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• W4225522912 abstract "To the Editor Hydroxychloroquine in combination with azithromycin (HY+AZ) has been used since the early stages of the ‘Coronavirus disease 2019’ (COVID-19) epidemic,1,2 despite its efficacy and safety having been challenged.3–7 ECG is one of the leading tools to assess cardiac involvement in COVID-19 patients, although further studies have been advocated to better understand its role, especially in evaluating the medications’ effect and in refining risk stratification.8 We aimed to assess the QTc prolongation risk in COVID-19 patients treated with HY+AZ. Methods We retrospectively analyzed ECGs of 147 patients admitted for COVID-19 to Fondazione IRCCS Policlinico San Matteo hospital in Pavia (Italy) from 22 February to 24 April 2020. Patients were treated at the clinicians’ choice, according to the available evidence, with various drugs, including Tocilizumab, antiretrovirals (Lopinavir/Ritonavir or Remdesivir), azithromycin and hydroxychloroquine. A baseline ECG performed at the hospital admission and at least another ECG performed during hospitalization were available for all the patients. The primary outcome was QTc prolongation and the last follow-up was on 31 July 2020. We presented data as counts (%) or as median [interquartile range (IQR)] or median (range). We compared categorical and continuous variables using the χ2 and Mann--Whitney test, respectively. A P-value less than 0.05 was considered statistically significant. Results Male patients numbered 100 (68%), the median age was 69.5 years (range, 25–93) and in-hospital death occurred in 44 (29.9%). We divided the patients into three groups in order to assess the effect of HY+AZ on QT interval: HY+AZ group (n = 75), patients treated exclusively with a combination of azithromycin (500 mg per day) and hydroxychloroquine (200 mg twice or three times per day); off-QTc-prolonging-drug group (n = 17), patients who did not assume either the combination of HY+AZ or any other drug known to have the capability to prolong the QT interval; other-QTc-prolonging-drug group (n = 48), patients treated with other drugs with respect to HY+AZ, which can potentially increase the QT interval. Seven patients treated with HY+AZ and other QTc-prolonging drugs were excluded. Baseline characteristics of the whole population and of the three groups are presented in Table 1. Table 1 - Characteristics of the whole population and of the different subgroups Overall population (n = 147) HY+AZ group (n = 75) Off-QTc-prolonging-drug group (n = 17) Other-QTc-prolonging-drug group (n = 48) P Age (years), median, IQR 69.5 [59–78] 69 [58–75] 74 [61–81] 69 [61–77] 0.39 Male sex [n (%)] 100 (68) 54 (72) 13 (76.5) 31 (64.6) 0.56 History of CV disease [n (%)] 100 (68) 48 (50.5) 12 (70.6) 35 (72.9) 0.57 PaO2/FiO2 at HA [median, IQR] 271 [161–330] 264 [120–318] 332 [255–366] 255 [193–657] 0.06 CRP value at HA (mg/l), median, IQR 10.9 [5.1–18] 11.6 [5–19] 6.8 [2.4–14.2] 11.5 [6.2–19.8] 0.08 hs-TnI value at HA, ng/l, median, IQR 16 [7–40] 12.5 [6–32] 19 [11–64] 20 [5–47] 0.42 WBC/μl at HA, median, IQR 6700 [5275–9080] 6440 [4955–8800] 6420 [4972–9287] 7500 [6165–9520] 0.11 QTc at first ECG (ms), median, IQR 445 [421.5–460] 445 [417.2–460] 440 [414–450] 441 [422–460] 0.75 CRP, C-reactive protein; CV, cardiovascular; HA, hospital admission; hs-TnI, high-sensitivity troponin I; WBC, white blood cells. The median QTc at the admission for the HY+AZ group was 445 ms (IQR, 417–460) with a lengthening to 462 ms (IQR, 442–483) (P < 0.001) after therapy, whereas, among the off-QTc-prolonging-drug group, the median QTc was 440 ms (IQR, 414–450) at hospital admission and 445 ms (IQR, 420–457) during hospitalization (P = 0.73). Regarding the other-QTc-prolonging-drug group, the QTc was 441 ms (IQR, 422–460) at hospital admission and 452 ms (IQR, 430–479) after therapy (P = 0.04). Twenty-one patients (15%) prolonged the QTc by at least 500 ms during hospitalization: 53.6% (14/21) were in the HY+AZ group, 34.3% (7/21) in the other-QTc-prolonging-drug group, whilst no patient showed a QTc of at least 500 ms in the off-QTc-prolonging-drug group. The only difference between the patients who reached a QTc value of at least 500 ms during hospitalization in the HY+AZ group and those who did not was the QTc at the admission ECG, which was 467.5 ms (IQR, 447–480) in the first group and 440 ms (IQR, 413–455) in the latter one (P = 0.002) (Table 2). Table 2 - Characteristics of the patients in the hydroxychloroquine with azithromycin group divided according to the maximum QTc value reached during hospitalization QTc during hospitalization <500 ms (n = 61) QTc during hospitalization ≥500 ms (n = 14) P Age (years), median, IQR 68.5 [57–74.5] 70.5 [62–79] 0.27 Male sex [n (%)] 44 (72.1) 10 (71.4) 0.96 History of CV disease [n (%)] 39 (63.9) 9 (64.3) 0.98 PaO2/FiO2 at HA, median, IQR 264 [120–319] 224 [113–313] 0.66 CRP value at HA (mg/l), median, IQR 11.1 [5.3–17.6] 17.8 [3.5–24] 0.46 hs-TnI value at HA (ng/l), median, IQR 12.5 [6–33.5] 15.5 [11–26] 0.66 WBC/μl at HA, median, IQR 6400 [5042–8475] 6480 [4740–11450] 0.85 QTc at first ECG (ms), median, IQR 440 [413–455.5] 467.5 [447–480] 0.002 CRP, C-reactive protein; CV, cardiovascular; HA, hospital admission; hs-TnI, high-sensitivity troponin I; WBC, white blood cells. Regarding mortality, 41 patients died of expected deaths (after progressive worsening of the respiratory conditions), whilst 3 suffered an unexpected death (sudden and inexplicable death during clinical and medical tests improvement). Among this latter group, one died of anterior myocardial infarction, whilst the other two showed a QTc of at least 500 ms at the ECG performed on the day of death, suggesting a sudden cardiac, possibly arrhythmic, death. Comment Our study highlights that combination therapy of HY+AZ prolongs QTc in COVID-19 patients. Moreover, in a not negligible percentage of patients, QTc reached a duration of 500 ms, which is a cut-off value known to increase the arrhythmic risk independently of comorbidity,9 also in COVID-19 patients,10 therefore putting them at increased risk of an arrhythmic and potentially lethal event. Notably, of the three unexpected deaths in our population, two patients showed a QTc of at least 500 ms on the same day as death. Interestingly, patients who reached a QTc of at least 500 ms among those treated with HY+AZ had a significant prolonged QTc at the admission ECG compared with those who did not reach this QTc value despite the same treatment, whilst no other differences in patients’ characteristics, medical history and clinical presentation were highlighted. This last finding suggests a potentially higher arrhythmic risk in patients with QTc slightly prolonged at hospital admission who are treated with HY+AZ. This evidence may also be one of the explanations for the deaths observed in recent studies in patients treated with hydroxychloroquine and azithromycin.6,7 Moreover, our results stress the need to carefully consider whether to start these drugs in COVID-19 patients in order not to expose them to a risk of fatal arrhythmias without a certainty of clinical benefit and to perform a close ECG monitoring in those with a prolonged QTc value before starting the treatment. Summarizing, combination therapy of HY+AZ prolongs QTc in COVID-19 patients, especially in those with a prolonged QTc at hospital admission, and this can explain the increased risk of ventricular arrhythmias, which was highlighted. Conflicts of interest There are no conflicts of interest." @default.
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• W4225522912 date "2021-08-02" @default.
• W4225522912 modified "2023-10-14" @default.
• W4225522912 title "QTc prolongation and mortality in SARS-2-CoV-infected patients treated with azithromycin and hydroxychloroquine" @default.
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• W4225522912 doi "https://doi.org/10.2459/jcm.0000000000001238" @default.
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