To examine the metabolic syndrome (MetS) and its components as risk factors for a cardiovascular (CV) event, in individuals without diabetes and/or hypertension, and to explore which of the risk factors are the most predictive for cardiovascular disease (CVD) and whether the assessment of risk could be simplified.

A longitudinal, cross-sectional study.

A randomly selected population.

In 2002–2005, 2816 randomly selected residents of Skaraborg, Sweden, underwent physical examinations and blood tests as part of the Skaraborg Project. Exclusion of individuals with diabetes mellitus and/or hypertension at baseline left 2328 persons for analyses.

CV events were assessed in 2011 using national Swedish registers.

A total of 293 (13%) were defined as having the MetS according to the National Cholesterol Education Programme (NCEP) and 292 according to the International Diabetes Federation (IDF) definition, whereof 27 had a CV event after a mean follow-up time of 9.7 years. The MetS according to NCEP was significantly predictive of a CVD with an HR 2.4 (95% CI 1.4 to 3.9) but not according to the IDF definition. Blood pressure was significantly predictive according to both definitions (HR 1.77, 95% CI 1.06 to 2.97). Also, triglycerides (Tg) were significantly predictive for a CV event (HR 2.05, 95% CI 1.17 to 3.59). Neither waist circumference, high-density lipoprotein nor fasting plasma glucose was predictive for a CV event. Combining a blood pressure ≥125/≥80 mm Hg with Tg ≥1.5 mmol/L was predictive for CVD (HR 2.1, 95% CI 1.3 to 3.6) with a sensitivity of 32.5% and numbers needed to examine (NNE) 7.1. Lowering the cut-off for Tg to ≥1.2 mmol/L (HR 2.1, 95% CI 1.3 to 3.4) increased sensitivity to 44.9% and NNE became 8.

Using blood pressure combined with Tg was shown to be an equally good predictor for CVD as the complete MetS in individuals without diagnosed diabetes or hypertension. Therefore, healthcare personnel should pay attention to individuals with a borderline blood pressure, and if equivalent to or equal to 125/85, continue with measuring Tg for a discussion concerning lifestyle.

Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally.

This study comprises two cohorts. The ‘untreated cohort’ is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The ‘previously treated cohort’ is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up.

The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women’s Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences.

jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).