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. 2021 Aug 25;5(6):e12592. doi: 10.1002/rth2.12592

TABLE 3.

Safety of corticosteroids in ITP

Study Design Group Adverse Events
Arai 201825 Network meta‐analysis of randomized controlled trials evaluating treatments for newly diagnosed ITP evaluating sustained response rates, overall response rates, safety, and tolerability across 21 randomized controlled trials (n = 1898) Severe AEs (CTCAE grade 3 or higher) in corticosteroid‐treated patients Rate of severe AEs in DEX‐treated patients: 4.1% (22/531)
Wei 201618 A prospective multicenter trial of HD‐DEX (40 mg daily for 4 d; n = 95) vs PDN (1.0 mg/kg daily for 4 wk, then tapered; n = 97) in adults with ITP followed for up to 36 mo HD‐DEX arm (total population) AEs in the HD‐DXM arm (percentage in the total population): Insomnia (8.4%), mood disorders (7.4%), hypertension (4.2%), and hyperglycemia (4.2%)
HD‐DEX arm (patients aged >60 years) Insomnia (16.7%), mood disorders (11.1%), hypertension (11.1%), and hyperglycemia (5.6%)
PDN arm (total population) Cushingoid appearance (13.4%), weight gain (10.3%), hypertension (8.2%), hyperglycemia (6.2%)
PDN arm (patients aged >60 y) Cushingoid appearance (10%), weight gain (15%), hypertension (15%), hyperglycemia (15%)
Mithoowani 201626 Meta‐analysis of a pooled group of 529 patients across 5 trials of short‐course HD‐DEX (n = 280) versus long‐term PDN (n = 249) in patients with previously untreated ITP All patients All patients: Gastrointestinal toxicities (6%), hyperglycemia (6%), weight gain (5%), insomnia/fatigue (3%), and hypertension (3%)
Short‐course HD‐DEX Gastrointestinal toxicities (5%), hyperglycemia (5%), insomnia/fatigue (3%), and anxiety/mood disorder (3%)
Long‐term PDN Weight gain (9%), gastrointestinal toxicities (8%), hyperglycemia (6%), Cushingoid appearance (5%)
Sun 201619 A retrospective study of ITP in pregnancy in 195 women across 235 pregnancies, including 51 patients receiving corticosteroids (mean dose 0.65 mg/kg/d PDN for a median of 10 d) initially and 47 patients receiving IVIg (1 g/kg) AEs in 67 pregnant women treated with corticosteroids

13.4% (9/67)

AEs included hyperglycemia requiring treatment (9%), hyperglycemia with neonatal hypoglycemia (2%), infection (2%), and insomnia/jitteriness (2%)

Din 201520 Single‐center randomized study of HD‐DXM (40 mg daily for 4 d; including groups receiving maintenance DEX 0.035 mg/kg/d [HD‐DEX‐M; n = 30] and without maintenance [HD‐DEX‐nM; n = 31]) versus PDN 1 mg/kg/d (n = 29) followed for a median of 16 mo (range, 12‐21 mo) AEs occurring with HD‐DEX induction therapy in both HD‐DEX‐M and HD‐DEX‐nM patients (n = 61)

16.4% (10/61)

AEs included anxiety (n = 2), gastric distress (n = 2), and steroid‐induced diabetes (n = 2). AEs that led to trial discontinuation included severe vomiting (n = 3) and transitory hypertension (n = 1)

Suvajdzic 201432 Survey of HRQoL of adult patients with chronic ITP in Serbia (n = 111) Percentage of patients with self‐reported AEs associated with corticosteroid treatment 96.5%
Nakazaki 201221
Prospective randomized study of previously untreated adult ITP with:
  • PSL (0.5–1 mg/kg daily PSL for 2 to 4 wk followed by taper; n = 8)
  • 1×HD‐DEX (DEX 40 mg daily for 4 d; n = 12)
  • 3×HD‐DEX (up to 3 courses of 1×HD‐DEX over the course of 21 mo; n = 5)

The median follow‐up was 32.2 mo (range 1.3‐102.6 mo)

PSL

75% (6/8)

AEs included hypertension (2/8), hyperglycemia (2/8), hyperlipidemia (1/8), and insomnia (1/8). Grade 3/4 AEs included 1 case of hypertension and 1 case of atrial flutter

1×HD‐DEX

42% (5/12)

AEs included insomnia (2/12), hyperglycemia (1/12), gastrointestinal pain (1/12), and flushing (1/12)

3×HD‐DEX

40% (2/5)

AEs included hyperglycemia (1/5) and insomnia (1/5)

Mashhadi 201222 Randomized prospective study of HD‐DEX 40 mg/d for 4 d (n = 30) versus conventional PSL 1 mg/kg/d tapered over 6 wk (n = 30) therapy in adults with newly diagnosed symptomatic ITP in Iran followed for 1248 mo HD‐DEX AEs included weight gain (17.3%), glucose intolerance (3.3%), hypertension (3.3%), and gastrointestinal distress (6.6%)
Conventional PSL AEs included weight gain (43.3%), glucose intolerance (16.5%), hypertension (10%), and gastrointestinal distress (23.3%)
Brown 201233 Survey of patients with chronic ITP in 589 patients who are members of a US‐based support group Percentage of patients receiving corticosteroids experiencing AEs 98%
Percentage of patients highly bothered by steroid‐related AEs 53.1%
Percentage of patients requiring dose reduction or discontinuation of treatment to reduce AE severity 37.8%
Newton 201134 A survey study of 585/1871 members of the UK ITP Support association and 68/93 patients enrolled in the Oklahoma ITP Registry evaluating fatigue, daytime sleepiness, and orthostatic symptoms associated with ITP Percentage of patients receiving steroids experiencing fatigue 50%
Bilgir 201131 A study of conventional‐dose steroid treatment (1 mg/kg; n = 20) versus high‐dose steroid (30 mg/kg methylprednisolone; n = 30) treatment prior to splenectomy in Turkey; patients were followed for 1 wk after their procedure Percentage of patients experiencing AEs in the high‐dose steroid arm

20% (6/30)

AEs included infection (3.3%), steroid‐induced diabetes mellitus (3.3%), gastrointestinal symptoms (10%), and hypertension (3.3%)

Percentage of patients experiencing AEs in the conventional‐dose steroid arm

25% (5/20)

AEs included steroid‐induced diabetes mellitus (5%), gastrointestinal symptoms (10%), hypertension (5%), and Cushingoid appearance (5%)

Bae 201023 A prospective randomized multicenter trial of conventional‐dose PSL (1 mg/kg/d; n = 60) versus HD‐DEX (40 mg/d for 4 d; n = 57) in patients with newly diagnosed ITP in Korea followed for ≥6 mo Percentage experiencing AEs with conventional‐dose PSL resulting in treatment discontinuation

5% (3/60)

Pneumonia (n = 1), hyperglycemia (n = 1), and myalgia (n = 1)

Percentage experiencing AEs with HD‐DEX resulting in treatment discontinuation

10.5% (6/57)

Grade 3 hyperglycemia (n = 5), other (n = 1)

Praituan 200924 Randomized trial of short‐course DEX prior to PSL (10 mg every 6 h for 4 d followed by PSL 30 mg daily; n = 18) versus high‐dose PSL (PSL 60 mg daily; n = 18) in adults with primary ITP in Thailand with up to 6 mo of follow‐up Percentage of patients experiencing AEs in the DEX/PSL group

44% (8/18)

Hyperglycemia (n = 1), dyspepsia (n = 3), acne (n = 4)

Percentage of patients experiencing AEs in the high‐dose PSL group

33% (6/18)

Dyspepsia (n = 4), acne (n = 2)

Guidry 200935 Survey of hematologists (n = 83, of whom 71% responded) and patients (n = 80, of whom 80% responded) regarding side effects of corticosteroid therapy through the Oklahoma ITP Registry AEs reported by patients
  • Moon face, bloating, or swelling (43%)

  • Weight gain/increased appetite (41%)

  • Hair loss (13%)

  • Acne (11%)

  • Stretch marks (10%)

  • Insomnia, restlessness, or trouble sleeping (28%)

  • Anxiety and/or nervousness (24%)

  • Depression and/or stress (23%)

  • Anger and/or irritability (21%)

  • Generalized weakness or fatigue (22%)

  • Muscle weakness (16%)

  • Body pain (21%)

  • Hot flush/sweating (17%)

  • Visual problems (11%)

AEs reported by hematologists
  • Moon face, bloating, or swelling (27%)

  • Weight gain/increased appetite (31%)

  • Hair loss (3%)

  • Acne (2%)

  • Stretch marks (8%)

  • Insomnia, restlessness, or trouble sleeping (17%)

  • Anxiety and/or nervousness (9%)

  • Depression and/or stress (4%)

  • Anger and/or irritability (9%)

  • Generalized weakness or fatigue (7%)

  • Muscle weakness (7%)

  • Body pain (0%)

  • Hot flush/sweating (2%)

  • Visual problems (2%)

Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; DEX, dexamethasone; HD‐DEX, high‐dose dexamethasone; HD‐DEX‐M, high‐dose dexamethasone with maintenance; HD‐DEX‐nM, high‐dose dexamethasone without maintenance; HRQoL, health‐related quality of life; IQR, interquartile range; ITP, immune thrombocytopenia; IVIg, intravenous immunoglobulin; PDN, prednisone; PSL, prednisolone.