incidence of serious eso

8/11/2019 Incidence of Serious ESO

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Incidence of serious sideeffects from first-line antituberculosis drugs among patientstreated for active tuberculosis.

Authors:

Yee D;Valiquette C;Pelletier M;Parisien I;Rocher I;Menzies D

Author Address:

Respiratory Epidemiology Unit, Montreal Chest Institute, 1110 Pine

Avenue West, Room 103, Montreal, PQ, H3A 1A3 Canada.

Source:

American Journal Of Respiratory And Critical Care Medicine[Am J Respir

Crit Care Med] 2003 Jun 1; Vol. 167 (11), pp. 1472-7. Date of Electronic

Publication: 2003 Jan 31.

Publicat

ion

Type:

Journal Article

English


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Publisher:American Thoracic Society Country of Publication: United

States NLM ID:9421642 Publication Model: Print-Electronic Cited

Medium: Print ISSN: 1073-449X (Print) Linking ISSN:1073449X NLMISO Abbreviation:Am. J. Respir. Crit. Care Med.Subsets: Core Clinical

(AIM); MEDLINE


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Publication: 2000- : New York, NY : American Thoracic Society

Original Publication: New York, NY : American Lung Association, c1994-

Antitubercular Agents/*adverse effects

Antitubercular Agents/*therapeutic use

Tuberculosis, Pulmonary/*drugtherapy

Adolescent;Adult;Age Factors;Aged;Aged, 80 and

over;DrugEruptions/epidemiology;Drug-Induced Liver

Injury/epidemiology;Ethambutol/adverseeffects;Ethambutol/therapeutic use;Female;HIV

Seropositivity;Humans;Incidence;Isoniazid/adverse

effects;Isoniazid/therapeutic use;Male;Middle Aged;Proportional

Hazards Models;Pyrazinamide/adverse

effects;Pyrazinamide/therapeutic use;Rifampin/adverse

effects;Rifampin/therapeutic use;Risk Factors


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Major adverse reactions to antituberculosis drugs can cause significantmorbidity, and compromise treatment regimens for tuberculosis(TB).

Among patients treated for active TB we estimated the incidence, and

risk factors, of major sideeffects from first-line anti-TB

drugs. Sideeffects, resulting in modification or discontinuation of

therapy, or hospitalization, were attributed on the basis of resolution

after withdrawal, and/or recurrence with rechallenge. Among 430

patients treated between 1990 and 1999, the incidence of all major

adverse effects was 1.48 per 100 person-months of exposure (95%

confidence interval [95% CI], 1.31 to 1.61) for pyrazinamide, compared

with 0.49 (95% CI, 0.42 to 0.55) for isoniazid, 0.43 (95% CI, 0.37 to

0.49) for rifampin, and 0.07 (95% CI, 0.04 to 0.10) for ethambutol.

Occurrence of any major sideeffectwas associated with female sex

(adjusted hazard ratio, 2.5; 95% CI, 1.3 to 4.7), age over 60 years

(adjusted hazard ratio, 2.9; 95% CI, 1.3 to 6.3), birthplace in Asia

(adjusted hazard ratio, 2.5; 95% CI, 1.3 to 5.0), and humanimmunodeficiency virus-positive status (adjusted hazard ratio, 3.8; 95%

CI, 1.05 to 13.4). Pyrazinamide-associated adverse events were

associated with age over 60 years (adjusted hazard ratio, 2.6; 95% CI,

1.01 to 6.6) and birthplace in Asia (adjusted hazard ratio, 3.4; 95% CI,

1.4 to 8.3), whereas rifampin-associated adverse events were

associated with age over 60 years (adjusted hazard ratio, 3.9; 95% CI,

1.02 to 14.9) and human immunodeficiency virus-positive status

(adjusted hazard ratio, 8.0; 95% CI, 1.5 to 43). The incidence of

pyrazinamide-induced hepatotoxicity and rash during treatment for

active TB was substantially higher than with the other first-line anti-TB

drugs, and higher than previously recognized.


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Reaksi samping utama terhadap obat antituberkulosis dapat menyebabkan morbiditas yang signifikan,

dan rejimen pengobatan kompromi untuk tuberkulosis (TB). Di antara pasien yang diobati untuk TB aktif

kami memperkirakan kejadian, dan faktor risiko, efek samping utama dari obat anti-TB lini pertama. Efek

samping, sehingga modifikasi atau penghentian terapi, atau rumah sakit, dikaitkan atas dasar resolusi

setelah penarikan, dan / atau kekambuhan dengan rechallenge. Di antara 430 pasien yang diobati antara

1990 dan 1999, kejadian semua efek samping utama adalah 1,48 per 100 orang-bulan paparan (95%

confidence interval [95% CI], 1,31-1,61) untuk pirazinamid, dibandingkan dengan 0,49 (95% CI , 0,42-

0,55) untuk isoniazid, 0,43 (95% CI, 0,37-0,49) untuk rifampisin, dan 0,07 (95% CI, 0,04-0,10) untuk

ethambutol. Terjadinya efek samping utama dikaitkan dengan jenis kelamin perempuan (rasio hazard

yang disesuaikan, 2,5, 95% CI, 1,3-4,7), usia di atas 60 tahun (rasio hazard yang disesuaikan, 2,9, 95% CI,

1,3-6,3), tempat kelahiran di Asia (rasio hazard yang disesuaikan, 2,5, 95% CI, 1,3-5,0), dan status virus-

positif human immunodeficiency (rasio hazard yang disesuaikan, 3,8, 95% CI, 1,05-13,4). Efek samping

pirazinamid terkait dikaitkan dengan usia lebih dari 60 tahun (rasio hazard yang disesuaikan, 2,6, 95% CI,

1,01-6,6) dan kelahiran di Asia (rasio hazard yang disesuaikan, 3,4, 95% CI, 1,4-8,3), sedangkan

rifampisin kejadian buruk yang terkait dikaitkan dengan usia lebih dari 60 tahun (rasio hazard

disesuaikan, 3,9, 95% CI, 1,02-14,9) dan status virus-positif human immunodeficiency (rasio hazard yang

disesuaikan, 8,0, 95% CI, 1,5-43). Insiden pirazinamid hepatotoksisitas akibat dan ruam selama

pengobatan untuk TB aktif adalah jauh lebih tinggi daripada dengan obat anti-TB lini pertama lainnya,

dan lebih tinggi dari sebelumnya diakui.

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