Objective-To determine the eVect of adjunctive prednisolone on morbidity, pericardial fluid resolution, and mortality in HIV seropositive patients with eVusive tuberculous pericarditis. Design-Double blind randomised placebo controlled trial. Setting-Two medical school aYliated referral hospitals in Harare, Zimbabwe. Patients-58 HIV seropositive patients aged 18-55 years with tuberculous pericarditis. Interventions-All patients received standard short course antituberculous chemotherapy and were randomly assigned to receive prednisolone or placebo for six weeks. Main outcome measures-Clinical improvement, echocardiographic and radiologic pericardial fluid resolution, and death. Results-29 patients were assigned to prednisolone and 29 to placebo. After 18 months of follow up there were five deaths in the prednisolone treated group and 10 deaths in the placebo group. Mortality was significantly lower in the prednisolone group (log rank 2 = 8.19, df = 1, p = 0.004). Resolution of raised jugular venous pressure (p = 0.017), hepatomegaly (p = 0.007), and ascites (p = 0.015), and improvement in physical activity (p = 0.02), were significantly more rapid in the prednisolone treated patients. However, there was no diVerence in the rate of radiologic and echocardiographic resolution of pericardial eVusion. Conclusions-Adjunctive prednisolone for eVusive tuberculous pericarditis produced a pronounced reduction in mortality. It is suggested prednisolone should be added to standard short course chemotherapy to treat HIV related eVusive tuberculous pericarditis.
BACKGROUND
Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk.
OBJECTIVES
In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels.
METHODS
ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL).
RESULTS
In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE (
P
interaction
= 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with
P
interaction
= 0.43.
CONCLUSIONS
In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab;
NCT01663402
)
In a prospective study pleural biopsy specimens obtained with a Tru-cut needle were compared with those obtained with an Abrams pleural biopsy punch from 36 patients in Zimbabwe judged to have an effusion of at least 15 litres; one patient had two biopsies. Both instruments were used on each patient, the Abrams punch being followed by the Tru-cut needle. There were no serious complications. The diagnoses determined by biopsy were: tuberculosis (11); carcinoma (12); chronic inflammation (9); and pleural fibrosis (4); one biopsy showed nothing abnormal. In 23 (62%) patients both biopsy needles produced adequate diagnostic material; in eight the Tru-cut needle alone produced diagnostic material and in six the Abrams punch alone. Thus diagnostic material was obtained in 31 patients from the Tru-cut needle and in 29 from the Abrams punch. The Tru-cut needle was useful and safe for pleural biopsy in this series and appeared to be particularly useful when the pleura was thickened.
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