. eo.SIMARKET!!Il G SURVEILLANCE FOCUSSES ON STREPTOKINASE Streptokinase treatment successful in 70 % of patients Streptokinase, an acti vator of fibrinolysis which dissolves human thrombi has been marketed in the US since November 1977 . In a postmarketi ng surveillance programme, 308 Oinical Experien ce Report Forms were filled out by 260 ph ysicians in 44 states and the Distri ct of Col umbia. Indicati ons for streptokinase treat men t wer e deep vein t hr ombosis (OVT; 45 % ), pulmonary embolism and pulmonary embolism / deep venous thrombosi s{ PE and PE /DVT ; 38 96 ), aner iovenous cannu l ae occlu sions (AVeO; 4 96 ), arterial occlusions(AO; 7 96), and ot her uses (6 96). Streptoki nase treatment was rated 'successful' or 'partially successfu l' in 70 96 of pat ients. Patients with ' un successful' treatmem outcomes received shorter courses and l ess drug (mean . ) t iu for 33 hours in OVT and 25iu for 25 hours for PE and PE/ DVT) than patients with 's uocessfu!' outcomes (mean, 43iu fo r 45 hour s in DVT and 47iu for 50 hours in PE and PE/ DVn. Pat ient s .( 40 years of age with DVT and / or PE had better treatment outoomes than patients > 40 years old. 50 % or regimens were oo mplicaltxl by adverse effects. No previously unknown reaction was re ported du ring the surveill ance programme. Adverse effects induded severe bleeding(4.9 % of patients), other t ypes of bleed ing (haematoma, ecchymoses, haematuria or haematemesi s; 15.7 96 ), fever(26 .896 ) and allergic reactionsO .3 % ). 25 pati ents (8.2 %) died during or within a few weeks ofslreptokinase therapy . but on ly 3 deaths due to severt bleeding were possibl y related to the drug. TMyer. C. F. : Current Thcrapeul i<: Rnearch. ]0: 129 (Jul 1981) ,1' 10 INPHARMA t8J ul l981 0156_2703 / 81 /0718-0010$00.50/0 C AOIS Press

POSTMARKETING SURVEILLANCE FOCUSSES ON STREPTOKINASE

Download PDF Report

Upload
vudang
View
213
Download
0

Embed Size (px)

Citation preview

Page 1: POSTMARKETING SURVEILLANCE FOCUSSES ON STREPTOKINASE

.eo.SIMARKET!!IlG SURVEILLANCE FOCUSSES ON STREPTOKINASE

Streptokinase treatment successful in 70 % of patients Streptokinase, an activator of fibrinolysis which dissolves human thrombi has been marketed in the US since November 1977 . In a postmarketing surveillance programme, 308 Oinical Experience Report Forms were filled out by 260 physicians in 44 states and the District of Col umbia. Indications for streptokinase treatment were deep vein thrombosis (OVT; 45 % ), pulmonary embolism and pulmonary embolism/deep venous thrombosis{ PE and PE / DVT; 38 96 ), aneriovenous cannulae occlusions (AVeO; 4 96 ), arterial occlusions(AO; 7 96), and other uses (6 96). Streptokinase treatment was rated 'successful' or 'partially successful' in 70 96 of patients. Patients with 'unsuccessful' treatmem outcomes received shorter courses and less drug (mean. ) t iu for 33 hours in OVT and 25iu for 25 hours for PE and PE/ DVT) than patients with 'suocessfu!' outcomes (mean, 43iu for 45 hours in DVT and 47iu for 50 hours in PE and PE/ DVn. Patients .( 40 years of age with DVT and / or PE had better treatment outoomes than patients > 40 years old. 50 % or ~treptokjnase regimens were oomplicaltxl by adverse effects. No previously unknown reaction was reported du ring the surveillance programme. Adverse effects induded severe bleeding(4.9 % of patients), other types of bleeding (haematoma, ecchymoses, haematuria or haematemesis; 15.7 96 ), fever(26 .896 ) and allergic reactionsO.3 % ). 25 patients (8.2 % ) died during or within a few weeks ofslreptokinase therapy. but only 3 deaths due to severt bleeding were possibl y related to the drug. TMyer. C.F.: Current Thcrapeul i<: Rnearch. ]0: 129 (Jul 1981),1'

10 INPHARMA t8Jul l981 0156_2703 /81 /0718-0010$00.50 /0 C AOIS Press