"Pharmacological treatment of dyslipidemias with emphasis on statin-ezetimibe combinations - Statistical study of sales of original and generic drugs"

Abstract

Disorders of the metabolism of lipoprotein particles (LDL, chylomicrons, HDL, VLDL) that transport lipids in the body are called dyslipidemias. Familiar hypercholesterolemia (FH) is the most common dyslipidemia in humans. Statins are the drug of choice for regulating hypercholesterolemia. In Greece, the available statins are atorvastatin, simvastatin, rosuvastatin, pravastatin and pitavastatin. Their main mechanism of action is based on their ability to inhibit the enzymatic activity of 3-hydroxy-glutaryl-coenzyme A (HMG-CoA) reductase. Other drugs for the treatment of dyslipidemias include fibrates, niacin, bile acid-binding resins, and ezetimibe. Ezetimibe acts primarily by inhibiting the activity of Niemann-Pick C1-like protein (NPC1L1). (Garcia-Calvo M. et al, 2005) and works synergistically with statins to lower cholesterol, as the former reduces the absorption of cholesterol from the intestine and the latter reduces its endogenous biosynthesis. Newer cholesterol-regulating drugs are the two human monoclonal antibodies, evolocumab and alirocumab, which inhibit PCSK9 protease, dramatically lower LDL-C, and are administered subcutaneously. In addition, a new drug is inclisiran, a long-acting synthetic siRNA targeted against PCSK9.

In the present report, a study was conducted that aims to detect how the market is dynamically evolving in the field of medicine, when a new generic drug enters the market. In March 2020, sales data of 31 drugs were collected from 20 pharmacies in the Municipality of Ioannina for a period of 15 months (1-12-2018 to 28-02-2020). The processing of the data led to the following observations: Regarding the combinations of ezetimibe with atorvastatin and simvastatin, there is a stability in the sales. Since the introduction of a new drug containing the combination of ezetimibe with rosuvastatin, we have seen a steady increase in its sale. Regarding the combination of ezetimibe and simvastatin, it is observed that there is variation in the choice of original or generic drug. Once generics are available on the market there is a clear reduction in sales of the original. Regarding ezetimibe, it seems that there is a balance in the sales of original and generic drugs, with the number of sales of all generic drugs being slightly higher than the sale of the unique original.

VLACHA Dimitra