Is rosuvastatin protective against sepsis-associated encephalopathy? A secondary analysis of the SAILS trial

doi:10.5847/wjem.j.1920-8642.2022.072

Abstract

Abstract:

BACKGROUND: Sepsis is a common cause of death in emergency departments and sepsis-associated encephalopathy (SAE) is a major complication. Rosuvastatin may play a neuroprotective role due to its protective effects on the vascular endothelium and its anti-inflammatory functions. Our study aimed to explore the potential protective function of rosuvastatin against SAE.

METHODS: Sepsis patients without any neurological dysfunction on admission were prospectively enrolled in the “Rosuvastatin for Sepsis-Associated Acute Respiratory Distress Syndrome” study (SAILS trial, ClinicalTrials.gov number: NCT00979121). Patients were divided into rosuvastatin and placebo groups. This is a secondary analysis of the SAILS dataset. Baseline characteristics, therapy outcomes, and adverse drug events were compared between groups.

RESULTS: A total of 86 patients were eligible for our study. Of these patients, 51 were treated with rosuvastatin. There were significantly fewer cases of SAE in the rosuvastatin group than in the placebo group (32.1% vs. 57.1%, P=0.028). However, creatine kinase levels were significantly higher in the rosuvastatin group than in the placebo group (233 [22-689] U/L vs. 79 [12-206] U/L, P=0.034).

CONCLUSION: Rosuvastatin appears to have a protective role against SAE but may result in a higher incidence of adverse events.

Key words: Rosuvastatin calcium, Sepsis-associated encephalopathy, Anti-inflammatory agents, Sepsis, Adverse reactions

Shi-yuan Yu, Zeng-zheng Ge, Jun Xiang, Yan-xia Gao, Xin Lu, Joseph Harold Walline, Mu-bing Qin, Hua-dong Zhu, Yi Li. Is rosuvastatin protective against sepsis-associated encephalopathy? A secondary analysis of the SAILS trial[J]. World Journal of Emergency Medicine, 2022, 13(5): 367-372.

Figures/Tables 4

Figure 1.

Table 1.

Figure 2.

Table 2.

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Parameters	Rosuvastatin group (n=51)	Placebo group (n=35)	P-value
Male sex	30 (58.8)	13 (37.1)	0.078
Age, year	55 (37.2-75.6)	56 (39.5-73.4)	0.737
Heart rate, beats/min*	112±24	98±19	0.201
Mean arterial pressure, mmHg*	75 (69.3-83.5)	76 (71.2-92.5)	0.312
Respiratory rate, breaths/min*	29.0±9.2	25.0±10.5	0.197
Statin administration prior to enrollment	11 (21.5)	6 (16.1)	0.189
Sequential organ failure assessment (SOFA) score	4.6±3.2	5.1±4.6	0.061
APACHE II score	16.2±8.1	18.9±8.5	0.243
Glasgow Coma Scale	10.1±3.4	9.5±3.4	0.515
Infection site
Thorax	44 (86.3)	31 (88.6)	0.754
Abdomen	6 (11.8)	5 (14.3)	0.317
Skin or soft tissue	2 (3.9)	1 (2.8)	0.792
Urinary tract	3 (5.8)	1 (2.8)	0.500
Other	4 (7.8)	3 (8.4)	0.903
Underlying disease
Diabetes mellitus	13 (25.5)	9 (25.7)	0.981
Hypertension	30 (58.8)	17 (48.6)	0.348
Myocardial infarction	3 (5.8)	2 (5.6)	0.974
Requiring renal replacement therapy	0	1 (2.8)	0.178
Hepatic failure	1 (1.9)	0	0.405
Chronic pulmonary disease	5 (9.5)	6 (17.1)	0.317
Laboratory tests
PLT, ×10⁵/µL*	1.6±0.2	1.2±0.5	0.212
WBC, ×10³/µL*	15.2±6.3	13.9±5.1	0.381
Hb, g/dL*	11.2±2.2	12.5±3.5	0.765
Cr, µmol/L*	133±26	125±19	0.625
BUN, mmol/L*	9.3±5.6	8.6±4.2	0.286
CK, U/L	178 (22-755)	233 (18-1,325)	0.701
ALT, U/L	42 (12-96)	39 (8-102)	0.599
AST, U/L	57 (10-122)	37 (14-98)	0.221
Antibiotics
Daptomycin	3 (5.8)	1 (2.8)	0.643
Atazanavir	1 (1.9)	1 (2.8)	0.659
Ritonavir	1 (1.9)	0	0.593
Vasoactive drugs
Dobutamine	4 (7.8)	3 (8.5)	0.481
Dopamine	2 (3.9)	3 (8.5)	0.385
Epinephrine	0	0	1.000
Norepinephrine	2 (3.9)	1 (2.8)	0.640
Other medications
Narcotics	28 (54.9)	19 (54.3)	0.833
Paralytics	2 (3.9)	2 (5.6)	0.833

Parameters	Rosuvastatin group (n=51)	Placebo group (n=35)	P-value
SAE	17 (33.3)	20 (57.1)	0.028
Death	14 (27.5)	4 (11.4)	0.106
Hospital stay, d	11.2±9.0	11.7±9.7	0.811
ICU stay, d	5.5±4.4	5.7±3.7	0.815
Adverse events
CK, U/L	223 (22-689)	79 (12-206)	0.034
ALT, U/L	39 (8-105)	41 (11-98)	0.747
AST, U/L	34 (13-145)	14 (4-76)	1.000

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