Safety and vasopressor effect of rosuvastatin in septic patients

Available online 19 March 2014

Figures & data

Table 1 Patients characteristics, sepsis characteristics and demographic data. Mean (SD) for age and body mass index, median and mean rank APACHE II score, and SOFA score, number and percentage for sex, Origin of sepsis , type of infection, causative organism, and need for mechanical ventilation on admission.

Patients characteristics and demographic data	Group R (n 54)	Group C (n 54)	Significance
Age (year) mean (SD)	35 (8)	37 (9)	0.4
APACHE II score (median and mean rank)	25 (59)	24 (50)	0.2
Sex			0.7
Male	33 (61%)	31 (57%)
Female	21 (39%)	23 (43%)
Body mass index (kg/m^2) mean (SD)	28 (5)	26(4)	0.2
Type of patients (n) %			0.2
Medical	32 (59%)	25 (46%)
Surgical	22 (41%)	29 (54%)
SOFA score at screening (median and mean rank)	9 (57)	8 (52)	0.3
Sepsis characteristic
Severe sepsis (n) %	33(61%)	37(69%)	0.4
Septic shock (n) %	21(39%)	17(31%)	0.4
Need for mechanical ventilation on admission n (%)	13(24%)	18(33%)	0.2
Type of infection			0.7
Hospital acquired infection	38(70%)	36 (67%)
Community acquired infection	16(30%)	18 (33%)
Origin of sepsis, n (%)			0.8
Lungs	15 (28%)	12 (22%)
Abdomen	13 (24%)	10 (19%)
Urogenital	7 (13%)	6 (11%)
Skin, bone and soft tissue	5 (9%)	7 (13%)
Other	3 (6%)	5 (9%)
Unknown	1 (2%)	6 (11%)
Neurological system	4 (7%)	4 (7%)
Ear nose and throat	2 (4%)	5 (9%)
Causative organism, n (%)			0.5
Gram-negative bacteria	22 (41%)	25 (46%)
Gram-positive bacteria	18 (33%)	17 (31%)
Other class	14 (26%)	12 (22%)

^*P < 0.05 indicates significant difference between groups. APACHE II score, is the acute physiologic and chronic health score, SOFA score is sequential organ failure assessment.

Figure 1 Boxplot showing acceptable blood pressure and systemic perfusion (ABPSPD) days, ^*highly significance is p < 0.001, data is presented as mean (SD).

Figure 2 Boxplot showing organ dysfunction free days[mean(SD)]. Organ dysfunction was defined by a sequential organ failure assessment (SOFA) score above one for the appropriate function. ^*p < 0.05 indicates significant difference between groups.

Figure 3 Showing organ failure free days[mean(SD)]. Organ failure was defined by a sequential organ failure assessment (SOFA)^* above two for the appropriate function. ^*P < 0.05 indicates significant difference between groups.

Figure 4 Kaplan–meier survival analysis, Group R showed shorter time to ABPSPD (acceptable blood pressure and systemic perfusion days) than Group C.

Table 2 Outcome parameters; mean (SD) for time to initial stabilization norepinephrine doses, norepinephrine duration, arterial lactate, duration of invasive mechanical ventilation, ICU length of stay and hospital length of stay. While frequency and percentages for invasive mechanical ventilation, ICU mortality and Hospital mortality.

Outcome parameters	Group R (n 54)	Group C (n 54)	Significance
Time to reach ABPSP (hours)	18(21)	41(37)	P = 0.0001^⁎⁎
Norepinephrine doses (dose in ug/kg/min)	0.8(0.5)	1.6 (0.6)	P = 0.0001^⁎⁎
Norepinephrine duration (days)	3(2)	6 (3)	P = 0.0001^⁎⁎
Arterial lactate (mg/dl)	4(2)	5(2)	P = 0.0001^⁎⁎
Invasive mechanical ventilation, n (%)	16(30%)	27(50%)	0.02^*
Duration of invasive mechanical ventilation (days)	6(4)	9(5)	0.001^⁎⁎
ICU mortality, n (%)	12(22%)	16(30%)	0.3
ICU length of stay(days)	11(5)	13(5)	0.1
Hospital mortality n (%)	17 (31%)	22 (41%)	0.3
Hospital length of stay (days)	33(8)	37(11)	0.8

Data is presented in mean (SD), number and percentage.

* Significance is p < 0.05, whereas.

⁎⁎ Highly significance is p < 0.001.

Table 3 Safety parameters; number and percentage for serum creatine phosphokinase and serum transaminases.

Safety parameters	Group R (n 54)	Group C (n 54)	Significance
Serum CPK (number)	5(9%)	3(6%)	0.1
Serum transaminases (number)	11(20%)	7(13%)	0.2

Serum creatine phosphokinase (CPK) elevation was defined as CPK above five times the upper normal level. Transaminases level (ALT and AST) elevation was defined as elevation in serum transaminases above three times the upper normal level for the study period. ^*P < 0.05 indicates significant difference between groups.