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Multicenter Study
. 2022 Nov;31(11):1153-1163.
doi: 10.1002/pds.5513. Epub 2022 Aug 9.

Incidence and outcomes of adverse drug reactions to first-line anti-tuberculosis drugs and their effects on the quality of life: A multicenter prospective cohort study

Hayoung Choi  1   2 , Hang A Park  3 , In Gyu Hyun  2   4 , Joo-Hee Kim  2   5 , Yong-Il Hwang  2   5 , Seung Hun Jang  2   5 , Yun Su Sim  1   2 , Tae Rim Shin  1   2 , Yousang Ko  2   6 , Ga Young Ban  2   6 , Ji Young Hong  2   7 , Chang Youl Lee  2   7 , Myung Goo Lee  2   7 , Jeong-Hee Choi  2   4
Affiliations
Multicenter Study

Incidence and outcomes of adverse drug reactions to first-line anti-tuberculosis drugs and their effects on the quality of life: A multicenter prospective cohort study

Hayoung Choi et al. Pharmacoepidemiol Drug Saf. 2022 Nov.

Abstract

Background: In tuberculosis (TB) treatment, adverse drug reactions (ADRs) can interrupt treatment and decrease the quality of life (QoL). We aimed to prospectively investigate the incidence of ADRs to first-line anti-TB drugs and related outcomes and QoL.

Methods: Adult patients with TB who had been treated with first-line anti-TB drugs in five Korean hospitals were enrolled. ADR questionnaire surveys and blood tests were performed four times serially, and QoL was assessed on the fourth TB treatment week (±2 weeks).

Results: Of 410 enrolled patients with TB (males, 62%; mean age, 52.1 ± 18.1 years [those aged ≥65 years, 26.6%]), 67.8% experienced any ADRs (≥ grade 2) to TB drugs. The most common ADR was fatigue (53.2%), followed by itching (42.7%) and anorexia (41.7%). Older adult patients experienced relatively more ADRs, including anorexia, dyspepsia, rash, dizziness, anemia, abnormal hepatic/renal function tests, and increased uric acid levels (p < 0.05). Treatment regimens changed for 9.5% of patients owing to ADRs to anti-TB drugs. Patients with any ADRs and older adult patients had significantly lower QoL than their counterparts (p < 0.05). Old age (odds ratio [OR], 1.02) and being male (OR 2.65) were independently associated with ADRs, whereas active smoking (OR 4.73) and a relatively long treatment phase (OR 5.13) were independently associated with hepatotoxicity.

Conclusion: ADRs to first-line anti-TB drugs were common and related to relatively low QoL, especially among older adults. Although 9.5% of patients had ADR-related regimen changes, most patients with ADRs completed treatments successfully.

Keywords: adverse drug reactions; ant-tuberculosis drugs; incidence; outcomes; quality of life.

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References

REFERENCES

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