Prospective study based on the evaluation of daily and intermittent dosage regimen of anti-tubercular (ATT) drug therapy
By: Sankar, V
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Contributor(s): Nimitha, M | Rama, P.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2018Edition: Vol. 55 (03) March.Description: 49-57.Subject(s): PHARMACEUTICS | Tuberculosis | Risk factorsOnline resources: Click here
In:
Indian drugsSummary: Anti-TB drug induced hepatotoxicity causes treatment interruption, poor compliance, increased mortality and morbidity, and modification of treatment regimen. Hence, we need to assess the effect of dosing schedule of daily and intermittent regimens and identify patients with increased risk of developing drug induced hepatotoxicity. To determine the frequency and risk factors associated with anti-tuberculosis drug induced hepatotoxicity in daily and intermittent dosage regimen of anti- tubercular therapy, a prospective study was conducted with 130 patients diagnosed with tuberculosis, followed clinically and biochemically before and after the initiation of anti-tuberculosis drugs. Complete history including demographic details and physical examination were documented. Among 53 patients, 28.3% of the patients developed anti- tuberculosis drug induced hepatotoxicity with higher incidence in those receiving daily regimen than the intermittent regimen (P = 0.00). On comparing the site of tuberculosis, higher risk of drug induced hepatotoxicity was reported in cases with pulmonary tuberculosis (P = 0.01) than with extra-pulmonary tuberculosis. Among the 23 patients with anti– tuberculosis drug induced hepatotoxicity, 52% were noted to have moderate hepatotoxicity based on the severity grading of hepatotoxicity and 44% noted as probable based on the Roussel-Uclaf causality assessment method. Body mass index < 20kg/m2 (P = 0.042) and concomitant use of other hepatotoxic drug (P = 0.005) were risk factors for anti-TB DIH. Higher incidence of anti- tuberculosis drug induced hepatotoxicity was found in patients who received daily regimen rather than intermittent regimen. Extreme precaution should be taken in patients with body mass index < 20kg/m2 and also among those using concomitant hepatotoxic drugs
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Anti-TB drug induced hepatotoxicity causes treatment interruption, poor compliance, increased mortality and morbidity, and modification of treatment regimen. Hence, we need to assess the effect of dosing schedule of daily and intermittent regimens and identify patients with increased risk of developing drug induced hepatotoxicity. To determine the frequency and risk factors associated with anti-tuberculosis drug induced hepatotoxicity in daily and intermittent dosage regimen of anti- tubercular therapy, a prospective study was conducted with 130 patients diagnosed with tuberculosis, followed clinically and biochemically before and after the initiation of anti-tuberculosis drugs. Complete history including demographic details and physical examination were documented. Among 53 patients, 28.3% of the patients developed anti- tuberculosis drug induced hepatotoxicity with higher incidence in those receiving daily regimen than the intermittent regimen (P = 0.00). On comparing the site of tuberculosis, higher risk of drug induced hepatotoxicity was reported in cases with pulmonary tuberculosis (P = 0.01) than with extra-pulmonary tuberculosis. Among the 23 patients with anti– tuberculosis drug induced hepatotoxicity, 52% were noted to have moderate hepatotoxicity based on the severity grading of hepatotoxicity and 44% noted as probable based on the Roussel-Uclaf causality assessment method. Body mass index < 20kg/m2 (P = 0.042) and concomitant use of other hepatotoxic drug (P = 0.005) were risk factors for anti-TB DIH. Higher incidence of anti- tuberculosis drug induced hepatotoxicity was found in patients who received daily regimen rather than intermittent regimen. Extreme precaution should be taken in patients with body mass index < 20kg/m2 and also among those using concomitant hepatotoxic drugs
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