506-204-1 LIPITOR: HOW FAR SHOULD PFIZER PUSH THE PILL? Fernando, R Purkayastha, D ICFAI Center for Management Research The case is about Pfizer's blockbuster anti-cholesterol reducing drug, Lipitor, the largest selling pharmaceutical brand in the world. Despite Lipitor being a late entrant in the statin market, it managed to become the market leader due to the aggressive marketing strategy adopted by Pfizer. However, Pfizer's marketing of Lipitor came under intense scrutiny, when in March 2006 some labour unions in the US sued Pfizer for alleged off-label marketing of Lipitor. Pfizer also faced a class action lawsuit from some consumer advocacy groups regarding its promotional activities that were targeted at women and the elderly. Pfizer was also accused of withholding information about the potential side-effects of Lipitor. Lipitor was also the subject of controversy regarding its allegedly overzealous direct-to-consumer advertising. In addition to this, the case also discusses the concerns regarding the slowing down of Lipitor sales, the delay in launch of the Torcetrapib Lipitor combination, the ongoing patent litigations with generic manufacturers like Ranbaxy Laboratories Ltd over Lipitor, and the expected generic competition from substitutes like Pravach9l and Zocor, which had gone off-patent. The case will help the students to: 1 ; understand the nature of the global market for statin drugs and the major players; 2 ; understand the issues and concerns with regard to Pfizer's marketing of Lipitor; and 3 ; understand the legal and business challenges faced by research based global pharmaceutical companies. The case is meant for MBA MS students as part of the marketing management product management curriculum. The teaching note includes the abstract, teaching objectives and methodology, questions for discussion and analysis, case feedback, and additional readings and references. USA, Europe; Pharmaceuticals; Large; 1995-2006 Pfizer Lipitor Atorvastatin ; Direct-to-consumer DTC ; advertising Class action lawsuit Off-label marketing Patent litigation.
Q. My mother started taking Lipitor for high cholesterol almost two years ago at age 73. Since that time, her life has changed in many ways. She used to play golf twice a week, and now she has not played in a year. She worked in her yard every day then and rarely does so now. She has always been a sociable and cheerful person, even though many of her friends have passed away. Last week she told me that she wished she could die because of the pain she is in. She often wakes up in the middle of the night in so much pain she cannot go back to sleep. Her doctor says her pain is due to arthritis. She is convinced it has something to do with Lipitor. Is she right? A. The doctor might be correct that your mothers pain is coincindental to her using Lipitor. But cholesterol-lowering drugs such as Baycol, Lipitor, Zocor and Pravacol have been associated with muscle pain. Another reader wrote with a similar experience and said that the pain stopped after she ceased using Lipitor. Q. I have a severe sweating problems with my underarms and feet. Ive been able to control my underarm sweating with Certain Dri. Its been a godsend! Is it OK use Certain Dri on your feet just as you do on your underarms? I A. You can use Certain Dri on your feet just as you do on your underarms. Its primary ingredient, aluminium chloride, is one of the most effective antiperspirants on the market. This should help control odour, athletes foot and even blisters. Make sure your feet are dry before applying.
PC - thanks for this information. I'm sure the CCF benefited someway from this study and probably has some agreement to push Lipitor. I have no use for statins. I think they are dangerous drugs. My previous experience with earlier versions - Pravacho and Zocor - left me with severe muscle weakness which might even be considered permanent. My MD argued at the time there was no such side effect. When was told I could be placed on Lipitor, I addressed all my concerns with Dr. Natale's group about this and was given it anyway. one size fits all medicine ; . Well, sure enough, in about 3 days after the first dose, my legs were so weak and painful, I could hardly move around. By the end of a week, I called Michelle of the CCF to report in. She said cut the dose in half. The half dose did nothing to help the weakness and pain. Before ablation, I inquired if they recommended supplementing with CoQ10 because of the depletion factor answer was that they did not advise to take or not to take CoQ10. So, while I was pleased to have the expertise of Dr. Natale, I'm a disconcerted because of an apparent lack of concern for me as a patient who apparently can't metabolize Lipitor and also because they fail to recognize the importance of CoQ10. Previous to ablation, I had used policosanol for six months. PC has none of the side effects such as liver toxicity, muscle destruction or cognitive impairment. I took myself off the Lipitor and continuing with policosanol and stepping up all antioxidant supplements. Since the CCF feels the oxidized LDL is the inflammatory factor at the ablation site, most likely the Lipitor does indeed cut down on the presence of LDL. Liptor is reported to be the strongest and fastest acting statin out there today so it makes sense to use it for this short period and for a targeted purpose. I'm waiting to see my labs to determine if a baseline lipid profile was done before they calculated the dosage for me. I won't be surprised if a baseline was not done. But the point of my post was - might not individuals with high LDL levels be more prone to have afib as a result of the inflammatory effect of the oxidized HDL?.
A ACCU-CHEK BLOOD GLUCOSE METER ACCU-CHEK TEST STRIPS ACCUNEB ACIPHEX ACTIVELLA ACTOS ACULAR ADVAIR AGENERASE AGRYLIN ALINIA ALLEGRA ALLEGRA-D ALPHAGAN P ALTACE AMARYL AMBIEN ANDROGEL ARICEPT ARIMIDEX AROMASIN ASACOL ASCENSIA TEST STRIPS ASTELIN ATROVENT AVALIDE AVANDAMET AVANDIA AVAPRO AVONEX AZMACORT B BD TEST STRIPS BENICAR BENICAR HCT BETASERON BRAVELLE C CAFERGOT CANASA CARAC CARDIZEM LA CASODEX CEENU CELEBREX CELLCEPT CENESTIN CETROTIDE CIPRODEX CLIMARA CLIMARA PRO COMBIVENT COMBIVIR COMTAN CONCERTA CONDYLOX GEL COPAXONE COPEGUS COREG CORTEF CORTIFOAM COZAAR CREON CRIXIVAN CUPRIMINE CYTOXAN D DAPSONE DEPAKOTE DEPAKOTE ER DEPAKOTE SPRINKLE DETROL DILANTIN DIPENTUM DOSTINEX DOVONEX DUONEB DURAGESIC E EFFEXOR EFFEXOR XR EFUDEX CREAM ELMIRON EMCYT ENTOCORT EC EPINEPHRINE INJECTION EPIVIR EPIVIR-HBV EPZICOM ERGAMISOL ESTRADERM ESTRATEST ESTRATEST HS ETHMOZINE EVISTA EVOXAC EXELON F FARESTON FEMARA FINACEA FLOMAX FLONASE FLOVENT FLOVENT ROTADISK FLOXIN OTIC FORADIL AEROLIZER FORTOVASE FOSAMAX FREESTYLE TEST STRIPS FULVICIN P G FULVICIN U F G GLEEVEC GLUCAGON GLUCO-DEX TEST STRIPS GLUCOSTIX TEST STRIPS H HELIDAC HEPSERA HEXALEN HIVID HYZAAR I IMITREX, all forms INNOPRAN XL INTAL INHALER INTRON A INVIRASE K KALETRA, capsule and solution KEPPRA KYTRIL L LAMICTAL LAMISIL LESCOL LESCOL XL LEUKERAN LEVAQUIN LEVBID LEXAPRO LEXIVA LIDODERM LIPITOR LOPROX TOPICAL CREAM AND GEL LOTEMAX LOVENOX LUMIGAN LYSODREN M MALARONE MAXALT MEPHYTON METADATE CD METADATE ER METHERGINE METROGEL VAGINAL MIACALCIN MIGRANAL MIRAPEX MYLERAN MYLOCEL N NAMENDA NARDIL NASONEX NEUPOGEN NIASPAN NILANDRON NORITATE to be deleted, effective July 31, 2005 ; NORVASC NORVIR NOVOLIN NOVOLOG NOVOLOG MIX 70 30 NUTROPIN NUTROPIN AQ NUTROPIN DEPOT NUVARING O ONE TOUCH GLUCOMETER ONE TOUCH TEST STRIP ORTHO EVRA ORTHO TRI-CYCLEN LO OVIDE OXSORALEN ULTRA OXYCONTIN OXYTROL P PARNATE PEGASYS PEG-INTRON PHOSLO PLAN B PLAVIX PRANDIN PRAVACHOL to be deleted, effective July 31, 2005; alternative is LIPITOR ; * PRECOSE PRED MILD PREDNISONE 1mg PREMARIN PREMARIN CREAM PREMPHASE PREMPRO PREVEN PROCTOFOAM HC PROGRAF PROSCAR PRO VIGIL PULMICORT RESPULES PULMICORT TURBUHALER PULMOZYME Q QUIXIN QVAR R RAPAMUNE REBETRON REBIF REMINYL RENAGEL REQUIP RESCRIPTOR RESTASIS RESTORIL--7.5 mg DOSE ONLY RETIN-A MICRO RETROVIR RHINOCORT AQUA RIDAURA RISPERDAL S SAIZEN SEREVENT SEREVENT DISKUS SEROQUEL SINGULAIR SONATA SPIRIVA.
Mucositis, gastritis : inflammation of the mucous membrane, especially that of the stomach.
I a wave in the ocean with every breeze i rise and fall i a snow drop swirling wildly every breeze throws me around must i forever be the ocean or a snow drop tossed around why must i be a wave dear lord or a snow drop in a storm hare rama hare krishna sathya sai bhagawan o my lord dear jesus buddha nanak dear thuhan let me forever be the ocean let no wind throw me around 2 ; peace within is my goal lord never throw me up or down and in the end when i leave lord let you and i merge as one hare rama hare krishna and procardia.
About WelChol WelChol is indicated for LDL-C lowering and was approved by the U.S. Food and Drug Administration FDA ; for marketing in May 2000. WelChol is the top-selling branded drug in the bile acid sequestrants BAS ; class. WelChol is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, WelChol is not expected to have drug-drug interactions via the cytochrome P-450 pathway. Systemic medications, which include statins, fibrates, and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and or kidneys. WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia Fredrickson Type IIa ; when the response to diet and exercise has been inadequate. Liver-function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone. In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15% to 18%. When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% 32 mg dL ; reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin. WelChol is engineered for affinity, specificity and high capacity bile acid binding. It has been studied with four commonly prescribed statins Lipitor atorvastatin calcium ; , Zocor simvastatin ; , Prafachol pravastatin sodium ; and Mevacor lovastatin ; . Additionally, WelChol has been studied with fenofibrate and had no significant effect on the bioavailability of fenofibrate. Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol. WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side.
Collection of Data We obtained industrywide annual data on the promotion and sales of prescription drugs for the years 1994 through 2000. Data on spending on direct-to-consumer advertising were obtained from IMS Health and Competitive Media Reporting. IMS Health is an independent consulting company that provides data and analysis to the pharmaceutical industry, researchers, the FDA, and numerous state and federal agencies. Competitive Media Reporting tracks local and national advertising campaigns in major media such as television and radio. Advertisements that promote specific products and those that focus on diseases or symptoms without naming a product are both included in the estimates of spending on direct-to-consumer advertising. Competitive Media Reporting does not track Internet advertising or statements of program sponsorship such as those that appear on public television. Other published reports indicate that the expenditures on these types of advertising represent a small portion of total expenditures for direct-toconsumer advertising.5 Industrywide data on promotion to health care professionals were collected from IMS Health. Four major components of spending on promotion to professionals are reported here: detailing providing information on a product in a face-to-face meeting ; to office-based physicians, detailing to hospital-based physicians, free samples left with physicians, and advertising in professional journals. Because IMS Health does not track spending on meetings and events, this element of promotion to professionals does not appear in our analysis. Other published data indicate that such activities account for 12 to 15 percent of promotional efforts targeted at health care professionals.6 IMS Health estimates spending on detailing on the basis of information provided by a national panel of 6443 office-based physicians and hospital directors of pharmacy who track their contacts with pharmaceutical sales representatives. Data on the retail value of free samples provided by pharmaceutical companies were also obtained from IMS Health, which uses a panel of 1265 members of the front-office staff in medical practices sampled from the practices of the office-based physicians who are on the panel involved in collecting the data on detailing ; to monitor the quan and zestril.
The PREDICT study was conducted from April 14, 1998 to May 28, 1999. The purpose of the study was to advertise the opportunity to take an OTC cholesterol lowering medicine and then to randomize people who responded to simulated OTC and Rx environments prior to any knowledge about their medical conditions to observe their behavior over 6 months. This study was intended to address the following issues: Characterize who is interested in OTC lipid lowering therapy i.e., whether the defined OTC population would, in fact, be the one to utilize this product ; Evaluate whether Pdavachol 10 mg could be used responsibly in an OTC environment Determine whether the safety and efficacy profile that has been demonstrated in the prescription environment would be maintained in an OTC environment.
Antiretroviral therapy HAART ; is increased levels of fatty substances or lipids in the blood. Examples of the lipid changes that can occur in HAART users include the following: increased levels of triglycerides increased levels of cholesterol increased levels of LDL bad cholesterol ; decreased levels of HDL high-density lipoprotein good cholesterol ; These lipid changes increase the risk of cardiovascular disease in HAART users. To decrease this risk, doctors may encourage people with HIV AIDS PHAs ; to make changes to their diet and engage in a programme of regular aerobic exercise. If these steps dont work, then lipid-lowering agents commonly called statins can be prescribed. These drugs work by lowering the levels of triglycerides and LDL while raising HDL. Thus statins can greatly reduce, but do not eliminate, the risk of developing cardiovascular disease. Examples of statins include the following: Crestor rosuvastatin ; Lescol fluvastatin ; Lipitor atorvastatin ; NK-104 pitavastatin ; Mevacor lovastatin ; Pravachol pravastatin ; Zocor simvastatin ; These drugs exert their lipid-lowering effect by reducing the bodys ability to produce cholesterol. Unfortunately, Q10 production is also affected by statins. Not surprisingly, the bodys production of Q10 can fall between 25% and 40% with the use of statins. Reduced production of Q10 means that there is less of this important antioxidant to protect cells from free radicals. It is possible that with less Q10 available, there may be an increased risk of developing certain side effects associated with use of statins, including the following and trandate.
Gc although the most likely cause of your increased foot pain is neuropathy related to diabetes, there is a small possibility that pravachol is making it worse.
1. Why does ConnectiCare require prior authorization on certain cholesterol lowering medications? The cholesterol lowering medication Zocor simvastatin ; is available in a generic version. The statins, which lower "bad" cholesterol, are the best selling drug class in the world and the addition of generic alternatives presents a unique cost-saving opportunity for employers, consumers, and insurers. ConnectiCare's philosophy is to encourage the use of generic drug alternatives when available and medically appropriate. 2. Why should I consider switching medications? As consumers of medical care, people are not always aware of the various options which are available. Comparative information on medicine choices may not be easy to find or understand. Also, many people feel uncomfortable asking their doctors about alternatives when he or she is writing your prescription. In today's world of equally effective generic medications, consumers should always be asking their doctor about generic alternatives when their doctor "takes out the pen" to write the prescription. Efficacy, cost and safety are the items to consider when choosing a cholesterol medication. Efficacy: The primary purpose of cholesterol treatment is to reduce your LDL "bad" cholesterol. Simvastatin Zocor ; is a higher potency statin, like Lipitor, and most people will be able to reach their LDL goal with simvastatin Zocor ; For members on Lipitor 10mg or 20mg, simvastatin 20mg or 40mg should meet your LDL goal requirements. Cost: Simvastatin Zocor ; currently takes the lowest copayment, Tier 1. You can save up to 0 per year in out of pocket copayment costs if you are currently using a Tier 3 branded agent such as Liptior. See your benefit summary for your specific copayment amounts and deductible if applicable. ; Safety: Simvastatin Zocor ; and all statins including Crestor and Lipitor are among the most widely prescribed and studied drugs in recent history. If you and your doctor decide to switch medication, your doctor may ask you to have your LDL and liver function tested, which you may already be doing on your current medication. 3. I currently taking Lipitor, Vytorin, Crestor, or Lescol XL. What do I need to do? If you are considering a switch to simvastatin Zocor ; , you need to talk to your doctor. If you and your doctor determine simvastatin Zocor ; is an appropriate choice, he she will write you a prescription to start with your next refill. 4. I not currently on cholesterol medication, but my doctor and I have discussed starting one. What should I do? At your next visit or at the point you and your doctor determines statin treatment is required, remind your doctor that simvastatin Zocor ; , lovastatin Mevacor ; or pravastatin Pravachol ; are the required statins for initial treatment for ConnectiCare members. To obtain Lipitor, Vytorin, Crestor, or Lescol XL your doctor will need to submit a prior authorization request and rationale for use of these drugs. 5. I just went to the pharmacy and my new statin prescription Lipitor, Vytorin, Crestor, etc. ; was rejected. What should I do? Simvastatin, lovastatin or pravastatin are the required statins for members starting on cholesterol treatment. Please contact your doctor and ask him her if one of these would be appropriate for you. To obtain Lipitor, Vytorin, Crestor, Pravachol, or Lescol XL your doctor will need to submit a prior authorization request and rationale for use of these drugs and lasix.
106 commercialization process overseas and medical biotechnology products earn several hundred million dollars annually The Economist, 2003e ; . Many foreign firms could be deterred by the US embargo on the island and put off by the US Helms-Burton act, which could shut them out of US markets for doing business in Cuba. Yet so-called 'receptor-companies', such as Canada's YM Bio-Sciences YMB ; , which both develop and package Cuban products, have been busy agreeing joint-venture licenses with some of Havana's leading biotechnology centres The Economist, 2003e ; These companies take advantage of the quality and low-cost specialized humanpower in Cuba, where the international production, management and regulation practices and norms concerning drugs are strictly followed. Issues on intellectual property protection are also being solved, so as to enable Cuba to penetrate the markets of developed countries. Cuban officials state their country enforces international protocols, such as the World Trade Organization's Trade-Related Aspects of International Property Rights TRIPs ; agreement. The Cuban State does own the intellectual property embodied in the products of the country's biotechnology research institutes or centres. But this, they stress, is little different to the institutional ownership of patents in the USA by bodies such as university regents. The result in both cases can be good, affordable drugs The Economist, 2003e ; . On 16 July 2004, the California Carlsbad ; -based biotechnology company, CancerVax, announced that the US government had authorized it to license three experimental anticancer drugs from Cuba, making an exception to the policy of tightly restricting trade with that country. CancerVax's officials stated that it was the first time an American biotechnology company had obtained permission to license a drug from Cuba. In 1999, SmithKlineBeecham, now known as GlaxoSmithKline, licensed a Cuban vaccine for meningitis B, currently being tested in clinical trials. The three drugs that CancerVax was going to test were first licensed to the Canadian company YM Bio-Sciences, which transferred those rights to CancerVax Pollack, 2004b ; . David Hale, chief executive of CancerVax, stated: 'I think there are other product candidates and technology in Cuba that could be helpful not just to the American people, but people around the world'. CancerVax, a newly public company, did not yet have any drugs on the market. Its melanoma vaccine has been in development by an academic scientist for 40 years and was only currently in the final phase of clinical trials. The lead drug from Havana's Center of Molecular Immunology aimed to thwart epidermal growth factor in cancer cells; it has already been tested in small clinical trials.
By the way thank you for the great info on my question about shears and vasotec.
For orthopedic products have combined to form grouppurchasing organizations to lower costs. Group purchasing organizations negotiate pricing arrangements with medical supply manufacturers and distributors, and these negotiated prices are made available to a group purchasing organization's affiliated hospitals and other members. If the purchasing group does not select a particular vendor, other vendors may not be able to sell products to the purchasing group. Bristol-Myers Squibb is a diversified worldwide health and personal care company that manufactures medicines and other products. The company focuses its efforts on cardiovascular treatments, anti-infective drugs, and cancer-fighting products; cholesterolreduction drug Pravachol is its best-selling drug and cancer treatment Taxol is #2. The Company's products include therapies for various diseases and disorders, consumer medicines, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. Over the last several months, BMY has received disappointing news of its loss of its Taxol patent, of the non-approval of its cancer drug Orzel, and of the delay of its hypertension drug Vanlev. On June 7, BMY agreed to purchase DuPont Pharmaceuticals Company for .8 billion in cash. The deal helps build up BMY's line of AIDS and heart drugs as some of its other products face generic competition. The companies expect to close the sale in the fourth quarter of this year. BMY expects to cut costs at the unit and use the unit's drugs to shore up its product line until BMY's new drugs come to the market in a few years. BMY has sought and would continue to make acquisitions to fill the gap in its drug pipeline and to combat sales lost to competition from cheaper generic medicines. Management expects the transaction to be dilutive to earnings by up to ##TEXT##.03 in 2002 but accretive thereafter. For the quarter ended March 31, 2001, BMY reported sales of .7 billion, a decline of million 2% ; compared to the quarter ended December 31, 2000. Pretax income, net income and EPS share increased. Pretax income increased by 1 million 17% ; to .7 billion. Net income and EPS each increased by 15% to .3 billion and ##TEXT##.68, respectively. In the most recent.
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Steve Liles made recommendations for inclusion on the Preferred Drug List based on the new offers from the manufacturers. The Committee had asked Provider Synergies to go back to all the manufacturers and speak with them about better rebates on the statins. Dr. Liles compared the drugs in regard to drug-drug interactions, metabolic clearance of these drugs, and their safety. There was a discussion as to the importance of having "clean" statins on the PDL, Lescol being the low potency one and Pravachol being high potency, and that Pravachol was available through the.
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The medications listed below require prior authorization. Listings are subject to periodic review and update, as new drugs become available. Please call Customer Service if you have any questions. Items with a cost of , 000 per prescription require authorization. Rhinocort & Aqua Nexium Humira Botox Myobloc Aceon Ritalin LA Paxil CR IVIG Caduet Aciphex Synagis Respigam PEG-Intron Kineret Celebrex Actimmune Teveten & HCT Pravachol Lescol Clarinex & D Actiq Tracleer Pravigard Lyrica Compounded Meds Altace Univasc Uniretic Prevacid Macugen Copaxone Altocor Viadur Protonix Mavik Crestor Altoprev Wellbutrin XL Provigil Metadate CD Diovan & HCT Amevive Xolair Raptiva Micardis & HCT Enbrel Atacand & HCT Zegerid Rebif Mobic Flexeril 5mg. Avonex Zelnorm Relenza Tamiflu Nasalide Focalin & XR Benicar & HCT Zyrtec & D Remicade Nasarel Gleevec Betaseron Revatio Nasonex Growth hormone Boniva and vytorin.
SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PRAVACHOL AND ASSOCIATED NAMES See Annex I ; Quality issues No significant issues relating to Quality were identified. The pharmaceutical particulars of the SPC were harmonised, except the sections, which need to be introduced nationally by the Member States when implementing the harmonised SPC section 6 ; . Efficacy issues The divergences that previously existed across the SPCs of EU Member States included: Section 4.1 Therapeutic Indications The MAH was requested to propose and scientifically justify a common EU wide approach as there were divergences between national approvals regarding the use of Pravachol in: Isolated or mixed hypercholesterolaemia. This indication was approved in all EU Member States, Iceland and Norway. However the wording and therefore the precise meaning ; of the approved indication is very different in the different nationally approved summaries of product characteristics. Primary prevention in Coronary Heart Disease. This indication was approved as an indication only in some Member States and in others the data are described only under section 5.1 Pharmacodynamic properties. Secondary prevention in Coronary Heart Disease. This indication was approved in all Member States, Iceland and Norway. However, the wording and therefore the precise meaning ; of the indication was different from member state to member state. Furthermore, within the Coronary Heart Disease indication "slowing of the progression of coronary artery sclerosis and reduction of the incidence of cardiac events" were approved as separate indications only in some Member States. Finally, only some Member States approved an indication in the treatment of hyperlipidaemia following solid organ transplant. This indication was restricted to a treatment following cardiac and renal transplantation in some of these Member States and in some others restricted to a treatment following a cardiac transplant. Primary hypercholesterolaemia and mixed dyslipidaemia Pravastatin is a competitive inhibitor of A HMG-CoA ; reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid- lowering effect in two ways. First, with the reversible and specific competitive inhibition of HMG-CoA reductase, it induces a modest reduction in the synthesis of intracellular cholesterol. This results in an increase in the number of LDL-receptors on cell surfaces and enhanced receptor-mediated catabolism and clearance of circulating LDL-cholesterol. Secondly, pravastatin inhibits the low-density lipoproteins LDL ; production by inhibiting the hepatic synthesis of very low-density lipoproteins VLDL ; cholesterol, the LDL-cholesterol precursor. In both healthy subjects and patients with hypercholesterolaemia, pravastatin sodium lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while high-density lipoprotein HDL ; -cholesterol and apolipoprotein A are elevated.
Chi-Ming Liang, Director, Office of Public Affairs and Technology Transfer, at Academia Sinica, reported in an interview with R&D focus at BioSquare 2005, 13-15 April 2005, Lyon, France, that partners with clinical trials experience are sought worldwide for BO 0702, a lead compound from a series of 9-anilinoacridine derivatives, with an alkylating N-mustard residue. The agents are being co-developed with Cornell University USA ; and have potential for the treatment of cancer. In preclinical studies, BO 0702 was 107-fold more potent compared with 3- 9-acridinylamino ; -5- hydroxymeth yl ; aniline AHMA ; at inhibiting human lymphoblastic CCRF-CEM ; in leukemia culture. cells No or and zebeta.
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Pravachol 10 mg Tablets OTC Advisory Committee Briefing Book It was reported that the exact cause of the rhabdomyolysis and the relationship to pravastatin therapy were both considered unclear. M082307 USA, a report initially summarized and conveyed to the public in the Wall.
Denominator: Number of prescribing events for all statins both brand and generic. A prescribing event is defined as a 30-day supply. Altocor Altoprev Crestor Fluvastatin Lescol Lescol XL Lipitor Numerator: Number of prescribing events for statins paid as generic. Statin Drugs Lovastatin Mevacor Pravachol Pravastatin Sodium Simvastatin Zocor and mexitil and Cheap pravachol online.
By Ann Gerhardt, MD Subscribe to DrG'sMediSense at drgsmedisense ; Bottom line at the top: Red yeast rice works at least as well as purified statin drugs to improve serum lipid levels. Don't imagine that it accomplishes this by harmless magic: It contains lovastatin brand name Mevacor ; and other chemically active substances that require medical monitoring. Think of it as drug. What it is: Rice fermented by the mold Monascus purpureus is known as red yeast rice. The fermentation product contains monacolins, which lower cholesterol. Monacolin K, one of the active components of red yeast rice, is produced by all Monascus species and some other molds. Other names for the same chemical structure are mevinolin and lovastatin brand name Mevacor ; , the first FDA-approved statin drug. In the 1990's Merck, Sharp & Dohme researchers identified the chemical structure of monacolin K, calling it lovastatin, and revolutionized pharmacologic cholesterol control. Compactin, a similar compound isolated from Penicillium molds, induces excessive toxicity in humans, but its chemically modified forms Zocor and Pravachol ; have been safe, effective and lucrative products for the pharmaceutical industry. The biggest money-maker of all, Lipitor, has an entirely synthetic structure based on the monocolins. The Chinese have used red yeast rice since the Tang dynasty as an ingredient in rice wine, as a coloring the red color of Peking duck ; and flavoring agent and as an herb to treat indigestion, diarrhea and circulatory disorders. Why it works: After conversion in the liver to the active form, all of the various monocolins and statin drugs inhibit the enzyme Hmg CoA reductase, the first step of cholesterol synthesis in the human liver. Blocking this enzyme turns off the body's cholesterol production and induces the liver to pull more cholesterol out of the blood stream, thus lowering cholesterol levels in two ways. More potent than Mevacor: Red yeast rice lowers LDL-cholesterol the bad one ; more than an equivalent dose of lovastatin. In studies of patients taking standard doses of red yeast rice, LDL-cholesterol dropped by.
| What is PravacholCorresponding Author: A. Pourshams, M.D. Digestive Disease Research Center Tehran University of Medical Sciences, Tehran Iran E-mail: pourshams ams.ac.ir and norvasc.
11. A 72-year-old male with a history of previous inferior myocardial infarction sees you prior to surgery for symptomatic gallstones. He denies chest pain or dyspnea. His current medications include aspirin, 81 mg daily; ramipril Altace ; , 10 mg daily; and pravastatin Pravachol ; , 40 mg daily. He is in good health otherwise and has no other health complaints. He has been cleared for surgery by his cardiologist. Which one of the following should be considered before and after surgery, assuming no contraindications? A. Atenolol Tenormin ; B. Verapamil Calan, Isoptin ; C. Digoxin.
The slight decrease in gross-to-net sales adjustments in 2007 compared to 2006 was affected by a number of factors. Sales returns decreased primarily due to higher accruals in 2006 for Cardiovascular non-exclusive brands and from the discontinued commercialization of TEQUIN gatifloxacin ; . The decrease in prime vendor charge-backs was primarily due to lower sales of TAXOL paclitaxel ; as a result of loss of exclusivity. This was partially offset by increases in managed health care rebates and other contract discounts, primarily as a result of higher PLAVIX * sales and the reversal of reserves in 2006 related to the TRICARE Retail Pharmacy Refund Program, partially offset by lower sales of PRAVACHOL due to loss of exclusivity. Additionally, the increase in cash discounts was primarily due to higher PLAVIX * sales volumes. The decrease in gross-to-net sales adjustments in 2006 compared to 2005 was affected by a number of factors, including changes in customer mix and a portfolio shift, in each case towards products that required lower rebates, as well as changes in contract status. The decrease in prime vendor charge-backs was primarily the result of lower PLAVIX * net sales, volume erosion on highly-rebated PARAPLATIN carboplatin ; and TAXOL paclitaxel ; due to generic competition, as well as the impact from the discontinued commercialization of TEQUIN. Managed health care rebates and other contract discounts decreased primarily as a result of the reversal of reserves related to the TRICARE Retail Pharmacy Refund Program, as well as the exclusivity loss of PRAVACHOL, which also reduced Medicaid rebates. In addition, lower PLAVIX * net sales and the shift in patient enrollment from Medicaid to Medicare under Medicare Part D, resulted in a decrease in Medicaid rebates, partially offset by a corresponding increase in managed health care rebates. The decrease in cash discounts was primarily due to lower sales of PRAVACHOL due to loss of exclusivity and lower PLAVIX * sales volumes. The increase in sales returns was primarily due to higher returns trends for non-exclusive brands as well as from the discontinued commercialization of TEQUIN. 46.
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4. Interviews with Health Care Practitioners and Professionals If inconsistencies in care or potential negative outcomes have been identified, or care is not in accord with standards of practice, interview the nurse responsible for coordinating or overseeing the resident's care. Determine: How the staff monitor implementation of the care plan, changes in continence, skin condition, and the status of UTIs; If the resident resists toileting, how staff have been taught to respond; Types of interventions that have been attempted to promote continence i.e., special clothing, devices, types and frequency of assistance, change in toileting schedule, environmental modifications If the resident is not on a restorative program, how it was determined that the resident could not benefit from interventions such as a scheduled toileting program; For the resident on a program of toileting, whether the nursing staff can identify the programming applicable to the resident, and: o The type of incontinence; o The interventions to address that specific type; o How it is determined that the schedule and program is effective i.e., how continence is maintained or if there has been a decline or improvement in continence, how the program is revised to address the changes and o Whether the resident has any physical or cognitive limitations that influence potential improvement of his her continence.
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Each year more than 950, 000 people die from cardiovascular disease, making it the number-one cause of death in the United States. At least 250, 000 Americans die of sudden cardiac arrest before they reach the hospital. Sudden cardiac arrest strikes people of all ages and all degrees of fitness. It usually strikes without warning. Many of these lives can be saved if bystanders quickly phone for help and begin CPR, and when.
A recent study released last month revealed that getting cholesterol to superlow levels can stop the progression of arteriosclerotic heart disease, the culprit responsible for blockages in our coronary arteries which supply blood to our heart muscles. This was reported by Steven E. Nissen, the cardiologist who headed the investigation at the Cleveland Clinic, where the cholesterol-lowering drugs, Lipitor and Pravachol, were used in more than 500 patients. The study shows that taking 40 mg of Pravachol did not offer the same slowing effect on heart disease even though some patients were able to achieve the same super-low LDL levels. Heart disease in the Pravachol-treated patients was about 3% worse after 18 months of treatment. Lipitor seems to be superior in this regard. Nissen also observed that Lipitor stopped progression of plaque in a variety of patient groups including younger and older patients as well as people with diabetes and high blood pressure. But for Pravachol it was a different story: "We were unable to stop progression in any of the subgroups in the Pravachol group, " he says. Nissen based his findings based on ultrasound images inside the arteries in beating hearts. This technique is still in its infancy and needs to be correlated and confirmed with clinical results. However, evidence-based medicine has shown that these statin drugs, like Lipitor and Pravachol, among others, reduce deaths and complications from coronary heart disease. Nissen added that "in addition to bigger drops in LDL cholesterol with Lipitor, patients taking Lipitor also had much greater reductions in C-reactive protein: 36% vs. 5%". C-reactive protein, CRP, is an inflammatory marker found in the blood. High levels of CRP have recently been identified as a heart disease risk factor. "The potent anti-inflammatory effect seen with Lipitor might be a factor in the observed differences between the two treatments, " according to Nissen . Christopher Cannon, assistant professor, Harvard Medical School, Boston, says he is also studying Lipitor and Pravachol at the same dose but with several thousand patients. The results of his study will be presented next spring at the American College of Cardiology meeting.
MUCINEX D--PO 600 60mg TBSR MURO-128 5% SOLN-OPTH SOLN 15ML, 5% OPTH OINT 3.5GM NAFTIFINE NAFTIN ; --TOP 1% CREA 30GM NAPHAZOLINE ANTAZOLINE VASOCON-A EQ ; OPTH SOLN NAPHAZOLINE PHENIR OPCON-A ; --OPT SOLN NAPROXEN NAPROSYN ; -500mg TAB NEOMYCIN SULFATE-500mg TAB NEOSPORIN TOP OINT 15GM TUBE NEOSPORIN-OPTH SOLN 10ML, OPTH OINT 3.5GM NIACIN-50mg & 500mg TAB NIASPAN-500MG, 750MG, & 1000mg TABS NIFEDIPINE PROCARDIA ; -10mg CAP NIFEDIPINE LONG ACTING ADALAT CC ; -30, 60 & 90mg TABS NILUTAMIDE NILANDRON ; -150mg TAB NITROFURANTOIN MACROBID ; -100mg CAP NITROFURANTOIN- 25mg 5ml SUSP NITROFURANTOIN-50mg CAP NITROGLYCERIN NITROBID ; -2% OINT 60GM NITROGLYCERIN LINGUAL SPRAY-200DOSES BTL NITROGLYCERIN-0.2mg HR, 0.4mg HR TDS NITROGLYCERIN-0.4mg SL TAB 25TABS BTL NITROGLYCERIN-2.5MG, 6.5mg CPSR NORDETTE LEVLEN 28DAY-TAB NORETHINDRONE AYGESTIN ; 5mg TAB NORTRIPTYLINE PAMELOR ; -10, 25 & 75mg CAP NUVARING 0.12 0.015mg ; --VAG DEVI NYSTATIN-100, 000U GM-- 15GM Cream, 30GM Topical Powder NYSTATIN-100, 000U ml SUSP 60ml BTL OCUVITE PRESERVISION- Ophthalmology Optometry only ; OFLOXACIN FLOXIN ; -0.3% OTIC DROPS OLANZAPINE ZYPREXA ; -2.5, 5 & 10mg TABS OLOPATADINE PATANOL ; -O.1% OPTH SOLN 5ml * 1 BTL MONTH OMEPRAZOLE PRILOSEC ; --PO 20mg CAPS ONDANSETRON ZOFRAN ; --PO 4, 8mg TABS * MAX OF 15 TABS 30 DAYS OR 45 TABS 90DAYS ORTHO EVRA-TRANSDERMAL PATCH ORTHO NOVUM 1 50-28 DAY TAB ORTHO NOVUM 7 7-28 DAY-TAB ORTHO NOVUM NORINYL 1 35-28 DAY-TAB ORTHO TRI-CYCLEN * LO * 28 DAY -TAB ORTHO TRI-CYCLEN 28 DAY- TAB ORTHO-CYCLEN 28DAY- TAB OXAPROZIN DAYPRO ; -600mg TAB OXCARBAZEPINE TRILEPTAL ; --PO 150, 300, 600mg TABS 300mg 5ml SUSP OXYBUTIN DITROPAN ; -5mg TAB & 5mg 5ml SYRUP OXYBUTIN DITROPAN ; -5mg TAB & 5mg 5ml SYRUP PANCRELIPASE VIOKASE ; -TAB PANCRELIPASE PANCREASE ; TAB PAROXETINE PAXIL ; 20mg TAB PEDIAZOLE-SUSP PENBUTOLOL LEVATOL ; -20mg TAB PENCICLOVIR DENAVIR ; -1% CREAM PENICILLIN VK-250mg TAB, 250mg 5ml SUSP PENTOSAN ELMIRON ; --PO 100mg CAP * FOR INTERSTITIAL CYSTITIS ONLY PENTOXIFYLLINE TRENTAL ; -400mg TAB PERCOCET-TAB generic ; - 5 325mg ONLY Max: 60-day supply ; PERMETHRIN ELIMITE ; -5% TOP CRM 60GM PERPHENAZINE TRILAFON ; -4mg TAB PHENAZOPYRIDINE PYRIDIUM ; -100mg TAB PHENOBARBITAL-30mg TAB, 20mg 5ml ELIX Max: 60 Days ; PHENYTOIN DILANTIN ; -100mg CAPS & 50mg TBCH PHYTONADIONE MEPHYTON ; -5mg TAB PILOCARPINE OCUSERT ; -20MCG & 40MCG PILOCARPINE-1%, 2%, 4%, 6% OPTH SOLN 15ML, 4% OPTH GEL 4GM TUBE PIMECROLIMUS ELIDEL ; 1% CREAM PIROXICAM FELDENE ; -20mg CAP POLYTRIM Polymixin B trimethoprim ; -OPTH SOLN 10ml POLYVINYL ALCOHOL TEARGEN ; -1.4% OPTH SOLN 15ml POTASSIUM CHLOR K-DUR ; -20MEQ TBSR POTASSIUM CHLOR SLOW K ; -8MEQ TBSR POTASSIUM CHLOR-20MEQ 15ml ELIX POTASSIUM IODIDE-1GM ml SOLN 40DROPS ml ; SSKI ; POTASSIUM SODIUM PHOSPHATE NEUTRA PHOS ; -CAP PRAMOXINE PRAX ; -1% TOP CRM 30GM PRAVASTATIN PRAVACHOL ; -10, 20, 40, 80mg TABS PRAZOSIN MINIPRESS ; -1, 2, & 5mg CAPS PRECISION EXTRA TEST STRIPS-#100 BOX PREDNISOLONE PRED-FORTE ; -1% SUSP 5ml PREDNISOLONE PEDIAPRED ; -5mg 5ml SOL PREDNISOLONE PRELONE ; -15mg 5ml SYRP PREDNISONE-1MG, 5mg & 20mg TAB PREMPHASE-0.625mg 5mg TABS PRIMIDONE MYSOLINE ; -50mg & 250mg TABS, 250mg 5ml SUSP PRIMIQUINE-26.3 mg TABS PROBENECID BENEMID ; -500mg TAB PROCHLORPERAZINE COMPAZINE ; -5mg TAB, 25mg SUPP PROCTOFOAM HC-RECT AERO PROMETHAZINE PHENERGAN ; -25mg TABS, 12.5 & 25mg SUPP PROPAFENONE RYTHMOL ; -150mg TAB PROPARACAINE OPHTHETIC ; -0.5% OPTH SOLN 15ml PROPRANOLOL INDERAL ; -10, 40mg Tabs, 80, 120, 160mg LA Caps PROPYLTHIOURACIL PTU ; -50mg TAB PROTOPIC TACROLIMUS PROTOPIC ; - 0.1%, 0.03% OINT * Must Fail Elidel First PURALUBE-OINTMENT PYIDOSTIGMINE MESTINON ; -60mg TAB, 180mg TBSR PYRAZINAMIDE-500mg TAB PYRIDOXINE B-6 ; -50mg TAB QUETIAPINE SEROQUEL ; -- 25, 100, 200, TABS QUETIAPINE SEROQUEL * XR ; --200, 300, 400mg TBSR QUINIDINE QUINAGLUTE ; -324mg TAB RALOXIFENE EVISTA ; --PO 60mg TAB RANITIDINE ZANTAC EQ ; -150mg TAB RANITIDINE ZANTAC ; --PO 15mg ml SYRP REFRESH PLUS CMC ; --OPT 0.5% SOLN AMPS REFRESH TEARS CMC ; -- 0.5% OPT SOLN 15ml RIFAMPIN-300mg CAP, 100mg 5ml SUSP RISEDRONATE SODIUM ACTONEL ; --PO 5mg TAB RISEDRONATE ACTONEL ; --PO 35mg TAB Once Weekly RISEDRONATE ACTONEL ; --PO 75mg TAB * 1 TAB DAILY FOR 2 CONSECUTIVE DAYS EACH MONTH RISPERIDONE RISPERDAL ; -0.5, 1, 2mg TABS ; 1mg ml SOLN RIZATRIPTAN MAXALT-MLT ; -10mg TAB max of 3 months with 1 refill per Rx, max of 9 tabs month ; must use Zomig First ROBITUSSIN AC-SYRP 120ml ROBITUSSIN DM SYRP 120ml ROPINIROLE REQUIP ; --PO 0.25, 0.5, 1, TABS ROSIGLITAZONE AVANDIA ; -2, 4, & 8mg TABS SALICYLIC ACID OCCLUSAL HP SOL ; -17% EXT 15ml SALICYLIC ACID PLASTER-40% PSTE TOP SALMETEROL SEREVENT ; -21MCG DOSE DISKUS SALSALATE DISALCID ; -500mg TAB SCOPOLAMINE HYOSCINE ; -OPTH 0.25% SOLN 5ML.
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Deep buttress-type cancellous threads provide maximum fixation in the femoral head. Additionally, threads are blunted to lessen possibility of screw being misdirected during insertion or changing position postoperatively. The integral sliding feature maintains the reduc.
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