Dyslipidemia
Lipid-metabolism disorder with elevated LDL-C, total cholesterol, or triglycerides and/or low HDL-C. The leading modifiable risk factor for atherosclerosis. Per ESC/EAS 2019 and SEA 2023, LDL-C goals depend on ASCVD risk: <55 mg/dL very high, <70 mg/dL high, <100 mg/dL moderate. Treatment starts with statins; add ezetimibe, bempedoic acid, PCSK9 inhibitors, or inclisiran when response is insufficient.
ICD-10 E7812 drugs
Also known as: Hypercholesterolemia, Hyperlipidemia, Mixed dyslipidemia
Drugs used for this condition
- AAtorvastatin + EzetimibeSecond line · Fixed-dose combination: statin plus intestinal cholesterol absorption inhibitorPrimary hypercholesterolemia and mixed dyslipidemia in patients not reaching LDL-C goal on the maximum tolerated dose of atorvastatin. Per ESC/EAS 2019 and SEA 2023, post-MI or post-stroke LDL-C goal is <55 mg/dL; very high ASCVD risk also <55 mg/dL; high risk <70 mg/dL. Dose: 10/10, 20/10, 40/10, 80/10 mg once daily in the evening (cholesterol synthesis peaks at night). Effect at 4–6 weeks; lipid check at 6–8 weeks and every 6–12 months thereafter.
- AFluvastatinSecond line · Statin (HMG-CoA reductase inhibitor)Primary hypercholesterolemia and mixed dyslipidemia in patients intolerant of more potent statins (myopathy on atorvastatin or simvastatin) or needing to minimize CYP3A4 drug interactions. Per ESC/EAS 2019 and SEA 2023 – second-line. Dose: 20–80 mg once daily in the evening (XL form) or 40 mg twice daily. Full effect at 4 weeks. In transplant recipients (especially renal), fluvastatin is often chosen due to minimal interaction with tacrolimus and cyclosporine.
- ALovastatinThird line · HMG-CoA reductase inhibitor (statin)First-generation statin for LDL reduction. SEC and AEMPS prefer atorvastatin or rosuvastatin for greater efficacy and fewer CYP3A4 interactions. Lovastatin remains an option for patients intolerant to newer statins.
- ARosuvastatin + EzetimibeSecond line · Fixed-dose combination: statin plus intestinal cholesterol absorption inhibitorPrimary hypercholesterolemia and mixed dyslipidemia when LDL-C goal is not met on the maximum tolerated rosuvastatin dose. Per ESC/EAS 2019 and SEA 2023 – second-line. Dose: 5/10, 10/10, 20/10, 40/10 mg once daily anytime (rosuvastatin T½ 19 h). Full effect at 4 weeks. More effective than atorvastatin for the aggressive <55 mg/dL LDL-C goal.
- ASimvastatin + EzetimibeSecond line · Fixed-dose combination: statin plus intestinal cholesterol absorption inhibitorPrimary hypercholesterolemia and mixed dyslipidemia when LDL-C goal is not met on the maximum tolerated simvastatin dose. Per ESC/EAS 2019 and SEA 2023 – second-line. Dose: 10/10, 10/20, 10/40 mg once daily in the evening. 80 mg simvastatin is not recommended due to rhabdomyolysis (FDA Safety Communication 2011). If 10/40 fails, switch to atorvastatin + ezetimibe or rosuvastatin + ezetimibe.
- CGemfibrozilThird line · Lipid-lowering agent of the fibrate classFor mixed dyslipidemia, where low HDL comes together with elevated LDL and triglycerides, the FDA label permits gemfibrozil to reduce coronary heart disease risk. That entry rests on the Helsinki Heart Study (N Engl J Med 1987): over five years, middle-aged men without coronary disease had 34 percent fewer coronary events. The label sets strict conditions: only in people without established coronary disease, and only after weight loss, diet, exercise and other drugs have failed. The picture has shifted over the decades. Statins became first line for this lipid profile, and the 2019 ESC/EAS guidelines leave fibrates the role of an add-on for residual hypertriglyceridemia. Combination with simvastatin is prohibited and rosuvastatin is capped at 10 mg daily when given together: gemfibrozil blocks the OATP1B1 transporter, statin concentrations rise and rhabdomyolysis risk rises with them.
- COmega-9 monounsaturated fatty acid (oleic acid)Case-by-case decision · Monounsaturated fatty acidsOleic acid lowers LDL cholesterol as part of the diet, not as a capsule. In the 2018 PREDIMED trial, a Mediterranean diet with extra-virgin olive oil (50 g/day) cut major cardiovascular events by 30 % compared with a standard diet in high-risk patients. The AHA Presidential Advisory 2017 recommends replacing saturated fat with monounsaturated and polyunsaturated fats. Omega-9 capsules do not reproduce the diet effect and have no place in international dyslipidaemia guidelines – statins and olive oil in the kitchen do the work, not the supplement.
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
- CBlack seed (Nigella sativa)Not recommended · Botanical supplement, black seed oil (Nigella sativa, thymoquinone); no EMA HMPC monographThe Razmpoosh meta-analysis (Phytother Res 2019) pooled 17 RCTs with 1098 participants: at 1–3 g/day of oil or powder for 6–12 weeks in patients with dyslipidaemia, black seed reduced total cholesterol by a mean 0.4 mmol/L, LDL by 0.3 mmol/L and triglycerides by 0.2 mmol/L versus placebo. The effect is smaller than with statins, methodology heterogeneous and risk of bias high. ESC/EAS 2019 and Spanish SEA 2022 recommend statins as first line in confirmed cardiovascular risk. Black seed is not in international guidelines. If the oil was bought instead of a prescribed statin, discuss with a cardiologist; substitution in proven coronary disease raises the recurrent-infarct risk.
- CSpirulinaNot recommended · Cyanobacterium (Arthrospira platensis / maxima), supplement, plant protein source, marketed as «detox» and «superfood»Spirulina is an over-the-counter supplement. The Huang meta-analysis (J Clin Lipidol 2018) pooled 12 RCTs with 887 participants: at 1–10 g/day for 2–12 months in patients with dyslipidaemia, spirulina lowered total cholesterol by a mean 0.8 mmol/L and LDL by 0.5 mmol/L versus placebo. The effect is smaller than with statins, methodology heterogeneous and risk of bias high. ESC/EAS 2019 and Spanish SEA 2022 standards recommend statins as first line in confirmed cardiovascular risk plus lifestyle change (Mediterranean diet, physical activity, smoking cessation). Spirulina is not in international or Spanish guidelines. If spirulina was bought instead of a prescribed statin, discuss with a cardiologist; stopping a statin in confirmed coronary disease multiplies the heart-attack risk.
- DAged garlic extract (AGE, Kyolic)Not recommended · Supplement of Allium sativum extract aged for 20 months and standardised to S-allylcysteine (SAC); sold under the Kyolic brand; not registered as a medicine by AEMPSAged garlic is sold as a «natural statin substitute» for cholesterol reduction. The Ried 2013 Nutrition Reviews meta-analysis showed a weak total cholesterol reduction of about 8 mg/dL in hypercholesterolaemic subjects, without a meaningful effect on LDL or HDL. The effect is clinically marginal: statins reduce LDL by 30–50% in primary and secondary prevention and demonstrably reduce cardiovascular events. EMA EPAR and AEMPS have not registered aged garlic for dyslipidaemia. When a statin is offered based on SCORE2 risk, swapping it for garlic is neither equivalent nor justified. Discuss standard lipid-lowering therapy with a general practitioner or cardiologist.
- DGlucomannan (Amorphophallus konjac)Not recommended · Water-soluble dietary fibre from konjac root (Amorphophallus konjac); the only weight-loss supplement with an EFSA-approved health claim under Regulation 432/2012Glucomannan marketing often pushes «cholesterol and blood sugar» claims. EFSA explicitly rejected the broader health claim in 2009 – only the weight-loss indication is approved. Meta-analyses in hypercholesterolaemia show a weak reduction in total and LDL cholesterol of about 10–15 mg/dL, far less than statins and fibrates. ESC and SEC treat dyslipidaemia with lifestyle change and statins as indicated, not supplements. Raised cholesterol or LDL on the lipid panel requires in-person evaluation and risk stratification with SCORE2, not a pharmacy glucomannan course.
- DNicotinic acid (niacin)Not recommended · Lipid-modifying agent, nicotinic acid derivative; vitamin B3 in acid formNiacin is a potent lipid-modifying agent used for decades in dyslipidaemia. The AIM-HIGH trial (NEJM 2011) and HPS2-THRIVE (NEJM 2014) showed that adding niacin to statin therapy in patients with controlled LDL does not reduce cardiovascular mortality or myocardial infarction while doubling the risk of serious adverse effects – diabetes, myopathy, GI bleeding, infections. EMA withdrew Tredaptive (niacin plus laropiprant) from the European market in January 2013. ESC/EAS 2019 and SEA 2023 do not recommend niacin on top of statins. If niacin was prescribed for cholesterol, consider seeking a second opinion: statins and PCSK9 inhibitors have proven benefit.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit