Safety and vasopressor effect of rosuvastatin in septic patients

Abstract

Background: Statins anti-inflammatory and antioxidant properties improve vascular function in septic patients. The aim of this prospective study was to assess vasopressor effect and safety of rosuvastatin therapy in septic patient. Methods: One hundred and eight patients admitted to intensive care unit (ICU) with suspected or confirmed infection plus at least 2 systemic inflammatory response syndrome criteria were included in this prospective double-blinded randomized two groups' parallel study. Group R received standard therapy and rosuvastatin 20 mg/day and Group C received standard therapy with placebo/day for 14 days. The primary endpoint was number of acceptable blood pressure and systemic perfusion days (ABPSPD). Secondary outcome included time to initial ABPSPD, vasopressor dose and duration, arterial lactate, organ dysfunction or failure free days, ICU and hospital stay, 28 ICU and hospital mortality, CPK and transaminases level. Results: The number of ABPSPD was significantly increased 11(3) vs. 8 (3) (p = 0.0001), with a shorter time to initial ABPSPD 18(21) vs. 41(37) h (p = 0.0001) in Group R than Group C. Norepinephrine dose 0.8 (0.5) vs. 1.6 (0.6) and duration 3(2) vs. 6(3) were significantly reduced in Group R with no significant elevation in transaminases or CPK. Conclusions: Rosuvastatin 20 mg/day in septic patients increased number ABPSPD, decreased time to initial ABPSPD, norepinephrine dose and duration, with no significant elevation in transaminases or CPK.

The effects of atorvastatin on inflammatory responses and mortality in septic shock: A single-center, randomized controlled trial

“…Significant earlier hemodynamic stabilization at both lower dose and shorter duration of vasopressor was reportedly achieved with rosuvastatin in the study by El Gendy and Elsharnouby. [ 15 ] In contrast to this, we did not observe any significant difference in either hemodynamics or vasopressor dose or vasopressor-free days between statin and placebo group. The reasons for these differences could be multifactorial.…”

“…Varying proportions (0%–79%) of septic shock patients have been included in previous RCTs. [ 10 11 12 13 14 15 16 ] The present RCT, an exclusive cohort of septic shock patients using atorvastatin (higher dose albeit shorter course), is in concordance with previous RCTs.…”

The effects of statin therapy on mortality in patients with sepsis

“…Of the 9 trials, patients in 4 trials received atorvastatin, [ 14 , 15 , 19 , 22 ] patients in 3 trials received simvastatin, [ 16 – 18 ] and patients in 2 trials received rosuvastatin. [ 20 , 21 ] Four trials reported in-hospital mortality, [ 14 , 17 , 20 , 21 ] 2 trials reported 28-day mortality, [ 19 , 22 ] and 3 trials reported both as outcome of interest. [ 15 , 16 , 18 ] Detailed characteristics of the included studies are presented in Table 1 .…”

Statin therapy for acute respiratory distress syndrome: an individual patient data meta-analysis of randomised clinical trials

“…Reasons for exclusion of full text records are detailed in figure 1. Authors for three studies were contacted to determine eligibility because the limited information in the publication did not allow for definitive assessment [26][27][28].…”

“…We mitigated against this by conducting a comprehensive search of both electronic and non-electronic based repositories. Nonetheless, there were three trials that may potentially have provided additional data but that we were forced to exclude due to lack of further information from study authors, although given that the sample sizes in these studies were small it is unlikely to have materially affected the results [26][27][28].…”