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A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia.
Chest. 2005 Nov; 128(5):3398-406.Chest

Abstract

CONTEXT

Antimicrobial cardiac safety is of particular concern during the treatment of community-acquired pneumonia (CAP) in elderly patients, due to the presence of comorbid conditions and the use of multiple medications that may individually or synergistically affect cardiac repolarization.

STUDY OBJECTIVE

To assess the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with CAP.

DESIGN AND SETTING

Prospective, randomized, double-blind trial conducted at 47 hospitals in the United States.

PATIENTS

Subjects > or = 65 years old with clinical signs/symptoms of CAP requiring initial parenteral therapy, including those with comorbidities. The safety population included 394 patients: 51.3% male; 85.3% white; mean age, 77.8 years. Two-thirds of the patients were > 75 years old, and 74.1% had a history of cardiac disease.

INTERVENTIONS

Patients received IV/oral moxifloxacin (400 mg qd) or IV/oral levofloxacin (500 mg qd) for 7 to 14 days. Safety evaluations included 72 h of digital continuous 12-lead Holter monitoring, 12-lead ECGs at baseline and at maximum serum concentration on day 3, and adverse events.

MAIN OUTCOME MEASURES

The primary safety end point was a composite of ventricular arrhythmia events based on Holter monitoring.

RESULTS

Holter monitor data were available for 387 patients (192 receiving moxifloxacin and 195 receiving levofloxacin). Sixteen moxifloxacin-treated patients (8.3%) and 10 levofloxacin-treated patients (5.1%) had a primary composite cardiac event (p = 0.29); most events were nonsustained ventricular tachycardia (VT) [14 patients receiving moxifloxacin, 7.3%; and 10 patients receiving levofloxacin, 5.1%]. One moxifloxacin-treated patient had sustained monomorphic VT (> 30 s), and one levofloxacin-treated patient had torsade de pointes. Mean +/- SD QTc (Fridericia formula) change on day 3 was + 6.4 +/- 23.2 ms for moxifloxacin and - 2.5 +/- 22.9 ms for levofloxacin (p = 0.04). No deaths clearly related to study drugs occurred during the observation period.

CONCLUSIONS

IV/oral moxifloxacin, although known to cause QTc interval prolongation, has a comparable cardiac rhythm safety profile to IV/oral levofloxacin in high-risk elderly patients with CAP.

Authors+Show Affiliations

University of Pennsylvania School of Medicine and eResearch Technology, Philadelphia, USA. jmorganroth@ert.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16304291

Citation

Morganroth, Joel, et al. "A Randomized Trial Comparing the Cardiac Rhythm Safety of Moxifloxacin Vs Levofloxacin in Elderly Patients Hospitalized With Community-acquired Pneumonia." Chest, vol. 128, no. 5, 2005, pp. 3398-406.
Morganroth J, Dimarco JP, Anzueto A, et al. A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia. Chest. 2005;128(5):3398-406.
Morganroth, J., Dimarco, J. P., Anzueto, A., Niederman, M. S., & Choudhri, S. (2005). A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia. Chest, 128(5), 3398-406.
Morganroth J, et al. A Randomized Trial Comparing the Cardiac Rhythm Safety of Moxifloxacin Vs Levofloxacin in Elderly Patients Hospitalized With Community-acquired Pneumonia. Chest. 2005;128(5):3398-406. PubMed PMID: 16304291.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia. AU - Morganroth,Joel, AU - Dimarco,John P, AU - Anzueto,Antonio, AU - Niederman,Michael S, AU - Choudhri,Shurjeel, AU - ,, PY - 2005/11/24/pubmed PY - 2005/12/24/medline PY - 2005/11/24/entrez SP - 3398 EP - 406 JF - Chest JO - Chest VL - 128 IS - 5 N2 - CONTEXT: Antimicrobial cardiac safety is of particular concern during the treatment of community-acquired pneumonia (CAP) in elderly patients, due to the presence of comorbid conditions and the use of multiple medications that may individually or synergistically affect cardiac repolarization. STUDY OBJECTIVE: To assess the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with CAP. DESIGN AND SETTING: Prospective, randomized, double-blind trial conducted at 47 hospitals in the United States. PATIENTS: Subjects > or = 65 years old with clinical signs/symptoms of CAP requiring initial parenteral therapy, including those with comorbidities. The safety population included 394 patients: 51.3% male; 85.3% white; mean age, 77.8 years. Two-thirds of the patients were > 75 years old, and 74.1% had a history of cardiac disease. INTERVENTIONS: Patients received IV/oral moxifloxacin (400 mg qd) or IV/oral levofloxacin (500 mg qd) for 7 to 14 days. Safety evaluations included 72 h of digital continuous 12-lead Holter monitoring, 12-lead ECGs at baseline and at maximum serum concentration on day 3, and adverse events. MAIN OUTCOME MEASURES: The primary safety end point was a composite of ventricular arrhythmia events based on Holter monitoring. RESULTS: Holter monitor data were available for 387 patients (192 receiving moxifloxacin and 195 receiving levofloxacin). Sixteen moxifloxacin-treated patients (8.3%) and 10 levofloxacin-treated patients (5.1%) had a primary composite cardiac event (p = 0.29); most events were nonsustained ventricular tachycardia (VT) [14 patients receiving moxifloxacin, 7.3%; and 10 patients receiving levofloxacin, 5.1%]. One moxifloxacin-treated patient had sustained monomorphic VT (> 30 s), and one levofloxacin-treated patient had torsade de pointes. Mean +/- SD QTc (Fridericia formula) change on day 3 was + 6.4 +/- 23.2 ms for moxifloxacin and - 2.5 +/- 22.9 ms for levofloxacin (p = 0.04). No deaths clearly related to study drugs occurred during the observation period. CONCLUSIONS: IV/oral moxifloxacin, although known to cause QTc interval prolongation, has a comparable cardiac rhythm safety profile to IV/oral levofloxacin in high-risk elderly patients with CAP. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/16304291/A_randomized_trial_comparing_the_cardiac_rhythm_safety_of_moxifloxacin_vs_levofloxacin_in_elderly_patients_hospitalized_with_community_acquired_pneumonia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(15)52908-5 DB - PRIME DP - Unbound Medicine ER -