The aim of the present study was to evaluate the safety and efficacy of the combination of
indomethacin and
statin compared with
indomethacin plus placebo in patients with a first episode of
pericarditis. A total of 55 consecutive patients with acute
pericarditis were randomized in a double-blind manner into two groups: group 1 (
statin group) was treated with 150 mg of
indomethacin plus 10 mg of
rosuvastatin, and group 2 (placebo group) was treated with 150 mg of
indomethacin plus placebo. Both groups received treatment up to the normalization of
inflammation markers and for the following week. Clinical and laboratory assessments [white cell count, ESR (erythrocyte sedimentation rate) and CRP (
C-reactive protein),
troponin I,
creatine kinase and
brain natriuretic peptide plasma levels], ECG and echocardiogram were performed at baseline and daily up to discharge. All of the patients were followed as outpatients for 3 months to evaluate any recurrence of
pericarditis. The two groups were similar in age, sex and laboratory parameters [group 1 (the
statin group), n=28 patients; gender, 18 male and ten female; and age, 29.5+/-5.7 years; group 2 (placebo group), n=27 patients; gender, 16 male/11 female; and age, 29.2+/-4.8 years]. The
statin group, when compared with the placebo group, had a significantly faster reduction in CRP values (5.0+/-1.0 compared with 6.0+/-2.0 days respectively; P=0.022), ST segment normalization (3.5+/-1.0 compared with 4.5+/-1.0 days respectively; P=0.001),
pericardial effusion (4.5+/-1.0 compared with 5.5+/-1.0 days respectively; P=0.001) and ESR (5.0+/-1 compared with 6.0+/-2 days respectively; P=0.022). Our results show that the combination of
statin and
indomethacin treatment in patients with acute
pericarditis is feasible, with a significant reduction in inflammatory markers and a favourable trend in hospitalization time (5.5+/-2.0 compared with 6.5+/-2.0 days respectively; P=0.069). However, these preliminary findings require further studies in a larger sample of patients.