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Statini za primarnu prevenciju venske tromboembolije

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Abstract

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Background

Venous thromboembolism (VTE) is common in clinical practice. The efficacy of statins in the primary prevention of VTE remains unproven.

Objectives

To assess the efficacy of statins in the primary prevention of VTE.

Search methods

The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (last searched April 2011) and CENTRAL (2011, Issue 2). The authors searched MEDLINE (January 1966 to March 2011); EMBASE (1974 to March 2011); ISI Web of Knowledge (2001 to March 2011); the Chinese Biomedical Literature Database (1978 to March 2011) and other resources (including clinical trials registers, reference lists and presentations at various conferences.

Selection criteria

Randomised controlled trials (RCTs) that assessed statins were considered. The outcomes we evaluated were the rates of VTE, cardiovascular and cerebrovascular events, death and adverse events. Two authors independently selected RCTs against inclusion criteria. Disagreements were resolved by discussion with a third author.

Data collection and analysis

Data extraction was independently carried out by two authors. Disagreements were resolved by discussion with a third author. Two authors independently assessed the risk of bias according to a standard quality checklist provided by the PVD Group.

Main results

We included one RCT (17 citations) with 17,802 participants that assessed rosuvastatin for preventing VTE. Our analysis showed that rosuvastatin reduced the incidence of VTE (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.37 to 0.86) and deep vein thrombosis (DVT) (OR 0.45, 95% CI 0.25 to 0.79), the risk of any (fatal and non‐fatal) myocardial infarction (MI) (OR 0.45, 95% CI 0.30 to 0.69), any (fatal and non‐fatal) stroke (OR 0.51, 95% CI 0.34 to 0.78), but did not reduce the incidence of pulmonary embolism (PE) (OR 0.77, 95% CI 0.41 to 1.46) and death after VTE (OR 0.50, 95% CI 0.20 to 1.24). Rosuvastatin did not reduce the incidence of any serious adverse event (OR 0.95, 95% CI 0.90 to 1.06).

Authors' conclusions

Available evidence showed that rosuvastatin was associated with a reduced incidence of VTE, but the evidence was limited to a single RCT. Randomised controlled trials of statins (including rosuvastatin) are needed to evaluate the efficacy of statins in the prevention of VTE.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Laički sažetak

Statini za primarnu prevenciju venske tromboembolije

Venska tromboza ili tromboembolija nastaje kad krvni ugrušak (tromb) nastane u veni i uzrokuje njeno začepljenje. To se začepljenje najčešće događa u "dubokim venama" potkoljenice, natkoljenice ili zdjelice te se zove duboka venska tromboza. Ako se dio ugruška ili cijeli ugrušak odvoji i odnese ga venska cirkulacija, to se stanje naziva embolija. Venska tromboembolija pogađa oko 3.705.000 osoba širom svijeta godišnje i predstavlja uzrok bolničke smrti koji se može najlakše spriječiti. Statini su dobro poznati lijekovi za snižavanje razine kolesterola, koji se koriste kod srčanih bolesti. Imaju i druge zaštitne učinke, kao što je djelovanje protiv zgrušavanja i mogli bi biti učinkoviti u prevenciji venske tromboembolije.Ovaj Cochrane sustavni pregled uključio je jedno veliko randomizirano kontrolirano ispitivanje u kojem je sudjelovalo 17.802 ispitanika, i u kojem je istražen rosuvastatin za prevenciju venske tromboembolije. Muški ispitanici imali su 50 godina ili više, a žene 60 godina ili više. Ispitanici nisu imali raniju povijest kardiovaskularnih bolesti, niskim LDL‐om (manje od 3,4 mmol/l) i vrijednošću visoko‐osjetljivog CRP‐a 2,0 mg/l ili većim. Metabolički sindrom imalo je 41,7% ispitanika.Ovaj Cochrane sustavni pregled uključio je jedno veliko randomizirano kontrolirano ispitivanje u kojem je sudjelovalo 17.802 ispitanika, i u kojem je istražen rosuvastatin za prevenciju venske tromboembolije. Muški ispitanici imali su 50 godina ili više, a žene 60 godina ili više. Ispitanici nisu imali raniju povijest kardiovaskularnih bolesti, niskim LDL‐om (manje od 3,4 mmol/l) i vrijednošću visoko‐osjetljivog CRP‐a 2,0 mg/l ili većim. Metabolički sindrom imalo je 41,7% ispitanika. Rosuvastatin nije bio povezan sa značajnim nuspojavama. Zaključno, potrebno je više randomiziranih kontroliranih studija o statinima (uključujući rosuvastatin) kako bi se mogao dobro procijeniti učinak statina za sprječavanje venske tromboembolije.