The American journal of medicine
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In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.
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In 2018, cardiovascular society cholesterol guidelines recommended the use of coronary artery calcium to guide statin therapy in patients 40-79 years of age who are at intermediate risk by multiple risk factor equations (ie, estimated 10-year risk for atherosclerotic disease of 7.5%-19.9% but in whom statin benefit is uncertain). Many such patients have no coronary calcium and remain at <5% risk over the next decade; hence, statin therapy can be delayed until a repeat calcium scan is conducted. Exceptions include patients with severe hypercholesterolemia, diabetes, and a strong family history of atherosclerotic disease. ⋯ If coronary calcium equals 100-299 Agatston units, the patient is clearly statin eligible (7.5% to <20% 10-year risk). And finally, if coronary calcium is ≥300 Agatston units, a patient is at high risk and is a candidate for high-intensity statins. Risk factor analysis combined judiciously with coronary calcium scanning offers the strongest evidence-based approach to use of statins in primary prevention.