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Article

The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial

by
Abid Ullah
1,
Shujaat Ahmad
1,*,
Niaz Ali
2,3,*,
Haya Hussain
1,
Mamdouh Allahyani
4,
Mazen Almehmadi
4,
Ahad Amer Alsaiari
4,
Osama Abdulaziz
4,
Feras Almarshad
5 and
Syeda Hajira Bukhari
3
1
Department of Pharmacy, Shaheed Benazir Bhutto University Sheringal, Dir Upper 18000, Khyber Pakhtunkhwa, Pakistan
2
Department of Pharmacology, College of Medicine, Shaqra University, Shaqra 11961, Saudi Arabia
3
Department of Pharmacology, Institute of Basic Medical Sciences, Khyber Medical University, Peshawar 25100, Khyber Pakhtunkhwa, Pakistan
4
Department of Clinical Laboratory, Sciences Saudi Arabia Department, College of Applied Medical Sciences, Taif University, Taif 21944, Saudi Arabia
5
Department of Medicine, College of Medicine, Shaqra University, Shaqra 11961, Saudi Arabia
*
Authors to whom correspondence should be addressed.
Diagnostics 2023, 13(7), 1234; https://doi.org/10.3390/diagnostics13071234
Submission received: 23 February 2023 / Revised: 16 March 2023 / Accepted: 17 March 2023 / Published: 24 March 2023
(This article belongs to the Special Issue Diagnosis of Adverse Reactions to Drugs)
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Abstract

Moxifloxacin and gemifloxacin are the two newer broad-spectrum 8-methoxy-quinolone derivatives that are used to treat various bacterial infections in cardiac patients. In this research study, we assessed the impact of moxifloxacin and gemifloxacin on the QT intervals of electrocardiograms in normal adult doses and draw a comparison, in a controlled environment, on healthy volunteers. Additionally, the effect of both test drugs on the QRS complex was checked. Sixty healthy volunteers were randomly assigned to two groups via R-software, and each respectively received moxifloxacin and gemifloxacin for five days. The research ethics committee approved the research, and it was registered for clinical trial under NCT 04692623. The participants’ electrocardiograms were obtained before the start of the dose (baseline) and on the fifth day. Significant prolongation of QT interval was noted in moxifloxacin (p < 0.0001) as compared to gemifloxacin treated groups. There were no cases of QTc prolongation over the usual limits (450–470 ms) in the gemifloxacin-treated group, however, QTc prolongations at the rate of 30 and 60 ms from the baseline were noted, interpreted as per the EMEA guidelines. These findings indicate that moxifloxacin caused significant (p < 0.0001) QT interval prolongation (QTIP) as compared to gemifloxacin. In contrast to the previously reported literature, the prominent effect of moxifloxacin on the widening of the QRS-complex was noted with no such effect on QRS-widening in the gemifloxacin-treated group. It is concluded that both drugs have the potential for considerable QT interval prolongation (QTIP) effects, which is one of the risk factors for developing torsade de pointes (TdPs) in cardiac patients. Thus, clinicians should exercise caution when prescribing moxifloxacin and gemifloxacin to cardiac patients and should consider alternate treatment options.
Keywords: moxifloxacin; gemifloxacin; QT prolongation; QRS-widening effect; healthy volunteers; Clinical Trial Phase 1 moxifloxacin; gemifloxacin; QT prolongation; QRS-widening effect; healthy volunteers; Clinical Trial Phase 1

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MDPI and ACS Style

Ullah, A.; Ahmad, S.; Ali, N.; Hussain, H.; Allahyani, M.; Almehmadi, M.; Alsaiari, A.A.; Abdulaziz, O.; Almarshad, F.; Bukhari, S.H. The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial. Diagnostics 2023, 13, 1234. https://doi.org/10.3390/diagnostics13071234

AMA Style

Ullah A, Ahmad S, Ali N, Hussain H, Allahyani M, Almehmadi M, Alsaiari AA, Abdulaziz O, Almarshad F, Bukhari SH. The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial. Diagnostics. 2023; 13(7):1234. https://doi.org/10.3390/diagnostics13071234

Chicago/Turabian Style

Ullah, Abid, Shujaat Ahmad, Niaz Ali, Haya Hussain, Mamdouh Allahyani, Mazen Almehmadi, Ahad Amer Alsaiari, Osama Abdulaziz, Feras Almarshad, and Syeda Hajira Bukhari. 2023. "The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial" Diagnostics 13, no. 7: 1234. https://doi.org/10.3390/diagnostics13071234

APA Style

Ullah, A., Ahmad, S., Ali, N., Hussain, H., Allahyani, M., Almehmadi, M., Alsaiari, A. A., Abdulaziz, O., Almarshad, F., & Bukhari, S. H. (2023). The Effects of Moxifloxacin and Gemifloxacin on the ECG Morphology in Healthy Volunteers: A Phase 1 Randomized Clinical Trial. Diagnostics, 13(7), 1234. https://doi.org/10.3390/diagnostics13071234

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