Microsoft word - newsletter_statins_engl.doc

newsletter
Statins
The first patents for some of the group of drugs known as statins (cholesterol-
lowering drugs) will shortly be expiring. This will set a market segment in motion
that is important both from an economic and insurance perspective.
Avoidable causes High cholesterol ranks number seven
of death;
on the list of avoidable causes of death (see table). 4. Tobacco therapies
The market segment for cholesterol-lowering generating
drugs is predictably large. In 2002, worldwide largest revenues sales of cholesterol- and lipid-lowering
* The review tracks actual sales of approximately 90% of all prescription drugs and some over- the-counter products in more than 80 countries. Reference: IMS Health Report, 2002 Cholesterol-
There are currently two ways of treating a high cholesterol level: by improving lowering; statins one’s diet or by undergoing medical treatment with cholesterol synthesis
inhibitors (CSE inhibitors, statins), nicotinic acid or ion exchangers. In the case of medical treatment, statins constitute the most important group of drugs. The first active substance (lovastatin) was brought onto the market in 1989. In 2002 sales of atorvastatin (Pfizer; USD 8.6 billion) and simvastatin (Merck; USD 6.2 billion) were larger than for any other prescription drug worldwide (see overview 2002 [US $billion]
3. Omeprazole (Losec®/Prilosec®) AstraZeneca Anti-ulcerant Mode of action
Statins are specific inhibitors of the key enzyme in cholesterol biosynthesis (HMG-CoA reductase). The inhibition of this enzyme reduces the level of cholesterol synthesis taking place in the cells, particularly liver cells. This, in turn, results in more low-density lipoprotein-bound cholesterol (LDL or “bad“ cholesterol) being absorbed into the cell from the blood, thereby reducing the amount of LDL cholesterol by 30-40%. This significantly reduces the likelihood of a patient succumbing to a vascular wall disorder and suffering resulting health impairments such as heart attack or stroke. A projection of the results of various studies revealed that treating risk patients with statins could prevent approximately 9,000 deaths in Germany every year. Side effects:
Ever since the first clinical studies were carried out in the early 1980s, the rhabdomyolysis
medical profession has been aware that statins may, in rare instances, lead to rhabdomyolysis, causing striated muscle fibres in the body to disintegrate. The catabolites from this process may cause damage to the kidneys and other organs. Kidney failure, in particular, may result in death. This risk may be amplified in cases where patients consume a combined dose of statins and fibrates (lipid-lowering medication). As a higher occurrence rate of this disease was observed in patients taking cerivastatin (Lipobay®, Baycol®, Zenas®) – usually in larger doses or in combination with the fibrate gemfibrocil – than in those being treated with other statins, this active substance was voluntarily withdrawn from the market in August 2001. Patent expiry:
In 2003 the patents for simvastatin and lovastatin will expire in May and June simvastatin,
respectively. This means that two active substances, which are highly attractive lovastatin
from a commercial point of view, are shortly to become available generically. Hexal and Betapharma will be the first companies to launch products using simvastatin preparations (brand names: Simvahexal® or Simvabeta®) under licence agreements. Others will enter the market once the patents have expired.
Reference: Arznei-telegramm 2003, Jg. 34, Nr.3 Simvastatin is one of the statins that has been researched the most comprehensively. Its effectiveness as a drug was established in the important “4S-Study“ (Scandinavian Simvastatin Survival Study) involving 4,444 patients who had already suffered a heart attack or were suffering from a coronary disease. The study, which was conducted over a period of five years, indicated a reduction in risk (number of deaths) from 11.5 % to 8.2 %. Subsequent studies on this or similar statins – including some that were carried out on patients that demonstrated high levels of fatty substances in their blood but had no record of heart disease – produced comparable risk reductions. Rosuvastatin
Rosuvastatin (Crestor®), also referred to as a “superstatin“, is a new product, the (Crestor®)
effects of which are alleged be positive both for patients and doctors. To date, the clinical development programme for Crestor® includes more than 15,000 patients that have taken part in a series of comparative studies. Crestor® has proven to be more effective than other previously prescribed statins (ator- vastatin, simvastatin and pravastatin) as a means of lowering the LDL cholesterol level in the blood. Furthermore, dose adjustments are required less frequently. The manufacturers (Astra Zeneca) admit, however, that the total incidence and severity of clinically relevant, undesired side effects resulting from rosuvastatin is comparable to that of other statins currently available. The Food and Drug Administration (FDA) has delayed issuing an approval to market the drug in the US and is demanding more data: it has expressed safety concerns, notably in connection with the health effects of large doses. Rosuvastatin is currently approved for sale in Canada and Holland. Conclusions
The patents for the statins simvastatin and lovastatin are due to expire in the near future, making them available as generic drugs. In the case of simvastatin, this means that a blockbuster drug will become available generically. Rosuvastatin, promoted as a “superstatin”, is a new active substance in this group. It is authorised for sale in Canada and Holland and is likely to be approved Information for
Generally speaking, insurers should treat statins critically. This is of particular the underwriter
importance in the case of the commonly prescribed combined dose treatments involving fibrates, as the withdrawal of cerivastatin (Baycol®, Lipobay®) from the In the near future several companies will be bringing products that contain simvastatin or lovastatin onto the market. This increases the accumulation risk for the insurer, as a larger number of products and companies will be impacted In the case of “rosuvastatin“ we have not yet had sufficient experience to determine the risk accurately. If the drug is approved for sale in other countries and new studies become available, we should re-evaluate our position with Postfach 1211 85766 Unterföhring bei München Telefax + 49 89 3844-1586 info@asstech.com

Source: http://www.asstech.com/en/downloads/Newsletter_statins_engl.pdf