The safety of benzodiazepine tranquilizers in patients with alcohol withdrawal syndrome in real clinical practice

Aim

To study the frequency of benzodiazepine tranquilizers' prescription in hospitalized patients with uncomlicated alcohol withdrawal syndrome and the structure of the adverse drug events (ADE) in those patients in relation to pharmacotherapy's rationality.

Material and methods

We randomly collected case records of patients with diagnosis of Alcohol withdrawal syndrome (F10.3 by ICD-10) hospitalized to the narcological department from 01.01.2014 to 31.12.2016. The following information was extracted: clinical and demographical data, prescribed benzodiazepine tranquilizer and it's dose, duration of administration, concomitant psychopharmacotherapy. The rationality of benzodiazepine's prescription was evaluated by Medical Appropriateness Index (MAI). The safety of medicines was studied with the Global Trigger Tool (GTT).

Results

We selected for analysis 231 of 700 case records. Bromdihydrochlorphenylbenzodiazepine was prescribed in 98.7% patients with alcohol withdrawal syndrome. Daily dose never exceeded the maximum recommended dose and averaged 5.82±2.14 mg. The mean duration of treatment was 10.42±6.07 days. The study of safety with the GTT showed 55 triggers. ADE were confirmed in 19 cases and included “Elevated serum creatinine” (n=13), “Elevated serum ALT/AST by more than 20% of initial value” (n=4) and “Excessive sedation” (n=2). Bromdihydrochlorphenyl benzodiazepine's dose, duration of administration, MAI value and concomitant psychiatric medications had no impact on ADE's risk or trigger's occurence.

Conclusion

Bromdihydrochlorphenylbenzodiazepine was the most common benzodiazepine prescribed to patients with alcohol dependence syndrome and post-abstinent disorders. Clinical and demographic factors did not influence the frequency and structure of trriggers and ADE. In order to reveal benzodiazepine-induced ADE's risk factors it is necessary to study interindividual differences between patients. The contribution of genotype and phenotype might be significant though their association with bromdihydrochlorphenylbenzodiazepine safety profile requires additional studies.

Key words

Benzodiazepine tranquilizers, safety, pharmacoepidemiology, alcohol dependence syndrome, bromdihydrochlorphenylbenzodiazepine.