Medicine

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    Alirocumab and cardiovascular outcomes according to sex and lipoprotein(a) after acute coronary syndrome: a report from the ODYSSEY OUTCOMES study
    (Elservier, 2024) Schwartz, G.G.; Bhatt, D.L.; Chua, T; de Silva, H.A.; Diaz, R.; Goodman, S.G.; Harrington, R.A.; Jukema, J.W.; McGinniss, J.; Pordy, R.; Garon, G.; Scemama, M.; White, H.D.; Steg, P.G.; Szarek, M.; ODYSSEY OUTCOMES Investigators; Bittner, V. A.
    Background: The ODYSSEY OUTCOMES trial (NCT01663402) compared the effects of the pro- protein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo on major adverse cardiovas- cular events (MACE) in patients with recent acute coronary syndrome (ACS). Objective: We assessed efficacy and safety of alirocumab versus placebo according to sex and lipoprotein(a) level. Methods: This prespecified analysis compared the effects of alirocumab versus placebo on lipopro- teins, MACE (coronary heart disease death, non-fatal myocardial infarction, fatal/non-fatal ischemic stroke, unstable angina requiring hospitalization), death, total cardiovascular events, and adverse events in 4762 women and 14,162 men followed for a median of 2.8 years. In post-hoc analysis, we evaluated total cardiovascular events according to sex, baseline lipoprotein(a), and treatment. Results: Women were older, had higher baseline LDL-C levels (89.6 vs 85.3 mg/dL) and lipopro- tein(a) (28.0 vs 19.3 mg/dL) and had more co-morbidities than men. At 4 months, alirocumab lowered LDL-C by 49.4 mg/dL in women and 54.0 mg/dL in men and lipoprotein(a) by 9.7 and 8.1 mg/dL, respectively (both p < 0.0001). Alirocumab reduced MACE, death, and total cardiovascular events sim- ilarly in both sexes. In the placebo group, lipoprotein(a) was a risk factor for total cardiovascular events in women and men. In both sexes, reduction of total cardiovascular events was greater at higher base- line lipoprotein(a), but this effect was more evident in women than men (pinteraction = 0.08). Medication adherence and adverse event rates were similar in both sexes. Conclusions: Alirocumab improves cardiovascular outcomes after ACS irrespective of sex. Reduc- tion of total cardiovascular events was greater at higher baseline lipoprotein(a). ©2024 National Lipid Association. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )
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    Validation of the World Health Organization/ International Society of Hypertension (WHO/ISH) cardiovascular risk predictions in Sri Lankans based on findings from a prospective cohort study
    (Public Library of Science, 2021) Thulani, U.B.; Mettananda, K.C.D.; Warnakulasuriya, D.T.D.; Peiris, T.S.G.; Kasturiratne, K.T.A.A.; Ranawaka, U.K.; Chakrewarthy, S.; Dassanayake, A.S.; Kurukulasooriya, S.A.F.; Niriella, M.A.; de Silva, S.T.; Pathmeswaran, A.; Kato, N.; de Silva, H.J.; Wickremasinghe, A.R.
    INTRODUCTION AND OBJECTIVES: There are no cardiovascular (CV) risk prediction models for Sri Lankans. Different risk prediction models not validated for Sri Lankans are being used to predict CV risk of Sri Lankans. We validated the WHO/ISH (SEAR-B) risk prediction charts prospectively in a population-based cohort of Sri Lankans. METHOD: We selected 40-64 year-old participants from the Ragama Medical Officer of Health (MOH) area in 2007 by stratified random sampling and followed them up for 10 years. Ten-year risk predictions of a fatal/non-fatal cardiovascular event (CVE) in 2007 were calculated using WHO/ISH (SEAR-B) charts with and without cholesterol. The CVEs that occurred from 2007-2017 were ascertained. Risk predictions in 2007 were validated against observed CVEs in 2017. RESULTS: Of 2517 participants, the mean age was 53.7 year (SD: 6.7) and 1132 (45%) were males. Using WHO/ISH chart with cholesterol, the percentages of subjects with a 10-year CV risk <10%, 10-19%, 20%-29%, 30-39%, ≥40% were 80.7%, 9.9%, 3.8%, 2.5% and 3.1%, respectively. 142 non-fatal and 73 fatal CVEs were observed during follow-up. Among the cohort, 9.4% were predicted of having a CV risk ≥20% and 8.6% CVEs were observed in the risk category. CVEs were within the predictions of WHO/ISH charts with and without cholesterol in both high (≥20%) and low(<20%) risk males, but only in low(<20%) risk females. The predictions of WHO/ISH charts, with-and without-cholesterol were in agreement in 81% of subjects (ĸ = 0.429; p<0.001). CONCLUSIONS: WHO/ISH (SEAR B) risk prediction charts with-and without-cholesterol may be used in Sri Lanka. Risk charts are more predictive in males than in females and for lower-risk categories. The predictions when stratifying into 2 categories, low risk (<20%) and high risk (≥20%), are more appropriate in clinical practice.
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