Lipitor
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Lipitor is a statin produced by Pfizer that was discovered in 1985 and released in 2000. Its primary function is to control cholesterol levels. When Lipitor loses its patent protection this year, its price is expected to fall by 15% on average, resulting in increased competition from generic versions and lower sales for Pfizer.
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This study evaluated C-reactive protein (CRP) levels before and during treatment with atorvastatin as a predictor of cardiovascular benefit in patients from the ASCOT trial. Baseline CRP levels were significantly higher in cases who experienced a cardiovascular event compared to controls. Adding baseline CRP to risk prediction models modestly improved discrimination beyond traditional risk factors. Treatment with atorvastatin significantly reduced both LDL-cholesterol and CRP levels independently of baseline risk factors. The cardiovascular benefit of atorvastatin did not differ significantly according to baseline CRP levels.
Vioxx Clinical Studies
This document summarizes key points about medical literature and clinical studies regarding the drug Vioxx:
1) Medical studies and literature published after harm is done to patients may be relevant to determining general or specific causation but not a manufacturer's fault.
2) There should be reasonable skepticism when evaluating validity of published drug studies due to influence of pharmaceutical industry on medical journals.
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Pravastatina
La pravastatina es un inhibidor de la HMG-CoA reductasa que se absorbe rápidamente y experimenta un importante efecto de primer paso hepático. Se metaboliza principalmente en el hígado y se excreta en un 20% por orina y un 70% por heces. Sus principales indicaciones son la hipercolesterolemia y la prevención de eventos cardiovasculares.
Atorvastatin: Statins in CVD management. Is just lipid lowering enough
This document discusses the benefits of statin drugs beyond their lipid-lowering effects. It summarizes several key studies that show statins reduce cardiovascular events in patients with diabetes or chronic kidney disease, even when baseline lipid levels are normal. The document highlights that atorvastatin and simvastatin have evidence from primary prevention trials of reducing cardiovascular outcomes in diabetes, whereas other statins do not. It also notes that atorvastatin seems to have greater renoprotective effects compared to rosuvastatin in diabetes patients with kidney disease and proteinuria.
Vioxx powerpt
Merck failed to properly communicate health risks of its drug Vioxx before and after recall. Studies in 2000 showed increased heart attack risks but Merck downplayed this. In 2004, a trial showed double heart attack risk with long term use, leading to recall. Merck's communication was ineffective - doctors learned from patients and hotlines were jammed. While Merck withdrew the drug swiftly, it did not express regret or prioritize health communication over legal and financial concerns. This case shows the challenges of balancing priorities during a drug recall crisis.
16.hypolipidemics
Statins like simvastatin and atorvastatin work by inhibiting HMG-CoA reductase and lowering cholesterol production in the liver. Bile acid sequestrants such as cholestyramine and colestipol bind bile acids in the gut. Ezetimibe decreases intestinal cholesterol absorption while statins lower endogenous production. Niacin can cause flushing and other side effects. Fibric acid derivatives like gemfibrozil and fenofibrate lower triglycerides and raise HDL levels but have potential side effects as well. Together, these classes of hypolipidemic drugs act through different mechanisms to lower cholesterol and lipid levels.
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Analysis of Global Atorvastatin Calcium Production, Supply, Sales and Market ...
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Atorvastatin: Statins in CVD management. Is just lipid lowering enough
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Lipitor is the trade name for atorvastatin, a statin drug produced by Pfizer used to lower cholesterol. It works by inhibiting the enzyme HMG-CoA reductase in the liver to reduce cholesterol production. Lipitor was discovered in 1985 by Bruce Roth while working at Warner-Lambert and became the best-selling drug of all time after its launch, generating $12.4 billion in global sales in 2008. It faces competition from generic versions after losing patent protection in 2012. Lipitor is regulated by the FDA and underwent various stages of development and clinical trials before being approved.
Marketing Mix, PLC, SWOT Analysis - LIPITOR
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Global vitamins market
The global vitamins and minerals market was valued at $24 billion in 2010 and is forecast to grow to $30 billion by 2015. The US is the largest market at $11 billion, followed by Japan at $8 billion. China and Brazil are emerging markets that will see high single-digit growth. Mature markets like the UK will see modest 2% growth. Multivitamins dominate many markets but single vitamins for specific health uses are growing in popularity. Regulatory trends and aging populations in developed nations will be key drivers of future market opportunities.
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Lipitor
- 1. What is Lipitor? • Lipitor is a statin produced by Pfizer • Its generic name is atorvastatin calcium – Lipitor is the proprietary name • It’s primary function is cholesterol control • It was discovered by Bruce Roth in 1985 (Warner Lambert) but not released for another 15 years! (Year 2000)
- 2. Manufacturing & Marketing Companies & Competitors • Pfizer are Lipitor’s primary producers • Ranbaxy intend to sell Lipitor as a generic when it loses its patent • Ranbaxy currently sell Lipitor in India under the brand name Atarvadel • Lipitor’s man competitor is Crestor which is produced by Astra Zeneca (AZ) • Crestor is different from Lipitor in that it is a generic rosuvastatin and also contains sulphur
- 3. Product Details (Mode of Action) Lipitor regulates the body’s cholesterol requirements It travels via the gastrointestinal route (human digestive system) It is administered orally It reduces the risk of cardiovascular diseases (strokes and heart attacks)
- 4. Manufacturing & Pakcaging Processes • Atorvastatin Calcium (white powder) – active pharmaceutical ingredient (API) in Lipitor • It initially goes through the delumping milling process • It is then mixed with its excipients (inactive ingredients) and the next phase of the process is wet granulation • The finished tablets are then dispensed into 20 kg drums and dispatched to an off- site packaging contractor • Once the tablets have been received at the packaging facility they are either placed in blister packs of 28 tablets or plastic bottles containing 90 tablets
- 5. Media Coverage • “The Irish Times” edition of September 1st 2011 featured an article entitled “Sanofi plans generic cholesterol drug” • Sanofi saw generics as a growth sector because a lot of their own products were losing their patents • This is Sanofi’s initiative with regard to keeping employment in France • The French government gave Pfizer a tax break • The French corporate tax rate is 33.33% - 20.83% higher than the Irish rate of 12.5%!
- 6. How is Lipitor Regulated? • Lipitor is regulated by the US FDA’s CEDR and the IMB • Pfizer were served with a warning letter regarding an over emphasis on efficacy claims in July 2001 • Lipitor had a recall in October 2010 due to an uncharacteristic odour in specific bottles of 40 mg Lipitor • Lipitor has been subject to counterfeiting • Counterfeit Lipitor has higher proportions of excipients than API’s • Pfizer’s Global Security seized 8.4 million counterfeit Pfizer products in 53 countries • Pfizer works very closely with law enforcement agencies in the war against healthcare criminals
- 7. Loss of Patent & Consequences • Lipitor is set to lose its patent protection this year • This will see Lipitor's price fall by an average of 15% • The cost of Lipitor will be on a par with other generics and this will result in increased competition between Lipitor and its competitors • As it is not unusual for generic drugs to be cheaper than innovator drugs (those protected by patents) this will have a big impact on Pfizer and Lipitor’s sales