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Atorvastatin Versus Placebo in Icu Patients With Covid-19: Ninety-Day Results of the Inspiration-S Trial Publisher Pubmed



Talasaz AH1, 2 ; Sadeghipour P3, 4, 5 ; Bakhshandeh H3, 4 ; Sharifkashani B6, 7 ; Rashidi F8 ; Beigmohammadi MT9 ; Moghadam KG10 ; Rezaian S11 ; Dabbagh A12 ; Sezavar SH13 ; Farrokhpour M14 ; Abedini A15 ; Aliannejad R16, 17 ; Riahi T18 Show All Authors
Authors
  1. Talasaz AH1, 2
  2. Sadeghipour P3, 4, 5
  3. Bakhshandeh H3, 4
  4. Sharifkashani B6, 7
  5. Rashidi F8
  6. Beigmohammadi MT9
  7. Moghadam KG10
  8. Rezaian S11
  9. Dabbagh A12
  10. Sezavar SH13
  11. Farrokhpour M14
  12. Abedini A15
  13. Aliannejad R16, 17
  14. Riahi T18
  15. Yadollahzadeh M14
  16. Lookzadeh S15
  17. Rezaeifar P8
  18. Matin S8
  19. Tahamtan O8
  20. Mohammadi K19
  21. Zoghi E19
  22. Rahmani H19
  23. Hosseini SH19
  24. Mousavian SM18
  25. Abri H14
  26. Sadeghipour P3, 4, 5
  27. Baghizadeh E3
  28. Rafiee F3
  29. Jamalkhani S20, 21
  30. Amin A3
  31. Mohebbi B5
  32. Parhizgar SE3
  33. Soleimanzadeh M12
  34. Aghakouchakzadeh M19
  35. Eslami V22
  36. Payandemehr P23
  37. Khalili H21
  38. Talakoob H24
  39. Tojari T25
  40. Shafaghi S7
  41. Tabrizi S18
  42. Kakavand H19
  43. Kashefizadeh A26
  44. Najafi A22
  45. Jimenez D27, 28, 29
  46. Gupta A30, 31
  47. Madhavan MV32, 33
  48. Sethi SS32, 33
  49. Parikh SA32, 33
  50. Monreal M34
  51. Hadavand N3
  52. Hajighasemi A1
  53. Ansarin K8
  54. Maleki M3
  55. Sadeghian S1
  56. Barco S35, 36
  57. Siegerink B37
  58. Spatz ES38, 39
  59. Piazza G40, 41
  60. Kirtane AJ40, 41
  61. Van Tassell BW2
  62. Lip GYH42, 43
  63. Klok FA44
  64. Goldhaber SZ40, 41
  65. Stone GW32, 45
  66. Krumholz HM30, 39, 46
  67. Bikdeli B32, 38, 40, 41

Source: Thrombosis and Haemostasis Published:2023


Abstract

Background In the INSPIRATION-S trial, atorvastatin versus placebo was associated with a nonsignificant 16% reduction in 30-day composite of venous/arterial thrombosis or death in intensive care unit (ICU) patients with COVID-19. Thrombo-inflammatory response in coronavirus disease 2019 (COVID-19) may last beyond the first 30 days. Methods This article reports the effects of atorvastatin 20 mg daily versus placebo on 90-day clinical and functional outcomes from INSPIRATION-S, a double-blind multicenter randomized trial of adult ICU patients with COVID-19. The main outcome for this prespecified study was a composite of adjudicated venous/arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause mortality. Functional status was assessed with the Post-COVID-19 Functional Scale. Results In the primary analysis, 587 patients were included (age: 57 [Q1–Q3: 45–68] years; 44% women). By 90-day follow-up, the main outcome occurred in 96 (33.1%) patients assigned to atorvastatin and 113 (38.0%) assigned to placebo (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.60–1.05, p = 0.11). Atorvastatin in patients who presented within 7 days of symptom onset was associated with reduced 90-day hazard for the main outcome (HR: 0.60, 95% CI: 0.42–0.86, pinteraction = 0.02). Atorvastatin use was associated with improved 90-day functional status, although the upper bound CI crossed 1.0 (ORordinal: 0.64, 95% CI: 0.41–1.01, p = 0.05). Conclusion Atorvastatin 20 mg compared with placebo did not significantly reduce the 90-day composite of death, treatment with ECMO, or venous/arterial thrombosis. However, the point estimates do not exclude a potential clinically meaningful treatment effect, especially among patients who presented within 7 days of symptom onset (NCT04486508). © 2023. Thieme. All rights reserved.
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