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people intolerant to statins may include\nswitching to a different high-intensitystatin if a high-intensity statin is indi-cated, switching to moderate-intensity or\nlow-intensity statin, lowering the statin | [
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low-intensity statin, lowering the statin\ndose, or using nondaily dosing of statins.While considering these alternative treat-ment plans, the addition of nonstatintreatment plans to maximum tolerated\nstatin therapy should be considered, as\nthese are frequently associated withimproved adherence and target LDL cho-les... | [
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PCSK9 Inhibition\nThe PCSK9 monoclonal antibodies aliro-cumab and evolocumab have both been\nstudied within populations considered\nstatin intolerant. The Study of Alirocumabin Patients With Primary Hypercholester-olemia and Moderate, High, or Very HighCardiovascular Risk, Who Are Intolerant\nto Statins (ODYSSEY ALTERN... | [
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to Statins (ODYSSEY ALTERNATIVE) trial\nevaluated the LDL cholesterol –lowering\nefficacy of alirocumab compared with\nezetimibe in addition to the safety\nof each of the prior two treatments\ncompared with a statin rechallenge armwith 20 mg atorvastatin in 314 individu-als with primary hypercholesterolemia\nand statin ... | [
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and statin intolerance. The proportion of\nthe study population with type 2 diabe-tes was /C2424%. After the 24 weeks, aliro-\ncumab lowered LDL cholesterol levels by\n54.8% compared with 20.1% with ezeti- | [
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54.8% compared with 20.1% with ezeti-\nmibe. Although there were similar ratesof any adverse event for all treatments,there were fewer events that led totreatment discontinuation for alirocu-\nmab (18.3% vs. 25.0% for ezetimibe\nand 25.4% for atorvastatin) as well asfewer skeletal muscle –related adverse\nevents (32.5%... | [
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events (32.5% vs. 41.1% with ezetimibe\nand 46% with atorvastatin) (126). Indi-\nviduals in all treatment arms were of-fered the opportunity of an open-labelextension phase, in which all received\nalirocumab for /C243 years. LDL cholesterol\nreductions of more than 50% were either | [
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reductions of more than 50% were either\nachieved or maintained for the 281 indi-viduals who either continued with or\nswitched to alirocumab for the extension\nphase, and these reductions were sus-tained throughout the treatment period(127).\nEvolocumab was evaluated for its\nsafety and ef ficacy in people with statin | [
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safety and ef ficacy in people with statin\nintolerance in the Goal Achievement Af-ter Utilizing an Anti-PCSK9 Antibody inStatin Intolerant Subjects 1, 2, and 3(GAUSS 1, 2, and 3) trials as well as the\nOSLER open-label extension of the GAUSS | [
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OSLER open-label extension of the GAUSS\n1a n d2t r i a l s .T h e r ew e r e1 6 0a n d3 0 7individuals in the GAUSS 1 and 2 trials, re-spectively, who were randomized to vari-\nous doses of evolocumab plus ezetimibe\n10 mg or ezetimibe 10 mg plus placeboinjection for 12 weeks. Reductions in LDLcholesterol ranged from ... | [
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(depending on the dose) for evolocumab/\nezetimibe compared with 15% to 18% forezetimibe/placebo. Similar to what wasfound in the alirocumab studies, musculo-skeletal adverse effects occurred in fewerof those treated with evolocumab/ezetimibe than with ezetimibe/placebo,\nalthough rates of discontinuation were | [
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although rates of discontinuation were\nsimilar (5% and 6%, respectively) due tothese effects. Use of low-dose statinswas allowed in these studies and was as-\nsociated with an increase in the inci-\ndence of musculoskeletal adverse effects(128,129). One hundred twenty-eight in-dividuals from the GAUSS 1 trial were\nre... | [
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rerandomized to evolocumab (420 mg\nmonthly) plus standard of care comparedwith the standard of care for 1 year, andthen all participants were treated with420 mg of evolocumab monthly plus\nstandard of care. Two hundred fifty-four\nindividuals were rerandomized into two\ndosing options of evolocumab (140 mgbiweekly or 4... | [
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with standard of care for 1 year, and\nthen all were continued on 420 mg monthlyfor an additional year. After 1 year, the LDLcholesterol was reduced from baseline\n(beginning of the GAUSS 1 or 2 trial) by a | [
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(beginning of the GAUSS 1 or 2 trial) by a\nmean of 57% in those treated with evolo-c u m a bc o m p a r e dw i t h1 3 %w i t ht h es t a n -dard of care, with a 59% reduction (frombaseline) by the end of year 2. Fourteen\npercent of participants in the extension | [
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percent of participants in the extension\ntrials experienced musculoskeletal adverseeffects; however, these effects did notlead to any participant discontinuing the\ntrials (130). Similar LDL cholesterol reduc-\ntions were demonstrated in the GAUSS 3trial after 24 weeks ( /C054.5% with evo-\nlocumab compared with –16.7... | [
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locumab compared with –16.7% with\nezetimibe), with slightly higher rates ofmusculoskeletal adverse events (20.7%with evolocumab and 28.8% with ezeti-mibe). The higher rates of these adverseevents may be due in part to the first\nphase of this trial, which randomized in-dividuals to a statin rechallenge with ei-ther ato... | [
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Inclisiran has also been proposed as\nan option for individuals with statin\nintolerance. Although most individuals\n(90–95%) in the later ORION-10 and\nORION-11 trials were on statin therapy(123), the Trial to Evaluate the Effect of\nALN-PCSSC Treatment on Low-density Li- | [
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ALN-PCSSC Treatment on Low-density Li-\npoprotein Cholesterol (ORION-1) includedindividuals with documented statin intoler-ance. The percentages of individuals not\ntaking statins were 26% of the 253 who re- | [
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taking statins were 26% of the 253 who re-\nceived either a single injection of inclisiranor placebo and 28% of the 248 whoS190 Cardiovascular Disease and Risk Management Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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received two injections of inclisiran or\nplacebo. Both groups were followed for1 year to assess the durability of theinitial (30 –45%, dose-dependent) low-\nering of LDL cholesterol. Almost all individ-\nuals treated with inclisiran maintained their | [
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uals treated with inclisiran maintained their\nLDL cholesterol levels at 180 days; how-ever, the levels returned to within 20%change from the baseline for 17 –52% of\nindividuals, and response depended onboth the number and strength of the incli-siran dose(s) received (132). A proportionof these individuals continued i... | [
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open-label Extension Trial of Inclisiran in\nParticipants With Cardiovascular Diseaseand High Cholesterol (ORION-3), in whichthey returned to inclisiran 300 mg given\nevery 6 months and were compared with | [
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every 6 months and were compared with\nindividuals given placebo in ORION-1 andthose who were given evolocumab140 mg every 2 weeks for 1 year and thentransitioned to inclisiran. The change in LDL\ncholesterol levels was compared with the\nbaseline, which was de fined as the base- | [
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baseline, which was de fined as the base-\nline for the ORION-1 trial for those initiallytreated with inclisiran (as they were incli-\nsarin naive at that point) or the start of the\nORION-3 trial for those previously treatedwith placebo. It is important to note thatof the ORION-3 participants, only 23% had\ndiabetes an... | [
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diabetes and 33% were not taking statin\ntherapy. Both arms maintained an LDLcholesterol reduction of /C2445% through\nthe end of year 4 (133). The signi ficant\nresponse was seen across the groupsduring the ORION-1 trial and in theORION-3 extension, and it may be ex-pected that those with statin intoleranceexperienced ... | [
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sponse of those on statin therapy; how-\never, evaluation of response based onbackground lipid-lowering therapy wasnot described.\nBempedoic Acid\nBempedoic acid is a novel LDL choles-terol–lowering agent that is indicated as\nan adjunct to diet and maximum toler-ated statin therapy for the treatment of\nadults with he... | [
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adults with heterozygous familial hyper-\ncholesterolemia or established ASCVDwho require additional lowering of LDLcholesterol. A pooled analysis suggests\nthat bempedoic acid therapy lowers LDL\ncholesterol levels by about 23% com-pared with placebo (134). This agentshould be considered for individualswho cannot use ... | [
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dence-based LDL cholesterol –lowering\napproaches or for whom those othertherapies are inadequately effective\n(135). The Evaluation of Major Cardio-\nvascular Events in Patients With, or at\nHigh Risk for, Cardiovascular Disease\nWho Are Statin Intolerant Treated WithBempedoic Acid or Placebo (CLEAR Out-\ncomes) trial... | [
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comes) trial evaluated the impact of\nbempedoic acid on cardiovascular events\nfor individuals with established ASCVD\n(70% of population) or at high risk forASCVD (30% of population) and consid-\nered to be intolerant to statin therapy.\nIt is important to note that /C2419% of | [
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It is important to note that /C2419% of\nindividuals were on very-low-dose statintherapy at baseline. Bempedoic acid wasf o u n dt or e d u c et h ec o m p o s i t eo u t c o m e\nof four-point major adverse cardiovascular\nevents by 13% compared with placebo\n( 1 3 6 )T h eH Rf o rt h ep r i m a r yo u t c o m ew a s | [
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( 1 3 6 )T h eH Rf o rt h ep r i m a r yo u t c o m ew a s\nmore reduced in the primary preventiongroup (HR 0.68 [95% CI 0.53– 0.87]) com-\npared with the secondary prevention groupof individuals with established cardiovascu-\nlar disease (HR 0.91 [95% CI 0.81– 1.01]). In\naddition, in a preplanned subanalysis of | [
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-0.009243112057447433,
-0.019204745069146156,
0.06451118737459183,
0.0024968546349555254,
0.0427374392747879,
-0.02346... |
addition, in a preplanned subanalysis of\nthe primary prevention population, the use\nof bempedoic acid resulted in a 30% re-\nduction in primary composite outcome\ncompared with placebo (137).\nTreatment of Other Lipoprotein\nFractions or Targets\nRecommendations\n10.29 For individuals with fasting\ntriglyceride level... | [
0.003801624523475766,
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-0.08249252289533615,
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-0.028951702639460564,
0.12288947403430939,
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-0.02006639540195465,
0.09276864677667618,
-0.020958930253982544,
-0.07408427447080612,
-... |
10.29 For individuals with fasting\ntriglyceride levels $500 mg/dL\n($5.7 mmol/L), evaluate for sec-\nondary causes of hypertriglyceride-\nmia and consider medical therapyto reduce the risk of pancreatitis. C\n10.30 In adults with moderate hyper-\ntriglyceridemia (fasting or nonfasting\ntriglycerides 175 –499 mg/dL [2.... | [
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0.010634598322212696,
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0.038615450263023376,
0.08325175195932388,
0.07145161926746368,
0.012834525667130947,
-0.09695056825876236,
0.04607640951871872,
-0.07796858996152878,
-0.061915382742881775,
-0.012... |
triglycerides 175 –499 mg/dL [2.0– 5.6\nmmol/L]), clinicians should address and\ntreat lifestyle factors (obesity and meta-bolic syndrome), secondary factors (dia-betes, chronic liver or kidney diseaseand/or nephrotic syndrome, and hypo-thyroidism), and medications that raisetriglycerides. C\n10.31 In individuals with ... | [
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-0.07... |
10.31 In individuals with ASCVD or\nother cardiovascular risk factors on astatin with controlled LDL cholesterolbut elevated triglycerides (135 –499\nmg/dL [1.5 –5.6 mmol/L]), the addition\nof icosapent ethyl can be considered\nto reduce cardiovascular risk. A\nHypertriglyceridemia should be addressed | [
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Hypertriglyceridemia should be addressed\nwith dietary and lifestyle changes includingweight loss and abstinence from alcohol\n(138). Severe hypertriglyceridemia (fasting\ntriglycerides $500 mg/dL and especially\n>1,000 mg/dL) may warrant pharmaco-\nlogic therapy ( fibric acid derivatives and/or\nfish oil) and reduction ... | [
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0.00... |
fish oil) and reduction in dietary fat to re-\nduce the risk of acute pancreatitis. Moder-ate- or high-intensity statin therapy shouldalso be used as indicated to reduce risk ofcardiovascular events (see\nSTATIN TREATMENT ).\nIn people with moderate hypertriglyceride-mia, lifestyle interventions, treatment of\nsecondary... | [
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secondary factors, and avoidance of\nmedications that might raise trigly-cerides are recommended.\nThe Reduction of Cardiovascular Events\nwith Icosapent Ethyl-Intervention Trial\n(REDUCE-IT) enrolled 8,179 adults re-\nceiving statin therapy with moderatelyelevated triglycerides (135 –499 mg/dL, | [
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0.02272910624742508,
-0.05720840394496918,
0.12720835208892822,
-0.02253144606947899,
0.0018798550590872765,
0.05042516812682152,
-0.038249436765909195,
-0.05248451605439186,
-0... |
median baseline of 216 mg/dL) whohad either established cardiovasculardisease (secondary prevention cohort)\nor diabetes plus at least one other car-\ndiovascular risk factor (primary preven-tion cohort) (139). Individuals wererandomized to icosapent ethyl 4 g/day(2 g twice daily with food) versus pla-\ncebo. The trial... | [
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0.04321040213108063,
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0.16864652931690216,
0.006393114570528269,
0.023963505402207375,
0.035027340054512024,
-0.018647564575076103,
-0.014105034992098808,
-0.05... |
cebo. The trial met its primary end point,\ndemonstrating a 25% relative risk reduc-tion ( P<0.001) for the primary end\npoint composite of cardiovascular death,nonfatal MI, nonfatal stroke, coronary re-vascularization, or unstable angina. This\nrisk reduction was seen in people with or | [
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0.023539351299405098,
0.049563657492399216,
-0.03646475821733475,
0.18044006824493408,
0.07251675426959991,
0.030567748472094536,
0.043992165476083755,
-0.031122436746954918,
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risk reduction was seen in people with or\nwithout diabetes at baseline. The compos-ite of cardiovascular death, nonfatal MI,or nonfatal stroke was reduced by 26%(P<0.001). Additional ischemic end\npoints were signi ficantly lower in the ico- | [
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points were signi ficantly lower in the ico-\nsapent ethyl group than in the placebogroup, including cardiovascular death,w h i c hw a sr e d u c e db y2 0 %( P=0 . 0 3 ) .\nThe proportions of individuals experienc-\ning adverse events and serious adverse | [
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0.003702... |
ing adverse events and serious adverse\nevents were similar between the activeand placebo treatment groups. It shouldbe noted that data are lacking for other n-3fatty acids, and results of the REDUCE-ITtrial should not be extrapolated to other\nproducts (139). As an example, the addi- | [
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products (139). As an example, the addi-\ntion of 4 g per day of a carboxylic acidformulation of the n-3 fatty acids eicosa-pentaenoic acid (EPA) and docosahexae-noic acid (DHA) (n-3 carboxylic acid) to\nstatin therapy in individuals with athero- | [
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0.0371684692800045,
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0.14718616008758545,
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0.08465147018432617,
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statin therapy in individuals with athero-\ngenic dyslipidemia and high cardiovascu-lar risk, 70% of whom had diabetes, didnot reduce the risk of major adversediabetesjournals.org/care Cardiovascular Disease and Risk Management S191\n©AmericanDiabetesAssociation | [
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0.001712542842142284,
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0.07976721227169037,
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0.01576... |
cardiovascular events compared with the\ninert comparator of corn oil (140).\nLow levels of HDL cholesterol, often\nassociated with elevated triglyceridelevels, are the most prevalent pattern of\ndyslipidemia in people with type 2 diabe-\nt e s .H o w e v e r ,t h ee v i d e n c ef o rt h eu s eo f\ndrugs that target t... | [
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-0.054657530039548874,
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0.009720537811517715,
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0.09248810261487961,
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0.01941755600273609,
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... |
drugs that target these lipid fractions is\nsubstantially less robust than that for\nstatin therapy (141). In a large trial in\npeople with diabetes, fenofi brate failed\nto reduce overall cardiovascular outcomes(142).\nOther Combination Therapy\nRecommendations\n10.32 Statin plus fibrate combina-\ntion therapy has not b... | [
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0.021187808364629745,
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0.033400386571884155,
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0.12467744201421738,
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-0.0081377187743783,
0.004740183241665363,
0.03557061776518822,
-0.06313052028417587,
0.02... |
10.32 Statin plus fibrate combina-\ntion therapy has not been shown to\nimprove ASCVD outcomes and isgenerally not recommended. A\n10.33 Statin plus niacin combination\ntherapy has not been shown to pro-vide additional cardiovascular bene-fit above statin therapy alone, may\nincrease the risk of stroke with ad-\nditional... | [
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0.00019897829042747617,
0.05046936497092247,
0.003073697676882148,
0.08908594399690628,
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0.06371190398931503,
0.06970221549272537,
0.040778182446956635,
-0.08152793347835541,
0.0953... |
ditional side effects, and is gener-\nally not recommended. A\nStatin and Fibrate Combination Therapy\nCombination therapy (statin and fibrate)\nis associated with an increased risk for\nabnormal transaminase levels, myositis,\nand rhabdomyolysis. The risk of rhabdo-\nmyolysis is more common with higher\ndoses of statin... | [
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0.009205043315887451,
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0.02753676474094391,
0.010714326985180378,
0.04936256259679794,
0.010129467584192753,
0.0728... |
doses of statins and renal insuf ficiency\nand appears to be higher when statinsare combined with gem fibrozil (com-\npared with feno fibrate) (143).\nIn the ACCORD study, in people with\ntype 2 diabetes who were at high risk forASCVD, the combination of fenofi brate\nand simvastatin did not reduce the rate offatal cardiov... | [
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0.03596315160393715,
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nonfatal stroke compared with simva-\nstatin alone. Prespeci fied subgroup analy-\nses suggested heterogeneity in treatmenteffects with possible bene fitf o rm e nw i t h\nb o t hat r i g l y c e r i d el e v e l $204 mg/dL\n($2 . 3m m o l / L )a n da nH D Lc h o l e s t e r o l\nlevel#34 mg/dL ( #0.9 mmol/L) (144).\nSta... | [
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0.017640741541981697,
0.05714419484138489,
0.009643732570111752,
-0.01903468742966652,
0.058... |
Statin and Niacin Combination Therapy\nThe Atherothrombosis Intervention inMetabolic Syndrome With Low HDL/High\nTriglycerides: Impact on Global Health\nOutcomes (AIM-HIGH) trial random-\nized over 3,000 people (about one-\nthird with diabetes) with establishedASCVD, LDL cholesterol levels <180 mg/dL\n(<4.7 mmol/L), lo... | [
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0.00027324591064825654,
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0.12998926639556885,
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0.06872691214084625,
-0.03475144878029823,
... |
(<4.7 mmol/L), low HDL cholesterol lev-\nels (men <40 mg/dL [ <1.0 mmol/L] and\nwomen <50 mg/dL [ <1.3 mmol/L]), and\ntriglyceride levels of 150 –400 mg/dL\n(1.7–4.5 mmol/L) to statin therapy plus\nextended-release niacin or placebo. The\ntrial was halted early due to lack of ef fi-\ncacy on the primary ASCVD outcome (fi... | [
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0.1281137466430664,
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0.025988871231675148,
0.052655965089797974,
-0.03664678335189819,
0.01... |
cacy on the primary ASCVD outcome (fi rst\nevent of the composite of death from\nCHD, nonfatal MI, ischemic stroke, hospi-\ntalization for an acute coronary syndrome,or symptom-driven coronary or cerebral re-vascularization) and a possible increase inischemic stroke in those on combinationtherapy (145).\nThe much larger... | [
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0.012817805632948875,
0.04795345664024353,
0.013835069723427296,
0.021471265703439713,
0.02387... |
The much larger Heart Protection Study\n2–Treatment of HDL to Reduce the Inci-\ndence of Vascular Events (HPS2-THRIVE)trial also failed to show a bene fit of adding\nniacin to background statin therapy (146).\nA total of 25,673 individuals with prior vas- | [
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0.048495739698410034,
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cular disease were randomized to receive2 g of extended-release niacin and 40 mgof laropiprant (an antagonist of the prosta-glandin D2 receptor DP1 that has beenshown to improve participation in niacintherapy) versus a matching placebo dailyand followed for a median follow-up periodof 3.9 years. There was no signi fican... | [
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0.0... |
ence in the rate of coronary death, MI,stroke, or coronary revascularization withthe addition of niacin– laropiprant versus\nplacebo (13.2% vs. 13.7%; rate ratio 0.96;P=0.29). Niacin –laropiprant was associated\nwith an increased incidence of new-onsetdiabetes (absolute excess, 1.3 percentagepoints; P<0.001) and distur... | [
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0.02908121421933174,
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0.02481672912836075,
0.06572555005550385,
0.03518876060843468,
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0.007534504402428865,
0.032460521906614304,
-0.10876376926898956,
0.05111008... |
diabetes management among those with\ndiabetes. In addition, there was an increase\nin serious adverse events associated withthe gastrointestinal system, musculoskele-tal system, skin, and, unexpectedly, infec-tion and bleeding.\nTherefore, combination therapy with\na statin and niacin is not recommended,given the lack... | [
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0.04889794439077377,
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0.052173469215631485,
0.12171278148889542,
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0.03248582407832146,
0.022515133023262024,
0.07900089025497437,
-0.06221696734428406,
0.06550... |
outcomes and increased side effects.\nDiabetes Risk With Statin Use\nSeveral studies have reported a mod-estly increased risk of incident type 2 di-abetes with statin use (147,148), which\nmay be limited to those with diabetes | [
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0.16504766047000885,
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0.12595292925834656,
-0.03641694411635399,
0.013903368... |
may be limited to those with diabetes\nrisk factors. An analysis of one of theinitial studies suggested that althoughstatin use was associated with diabetesrisk, the cardiovascular event rate re-duction with statins far outweighedthe risk of incident diabetes, even for\nindividuals at highest risk for diabetes(149). Th... | [
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0.035211656242609024,
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0.07796958088874817,
0.05570831894874573,
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0.002062455518171191,
0.1423550546169281,
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0.06146605685353279,
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0.0131... |
small (over 5 years of follow-up, 1.2% of\nparticipants on placebo developed dia-\nbetes and 1.5% on rosuvastatin devel-\noped diabetes) (149). A meta-analysis of\n13 randomized statin trials with 91,140\nparticipants showed an odds ratio of 1.09for a new diagnosis of diabetes, so that\n(on average) treatment of 255 in... | [
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0.006973805371671915,
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0.06737808138132095,
0.035300955176353455,
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0.0038906275294721127,
0.15088820457458496,
0.02184179611504078,
-0.040825068950653076,
-0.050426848232746124,
0.0624808743596077,
-0.040134456008672714,
0.0142... |
(on average) treatment of 255 individuals\nwith statins for 4 years resulted in one\nadditional case of diabetes while simulta-\nneously preventing 5.4 vascular events\namong those 255 individuals (148).\nLipid-Lowering Agents and Cognitive\nFunction\nAlthough concerns regarding a potential | [
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0.15702231228351593,
0.014365184120833874,
0.03401351720094681,
0.0008320131455548108,
0.07167686522006989,
-0.016065364703536034,
0.0092... |
Function\nAlthough concerns regarding a potential\nadverse impact of lipid-lowering agentson cognitive function have been raised,\nseveral lines of evidence point against\nthis association, as detailed in a 2018\nEuropean Atherosclerosis Society Con-\nsensus Panel statement (150). First,\nthere are three large randomiz... | [
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there are three large randomized trials\nof statin versus placebo where speci fic\ncognitive tests were performed, and no\ndifferences were seen between statin\nand placebo (151 –154). In addition, no\nchange in cognitive function has beenreported in studies with the addition\nof ezetimibe (112) or PCSK9 inhibitors\n(11... | [
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(115,155) to statin therapy, including\namong individuals treated to very low\nLDL cholesterol levels. In addition, themost recent systematic review of the\nU.S. Food and Drug Administration ’s\n(FDA ’s) postmarketing surveillance da-\ntabases, randomized controlled trials,\nand cohort, case-control, and cross-\nsectio... | [
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sectional studies evaluating cognition\nin individuals receiving statins foundthat published data do not reveal an\nadverse effect of statins on cognition\n(156). Therefore, a concern that statins\nor other lipid-lowering agents might\ncause cognitive dysfunction or demen-\ntia is not currently supported by evi- | [
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tia is not currently supported by evi-\ndence and should not deter their usein individuals with diabetes at high risk\nfor ASCVD (156).\nANTIPLATELET AGENTS\nRecommendations\n10.34 Use aspirin therapy (75 –162 mg/day)\nas a secondary prevention strategy | [
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as a secondary prevention strategy\nin those with diabetes and a historyof ASCVD. AS192 Cardiovascular Disease and Risk Management Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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10.35a For individuals with ASCVD\nand documented aspirin allergy, clopi-\ndogrel (75 mg/day) should be used. B\n10.35b The length of treatment with\ndual antiplatelet therapy using low-\ndose aspirin and a P2Y12 inhibitor\nin individuals with diabetes after an\nacute coronary syndrome or acute is-chemic stroke/transie... | [
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tack should be determined by an\ninterprofessional team approach thatincludes a cardiovascular or neurologi-\ncal specialist, respectively. E\n10.36 Combination therapy with aspi-\nrin plus low-dose rivaroxaban should\nbe considered for individuals with sta-\nble coronary and/or peripheral artery\ndisease (PAD) and low... | [
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disease (PAD) and low bleeding risk\nto prevent major adverse limb and\ncardiovascular events. A\n10.37 Aspirin therapy (75 –162 mg/day)\nmay be considered as a primary pre-\nvention strategy in those with diabetes\nwho are at increased cardiovascularrisk, after a comprehensive discussion\nwith the individual on the be... | [
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with the individual on the bene fits ver-\nsus the comparable increased risk of\nbleeding. A\nRisk Reduction\nAspirin has been shown to be effective\nin reducing cardiovascular morbidity andmortality in high-risk individuals with pre-vious MI or stroke (secondary prevention)\nand is strongly recommended. In primary | [
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and is strongly recommended. In primary\nprevention, however, among individualswith no previous cardiovascular events,its net bene fit is more controversial\n(147,157).\nPrevious randomized controlled trials\nof aspirin, speci fically in people with di-\nabetes, failed to consistently show a sig-nificant reduction in over... | [
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points, raising questions about the ef fi-\ncacy of aspirin for primary prevention inpeople with diabetes, although some sexdifferences were suggested (158 –160).\nThe Antithrombotic Trialists ’Collabo-\nration published an individual patient – | [
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ration published an individual patient –\nlevel meta-analysis (161) of the six largetrials of aspirin for primary preventionin the general population. These trials\ncollectively enrolled over 95,000 partici-\npants, including almost 4,000 with dia-betes. Overall, they found that aspirinreduced the risk of serious vascu... | [
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events by 12% (relative risk 0.88 [95%\nCI 0.82 –0.94]). The largest reductionwas for nonfatal MI, with little effect on\nCHD death (relative risk 0.95 [95% CI0.78–1.15]) or total stroke.\nMost recently, the ASCEND (A Study\nof Cardiovascular Events iN Diabetes)\ntrial randomized 15,480 people with diabe- | [
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trial randomized 15,480 people with diabe-\ntes but no evident cardiovascular diseaseto aspirin 100 mg daily or placebo (162).The primary ef ficacy end point was vascu- | [
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lar death, MI, stroke, or transient ischemicattack. The primary safety outcome wasmajor bleeding (i.e., intracranial hemor-rhage, sight-threatening bleeding in theeye, gastrointestinal bleeding, or other\nserious bleeding). During a mean follow-\nup of 7.4 years, there was a signi ficant\n12% reduction in the primary ef... | [
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12% reduction in the primary effi cacy\nend point (8.5% vs. 9.6%; P=0 . 0 1 ) .I n\ncontrast, major bleeding was signi ficantly\nincreased from 3.2 to 4.1% in the aspiringroup (rate ratio 1.29; P=0 . 0 0 3 ) ,w i t h\nmost of the excess being gastrointestinal\nbleeding and other extracranial bleeding.\nT h e r ew e r en ... | [
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T h e r ew e r en os i g n i ficant differences by\nsex, weight, or duration of diabetes orother baseline factors, including ASCVD\nrisk score.\nTwo other large, randomized trials of\naspirin for primary prevention, in peo-\nple without diabetes (ARRIVE [Aspirin toReduce Risk of Initial Vascular Events])\n(163) and in t... | [
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(163) and in the elderly (ASPREE [Aspi-\nrin in Reducing Events in the Elderly])(164), which included 11% with diabe-tes, found no benefi t of aspirin on the\nprimary ef ficacy end point and an in- | [
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primary ef ficacy end point and an in-\ncreased risk of bleeding. In ARRIVE, with12,546 individuals over a period of60 months of follow-up, the primary endpoint occurred in 4.29% vs. 4.48% of indi-\nviduals in the aspirin versus placebo groups\n(HR 0.96 [95% CI 0.81– 1.13]; P=0 . 6 0 ) . | [
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(HR 0.96 [95% CI 0.81– 1.13]; P=0 . 6 0 ) .\nGastrointestinal bleeding events (char-acterized as mild) occurred in 0.97% of\nindividuals in the aspirin group vs.\n0.46% in the placebo group (HR 2.11[95% CI 1.36– 3.28]; P= 0.0007). In\nASPREE, including 19,114 individuals, for\ncardiovascular disease (fatal CHD, MI, | [
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cardiovascular disease (fatal CHD, MI,\nstroke, or hospitalization for heart failure)after a median of 4.7 years of follow-up,the rates per 1,000 person-years were10.7 vs. 11.3 events in aspirin vs. placebo\ngroups (HR 0.95 [95% CI 0.83 –1.08]). The\nrate of major hemorrhage per 1,000 per- | [
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rate of major hemorrhage per 1,000 per-\nson-years was 8.6 events vs. 6.2 events,respectively (HR 1.38 [95% CI 1.18 –1.62];\nP<0.001).\nThus, aspirin appears to have a mod-\nest effect on ischemic vascular events,with the absolute decrease in events de-\npending on the underlying ASCVD risk. | [
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pending on the underlying ASCVD risk.\nThe main adverse effect is an increasedrisk of gastrointestinal bleeding. The ex-cess risk may be as high as 5 per 1,000per year in real-world settings. However,for adults with ASCVD risk >1% per year, | [
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the number of ASCVD events preventedwill be similar to the number of episodesof bleeding induced, although these com-\nplications do not have equal effects on\nlong-term health (165).\nRecommendations for using aspirin\nas primary prevention include both menand women aged $50 years with diabe- | [
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tes and at least one additional majorrisk factor (family history of prematureASCVD, hypertension, dyslipidemia, smok-ing, or CKD/albuminuria) who are not atincreased risk of bleeding (e.g., older age,anemia, or renal disease) (166 –169). Non- | [
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invasive imaging techniques such as coro-nary calcium scoring may help furthertailor aspirin therapy, particularly in thoseat low risk (170,171). For people >70 years\nof age (with or without diabetes), the bal-ance appears to have greater risk thanbenefit (162,164). Thus, for primary pre- | [
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vention, the use of aspirin needs to becarefully considered and may generally not\nbe recommended. Aspirin may be consid- | [
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be recommended. Aspirin may be consid-\nered in the context of high cardiovascularrisk with low bleeding risk but generallynot in older adults. Aspirin therapy for pri-mary prevention may be considered in thecontext of shared decision-making, whichcarefully weighs the cardiovascular bene fits\nwith the fairly comparable... | [
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with the fairly comparable increase in riskof bleeding.\nFor people with documented ASCVD,\nuse of aspirin for secondary prevention\nhas far greater bene fit than risk; for this\nindication, aspirin is still recommended\n(157).\nAspirin Use in People <50 Years of Age | [
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(157).\nAspirin Use in People <50 Years of Age\nAspirin is not recommended for thoseat low risk of ASCVD (such as men andwomen aged <50 years with diabetes\nwith no other major ASCVD risk factors),as the low bene fit is likely to be out-\nweighed by the risk of bleeding. Clinicaljudgment should be used for those at inte... | [
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mediate risk (younger individuals with one\nor more risk factors or older individualswith no risk factors) until further research isavailable. Individuals ’willingness to undergo\nlong-term aspirin therapy should also beconsidered in shared decision-making (172).diabetesjournals.org/care Cardiovascular Disease and Risk... | [
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©AmericanDiabetesAssociation | [
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0.0067015099339187145,
0.0... |
Aspirin use in individuals aged <21 years is\ngenerally contraindicated due to the associ-\nated risk of Reye syndrome.\nAspirin Dosing\nAverage daily dosages used in most clini-cal trials involving people with diabetes\nranged from 50 to 650 mg but were\nmostly in the range of 100 –325 mg/day. | [
0.027604030445218086,
0.0032628460321575403,
-0.046606212854385376,
0.08085304498672485,
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-0.03953007236123085,
0.0431... |
mostly in the range of 100 –325 mg/day.\nT h e r ei sl i t t l ee v i d e n c et os u p p o r ta n yspecifi c dose, but using the lowest possi-\nble dose may help to reduce side effects(173). In the ADAPTABLE (Aspirin Dosing:A Patient-Centric Trial Assessing Bene fits\nand Long-term Effectiveness) trial of indi-viduals w... | [
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-0.0... |
disease, 38% of whom had diabetes,\nt h e r ew e r en os i g n i ficant differences in\ncardiovascular events or major bleedingbetween individuals assigned to 81 mg\nand those assigned to 325 mg of aspirin\ndaily (174). In the U.S., the most com-mon low-dose tablet is 81 mg. Althoughplatelets from people with diabetes h... | [
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altered function, it is unclear what, if any,\neffect that finding has on the required\ndose of aspirin for cardioprotective ef-fects in people with diabetes. Many alter-\nnate pathways for platelet activation\nexist that are independent of thrombox-ane A\n2and thus are not sensitive to the\neffects of aspirin (175). “A... | [
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0.023034336045384407,
-0.108095683157444,
-0.0323... |
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