Prescription drugs statins

G Patients requiring cholesterol-lowering drugs Prescription drug One or more statin drugs Manufactured capsule Ingestion... 

Tone, Andrea, and Elizabeth Watkins, eds. Medicating Modem America Prescription Drugs in History. New York NYU Press, 2007. This history of medicine in America covers eight of the most influential and important drugs antibiotics, mood stabilizers, hormone replacement therapy, oral contraceptives, tranquilizers, stimulants, statins, and Viagra. Each chapter describes how the drugs become such an essential part of medical care and change the way Americans think about disease. 

An example that can provide hope to those who labor to come up with a new drug for an established target is that of Lipitor (atorvastatin. Figure 5.2). Currently the 1 prescription drug sold anywhere, with over 13 billion in annual worldwide sales," it was the fifth statin to be approved by the FDA, making it to market nine years after the first-in-class compound, Mevacor (lovastatin. Figure 5.2). At least one major study has demonstrated improved... 

The formation of mevalonate is the rate-limiting step in cholesterol biosynthesis. Drugs that inhibit HMG-CoA reductase are termed statins and are one of the most widely used types of prescription drugs. All statins share a structural component that is similar to the 3-hydroxy-3-methylglutaryl portion of HMG-CoA reductase. AH statins differ from HMG-CoA in being more bulky and more hydrophobic [10]. Statins occupy the binding site of HMG-CoA thus blocking access of this substrate [11]. All statins share this common mode of action but differ in their overall structural, biochemical, thermodynamic, and pharmokinetic properties which influences their efficacy [12]. 

Garlic s proven mechanisms of action include (a) inhibition of platelet function, (b) increased levels of two antioxidant enzymes, catalase and glutathione peroxidase, and (c) inhibition of thiol enzymes such as coenzyme A and HMG coenzyme A reductase. Garlic s anti-hyperlipidemic effects are believed to be in part due to the HMG coenzyme A reductase inhibition since prescription medications for hyperlipidemia have that mechanism of action (statins). It is unknown whether garlic would have the same drug interactions, side effects, and need for precautions as the statins. 

Calfee, Winston, and Stempski (2002), using national U.S. monthly data on retail prescriptions, as well as for cholesterol-reducing drugs, in 1995-2000, found little if any impact from DTCA on the pattern of statin... 

Rhabdomyolysis is a problem with several lipid-lowering drugs (SEDA-13, 1325 SEDA-13, 1328 SEDA-13, 1330 SEDA-19, 409), especially when they are used in combination (37). In individuals with pre-existing renal insufficiency this can lead to an earlier need for chronic dialysis (38). All statins can cause myopathy and rhabdomyolysis, but not all statins are alike. For example, the evidence to date, based on almost 2 decades of experience, points to an extremely low risk of myopathy and rhabdomyolysis with lovastatin, and lovastatin 20 mg tablets are being considered for non-prescription availability in several countries (39). Furthermore, muscle adverse effects do not necessarily occur after a change from one statin to another (40). Interactions between various hypolipidemic drugs and other drugs also sometimes cause rhabdomyolysis (SEDA-18, 426). For instance, itraconazole markedly increases plasma concentrations of lovastatin, and in one subject plasma creatine kinase was increased 10-fold within 24 hours of administration of this combination (41). 

The cost of prescriptions has risen dramatically in the last several decades. The average price for a single prescription in the USA in 2003 was more than 50.00. This rise is occasioned by new technology, marketing costs, and stockholder expectations. The pharmaceutical industry typically posts double-digit profits annually while the retail business sector shows a 3% profit. The cost to the patient for many new drugs like "statins" exceeds 1000 per year. Pharmaceuticals are the highest out-of-pocket health-related cost for the health sector because many other health care services are covered by health insurance whereas prescriptions are often not. 

Today HMG-CoA reductase inhibitors (statins) account for the large majority of prescriptions for lipid-lowering drugs in most countries. As discussed in a subsequent section of this chapter, the widespread acceptance of this drug class is due not only to excellent efficacy and tolerability but also to the publication of several very large intervention trials, which have unequivocally demonstrated the effectiveness of the first three members of the class—lovastatin, simvastatin, and pravastatin—in reducing coronary morbidity and mortality. 

But David W. Anstice, Merck s head of human health for the Americas, probably was closer to his company s true feelings when he described the potential market for Zocor and Zetia at the company s annual meeting for Wall Street analysts in December 2001. As he put it, If you look at patients not yet treated with statins [the cholesterol drugs like Zocor]—they may be in dietary or exercise regiments— there are 24 million in the United States alone. In other words, diet and exercise is all well and good, but sooner or later those 24 million will be ripe for a prescription. 

There is controversy about whether or not drugs are more likely to cause hepatotoxicity in patients with liver disease. There is little evidence that statins worsen pre-existing liver disease and hepatocellular damage is very rare, particularly given the high number of prescriptions written worldwide for these drugs [37, 38]. The SPCs... 

Policosanol was first researched by doctors in Cuba. It is derived from the waxy outer coating of sugarcane, which is grown extensively in that country. Studies showed its effectiveness to be equal to that of low doses of prescription statin drugs. Very little research, however, has been done outside of Cuba, and results of that research have never been published in any major medical journal. The death knell for policosanol was sounded with the publication of a report in the May 17, 2006, issue of the Journal of the American Medical Association. German researchers did what is termed an elegant study that was conducted at multiple medical centers, was double-blind and placebo controlled, and used exactly the dosage... 

---