Objective To evaluate whether the potential of statins to lower the risk of infections as published in observational studies is causal.Design Systematic review and meta-analysis of randomised placebo controlled trials.Data sources Medline, Embase, and the Cochrane Library.Study selection Randomised placebo controlled trials of statins (up to 10 March 2011) enrolling a minimum of 100 participants, with follow-up for at least one year. Data extraction Infection or infection related death.Results The first study selection yielded 632 trials. After screening of the corresponding abstracts and full text papers, 11 trials totalling 30 947 participants were included. 4655 of the participants (2368 assigned to statins and 2287 assigned to placebo) reported an infection during treatment. Meta-analysis showed no effect of statins on the risk of infections (relative risk 1.00, 95% confidence interval 0.96 to 1.05) or on infection related deaths (0.97, 0.83 to 1.13). ConclusionThese findings do not support the hypothesis that statins reduce the risk of infections. Absence of any evidence for a beneficial effect in large placebo controlled trials reduces the likelihood of a causal effect as reported in observational studies.
Aims Intravenous iron supplementation is widely used to treat iron deficiency and iron deficiency anemia when oral iron administration is ineffective or poorly tolerated. Hypersensitivity reactions (HSRs) during infusions are rare, but can be life‐threatening. This study aimed to compare the risk for HSRs with the intravenous administration of iron isomaltoside‐1000 and ferric carboxymaltose for the treatment of iron deficiency and iron deficiency anemia. Methods This was a single‐centre cohort study. Nurses and physicians were instructed to fill out an HSR registration form with every administration of intravenous iron. HSRs were distinguished into serious and non‐serious HSRs using the Ring and Messmer classification. Results HSRs occurred in 18/836 (2.1%) ferric carboxymaltose and 43/496 (8.7%) iron isomaltoside‐1000 administrations. The crude risk for HSRs was 75% lower after ferric carboxymaltose treatment (RR = 0.248, 95% CI: 0.145–0.426, P < 0.0001). The risk for grade II HSRs was 88% lower after ferric carboxymaltoside (RR = 0.123, 95% CI: 0.051–0.294). The likelihood of HSRs was 3.4 times higher after the administration of iron isomaltoside‐1000 (95% CI: 1.910–6.093, P < 0.0001). Regardless of the type of intravenous iron, patients with comorbidities have a factor 3.6 higher risk (95% CI: 1.899–6.739, P < 0.0001). Conclusions Ferric carboxymaltose is associated with a 75% lower risk for HSRs compared with iron isomaltoside‐1000 in our population. The presence of a comorbidity raises the likelihood of an HSR by a factor of three regardless of the type of intravenous iron infusion. Further research is needed to clarify the underlying mechanism in various patient groups.
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