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ORIGINAL PAPERS: Treatment aspects

Baseline use of angiotensin-converting enzyme inhibitor/AT1 blocker and outcomes in hospitalized coronavirus disease 2019 African-American patients

Shah, Priyanka,b; Owens, Jackc; Franklin, Jamesd; Jani, Yashe; Kumar, Ashishf; Doshi, Rajkumarg

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doi: 10.1097/HJH.0000000000002584
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Abstract

INTRODUCTION

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent for coronavirus disease 2019 (Covid-19), infects cells through spike protein binding to angiotensin-converting enzyme-2 (ACE-2) receptors, an amino-peptidase found ubiquitously throughout the body, primarily in the heart, gastrointestinal tract, and alveolar lung cells [1]. Animal studies have shown up regulation of ACE-2 expression with chronic exposure to angiotensin-converting enzyme inhibitor (ACE-i), and AT1 blockers (ARBs) [2–4]. This led to the hypothesis that ACE-i/ARBs can increase the risk, severity, and perhaps mortality in Covid-19 [5]. However, multiple retrospective studies found no negative correlation between ACE-i/ARB use and testing positive for Covid-19, the severity of illness, or mortality in Covid-19 [6–8].

An alternative hypothesis has been proposed in which ACE-2 may be beneficial in lung injury [9]. Subsequently, Zhang et al.[10] concluded that these medications do not predispose one to Covid-19 and are associated with a lower risk of all-cause mortality compared with ACE-i/ARB nonusers. None of the studies have reported outcomes in African-Americans taking these drugs. It is unclear if baseline use of ACE-i/ARBs in African-Americans with Covid-19 has any effect on the disease severity or outcomes. Hence the primary objective of our study is to determine the effect of baseline use of ACE-i/ARB on mortality in hospitalized Covid-19 African-American patients. The secondary objectives of our study are, to determine the effect of baseline use of ACE-i/ARB on the need for mechanical ventilation, new dialysis, ICU care, as well on the composite outcomes of mortality, need for mechanical ventilation, new dialysis, and ICU care in hospitalized Covid-19 African-American patients.

METHODS

The current study was conducted at Phoebe Putney Health System, the largest community health system in Southwest Georgia, serving a population of over half a million. The Phoebe Putney institutional review board approved the study and waived the requirement for informed consent due to minimal risk. Patients were admitted to any of the three Phoebe Putney hospitals between 2 March and 22 May 2020, inclusive of those dates. All hospitalized African-American patients with confirmed Covid-19, who had an outcome, were included in this study. The outcome was defined as discharge from the hospital or death. Hospitalized patients who did not have an outcome by the end of the study period were not included in the analysis. The patients transferred to another hospital (due to the hospital being at full capacity or need for treatment not available at our facility) were not included as well.

Data were collected from electronic medical records (Meditech and Athena Health). All patients were confirmed positive for Covid-19 by nasopharyngeal swab using a PCR test. Patients were considered to have confirmed infection if the initial test result was positive or if it was negative but repeat testing was positive. Repeat tests were performed on inpatients during hospitalization shortly after initial test results were available if there was a high clinical pretest probability of Covid-19 or if the initial negative test result had been judged likely to be a false-negative due to poor sampling technique. Transfers from one in-system hospital to another were merged and considered as a single visit.

Data collection included demographics, insurance, baseline comorbidities, tobacco use, alcohol use, illicit drug use, home medications, symptoms on presentation, vitals, initial laboratory tests, initial EKG, the severity of presenting illness, a need for ICU admission, mechanical ventilation, new requirement for dialysis, length of stay (LOS), discharge, and mortality. The composite outcome was defined as the presence of any of the following outcome: in-hospital mortality, new requirement of dialysis, a need for mechanical ventilation, or ICU care. The patients having more than one of the composite outcomes were only counted once. The comorbidities included hypertension (HTN), diabetes mellitus, coronary artery disease (CAD), congestive heart failure (CHF), chronic obstructive pulmonary disease, asthma, chronic kidney disease (CKD), cancer, immunosuppression, and chronic liver disease. We defined severe Covid-19 as septic shock, severe pneumonia, and/or acute respiratory distress syndrome on presentation. All comorbidities except immunosuppression were adjudicated on the basis of the 10th version of the International Classification of Diseases. Patients were considered immunosuppressed if they had been on chronic steroids or other immunosuppressive therapy. To calculate the LOS, we used the actual admission and discharge times. The total LOS in hours was divided by 24 to get the LOS in days.

We utilized SAS 9.4 (SAS Institute, Cary, North Carolina, USA) and R version 3.6.2 (R Foundation, Vienna, Austria) for all the statistical analyses. Patients were divided into two groups, those on ACE-i/ARB (for at least 3 months) at the time of presentation to the hospital, and those not on either one of these two classes of medications. Patients taking combination medication which had either ACE-i or ARB as one of the components, were also considered being on ACE-i/ARB. Due to the initial concerns regarding use of these medications in Covid-19, these medications were discontinued in majority of the patients upon admission. Categorical variables were expressed in numbers and percentages and analyzed using the Pearson chi-square test whereas continuous variables were summarized by the mean and SDs and analyzed using Student's t test. Hierarchical multivariable logistic regression analysis was used to test the primary and secondary objectives. To assess the difference in LOS between the two groups, we used linear regression model as it is a continuous variable. We included age, BMI, sex, all baseline comorbidities, and presentation severity as covariates in this model. C-statistics was above 0.7 for all the models to be acceptable. In addition, we tested the primary and secondary objectives in the following five subgroups: age above 65 years, female sex, diabetes mellitus, CKD and HTN. We created multivariate logistic regression model for each of the above-mentioned subgroups for following outcomes: In-hospital mortality, new requirement for dialysis, need for mechanical ventilation, ICU care, and composite outcomes. We included age, BMI, sex, presenting severity, and all the baseline comorbidities in this model similar to above-mentioned model. In addition, we performed separate analysis for ACE-i and ARB, to determine if either of these medications had any adverse outcome. All outcomes mentioned above were analyzed for these two medications separately. Multivariate logistic regression analysis was performed using all the variables mentioned above. Finally, we used E value to assess the robustness of association, by measuring the effect of unmeasured and uncontrolled confounders. The ‘EValue’ package in R was used for computing E value [11].

All the authors have reviewed the article and take responsibility for the accuracy and completeness of the data presented here.

RESULTS

A total of 531 African-Americans were hospitalized for Covid-19, and had an outcome by the end of the study period. Out of those, 207 (39%) were on ACE-i/ARB therapy at baseline (Table 1). Those on ACE-i/ARB were older compared with those not on them (64.0 vs. 57.6 years, P < 0.001). There was no difference by sex between the groups and the population was predominantly women in both groups (Table 1). There was no difference in BMI between the groups (35.6 vs. 34.4 kg/m2, P = 0.12). HTN and diabetes mellitus were the most common comorbidities in the two groups. There was no difference in the baseline characteristics between the groups except HTN (96.6 vs. 69.4%, P < 0.001), and diabetes mellitus (55.6 vs. 34.9%, P < 0.001), which were significantly higher in the ACE-i/ARB group (Table 1). There was no difference in the severity of Covid-19 at presentation between the two groups (Table 1).

TABLE 1 - Demographics and comorbidities in hospitalized African-American coronavirus disease 2019 patients with baseline angiotensin-converting enzyme inhibitor/AT1 blocker use compared with nonusers
Variable Without ACE-i/ARB, n = 324 With ACE-i/ARB, n = 207 P value
Age (years) 57.6 ± 17.8 64.0 ± 12.4 <0.001
Women 193 (59.6) 120 (58.0) 0.71
BMI 34.4 ± 9.2 35.6 ± 10.2 0.12
Comorbidities
 Hypertension 225 (69.4) 200 (96.6) <0.001
 Coronary artery disease 23 (7.1) 14 (6.8) 0.88
 Congestive heart failure 44 (13.6) 35 (16.9) 0.29
 Chronic obstructive pulmonary disease 28 (8.6) 12 (5.8) 0.22
 Asthma 39 (12.0) 23 (11.1) 0.74
 Chronic kidney disease 43 (13.3) 34 (16.4) 0.31
 Diabetes mellitus 113 (34.9) 115 (55.6) <0.001
 Cancer 25 (7.7) 24 (11.7) 0.13
 Immunosuppression 16 (4.9) 8 (3.9) 0.56
 Chronic liver disease 3 (0.9) 0 (0) 0.17
 Drug abuse 5 (1.5) 3 (1.5) 0.93
 Alcohol abuse 38 (11.7) 15 (7.3) 0.09
 Smoking 53 (16.4) 35 (16.9) 0.87
 ESRD on dialysis 23 (8.0) 12 (6.8) 0.64
Presentation severity
 Severe Covid-19 162 (50.0) 104 (50.2) 0.96
ACE-i, angiotensin-converting enzyme inhibitor; ARB, AT1 blocker; Covid-19, coronavirus disease 2019; ESRD, end-stage renal disease.

In an unadjusted analysis, we found no difference in the in-hospital mortality (18.4 vs. 14.8%, P = 0.28), a need for mechanical ventilation (22.2 vs. 16.0%, P = 0.07), or LOS (10.0 vs. 8.8 days, P = 0.14) between the two groups, although they were numerically higher in the ACE-i/ARB group. However, the need for dialysis (7.7 vs. 3.4%, P = 0.03), and ICU care (28.5 vs. 19.1%, P = 0.012) were significantly higher in the ACE-i/ARB group in the unadjusted analysis (Table 2). The composite outcomes did not differ between the groups in unadjusted analysis, although numerically higher in ACE-i/ARB group (31.9 vs. 24.7%, P = 0.07) (Table 2). After adjusting for age, sex, BMI, presenting disease severity, and all the baseline comorbidities, there was no difference in mortality [odds ratio (OR): 0.82; confidence interval (CI): 0.45–1.50, P = 0.52], new dialysis requirement (OR: 1.18; CI: 0.44–3.11, P = 0.74), need for mechanical ventilation (OR: 1.24; CI: 0.70–2.20, P = 0.46), ICU care (OR: 1.26; CI: 0.74–2.15, P = 0.40), or composite outcomes (OR: 0.99; CI: 0.62–1.56, P = 0.96) between the two groups (Table 2). After adjustment, there was no difference in the LOS between the two groups. The results were similar for all the five subgroups (Table 3). The E values (relative risk) for the point estimate and upper confidence bound for primary outcome were 1.44 and 1, respectively. Table 2 shows E values for the point estimate and upper confidence bound for primary and secondary outcomes.

TABLE 2 - Comparison of in-hospital outcomes in hospitalized African-American coronavirus disease 2019 patients with baseline angiotensin-converting enzyme inhibitor/AT1 blocker use vs. nonusers
In-hospital outcomes Without ACE-i/ARB, n = 324 With ACE-i/ARB, n = 207 Unadjusted odds ratio, P value Adjusted odds ratio, P value E value for estimate (CI)
In-hospital mortality 48 (14.8) 38 (18.4) 1.29 (0.81–2.016), P = 0.28 0.82 (0.45–1.50), P = 0.52 1.44 (1)
New dialysis requirement 11 (3.4) 16 (7.7) 2.38 (1.08–5.24), P = 0.027 1.18 (0.44–3.11), P = 0.74 1.39 (1)
Mechanical ventilation 52 (16.0) 46 (22.2) 1.49 (0.96–2.32), P = 0.07 1.24 (0.70–2.20), P = 0.46 1.47 (1)
ICU care 62 (19.1) 59 (28.5) 1.68 (1.12–2.54), P = 0.012 1.26 (0.74–2.15), P = 0.40 1.49 (1)
Composite outcomes 80 (24.7) 66 (31.9) 1.42 (0.97–2.10), P = 0.07 0.99 (0.62–1.56), P = 0.96 1.08 (1)
ACE-i, angiotensin-converting enzyme inhibitor; ARB, AT1 blocker; Covid-19, coronavirus disease 2019; CI, confidence interval.
Adjusted for age, sex, BMI, baseline comorbidities, and presenting illness severity.

TABLE 3 - Comparison of in-hospital outcomes in hospitalized African-American coronavirus disease 2019 patients with baseline angiotensin-converting enzyme inhibitor/AT1 blocker use vs. nonusers in subgroups
Variable OR and CI Adjusted P value E value for estimate (CI)
In-hospital mortality
 Age ≥65 1.22 (0.53–2.81) 0.63 1.44 (1)
 Women 0.79 (0.34–1.82) 0.57 1.5 (1)
 Diabetes mellitus 0.73 (0.31–1.74) 0.48 1.62 (1)
 Hypertension 0.79 (0.43–1.44) 0.44 1.5 (1)
 Chronic kidney disease 1.09 (0.22–5.40) 0.92 1.26 (1)
New dialysis requirement
 Age ≥65 1.13 (0.28–4.56) 0.87 1.32 (1)
 Women 0.71 (0.15–3.40) 0.67 1.66 (1)
 Diabetes mellitus 1.29 (0.33–5.10) 0.72 1.53 (1)
 Hypertension 1.20 (0.45–3.23) 0.71 1.42 (1)
 Chronic kidney disease 1.66 (0.03–85.8) 0.80 1.9 (1)
Mechanical ventilation
 Age ≥65 2.11 (0.83–5.33) 0.11 2.26 (1)
 Women 0.99 (0.46–2.13) 0.98 1.08 (1)
 Diabetes mellitus 1.29 (0.57–2.91) 0.54 1.53 (1)
 Hypertension 1.21 (0.67–2.19) 0.52 1.43 (1)
 Chronic kidney disease 3.91 (0.64–23.9) 0.14 3.37 (1)
ICU care
 Age ≥65 1.37 (0.59–3.24) 0.46 1.62 (1)
 Women 1.18 (0.57–2.45) 0.65 1.39 (1)
 Diabetes mellitus 1.56 (0.72–3.38) 0.26 1.81 (1)
 Hypertension 1.25 (0.72–2.16) 0.42 1.48 (1)
 Chronic kidney disease 2.23 (0.47–10.7) 0.31 2.35 (1)
Composite outcomes
 Age ≥65 1.20 (0.61–2.37) 0.59 1.42 (1)
 Women 0.90 (0.48–1.69) 0.74 1.29 (1)
 Diabetes mellitus 0.92 (0.47–1.79) 0.80 1.25 (1)
 Hypertension 0.98 (0.61–1.56) 0.92 1.11 (1)
 Chronic kidney disease 1.14 (0.35–3.77) 0.82 1.34 (1)
ACE-i, angiotensin-converting enzyme inhibitor; ARB, AT1 blocker; Covid-19, coronavirus disease 2019; CI, confidence interval; OR, odds ratio.

In an adjusted analysis, there was no difference in the in-hospital mortality (OR: 0.71; CI: 0.32–1.57, P = 0.40), need for dialysis (OR: 1.11; CI: 0.34–3.64, P = 0.86), need for mechanical ventilation (OR: 1.18; CI: 0.56–2.51, P = 0.66), ICU care (OR: 1.10; CI: 0.54–2.22, P = 0.79), and composite outcomes (OR: 0.67; CI: 0.33–1.34, P = 0.23) with baseline use of ACE-i. The E values for the point estimate and upper confidence bound for primary outcome with ACE-i, were 1.66 and 1, respectively (Table 4). Similarly, there was no difference in-hospital mortality (OR: 0.91; CI: 0.44–1.90, P = 0.80), need for dialysis (OR: 1.53; CI: 0.47–4.97, P = 0.48), need for mechanical ventilation (OR: 1.23; CI: 0.60–2.50, P = 0.57), ICU care (OR: 1.29; CI: 0.67–2.49, P = 0.45), and composite outcomes (OR: 0.92; CI: 0.50–1.71, P = 0.79) with use of ARBs. The E values for the point estimate and upper confidence bound for primary outcome with ARBs, were 1.27 and 1, respectively (Table 5).

TABLE 4 - Comparison of in-hospital outcomes in hospitalized African-American coronavirus disease 2019 patients with baseline angiotensin-converting enzyme inhibitor user vs. nonusers
Outcomes ACE-i, n = 99 Adjusted OR and CI Adjusted P value E value for estimate (CI)
In-hospital mortality 20 (20.2) 0.71 (0.32–1.57) 0.40 1.66 (1)
New dialysis requirement 9 (9.1) 1.11 (0.34–3.64) 0.86 1.29 (1)
Mechanical ventilation 23 (23.2) 1.18 (0.56–2.51) 0.66 1.39 (1)
ICU care 31 (31.3) 1.10 (0.54–2.22) 0.79 1.28 (1)
Composite outcomes 33 (33.3) 0.67 (0.33–1.34) 0.23 1.74 (1)
ACE-i, angiotensin-converting enzyme inhibitor; Covid-19, coronavirus disease 2019; CI, confidence interval; OR, odds ratio.
Adjusted for age, sex, BMI, baseline comorbidities, and presenting illness severity.

TABLE 5 - Comparison of in-hospital outcomes in hospitalized African-American coronavirus disease 2019 patients with baseline AT1 blocker user vs. nonusers
Outcomes ARB, n = 108 Adjusted OR and CI Adjusted P value E value for estimate (CI)
In-hospital mortality 18 (16.7) 0.91 (0.44–1.90) 0.80 1.27 (1)
New dialysis requirement 7 (6.5) 1.53 (0.47–4.97) 0.48 1.78 (1)
Mechanical ventilation 23 (21.3) 1.23 (0.60–2.50) 0.57 1.46 (1)
ICU care 28 (25.9) 1.29 (0.67–2.49) 0.45 1.53 (1)
Composite outcomes 33 (30.6) 0.92 (0.50–1.71) 0.79 1.25 (1)
ARB, AT1 blocker; Covid-19, coronavirus disease 2019; CI, confidence interval; OR, odds ratio.
Adjusted for age, sex, BMI, baseline comorbidities, and presenting illness severity.

DISCUSSION

Our results show that the baseline use of ACE-i/ARB in African-Americans does not increase the presenting severity of Covid-19, and does not increase mortality in hospitalized patients. We also show that baseline use of ACE-i/ARB does not increase the risk of mechanical ventilation, ICU care, and requirement for new dialysis in African-Americans presenting with Covid-19.

The initial hypothesis of potential harm with ACE-i/ARB stemmed from two observations: animal studies demonstrating upregulation of ACE-2 expression with ACE-i/ARBs, and high prevalence of HTN, diabetes mellitus, and cardiovascular disease in patients with Covid-19, where in these drugs are widely used [2–4,12–15]. African-Americans have a higher prevalence of cardiovascular disease including HTN, diabetes mellitus, CAD, and CHF [16]. Hence, they are more likely to be treated with ACE-i/ARBs. In addition, the varied response of the renin–angiotensin–aldosterone system in African-Americans as compared with other races stresses the need for evidence regarding the effect of ACE-i/ARBs in Covid-19 positive African-Americans [17].

Although the results of a few recent studies do not support the hypothesis of potential harm with ACE-i/ARB in Covid-19, it had not been specifically studied in African-Americans. The largest case series from New York included 1230 (22%) African-Americans. However, outcomes were reported in less than half of this population [18]. Although they reported no differences in outcomes in patients with or without baseline use of ACE-i/ARB, they did not present any adjusted analysis [18]. Ours is the first study to show no harm with baseline use of ACE-i/ARBs in Covid-19 African-American patients after adjustment of multiple covariates including age, sex, BMI, presenting disease severity, and all the baseline comorbidities.

Emerging evidence suggests dual role of ACE-2 in Covid-19. Although ACE-2 overexpression might increase the susceptibility of cells to SARS-CoV-2, it also inactivates angiotensin II and increases the generation of angiotensin 1–7, a peptide that, acting on the Mas receptor, exerts a vasodilatory effect and antiinflammatory and antioxidative actions [1,19]. Whether continued treatment with ACE-i/ARB in Covid-19 is potentially beneficial, will need to be tested in prospective randomized trials. For now, there does not appear to be any evidence to discontinue these drugs in Covid-19 patients, including African-American patients, unless contraindicated for other reasons.

Certain limitations of our study need to be acknowledged. There were 50 African-American Covid-19 patients in the hospital system, who did not have an outcome by the end of the study period. However, we do not believe that it would change our overall results. We did not have outcomes on 85 patients transferred to other facilities during the study period and hence were not included in this analysis. Due to the initial hypothesis of potential harm, most of the patients taking ACE-i/ARB at baseline were discontinued on hospitalization, and hence we could not evaluate the effect of continued use of these drugs on outcomes. Due to the retrospective nature of the study, we might not have identified all the variables that may affect clinical outcomes given in the analysis. However, we have generated E values which suggest insignificant effect of unmeasured variables. Finally, this was a retrospective study with data abstraction from the electronic medical record and hence some data elements might not be accurately captured.

In conclusion, the results of our study suggest that the baseline use of ACE-i/ARBs in African-Americans does not predispose to severe Covid-19, does not increase the need for mechanical ventilation, new dialysis, ICU care, or mortality in hospitalized Covid-19 patients. Hence, these drugs should not be discontinued upon admission, unless otherwise contraindicated.

ACKNOWLEDGEMENTS

The authors sincerely thank Jennifer Hill and Krista Barfield for their diligent efforts in data abstraction.

Conflicts of interest

There are no conflicts of interest.

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Keywords:

; angiotensin-converting enzyme inhibitor; African-Americans; AT1 blocker; coronavirus disease 2019; outcomes

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