1. Hydroxychloroquine plus prednisolone reduced the 12-month risk of the composite cardiovascular outcome by 72 percent compared with prednisolone alone.
2. Hydroxychloroquine plus prednisolone normalized a wide range of inflammation-related proteins, indicating multiple anti-inflammatory effects.
3. The safety profile was similar to prednisolone alone, with no serious treatment-related adverse events.
Evidence Rating Level: 1 (Excellent)
In this multicenter, open-label, evaluator-blinded, randomized phase II trial (HYPIC), 50 adults with chronic inflammatory cardiomyopathy (infl-CMP) following fulminant myocarditis (FM) were randomized to receive either hydroxychloroquine (HCQ) plus prednisolone (PDN) or PDN alone for 12 months, in addition to guideline-directed heart failure therapy. The primary endpoint was a composite of cardiovascular death or heart transplant, hospitalization for heart failure or recurrent myocarditis, and permanent pacemaker or implantable cardioverter-defibrillator implantation. Secondary outcomes included changes in left ventricular ejection fraction (LVEF), left ventricular internal diastolic diameter (LVIDd), high-sensitivity cardiac troponin I (hs-cTnI), NT-proBNP, hs-CRP, and ESR. HCQ + PDN significantly reduced the primary composite outcome versus PDN alone (24.0% vs. 60.0%, HR 0.28, 95% CI 0.11–0.71) and led to greater improvements in LVEF, LVIDd, hs-cTnI, NT-proBNP, and hs-CRP (all p < 0.05). Proteomic analysis showed HCQ + PDN normalized 16 inflammatory proteins compared with only 2 in the PDN group. Adverse events were similar between groups, with no serious drug-related events. The authors conclude that HCQ + PDN for 12 months improves prognosis, cardiac function, and inflammation control in infl-CMP after FM, with acceptable safety, supporting further large-scale trials.
Click to read the study in BMC Medicine
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