The efficacy and safety of hydroxychloroquine in patients with chronic inflammatory cardiomyopathy: a multicenter
Wu He1,2, Guanglin Cui1,2, Juan Chen3
1Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095# Jiefang Ave, Wuhan, 430030, China.
Insights
Hydroxychloroquine (HCQ) combined with prednisolone (PDN) significantly improved outcomes for patients with chronic inflammatory cardiomyopathy after fulminant myocarditis. This combination therapy demonstrated enhanced heart function and reduced inflammation with an acceptable safety profile.
Area of Science:
- Cardiology
- Immunology
- Pharmacology
Background:
- Chronic inflammatory cardiomyopathy (infl-CMP) is a sequela of acute myocarditis, particularly fulminant myocarditis (FM).
- Hydroxychloroquine (HCQ) shows potential in mitigating excessive inflammatory responses in these patients.
Purpose of the Study:
- To evaluate the efficacy and safety of HCQ combined with prednisolone (PDN) versus PDN monotherapy in patients with chronic infl-CMP post-FM.
- To assess the impact of HCQ on cardiovascular outcomes, cardiac function, and inflammatory markers.
Main Methods:
- A multicenter, randomized trial involving 50 patients with chronic infl-CMP after FM.
- Patients received either HCQ plus PDN or PDN monotherapy for 12 months.
- Primary outcome: composite of cardiovascular events; Secondary outcomes: changes in LVEF, LVIDd, hs-cTnI, NT-proBNP, hs-CRP, and ESR.
Main Results:
- HCQ plus PDN significantly reduced the primary composite outcome compared to PDN monotherapy (HR=0.28, 95% CI=0.11-0.71).
- Significant improvements were observed in LVEF, LVIDd, hs-cTnI, NT-proBNP, and hs-CRP levels with the combination therapy.
- No serious drug-related adverse events were reported, and 16 plasma cytokines were reduced to levels comparable to healthy controls.
Conclusions:
- Twelve months of HCQ combined with PDN therapy significantly improves prognosis and cardiac function in patients with chronic infl-CMP post-FM.
- The combination therapy effectively inhibits inflammation and demonstrates an acceptable safety profile.
Background:
Chronic inflammatory cardiomyopathy (infl-CMP) is a long-term sequela caused by the chronicity of acute myocarditis, especially fulminant myocarditis (FM). Hydroxychloroquine (HCQ) may benefit these patients by inhibiting the excessive inflammatory response.
Methods:
In this multicenter, randomized trial, we evaluated the efficacy and safety of HCQ in patients with chronic infl-CMP after FM. The primary outcome of the trial was a composite of the cardiovascular outcomes of time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker, or implantable cardioverter defibrillator implantation. Secondary outcomes were changes in left ventricular ejection fraction (LVEF), left ventricular internal diastolic diameter (LVIDd), plasma levels of high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein (hs-CRP), and erythrocyte sedimentation rate (ESR) from baseline to 12 months.
Results:
Fifty patients were randomized to receive HCQ combined with prednisolone (PDN) or PDN monotherapy for 12 months. Compared to PDN monotherapy, HCQ combined with PDN therapy reduced the primary composite outcome [hazard ratio (HR) = 0.28, 95% confidence interval (CI) = 0.11-0.71] and had significant changes in the increase of LVEF and the decrease of LVIDd, hs-cTnI, NT-proBNP, and hs-CRP in patients with infl-CMP. No serious drug-related adverse events were recorded in either group, indicating an acceptable safety profile. Furthermore, HCQ combined with PDN significantly reduced the levels of 16 plasma cytokines to levels comparable to healthy controls.
Conclusions:
Twelve months of HCQ combined with PDN therapy significantly improved the prognosis and heart function, inhibited inflammation, and had acceptable safety in patients with infl-CMP after FM.
Trial Registration:
ClinicalTrials.gov identifier: NCT05961202.
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