Dataset Information

Statins in heart failure: the paradox between large randomized clinical trials and real life.

ABSTRACT:

Objective

To assess the relationship between statins and prognosis in ischemic and nonischemic patients with heart failure (HF) in a real-life cohort followed up for a long period.

Patients and methods

This prospective study included 960 patients with HF with preserved or depressed left ventricular ejection fraction (LVEF), irrespective of HF etiology, who were referred to the HF clinic of a university hospital between August 1, 2001, and December 31, 2008. The patients were followed up for a maximum of 9.1 years (median, 3.7 years), and survival in ischemic and nonischemic patients was determined.

Results

Median age was 69 years, and median LVEF was 31%. Of the 960 patients, 532 (55.4%) had ischemic HF etiology, and most received angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (846; 88.1%) and ?-blockers (776; 80.8%). Patients with HF of ischemic origin were more often treated with statins (P<.001). During follow-up, 440 patients (45.8%) died. Statin therapy was associated with significantly improved survival (hazard ratio, 0.45 [95% confidence interval, 0.37-0.54]; P<.001). After adjustment for HF prognostic factors (age, sex, cholesterol level, New York Heart Association class, HF etiology, LVEF, body mass index, HF duration, atrial fibrillation, implantable cardioverter-defibrillator therapy, and medicines), statins remained significantly associated with lower mortality risk in both ischemic (P=.007) and nonischemic (P=.002) patients.

Conclusion

In contrast to results of large randomized trials, statins were independently and significantly associated with lower mortality risk in our real-life HF cohort, including patients with nonischemic HF etiology.

SUBMITTER: Gastelurrutia P

PROVIDER: S-EPMC3541695 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Publications

Statins in heart failure: the paradox between large randomized clinical trials and real life.

Gastelurrutia Paloma P Lupón Josep J Lupón Josep J de Antonio Marta M Urrutia Agustin A Díez Crisanto C Coll Ramón R Altimir Salvador S Bayes-Genis Antoni A

Mayo Clinic proceedings 20120601 6

<h4>Objective</h4>To assess the relationship between statins and prognosis in ischemic and nonischemic patients with heart failure (HF) in a real-life cohort followed up for a long period.<h4>Patients and methods</h4>This prospective study included 960 patients with HF with preserved or depressed left ventricular ejection fraction (LVEF), irrespective of HF etiology, who were referred to the HF clinic of a university hospital between August 1, 2001, and December 31, 2008. The patients were follo ...[more]

PMID: 22677075

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Project description:Background and objectivesStatins showed mixed results in heart failure (HF) patients. The benefits in major HF outcomes, including all-cause mortality and sudden cardiac death (SCD), have always been discordant across systematic reviews and meta-analyses. We intended to systematically identify and appraise the available evidence that evaluated the effectiveness of statins in clinical outcomes for HF patients.DesignSystematic review and meta-analysis.Data sourcesWe searched, until April 28, 2016: Medline, Embase, ISI Web of Science and EBM reviews (Cochrane DSR, ACP journal club, DARE, CCTR, CMR, HTA, and NHSEED), checked clinicaltrials.gov for ongoing trials and manually searched references of included studies.Eligibility criteria for selecting studiesWe identified 24 randomized clinical trials that evaluated the efficacy of statins for HF patients. All randomized clinical trials were assessed for risk of bias and pooled together in a meta-analysis. Pre-specified outcomes were sudden cardiac death, all-cause mortality, and hospitalization for worsening heart failure.ResultsStatins did not reduce sudden cardiac death (SCD) events in HF patients [relative risk (RR) 0.92, 95% confidence interval (CI) 0.70 to 1.21], all-cause mortality [RR 0.88, 95% CI 0.75 to 1.02] but significantly reduced hospitalization for worsening heart failure (HWHF) although modestly [RR 0.79, 95% CI 0.66 to 0.94]. Nevertheless, estimated predictive intervals were insignificant in SCD, all-cause mortality and HWHF [RR, 0.54 to 1.63, 0.64 to 1.19, and 0.54 to 1.15], respectively. An important finding was the possible presence of publication bias, small-study effects and heterogeneity of the trials conducted in HF patients.ConclusionsStatins do not reduce sudden cardiac death, all-cause mortality, but may slightly decrease hospitalization for worsening heart failure in HF patients. The evaluation of the risk of biases suggested moderate quality of the published results. Until new evidence is available, this study supports the 2013 ACCF/AHA guidelines to not systematically prescribe statins in "only" HF patients, which should help avoid unnecessary polypharmacy.

Project description:BackgroundSodium-glucose cotransporter 2 (SGLT2) inhibitors have shown promise in improving cardiovascular outcome in patients with heart failure (HF) and diabetes mellitus (DM). Although these benefits have been confirmed by several meta-analyses, small studies have not been included into these pooled analyses.AimPublication of recent RCTs prompted us to perform this updated meta-analysis to examine the consistency of favorable cardiovascular outcomes of SGLT2 inhibitors in HF patients by inclusion of clinical trials with small sample size.MethodsWe conducted a systematic review of the literature in PubMed/Medline and ClinicalTrials.gov to identify all RCTs investigating the benefits of SGLT2 inhibitors in patients with HF. The primary endpoint of this meta-analysis was to compare the cardiovascular death (CVD) and hospitalization for HF (HHF) between patients who received an SGLT2 inhibitor and those who received a placebo or a non-SGLT2 inhibitor. We used a risk difference (RD) and log hazard ratio (HR) to pool the reported difference across the included RCTs.ResultsA total of 12 RCTs encompassing 59,825 patients at different stages of HF and DM were included, 32,448 patients in the SGLT2 inhibitor group and 27,377 patients in the control group. A pooled analysis of RCTs, regardless of HF severity or DM status, showed a significantly reduced RD for CVD (RD =-0.01, 95% CI [-0.01, 0.00], P=0.01) and HHF (RD =-0.02, 95% CI [-0.03, -0.01], P=0.0005) in patients who received a SGLT2 inhibitor compared to those who did not. A sub-group analysis showed a significantly reduced RD for CVD (RD =-0.01, 95% CI [-0.02, 0.00], P=0.03) and HHF (RD =-0.02, 95% CI [-0.03, 0.00], P=0.01) in patients with DM who received SGLT2 inhibitors regardless of the severity of HF. Also, regardless of DM status, RD for HHF favored the use of SGLT2 inhibitor than the control medication (RD =-0.05, 95% CI [-0.06, -0.03], P<0.00001).ConclusionSGLT2 inhibitors have shown a promise in reducing CVD and HHF in patients with HF, regardless of ejection fraction or diabetes status.

Dataset Information

Statins in heart failure: the paradox between large randomized clinical trials and real life.

Objective

Patients and methods

Results

Conclusion

Publications

Statins in heart failure: the paradox between large randomized clinical trials and real life.

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