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Retrospective analysis of the safety profile of oral moxifloxacin in elderly patients enrolled in clinical trials.
Drug Saf. 2005; 28(5):443-52.DS

Abstract

BACKGROUND AND OBJECTIVE

As aging is associated with physiological changes, including renal and hepatic insufficiency, and a higher risk of drug interactions, special attention needs to be directed towards the safety of medications in the elderly. The objective of this analysis was to evaluate the safety of oral moxifloxacin in elderly patients who were enrolled in clinical trials and to compare these results to those of other commonly used antibacterials.

METHODS

Safety data from 27 prospective, randomised, comparative phase II/III trials of oral moxifloxacin included in the Bayer clinical trial database were pooled and analysed by age group (<65 years of age, 65-74 years of age, > or = 75 years of age) and by treatment group (moxifloxacin vs comparator). The primary endpoints included rates of treatment-emergent adverse events (all adverse events regardless of causality), drug-related adverse events, drug-related serious adverse events, deaths and premature discontinuations because of a treatment-emergent adverse event. A treatment by age group interaction test was used to determine if the comparison between moxifloxacin and the comparator group in the incidence rates of any treatment-emergent or drug-related adverse events were affected by increasing age.

RESULTS

Of the 12 231 patients who had valid safety data, 6270 had been treated with oral moxifloxacin and 5961 with a comparator antibacterial. The most frequently used comparators were cefuroxime and clarithromycin. Most patients (n = 9671) were <65 years of age (4939 moxifloxacin, 4732 comparator); 1636 patients were 65-74 years of age (842 moxifloxacin, 794 comparator); and 924 patients were > or = 75 years of age (489 moxifloxacin, 435 comparator). The treatment by age group interaction test revealed that the comparison of drug-related adverse event rates between the moxifloxacin and comparator group were not affected by increasing age (p = 0.43). Rates of premature termination between the moxifloxacin and comparator treatment groups also did not increase with age (p = 0.552). No arrhythmias related to corrected QT (QTc) interval prolongation were reported following oral moxifloxacin or comparator treatment in this large group of young and elderly patients. Overall, the number of deaths was similar between the treatment groups (17 moxifloxacin, 19 comparator).

CONCLUSIONS

Drug-related adverse event rates associated with oral moxifloxacin or the comparator therapy used in these studies did not significantly increase with advancing age. This pooled analysis suggests that oral moxifloxacin can be safely used in elderly patients with characteristics consistent with those enrolled into the clinical trials.

Authors+Show Affiliations

Yale School of Medicine, New Haven, Connecticut 06520-8022, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15853445

Citation

Andriole, Vincent T., et al. "Retrospective Analysis of the Safety Profile of Oral Moxifloxacin in Elderly Patients Enrolled in Clinical Trials." Drug Safety, vol. 28, no. 5, 2005, pp. 443-52.
Andriole VT, Haverstock DC, Choudhri SH. Retrospective analysis of the safety profile of oral moxifloxacin in elderly patients enrolled in clinical trials. Drug Saf. 2005;28(5):443-52.
Andriole, V. T., Haverstock, D. C., & Choudhri, S. H. (2005). Retrospective analysis of the safety profile of oral moxifloxacin in elderly patients enrolled in clinical trials. Drug Safety, 28(5), 443-52.
Andriole VT, Haverstock DC, Choudhri SH. Retrospective Analysis of the Safety Profile of Oral Moxifloxacin in Elderly Patients Enrolled in Clinical Trials. Drug Saf. 2005;28(5):443-52. PubMed PMID: 15853445.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Retrospective analysis of the safety profile of oral moxifloxacin in elderly patients enrolled in clinical trials. AU - Andriole,Vincent T, AU - Haverstock,Daniel C, AU - Choudhri,Shurjeel H, PY - 2005/4/28/pubmed PY - 2005/8/3/medline PY - 2005/4/28/entrez SP - 443 EP - 52 JF - Drug safety JO - Drug Saf VL - 28 IS - 5 N2 - BACKGROUND AND OBJECTIVE: As aging is associated with physiological changes, including renal and hepatic insufficiency, and a higher risk of drug interactions, special attention needs to be directed towards the safety of medications in the elderly. The objective of this analysis was to evaluate the safety of oral moxifloxacin in elderly patients who were enrolled in clinical trials and to compare these results to those of other commonly used antibacterials. METHODS: Safety data from 27 prospective, randomised, comparative phase II/III trials of oral moxifloxacin included in the Bayer clinical trial database were pooled and analysed by age group (<65 years of age, 65-74 years of age, > or = 75 years of age) and by treatment group (moxifloxacin vs comparator). The primary endpoints included rates of treatment-emergent adverse events (all adverse events regardless of causality), drug-related adverse events, drug-related serious adverse events, deaths and premature discontinuations because of a treatment-emergent adverse event. A treatment by age group interaction test was used to determine if the comparison between moxifloxacin and the comparator group in the incidence rates of any treatment-emergent or drug-related adverse events were affected by increasing age. RESULTS: Of the 12 231 patients who had valid safety data, 6270 had been treated with oral moxifloxacin and 5961 with a comparator antibacterial. The most frequently used comparators were cefuroxime and clarithromycin. Most patients (n = 9671) were <65 years of age (4939 moxifloxacin, 4732 comparator); 1636 patients were 65-74 years of age (842 moxifloxacin, 794 comparator); and 924 patients were > or = 75 years of age (489 moxifloxacin, 435 comparator). The treatment by age group interaction test revealed that the comparison of drug-related adverse event rates between the moxifloxacin and comparator group were not affected by increasing age (p = 0.43). Rates of premature termination between the moxifloxacin and comparator treatment groups also did not increase with age (p = 0.552). No arrhythmias related to corrected QT (QTc) interval prolongation were reported following oral moxifloxacin or comparator treatment in this large group of young and elderly patients. Overall, the number of deaths was similar between the treatment groups (17 moxifloxacin, 19 comparator). CONCLUSIONS: Drug-related adverse event rates associated with oral moxifloxacin or the comparator therapy used in these studies did not significantly increase with advancing age. This pooled analysis suggests that oral moxifloxacin can be safely used in elderly patients with characteristics consistent with those enrolled into the clinical trials. SN - 0114-5916 UR - https://www.unboundmedicine.com/medline/citation/15853445/Retrospective_analysis_of_the_safety_profile_of_oral_moxifloxacin_in_elderly_patients_enrolled_in_clinical_trials_ L2 - https://dx.doi.org/10.2165/00002018-200528050-00007 DB - PRIME DP - Unbound Medicine ER -