What is the evidence ​​for inhaled prostacyclin in ARDS not related to COVID?

Comment by InpharmD Researcher

Evidence regarding the use of inhaled prostacyclin in acute respiratory distress syndrome (ARDS) unrelated to COVID-19 yields mixed results, with some data suggesting potential benefits and other findings remaining inconclusive. Pooled data indicates improvements in oxygenation and reductions in pulmonary artery pressures with inhaled prostacyclin use; however, no significant differences in mortality and PaO2/FiO2 ratio have been observed in some trials. Overall, while inhaled prostacyclin may improve certain respiratory parameters, further research is needed to clarify its role in non-COVID-19-related ARDS.

Background

A 2023 systematic review and meta-analysis aimed to assess the change in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio after administration of an inhaled prostacyclin in patients with acute respiratory distress syndrome (ARDS). A total of 23 studies were included with a study population of N=1658 subjects, assessing the efficacy of inhaled prostacyclin in patients with and without COVID-19 ARDS. It also assessed inhaled epoprostenol, inhaled alprostadil, and inhaled iloprost. There was a significant improvement in Pao2/Fio2 from baseline (mean deviation [MD], 40.35; 95% confidence interval [CI], 26.14 to 54.56 mm Hg; p <0.00001; I^2 = 95%; very low-quality evidence), as well as an increase in Pao2 (MD, 12.68; 95% CI, 2.89 to 24.48 mm Hg; p = 0.01; I^2 = 96%; very low-quality evidence). Additionally, there was a decrease in mean pulmonary artery pressure (mPAP) (MD, –3.67; 95% CI, –5.04 to –2.31 mm Hg; p <0.00001; I^2 = 68%; very low-quality evidence). For non-COVID-19 ARDS specifically, Pao2/Fio2 improvement was also notable (MD, 33.83; 95% CI, 30.48 to 37.18 mm Hg; p <0.00001; I^2 = 95%). Overall, this data suggests that inhaled prostacyclins improve oxygenation and pulmonary artery pressures in patients with ARDS; however, these improvements have not resulted in decreased clinical outcomes like hospital length of stay, need for mechanical ventilation, and mortality. [1]

Another meta-analysis, published in 2015, assessed the effectiveness of inhaled prostaglandins in improving pulmonary physiology and mortality in patients with ARDS, while also evaluating potential adverse effects. A total of 25 studies were included in the analysis. Results indicated that one randomized controlled trial (RCT) found no significant difference in the change in mean PaO2 to FiO2 ratio when comparing inhaled alprostadil to placebo. However, the analysis of the remaining studies demonstrated that inhaled prostaglandins were associated with a 39.0% improvement in the PaO2 to FiO2 ratio (95% CI 26.7% to 51.3%) and a 21.4% increase in PaO2 (95% CI 12.2% to 30.6%). Additionally, there was a decrease in pulmonary artery pressure by -4.8 mm Hg (95% CI -6.8 to -2.8 mmHg). However, high levels of bias and heterogeneity were noted among the studies. Regarding adverse effects, the authors noted that they were variably reported. Twenty studies mentioned adverse effects or lack thereof, while 11 studies reported no impact on systemic hemodynamics. Five studies documented hypotension (rates ranging from 12.5% to 33.3%), with a significant difference noted between prospective studies (0.69%) and observational studies (17.4%; p<0.001). Additionally, three studies reported thrombocytopenia, anemia, or transfusion requirements. Based on these findings, it was suggested that inhaled prostaglandins may improve oxygenation and decrease pulmonary artery pressures in ARDS, though there may also be associated risks. [2]

A 2017 Cochrane review evaluated the benefits and harms of aerosolized prostacyclin in adults and children with ARDS. Two RCTs involving 81 participants were included (one involving 14 children and the other 67 adults), both with very low-quality evidence. The pediatric trial reported no difference in mortality between the intervention and control groups, but it was limited by a cross-over design. The adult trial reported no significant improvement in the PaO2/FiO2 ratio, with a mean difference of -25.35 (95% CI -60.48 to 9.78; p= 0.16) No adverse events, such as bleeding or organ dysfunction, were reported in either trial. The limited number of RCTs prevented further subgroup and sensitivity analyses. Overall, it was concluded that the evidence was too imprecise to determine whether aerosolized prostacyclin has a meaningful effect on mortality, and further research is needed to evaluate its routine use in ARDS. [3]

A 2015 review discussed the role of inhaled prostacyclin as a treatment for ARDS. Overall, there appears to be a lack of robust evidence on selective pulmonary vasodilators (SPVs), a class that includes inhaled prostacyclins, and their use in ARDS management. In a study comparing inhaled epoprostenol (iEPO) and nitric oxide (NO) (N= 8), both agents demonstrated a dose-dependent reduction in mean pulmonary artery pressure (PAP). Notably, iEPO led to at least a 10% decrease in PAP at all doses in all eight patients with ARDS and pulmonary hypertension. Additionally, iEPO significantly increased PaO2 at doses of 10 and 25 ng/kg/min, though it had no effect at 1 ng/kg/min. However, intrapulmonary shunt flow remained unchanged. Another study found that iEPO significantly reduced PAP from 35.0 to 31.9 mmHg (p<0.05). Another prospective study concluded that there was no significant difference between various iEPO doses on oxygenation indices. The authors noted that iEPO reduced PaO2/FiO2 (from 146 ± 16 to 135 mmHg ± 17; p<0.05) and PaO2 (from 87 ± 2 to 79 mmHg ± 2; p<0.02) in patients with primary ARDS, whereas in secondary ARDS, there was an increase in PaO2/FiO2 (from 161 ± 23 to 171 mmHg ± 22; p<0.01) and PaO2 (from 76 ± 4 to 84 mmHg ± 4; p<0.01). Regarding safety, iEPO has not been associated with cytotoxic effects compared to iNO. However, iEPO may worsen ventilation-perfusion (V/Q) mismatch, cause hypotension, inhibit platelet aggregation, and induce tachycardia. These effects may be minimized or avoided due to iEPO’s pulmonary selectivity and mode of administration. Hypotension, for instance, is more common in patients receiving intravenous epoprostenol. Evidence on iloprost is limited and conflicting; while one study suggested it produces effects similar to iNO, it was associated with marked bronchoconstriction and other adverse effects. In contrast, a case series in infants receiving iloprost showed significant oxygenation improvement without bronchoconstriction. Overall, while these agents may improve certain parameters in ARDS patients, their benefits have not been consistently substantiated. [4]

References:

[1] Torbic H, Saini A, Harnegie MP, Sadana D, Duggal A. Inhaled Prostacyclins for Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Crit Care Explor. 2023;5(6):e0931. Published 2023 Jun 8. doi:10.1097/CCE.0000000000000931
[2] Fuller BM, Mohr NM, Skrupky L, Fowler S, Kollef MH, Carpenter CR. The use of inhaled prostaglandins in patients with ARDS: a systematic review and meta-analysis. Chest. 2015;147(6):1510-1522. doi:10.1378/chest.14-3161
[3] Afshari A, Bastholm Bille A, Allingstrup M. Aerosolized prostacyclins for acute respiratory distress syndrome (ARDS). Cochrane Database Syst Rev. 2017;7(7):CD007733. Published 2017 Aug 14. doi:10.1002/14651858.CD007733.pub3
[4] Searcy RJ, Morales JR, Ferreira JA, Johnson DW. The role of inhaled prostacyclin in treating acute respiratory distress syndrome. Ther Adv Respir Dis. 2015;9(6):302-312. doi:10.1177/1753465815599345

Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

What is the evidence ​​for inhaled prostacyclin in ARDS not related to COVID?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-3 for your response.


 

Nebulized prostacyclin (PGI2) in acute respiratory distress syndrome: impact of primary (pulmonary injury) and secondary (extrapulmonary injury) disease on gas exchange response

Design

Prospective, nonrandomized interventional study

N= 15

Objective

To examine the hypothesis that the response to inhaled prostacyclin (PGI2) on oxygenation and pulmonary hemodynamics may be related to different morphologic features in acute respiratory distress syndrome (ARDS) originating from pulmonary (primary) or extrapulmonary (secondary) disease

Study Groups

ARDS from pulmonary injury (ARDSPR; n= 6)

ARDS from extrapulmonary injury (ARDSSEC; n= 9)

Inclusion Criteria

Mechanically ventilated patients with ARDS (PaO2/FIO2 < 150 torr, severe hypoxemia)

Exclusion Criteria

Patients with preexisting obstructive or restrictive lung disease, left heart failure, immunodeficiency, pregnancy, age <18 or >75 years

Methods

After a 60-minute stabilization period, patients were administered nebulized PGI2 in increments every 15 minutes, starting at a dose of 2 ng/kg/min, with titration up to a maximum of 40 ng/kg/min. The dose that showed the best improvement in oxygenation (PaO2) was determined. Measurements for blood gases, gas exchange, and hemodynamics were taken at three points: before the administration (baseline), during the optimal or maximum dose, and one hour after stopping the drug. Additionally, a computed tomography (CT) scan of the lungs was done to analyze lung density. Patients were classified as responders if PaO2 increased by more than 7.5 torr or the PaO2/FIO2 ratio improved by >10%.

Duration

Intervention: 15-minute steps

Outcome Measures

Gas exchange response (PaO2 increase >7.5 torr or PaO2/FIO2 increase >10%) and pulmonary hemodynamic changes, including pulmonary artery pressure and vascular resistance

Baseline Characteristics

 

ARDSPR (n= 6)

ARDSSEC (n= 9)

Age, years

57 ± 5 61 ± 3

Male 

6 (100%) 7 (78%)

SAPS II

59 ± 6  65 ± 6

LIS

2.88 ± 0.10

2.87 ± 0.10

PaO2/FIO2

108 ± 10

96 ± 9

Mortality rate

3 (50%) 4 (44%)

Admitting etiology

Pneumonia

Aspiration

Primary sepsis syndrome

Necrotizing pancreatitis

Multiple trauma 

 

5

1

0

0

 

0

0

7

1

Abbreviations: SAPS II, Simplified Acute Physiology Score II; LIS, Lung Injury Score

Results

Endpoint

ARDSPR (n= 6)

ARDSSEC (n= 9)

Gas exchange and hemodynamic variables after PGI2 administration

PaO2/FIO2

PAP, mmHg

PVR, dyne*sec/cm5

MAP, mmHg

SVR, dyne*sec/cm5

CI, L/min/m2

 

150 ± 26

30 ± 2

120 ± 10

73 ± 5

470 ± 40

5.2 ± 0.3

 

180 ± 30

30 ± 2

176 ± 21

75 ± 3

721 ± 99

4.0 ± 0.3 

Mean PGI2 dose, ng/kg/min

40

32 ± 1

Abbreviations: PAP, mean pulmonary artery pressure; PVR, pulmonary vascular resistance; MAP, mean arterial pressure; SVR, systemic vascular resistance; CI, cardiac index

Adverse Events

N/A

Study Author Conclusions

Based on the data from this study, the clinical recognition of the two types of the syndrome together with the CT number frequency distribution analysis may be associated with a prediction of the PGI2 nebulization response on oxygenation. 

InpharmD Researcher Critique

The study distinguishes between different types of ARDS, allowing for a more targeted approach to treatment. However, the small sample size limits the generalizability of the findings and further research is needed to explore long-term outcomes.



References:

Domenighetti G, Stricker H, Waldispuehl B. Nebulized prostacyclin (PGI2) in acute respiratory distress syndrome: impact of primary (pulmonary injury) and secondary (extrapulmonary injury) disease on gas exchange response. Crit Care Med. 2001;29(1):57-62. doi:10.1097/00003246-200101000-00015

 

Comparison of Inhaled Milrinone, Nitric Oxide, and Prostacyclin in Acute Respiratory Distress Syndrome

Design

Open-label, Prospective, Cross-over Pilot study 

N=15 

Objective

To evaluate the safety and efficacy of inhaled Milrinone in acute respiratory distress syndrome (ARDS)

Study Groups

Sequential nebulization of iNO  

Epoprostenol

Milrinone

Milrinone with iNO

Inclusion Criteria

Had hypoxemic respiratory failure meeting standard moderate to severe ARDS criteria: ratio of particle pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of ≤ 200, pulmonary capillary wedge pressure (Pcwp) ≤ 18 mmHg, bilateral infiltrates on frontal chest radiograph, with pulmonary artery catheter and arterial line

Exclusion Criteria

Severe hemodynamic instability (defined as need for >1 vasopressor or >0.5 mcg/kg per minute of norepinephrine); on intravenous milrinone or nitrate derivatives that could not be weaned; on a high frequency of oscillatory ventilation; patients in another study involving oxymetric value or pulmonary hemodynamics; pregnant women

Methods

Patients were randomly assigned to receive sequential nebulization of iNO (20 ppm) or epoprostenol (10 mcg/mL for a total volume of 5 mL). Following this, milrinone (1 mg/mL for a total volume of 5 mL per nebulization), both alone and in combination with iNO, was administered. Each drug was nebulized for 20 minutes, with a 30-minute washout period between administrations.

Duration

Data collection: 2 years

Outcome Measures

Hemodynamic parameters, oxygenation measurement

Baseline Characteristics

 

All patients (N= 15)

 

   

Age, years

57 (22)      

Male/Female

12/3      

SOFA score

ICU admission

Day of protocol 

 

7.5 (7)

10.0 (5)

     

APACHE II score

ICU admission

Day of protocol 

 

23 (7)

23.5 (7)

     

PaO2, mmHg

80 (39)

     
FiO2 80%      
PaO2/FiO2 138 (68)      
PEEP, cm H2O 10 (2)      
MAP, mmHg 75 (16)      
mPAP, mmHg 28 (7)      
CI, L/min per square meter 3.7 (2.6)      

Note: All values are presented as Median (IQR) unless specified otherwise

Abbreviations: IQR= Interquartile range; SOFA=Sequential organ failure assessment; APACHE=Acute physiological and chronic health evaluation; PEEP=Positive end-expiratory pressure; MAP=Mean arterial pressure; mPAP=Mean pulmonary arterial pressure; CI= Cardiac index

 Results

Endpoint

iNO

Epoprostenol

Milrinone

Milrinone + NO

Hemodynamic Parameter Variations: 

MAP, mmHg

HR, bpm

CVP, mmHg

PAOP, mmHg

mPAP, mmHg

CI, L/min per square meter

iPVR

 

-2.0 (11.0)

-2.0 (6.0)

0.0 (1.4)

0.0 (3.0)

-2.0 (4.0)

0.1 (0.6)

-30.6 (130.9)

 

1.0 (8.0)

0.0 (4.0)

0.0 (4.0)

1.0 (4.0)

-1.0 (3.0)

0.0 (0.7)

-51.7 (165.2) 

 

3.0 (6.0)

0.0 (4.0)

0.0 (1.0)

0.0 (2.0)

0.0 (3.0)

0.6 (0.9)

-9.4 (103.1) 

 

3.0 (7.0)

0.0 (6.0)

-1.0 (2.0)

-1.0 (3.0)

-2.0 (3.0)

-0.1 (0.4)

0.0 (91.2) 

Oxygenation measurement:

PaO2*, mmHg

 

8.8 (16.3)

 

6.0 (18.4)

 

6.0 (15.8)

 

9.2 (20.2)

Abbreviations: MAP=Mean arterial pressure; HR=Heart rate; CVP=Central venous pressure; PAOP=Pulmonary artery occlusion pressure; mPAP=Mean pulmonary arterial pressure; CI=Cardiac index; iPVR=Indexed pulmonary vascular resistance; iNO=Inhaled nitric oxide.

*PaO2 value is the median increase from the baseline

No hemodynamic variation reached statistical significance (P > 0.1 for any value) except for the median mPAP variations in the Milrinone + NO group (P= 0.47)

Compared to baseline, the combination of inhaled milrinone and iNO showed a significant effect (P = 0.004), as did iNO alone (P = 0.036). The median percent response to iNO, epoprostenol, inhaled milrinone, and the combination of milrinone and iNO was 11.2%, 5.3%, 7.9%, and 11.8%, respectively. Response rates (defined as >20% increase) were 33.3% for iNO, 20.0% for epoprostenol, 13.3% for inhaled milrinone, and 33.3% for the combination. The median PaO2 response in responders was 39.0 mmHg with iNO, higher than with epoprostenol (26.5 mmHg) or milrinone (10 mmHg).

Adverse Events

Not observed

Study Author Conclusions

In summary, it appeared safe to administrate inhaled milrinone and a combination of inhaled milrinone and iNO to ARDS patients over a short period of time. When comparing the effects of the three inhaled vasodilators (NO, milrinone and epoprostenol), inhaled NO was the only medication significantly improving gas exchanges. Inhaled milrinone appeared safe but failed to improve oxygenation in ARDS. Further studies are needed in order to confirm usefulness of inhaled milrinone in ARDS and its appropriate administration regimen and nebulising technique.

InpharmD Researcher Critique

The limitations of this study include its single-center design, which may introduce bias, and the focus on a short-term observation period, overlooking the long-term effects of the study drug. Additionally, the small sample size further limits the generalizability of the findings.
References:

Albert M, Corsilli D, Williamson DR, et al. Comparison of inhaled milrinone, nitric oxide and prostacyclin in acute respiratory distress syndrome. World J Crit Care Med. 2017;6(1):74-78. Published 2017 Feb 4. doi:10.5492/wjccm.v6.i1.74

 

Dose-Response to Inhaled Aerosolized Prostacyclin for Hypoxemia Due to ARDS

Design

Unblinded, interventional, prospective clinical study

N= 9

Objective

To determine the efficacy of and dose-response relationships to inhaled aerosolized prostacyclin (IAP), when used as a selective pulmonary vasodilator (SPV) in patients with severe hypoxemia due to ARDS

Study Groups

IAP (N= 9)

Inclusion Criteria

Age 18 years; receiving mechanical ventilation in the intensive care unit (ICU); and ARDS due to any cause.

Exclusion Criteria

A bleeding diathesis (international normalized ratio, ≥ 1.5; or activated partial thromboplastin time, ≥45 s); or any head injury.

Methods

All patients received IAP over the dose range 0 to 50 mcg/kg/min. The IAP was delivered via a jet nebulizer placed in the ventilator circuit. Dose increments were 10 mcg/kg/min every 30 min.

Duration

December 17, 1998 to October 20, 1999

Outcome Measures

Indexes of oxygenation (PaO2/fraction of inspired oxygen [FIO2] ratio and alveolar-arterial oxygen partial pressure difference [P(A-a)O2]

Baseline Characteristics

 

Patient #1

Patient #2

Patient #3  Patient #4  Patient #5  Patient #6  Patient #7 Patient #8  Patient #9

Age, years

51

75 

56 77 76 52 68 70 33 

Sex

M F F F

APACHE II Score

14 19 20  11  20  20  20  16 

LIS

3

2.5 

2.5  2.75  2.75 2.75 2.5 2.5

Ve, L /min

12.4 21 12 22.4  11.2  18  21  10.3 
 PEEP, cm H2O 10 12 10 10 2.5  10  10 
Fio2 0.8 0.75 0.5 0.5 0.6 0.5 0.5 0.55 1.0

Abbreviations: M= male; F= female; APACHE II= acute physiology and chronic health evaluation; LIS= Murray lung injury score; Ve= minute ventilation; PEEP= positive end-expiratory pressure

Endpoint

IAP Dose, ng/kg/min

Results

0 vs 10

0 vs 50  10 vs 50

Pao2/Fio2 ratio, mmHg

187.2 vs 183.2 *187.2 vs 202.2*  183.2 vs 202.2

P(A-a)O2, mmHg

 238 vs 247   238 vs 237   247 vs 237 

Qs/Qt, %

28 vs 21.4  28 vs 18  21.4 vs 18 

*p <0.008 approaches significance

Note: results are presented as median values

IAP acted as an selective pulmonary vasodilator (SPV), with a statistically significant dose-related improvement in PaO2/FIO2 ratio (p= 0.003) and P(A-a)O2 (p= 0.01). Systemic prostacyclin metabolite levels increased significantly in response to delivered IAP (p 5 0.001). There was no significant dose effect on systemic or pulmonary arterial pressures, or platelet function, as determined by platelet aggregation in response to challenge with adenosine diphosphate.

Adverse Events

Not disclosed

Study Author Conclusions

This study confirms the efficacy of IAP as an SPV for the treatment of hypoxemia due to ARDS. The study also demonstrates the dose-related actions of IAP when delivered by this simple delivery system.

InpharmD Researcher Critique

A limitation of the study is its small sample size, which may affect the reliability and generalizability of the findings. With fewer participants, the results may not accurately represent broader patient populations. The study's inability to demonstrate dose-responsive antiplatelet effects is likely due to wide baseline variations in critically ill patients, causing "background noise" that obscures these effects, which would be more apparent in controlled in vitro or healthy volunteer studies.



References:

van Heerden PV, Barden A, Michalopoulos N, Bulsara MK, Roberts BL. Dose-response to inhaled aerosolized prostacyclin for hypoxemia due to ARDS. Chest. 2000;117(3):819-827. doi:10.1378/chest.117.3.819