan, 1 l畉n/ngy (150-900 mg) trong v嘆ng 6-8 tu畉n 2. Placebo, 1 l畉n/ngy, trong v嘆ng 6-8 tu畉n K畉t qu畉: D湛ng Irbesartan 畛i v畛i b畛nh nh但n c坦 b畛nh CHA 達 gi畉m 叩ng k畛 ch畛 s畛 huy畉t 叩p so v畛i nh坦m placebo Hi畛u qu畉 gi畉m huy畉t 叩p tng d畉n theo li畛u d湛ng, 畉t m畛c t畛i a 畛 li畛u 300 mg Kh担ng c坦 s畛 thay 畛i r探 r畛t c畛a nh畛p tim v畛i b畉t k畛 hm l動畛ng Irbesartan no (x辿t theo k畉t qu畉 l但m sng c滴ng nh動 th畛ng k棚) NGHIN C畛U LM SNG Hi畛u Qu畉 i畛u Tr畛 畛 C叩c Li畛u Kh叩c Nhau
- 11. 11 NGHIN C畛U LM SNG CHA K竪m T Type 2 V B畛nh Th畉n Irbesartan vs. Amlodipine NCLS Theo d探i v th畛 nghi畛m tr棚n 1,715 b畛nh nh但n CHA k竪m T type 2 v畛 vi畛c 畉nh h動畛ng c畛a Irbesartan t畛i s畛 ti畉n tri畛n c畛a b畛nh th畉n Ch畛n b畛nh nh但n ng畉u nhi棚n, NC m湛 担i, chia ra lm 3 nh坦m nh動 sau: 1. Irbesartan, 1l畉n/ngy (300 mg), k辿o di trung b狸nh 2.6 nm 2. Amlodipine, 1l畉n/ngy (10 mg), k辿o di trung b狸nh 2.6 nm 3. Placebo, 1 l畉n/ngy, k辿o di trung b狸nh 2.6 nm Placebo vs. Source: 1 Prpms-Irbesartan Product Monograph. Health Canada. February 17, 2011 K畉t qu畉: Nguy c董 tng g畉p 担i creatinine huy畉t thanh ho畉c suy th畉n giai o畉n cu畛i gi畉m so v畛i nh坦m gi畉 d動畛c: nguy c董 t動董ng 畛i gi畉m 26%, nguy c董 tuy畛t 畛i gi畉m 6.2%. T叩c d畛ng b畉o v畛 th畉n c畛a irbesartan d動畛ng nh動 畛c l畉p v畛i t叩c d畛ng gi畉m huy畉t 叩p h畛 th畛ng.
- 12. 12 Nghi棚n c畛u Irbesartan tr棚n b畛nh nh但n 畉m ni畛u (IRMA2): 590 b畛nh nh但n CHA k竪m T type 2 v 畉m ni畛u c坦 ch畛c nng th畉n b狸nh th動畛ng (d畛a tr棚n ch畛 s畛 creatinine) B畛nh nh但n 畉m ni畛u c坦 nguy c董 c坦 th棚m b畛nh T type 2 k竪m b畛nh th畉n cao g畉p 10-20 l畉n so v畛i b畛nh nh但n kh畛e m畉nh B畛nh nh但n 動畛c ch畛n ng畉u nhi棚n, nghi棚n c畛u m湛 担i, chia thnh 2 nh坦m nh動 sau: 1. Irbesartan 1 l畉n/ngy (150mg ho畉c 300mg), k辿o di trung b狸nh 1.5 nm 2. Placebo 1 l畉n/ngy, k辿o di trung b狸nh 1.5 nm K畉t qu畉: Irbesartan 300mg 達 gi畉m 動畛c 70% nguy c董 t動董ng 畛i c畛a b畛nh 畉m ni畛u l但m sng, so v畛i placebo Gi畉m m畛c 畛 畉m ni畛u xu畛ng 43% sau 24 th叩ng s畛 d畛ng Irbesartan 300mg Kh担ng c坦 箪 ngh挑a th畛ng k棚 khi d湛ng hm l動畛ng 150mg/ngy Source: 1 Prpms-Irbesartan Product Monograph. Health Canada. February 17, 2011 Irbesartan vs. Placebo NGHIN C畛U LM SNG CHA K竪m T Type 2 V B畛nh Th畉n
- 13. 13 Source : http://www.nejm.org/doi/full/10.1056/NEJMoa011489#t=articleTop T叩c D畛ng Irbesartan L棚n S畛 Ph叩t Tri畛n B畛nh Th畉n Ti畛u 動畛ng 畛 Bn Ti畛u 動畛ng Type 2
- 14. 14 Source : http://www.nejm.org/doi/full/10.1056/NEJMoa011489#t=articleTop T叩c D畛ng Irbesartan L棚n S畛 Ph叩t Tri畛n B畛nh Th畉n Ti畛u 動畛ng 畛 Bn Ti畛u 動畛ng Type 2
- 15. 15 Source : http://www.nejm.org/doi/full/10.1056/NEJMoa011489#t=articleTop T叩c D畛ng Irbesartan L棚n S畛 Ph叩t Tri畛n B畛nh Th畉n Ti畛u 動畛ng 畛 Bn Ti畛u 動畛ng Type 2
- 16. ARBS CHO T畛 L畛 TUN TH畛 I畛U TR畛 CAO NH畉T ARB, angiotensin II receptor blocker; CI, confidence interval * Relative to ACE inhibitors after 1 year of treatment Corrrao et al. J Hypertens 2008;26:819-24. Diuretics 硫-blockers 留-blockers Calcium channel blockers ACE inhibitors ARBs Cause-specific hazard ratio (95% CI) for discontinuation* 0.5 1.0 2.0 Diuretics 硫-blockers 留-blockers Calcium channel blockers ACE inhibitors ARBs 1.83 1.64 1.23 1.08 1.00 0.92 - + Cause-specific hazard ratio (95% CI) for discontinuation* Total n = 445,356 16
- 17. Irbesartan Cho T畛 L畛 G畉n B坦 i畛u Tr畛 L但u Di Nh畉t Ph但n t鱈ch 董n bi畉n ACEI, 畛c ch畉 men chuy畛n; ARB, ch畉n th畛 th畛 angiotensin * p < 0,05; p = 0,009 so v畛i irbesartan lo畉i tr畛 irbesartan 70 60 50 40 30 20 10 0 34,4 42,0 43,6 44,7 49,7 51,3 60,8 * * * * * T畛 l畛 % b畛nh nh但n duy tr狸 v畛i kh畛i 畉u 董n tr畛 L畛i ti畛u ACEI Ch畉n k棚nh Ca Losartan Ch畉n Beta ARB Irbesartan Hasford J et al. J Hum Hypertens 2002; 16:569575. 17
- 18. CH畛NG MINH T働NG 働NG SINH H畛C 18 Irbesartan (1 x 300 mg tablet) From measured data Uncorrected for potency Geometric Mean Arithmetic Mean (CV %) Parameter Test* Reference % Ratio of Geometric Means 90% Confidence Interval AUCT (ng揃h/mL) 19409.28 20847.82 (37.29) 19672.29 20813.02 (34.75) 98.66 88.56 109.92 AUCI (ng揃h/mL) 22490.59 23763.90 (31.74) 22269.26 23251.43 (30.07) 100.99 91.95 110.92 Cmax (ng/mL) 3613.1 3693.8 (21.55) 3643.2 3832.9 (31.12) 99.17 91.29 107.74 Tmax 則 (h) 1.25 (0.500 5.00) 1.25 (0.500 5.00) T遜 (h) 12.82 (41.09) 13.23 (49.74) * pms-IRBESARTAN , Pharmascience Inc., Montr辿al, Qu辿bec, Canada AVAPRO速 , Sanofi- Synthelabo Canada Inc., purchased in Canada 則 Expressed as the median (range) only Expressed as the arithmetic mean (CV%) only $ % ratios of the geometric means and 90% confidence intervals are based on the 'least squares mean estimates'. Source: 1 Prpms-Irbesartan Product Monograph. Health Canada. February 17, 2011
- 19. 19 CH畛NG MINH T働NG 働NG SINH H畛C
- 20. 畉C I畛M & L畛I CH 20 H畉 HA nh動ng kh担ng g但y ho khan nh動 thu畛c 畛c ch畉 men chuy畛n pms-Irbesartan kh担ng 畛c ch畉 men chuy畛n ACE v lm tho叩i ho叩 bradykinine B棚n c畉nh t叩c d畛ng h畉 HA c嘆n c坦 t叩c d畛ng b畉o v畛 th畉n Lm ch畉m l畉i s畛 ti畉n tri畛n 畉n b畛nh th畉n giai o畉n cu畛i, BN tng huy畉t 叩p v 叩i th叩o 動畛ng II 畛 li畛u duy tr狸 300mg/ngy pms- Irbesartan 動畛c ch畛ng minh qua c叩c NCLS lm gi畉m 叩ng k畛 t狸nh tr畉ng ti畛u protein Kh担ng g但y 畉nh h動畛ng 畉n c叩c chuy畛n ho叩 hay c但n b畉ng hormon, c但n b畉ng i畛n gi畉i pms-Irbesartan kh担ng 畉nh h動畛ng 畉n renin hay c叩c th畛 th畛 hormon kh叩c hay c叩c k棚nh ion c坦 li棚n quan 畉n i畛u ho tim m畉ch c畛a CHA v c但n b畉ng n動畛c i畛n gi畉i
- 21. 21 C坦 th畛 u畛ng sau khi n 畛 gi畉m t叩c d畛ng ph畛 tr棚n h畛 ti棚u ho叩 Th畛c n kh担ng 畉nh h動畛ng 畉n sinh kh畉 d畛ng c畛a thu畛c Kh担ng c畉n ch畛nh li畛u 畛 ng動畛i cao tu畛i T叩c d畛ng thu畛c kh担ng thay 畛i v畛i ng動畛i gi hay hay gi畛i t鱈nh Kh担ng c畉n ch畛nh li畛u 畛 b畛nh nh但n suy th畉n, ch畉y th畉n nh但n t畉o, x董 gan 畛 BN suy th畉n ho畉c ch畉y th畉n nh但n t畉o, b畛nh nh但n x董 gan nh畉 畉n trung b狸nh, c叩c th担ng s畛 d動畛c 畛ng h畛c c畛a Irbesartan kh担ng thay 畛i 叩ng k畛 Ch畉t l動畛ng t動董ng 動董ng s畉n ph畉m g畛c Gi叩 thnh h畛p l箪 h董n s畉n ph畉m g畛c (-40%) T動董ng 動董ng sinh h畛c 畉C I畛M & L畛I CH
- 22. MARCH 2022 WWW.ANVOPHARMA.COM pms-IRBESARTAN Gi畉i ph叩p i畛u tr畛 cao huy畉t 叩p v b畉o v畛 th畉n
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