TABLE 3.
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:
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) |
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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%) |
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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) |
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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) |
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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 |
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AEs reported by hematologists |
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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.