What is the clinical evidence from this study?

Study design: Observational. Population: Viral myocarditis (Parvovirus B19 and Adenovirus) (n=152). Intervention: Pentaglobin vs. Baseline (before therapy). Primary outcome: Left ventricular ejection fraction (LVEF) (p=<0.005).

October 16, 2007

Abstract 1616: Intermediate Dose of Pentaglobin Eradicates Effectively Inflammation in Parvo B19 and Adenovirus Positive Myocarditis

Q: What are the key findings of this study?

Pentaglobin therapy significantly improved LVEF from 54.4% to 60.0% (p<0.005) and resolved myocardial inflammation in 71% of rebiopsied patients.

Key Result

Pentaglobin therapy significantly improved LVEF from 54.4% to 60.0% (p<0.005) and resolved myocardial inflammation in 71% of rebiopsied patients.

Study Design

Type

Observational (n=152)

PICO

Population

152 consecutive patients with viral myocarditis (Parvovirus B19 or Adenovirus) treated with Pentaglobin and followed for 6 months.

Exposure / Comparator

Pentaglobin vs Baseline (before therapy) (10 g/day at day 1 and 3)

Primary Outcome

Left ventricular ejection fraction (LVEF), p=<0.005

Main Result

Absolute Event Rate: 60% vs 54.4%

p-value: p=<0.005

Abstract

152 consecutive patients with myocarditis according to the quantitative World Heart Federation Criteria (> 14 infiltrating cells/mm 2 by endomyocardial biopsy(EMB)) were analysed for cardiotropic agents. In 90 pts parvoviruses B19 (59,5%) and in 36 pts adenoviruses (23,8%) were assessd by PCR as causative viral pathogens. All virus positive patients were treated with 10 g/day Pentaglobin® i. v.(enriched IgG, IgA and IgM preparation, Biotest) at day 1 and 3. After six months all patients were reevalutated clinically, 73 patients (48%) in addition by EMB. Methods: We compared the following parameters before and after therapy: left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), shortening fraction (SF) by transthoracic echocardiography and LVEF or the left ventricular end-diastolic volume index (LVEDVI) using angiography. For exercise capacity we evaluated exercise ECG by treadmill test and clinical parameters according to the NYHA classification, before and after therapy. Results: After Pentaglobin therapy, all patients demonstrated a significant clinical improvement of the NYHA class, of exercise capacity and of LVEF (from 54,4 to 60,0%, p<0,005) independent from the respective virus. In 52 of 73 (71%) rebiopsied pts inflammation had resolved. In 17 of the 19 rebiopsied patients (90%) with a positive PCR for ADV before therapy no more virus DNA was recovered after treatment, inflammation had resolved completely. In Parvo B 19 myocarditis inflammation had resolved in 31 of the 44 pts (70%), whereas Parvo B19 DNA was eradicated in only in 18 out of 44 pts(40%). In patients in whom both virus and inflammation were eliminated enddiastolic LV dimension decreased and EF increased significantly (p<0,001). Conclusion: Treatment with an intermediate dose of Pentaglobin is highly effective in resolving myocardial inflammation independent of the underlying viral etiology, but it eradicates adenoviral much better than Parvo B19 infection.