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MKSAP: 64-year-old man with knee osteoarthritis
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians. A 64-year-old man is evaluated for a 2-year history of knee osteoarthritis. He has bilateral knee pain that worsens with walking. He has tried topical therapies, physical therapy, and acetaminophen, none of which has provided relief. The patient also has peripheral vascular disease, hyperlipidemia, and hypertension. Medications are hydrochlorothiazide, pravastatin, and a daily aspirin. On physical examination, temperature is 37.0 °C (98.6 °F), blood pressure is 116/76 mm Hg, pulse rate is 60/min, and respirati...
Source: Kevin, M.D. - Medical Weblog - July 12, 2014 Category: Journals (General) Authors: Tags: Meds Rheumatology Source Type: blogs

Statin Therapy Does Not Improve Cardiovascular Risk for Patients With HIV and Low HDL
The main lipid abnormality of people living with HIV is low high density lipoprotein (HDL).  There are 5 subfractions of HDL: 2a, 2b, 3a, 3b, and 3c, from largest (and most effective in cholesterol removal) to smallest (and least effective). Neither pravastatin nor rosuvastatin changes the distribution of high-density lipoprotein (HDL) subfractions in patients who are HIV-seropositive with (Source: Nelson Vergel's HIV Blog)
Source: Nelson Vergel's HIV Blog - June 5, 2014 Category: HIV AIDS Authors: Nelson Vergel Source Type: blogs

A clear-eyed look at treating the elderly with medicine
A recent case taught me a lot about how people perceive their medicines. I was trying to help a 92-year-old man get off some of his medicine. I can’t go into the details, but suffice to say, there was much opportunity to trim a long list of drugs, many of which were threatening his existence and impairing his quality of life. As I was discussing stopping many of the meds, the patient said (with a quite sincere tone): “You doctors these days just want us old people to go off and die.” That was a zinger, a real punch in the gut. I was trying to do the opposite–allow him to live a longer and better lif...
Source: Dr John M - March 7, 2014 Category: Cardiology Authors: Dr John Source Type: blogs

A clear example of how values matter in judging statins for primary prevention
The new JAMA has an article and an editorial that favor using statins for primary prevention. The clinical evidence and the editorial focus on the relative risk improvement with statins. However, the clinical evidence reports on a number needed to treat for 5 years of 138 to prevent 1 death. So 5 years of statin therapy for 138 patients to prevent 1 death. Is this a reasonable trade off? The lipidologists obviously see this as a victory for their hypothesis. They quote data that patients tolerate statin therapy as well as they tolerate placebo. They now have the evidence. We should give many more patients statins! Many cri...
Source: DB's Medical Rants - December 11, 2013 Category: Health Medicine and Bioethics Commentators Authors: rcentor Tags: Medical Rants Source Type: blogs

How Manipulated Clinical Evidence Could Distort Guidelines - the Case of Statins for Primary Prevention
This study excluded many patient for whom the statins were not contraindicated or warned against: uncontrolled hypertension; type 1 or type 2 diabetes mellitus on insulin or with a HgBA1C at least 10%; and body weight more than 50% "desirable limit for height."  (Based on the official contraindications and warnings for commonly used statins, e.g., see contraindications for Lipitor here, active liver disease, pregnancy for likely to become pregnant, nursing mothers, hypersensitivity to the medicine; and warnings: use of cyclosprine or strong CYP3A4 inhibitors, uncontrolled hypothyroidism, renal impairment.)  Thus ...
Source: Health Care Renewal - December 3, 2013 Category: Health Medicine and Bioethics Commentators Tags: American College of Cardiology American Heart Association clinical trials conflicts of interest evidence-based medicine guidelines manipulating clinical research review articles Source Type: blogs

Greatly improved new statin guidelines – with one exception
The Twitterverse blew up yesterday when they released the new lipid guidelines. I read many articles and finally think I am understanding the big progress these guidelines achieve. My favorite review is on Medscape (free registration required) – New Cholesterol Guidelines Abandon LDL Targets. I titled this post the statin guidelines, because these guidelines no longer focus on LDL levels, but rather the use of statins. We are no longer asked to treat to goal, rather to put appropriate patients on a statin. The four major primary- and secondary-prevention patient groups who should be treated with statins were identifi...
Source: DB's Medical Rants - November 13, 2013 Category: Health Medicine and Bioethics Commentators Authors: rcentor Tags: Medical Rants Source Type: blogs

Low Rate Of Problems With Statins In Study Of Quarter Million Patients
A very large analysis of previously published studies finds that statins are generally safe and well tolerated, but helps confirm previous links to a small increased risk for diabetes and elevation of liver enzymes. Some statins were better tolerated than other statins and lower-dose statins were better tolerated than high dose statins. In a paper published in Circulation: Cardiovascular Quality and Outcomes, Huseyin Naci and colleagues report their findings from a systematic review of clinical trials with statins for both primary and secondary prevention. The data from 55 placebo controlled trials and 80 trials inclu...
Source: CardioBrief - July 9, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes atorvastatin Pravastatin primary prevention Rosuvastatin secondary prevention Simvastatin Source Type: blogs

May Diabetes-Related News Snippets
Conclusion: "Compared with pravastatin, treatment with higher potency statins, especially atorvastatin and simvastatin, might be associated with an increased risk of new onset diabetes."22% higher risk with Lipitor (atorvastatin) and 18 percent higher with Crestor (rosuvastatin).In mainstream press coverage, Drug company shills,, a.k.a. well known cardiologists, bend over backward to ignore this latest confirmation of a phenomenon that has been public knowledge for more than a year. The reason that statins cause diabetes may have to do with the fact that they impair the operation mitochondria--the part of the cel...
Source: Diabetes Update - June 3, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

Drug News in Brief
Short takes on matters various. Taking Aim at Pot—Researchers have recently made clinical efforts to test three drugs that might help during marijuana withdrawal to keep pot abstainers on the straight and narrow. Researchers at Columbia University, led by Margaret Haney, have been testing a synthetic THC compound called nabilone. The drug is designed to address sleep and appetite problems during withdrawal.  Whether it is any better tolerated by users than Marinol, Uncle Sam’s widely unpopular version of synthetic THC, remains to be seen. This approach can be viewed rather like methadone or buprenorphine substitu...
Source: Addiction Inbox - March 20, 2013 Category: Addiction Authors: Dirk Hanson Source Type: blogs

Unreported Drug Side Effects Discovered by Analysis of Google Big Data
Discussion about Big Data; Relevance for Healthcare). The key aspect of such Google research is understanding how to interpret search engine queries. Here's a graph of the search term gonorrhea from Google Trends with volume peaking in October, 2010. A correlation with relevant news headlines is also provided. (Source: Lab Soft News)
Source: Lab Soft News - March 14, 2013 Category: Pathologists Authors: Bruce Friedman Tags: Electronic Medical Record Healthcare Information Technology Medical Consumerism Medical Research Pharmaceutical Industry Source Type: blogs

Bad Pharma And The Statin Wars - Forbes
It’s been amusing to watch former Pfizer executive John LaMattina try to pick apart Ben Goldacre’s new book, Bad Pharma,  a powerful indictment of the industry in which LaMattina used to work. This is not the occasion to get into the details of this battle, but as an aside let me just say that I would advise any representatives of the pharmaceutical industry to think very carefully before choosing to take on Goldacre. John LaMattina What I want to focus on here is an assertion, accepted by both Goldacre and LaMattina, that is simply mistaken. LaMattina’s latest post is a respon...
Source: PharmaGossip - March 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

MKSAP: 72-year-old man is evaluated for fatigue and dyspnea
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians.A 72-year-old man is evaluated for fatigue and dyspnea. Over the last several months to a year, he has had increasing fatigue, exercise intolerance, and dyspnea on even mild exertion. He becomes short of breath walking across a room, although he is asymptomatic at rest. He denies chest pain, palpitations, syncope, orthopnea, and lower extremity edema. He has a history of coronary artery disease, with a myocardial infarction and four-vessel coronary artery bypass graft surgery 4 years ago. He also has hyperlipidemi...
Source: Kevin, M.D. - Medical Weblog - October 6, 2012 Category: Family Physicians Authors: Kevin Tags: Conditions Heart Source Type: blogs

Do Drug Coupons Hurt Employee Health Plans and Ultimately Employees?
"Coupons for drug co-payments are illegal and drive up long-term health-care costs for all, a consumer group and four trade-union health-insurance plans said Wednesday in announcing lawsuits against eight pharmaceutical companies," reported the Philadelphia Inquirer (see "Trade union health plans sue 8 pharma companies over drug coupons").The eight drug companies being sued are:Abbott LaboratoriesAmgenAstraZenecaBristol-Myers Squibb GlaxoSmithKlineMerck & Co.NovartisPfizerThe lawsuits claim that although coupons reduce the consumer’s out-of-pocket cost, the health insurer still pays the previously negotiated pri...
Source: Pharma Marketing Blog - March 8, 2012 Category: Pharma Commentators Tags: Lipitor Pfizer generics coupons Source Type: blogs

Countdown to Generic Lipitor: Atorvastatin By Any Other Name
What everyone knows as Lipitor has also had a chemical name: atorvastatin. And it’s atorvastatin that the generic version of Lipitor will be called, once the brand goes off patent Wednesday. This is normal. Drug makers give a chemical name to medicines in development, before unveiling a brand name. Many doctors write out the chemical name of drugs on prescriptions, even if only the brand is available. Many folks in health care prefer using the tongue-twisting chemical name. The switch from a branded cholesterol drug to a no-name is also standard now. Millions of patients have been taking lovastatin, pravastatin and s...
Source: WSJ.com: Health Blog - November 28, 2011 Category: Health Medicine and Bioethics Commentators Authors: Jonathan D. Rockoff Tags: Drugs Generics Source Type: blogs

How switching from brand name drugs to generics is sometimes absurd
by Paul Sax, MDI had an interesting exchange with one of our nurses recently about a long-term patient of ours.The e-mails went something like this:Got a fax from —-’s insurance that his Lipitor won’t be covered anymore.  They will cover simvastatin, lovastatin, and pravastatin.  Let me know what you want to do. CharlieHe’s on darunavir, and all three of those statins are contraindicated because of drug-drug interactions. Rosuvastatin? PaulChecked with them — rosuvastatin needs prior approval, and will cost him a lot more, but less than Lipitor. I’ll get the paperwork ready. Charlie(...)Read the rest of How s...
Source: Kevin, M.D. - Medical Weblog - June 16, 2011 Category: Family Physicians Authors: Kevin Tags: Meds Medications Specialist newtag Source Type: blogs

Common Drug Combo Raises Blood Glucose
By Diane Fennell Researchers have discovered that the commonly used combination of two drugs — the antidepressant paroxetine (brand name Paxil) and the cholesterol-lowering medicine pravastatin (Pravachol) — can cause unexpected increases in blood glucose levels, even though neither medicine has this effect when taken alone. It is estimated that between 500,000 and 1 million people in the United States may be taking this drug combination. It is not unusual for medicines to have effects when taken simultaneously with other medicines that they do not have when taken alone, but since most drugs are approved in...
Source: Diabetes Self-Management - June 10, 2011 Category: Diabetes Authors: Diane Fennell Source Type: blogs

The Scary Thing About the FDA’s Simvastatin Decision - Matthew Herper - The Medicine Show - Forbes
Yesterday the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain. This decision will affect millions of patients. To keep perspective, the fact that other cholesterol-lowering statin drugs like Lipitor and Crestor are more potent probably factored into this decision — if the top dose of Zocor were the only option, the FDA might have kept it. Steven Nissen of the Cleveland Clinic, who said as early as 2004 that doctors should not be using the 80 mg dose, emphasized that stati...
Source: PharmaGossip - June 10, 2011 Category: Pharma Commentators Source Type: blogs

Many Not Adhering to Statin Regimen
By Diane Fennell The majority of people at high risk for heart disease or stroke, including those with Type 2 diabetes, are not adhering to their prescribed statin treatment regimens, according to researchers at North Carolina State University. People with Type 2 diabetes are predisposed to having abnormal blood fat levels, putting them at higher risk of conditions such as heart disease and stroke (the leading causes of death in those with Type 2). Statins are a class of drugs that slow down the production of cholesterol, allowing the liver to clear it from the blood more effectively. Medicines in this class, including...
Source: Diabetes Self-Management - May 20, 2011 Category: Diabetes Authors: Diane Fennell Source Type: blogs

Hey, big spender. How much did you shell out for Rx drugs?
Which prescription drugs did Americans—and their insurance companies—spend the most on in 2010? Here are the top 10, according to IMS Health, a health-care information company. No surprise, most were heavily advertised brands for common ailments such as heart burn and high cholesterol. But in many cases, they wouldn’t be our first picks. 1. Pfizer’s Lipitor (for high cholesterol): $7.2 billion 2, AstraZeneca’s Nexium (for heartburn, gastroesophageal reflux, and ulcers): $6.3 billion 3. Bristol-Myers’ Plavix (blood thinner for heart attack and stroke prevention): $6.1 billion 4. GlaxoSmithKline's Advair Diskus...
Source: PharmaGossip - April 21, 2011 Category: Pharma Commentators Source Type: blogs

I’ll Have a Burger With a Side of Lipitor, Please
In conclusion, statin therapy can neutralize the cardiovascular risk caused by harmful diet choices.”  The idea is to use statins as “primary prevention” for heart disease, especially for people who have not “had contact with the health care system;” presumably including those who have no risk factors. The authors say data is still “inconclusive” that reducing dietary saturated fat can significantly lower serum cholesterol levels and, in turn, lower an individual’s risk for heart attack. Primary prevention may be made more effective, they say, by including pharmacotherapy (i.e. statins). Do they have ...
Source: Health Beat - September 29, 2010 Category: Health Medicine and Bioethics Commentators Authors: Naomi Freundlich Source Type: blogs

Statins for heart disease and stroke, and debunking statin myths
by Eric Van De Graaff, MDThere is no class of medications in the history of the world that has been better studied that statins.This class of drugs is more properly termed HMG CoA reductase (3-hydroxy-3-methyl-glutaryl co-enzyme A reductase) inhibitors, but with a name like that a terser nickname is almost mandatory (the name statin comes from the suffix of the members of this class: lovastatin, pravastatin, etc.).Simply speaking, this chemical blocks the metabolic pathway that produces cholesterol, which, of course, is known* to be a chief culprit in the formation of arterial blockages and is a direct risk factor for hear...
Source: Kevin, M.D. - Medical Weblog - August 27, 2010 Category: Family Physicians Authors: Kevin Tags: Drugs and pharma Heart newtag Source Type: blogs

How To Save Money On Prescription Medications: 10 Steps To A Cheaper Life
Do you want to know how to save money on prescription medications?  If you have diabetes or hypercholesterolemia,  read on. Step one:  Get admitted to the hospital for your total hip arthroplasty Step two:  Have the hospitalist review your list of medications and note you are on Crestor every other day for your hypercholesterolemia and Januvia for your diabetes. Step three:  Ask the patient why they are on every other day Crestor and have them respond, "because I don't need it every day." Step four:  Ask them why they are on Januvia and have them respond, "I don't know.  The doctor says I...
Source: The Happy Hospitalist - August 18, 2010 Category: Internists and Doctors of Medicine Authors: The Happy Hospitalist Source Type: blogs

THE MURKY SIDE OF STATINS page1
THE MURKY SIDE OF STATINS  pg1 Under the current cholesterol-based guidelines, 80 million people should be taking statins.   50% of them are. You may be one of them. There is mounting concern that statins may not be safe as a preventive medicine as previously believed.  The benefits may not outweigh any side effects for a healthy person to take statins. There is great skepticism about healthy people taking a long-term stain.THE NEW STATINWhen doctors look for new statin  candidates, they measure the degree of inflammation in the body rather than look for bad cholesterol.   Yet there ...
Source: Dr. Needles Medical Blogs - May 28, 2010 Category: Physicians With Health Advice Tags: THE MURKY SIDE OF STATINS page1 Source Type: blogs

Statin Use Could Cause Amyotrophic Lateral Sclerosis
From AssociatedContent.com: Those with high blood cholesterol could be prescribed any number of medications in order to bring their cholesterol into the normal range. However, one of the most commonly prescribed types of medications is in the statin family. This family of medications work by blocking certain substances found within the liver. This blocking action then causes the liver to remove cholesterol from itself. Statin medications also help the body reabsorb cholesterol deposits that may already line arteries, therefore, creating a situation in which coronary artery disease may be reversed. One of the side effects o...
Source: Renegade Neurologist - A Blog by David Perlmutter, MD, FACN - April 27, 2010 Category: Neurologists Authors: Dr. Perlmutter Tags: Heads Up Source Type: blogs

Statins in patients with NASH?
From the Medscape Ask the Experts series:There are 2 considerations for the use of statins in patients with nonalcoholic steatohepatitis: to control the hyperlipidemia that is frequently associated with NASH, and to use them as therapy for NASH itself. Statins can be used to treat hyperlipidemia in patients with chronic liver disease.[1-3] The risk for statin-induced hepatotoxicity is minimal in patients with chronic liver disease, and serum aminotransferase levels can be monitored. Any statin can be used; both pravastatin and atorvastatin are acceptable for such patients.[4-6] (Source: Notes from Dr. RW)
Source: Notes from Dr. RW - April 9, 2010 Category: Internists and Doctors of Medicine Source Type: blogs

Building a Comparative FDA May Not Lead to Effectiveness
Conclusions In the end, the obstacles facing CE research seem to necessitate a closer look into its use and impact on patient centered care. While it is important that the United States continue to lead the world in biomedical science, “implementing a framework for research that advances patient-centered care” must be carefully created. While the authors believe that the public would benefit from new protections against new treatments, they also acknowledge that “an FDA requirement for active-comparator trials could conceivably reduce new drug and device development due to the increased costs of trials.” The redu...
Source: Policy and Medicine - March 25, 2010 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Your stupid paper card is just that…
Happy Super Bowl Day! I don’t watch much football. I’m a BASEBALL fan, myself, but I will get drunk and scre eat some wings with my wife. I know you’ve seen these stupid ass little paper cards floating around in magazines and periodicals. They are laid out like your standard insurance card, and they do a great job at tricking stupid people into thinking they are insurance cards. What I don’t understand is how someone could be so dense as to think that, “I bought a magazine / insurance policy last Tuesday. On Wednesday, I went to the pharmacy and got all my ’scripshuns filled up for free&...
Source: The Angriest Pharmacist - February 7, 2010 Category: Pharmacists and Pharmacologists Authors: The *Angriest* Pharmacist Tags: Drug Companies Drug Topics Education Laws PHARMACY SECRETS! Patient Education Robbery Stupid People True Story 4 dollar plan 4 Dollar Prescriptions Adderall Adderall XR Amphetamine Amphetamine XR Average Wholesale Price AWP Source Type: blogs

You stupid paper card is just that…
Happy Super Bowl Day! I don’t watch much football. I’m a BASEBALL fan, myself, but I will get drunk and scre eat some wings with my wife. I know you’ve seen these stupid ass little paper cards floating around in magazines and periodicals. They are laid out like your standard insurance card, and they do a great job at tricking stupid people into thinking they are insurance cards. What I don’t understand is how someone could be so dense as to think that, “I bought a magazine / insurance policy last Tuesday. On Wednesday, I went to the pharmacy and got all my ’scripshuns filled up for free&...
Source: The Angriest Pharmacist - February 7, 2010 Category: Pharmacists and Pharmacologists Authors: The *Angriest* Pharmacist Tags: Drug Companies Drug Topics Education Laws PHARMACY SECRETS! Patient Education Robbery Stupid People True Story 4 dollar plan 4 Dollar Prescriptions Adderall Adderall XR Amphetamine Amphetamine XR Average Wholesale Price AWP Source Type: blogs

News You Didn't See About New Dangers with Supplements and Drugs
More Bad New About Vitamin CI already blogged about the evidence that Vitamin C supplementation may make us more insulin resistant and render exercise useless, but the bad news about vitamin supplementation just keeps pouring in.Vitamin C supplementation, it turns out, is also associated with a higher rate of cataracts. This finding emerged in a long study of 24,593 women 49–83 years old from the Swedish Mammography Cohort who were followed from September 1997 to October 2005. Data about their supplement use was collected by questionnaire, and cataract extraction cases were identified by linkage to the cataract extractio...
Source: Diabetes Update - January 7, 2010 Category: Diabetes Authors: Jenny Source Type: blogs

Statins + coenzyme Q10 may benefit heart failure patients
From OliofSpices.com: WUHAN CITY, CHINA. There is now growing evidence that oxidative stress and inflammation are involved in chronic heart failure. Statin drugs such as atorvastatin, simvastatin and pravastatin have recently been shown to posses anti-inflammatory properties and coenzyme Q10 is a powerful antioxidant and essential for cardiac mitochondrial energy production. Unfortunately, statin drugs reduce the level of coenzyme Q10, sometimes to the point of fostering muscle-related problems (myopathies) like rhabdomyolysis. A team of Chinese researchers at Wuhan University has now come up with the idea of combining the...
Source: Renegade Neurologist - A Blog by David Perlmutter, MD, FACN - November 4, 2009 Category: Neurologists Authors: Dr. Perlmutter Tags: Heads Up Source Type: blogs

Statins Show Dramatic Drug And Cell Dependent Effects In The Brain
From ScienceDaily.com: Besides their tremendous value in treating high cholesterol and lowering the risk of heart disease, statins have also been reported to potentially lower the risks of other diseases, such as dementia. However, a study in the October Journal of Lipid Research finds that similar statin drugs can have profoundly different effects on brain cells -both beneficial and detrimental. These findings reinforce the idea that great care should be taken when deciding on the dosage and type of statin given to individuals, particularly the elderly. John Albers and colleagues compared the effects of two commercially u...
Source: Renegade Neurologist - A Blog by David Perlmutter, MD, FACN - October 31, 2009 Category: Neurologists Authors: Dr. Perlmutter Tags: Heads Up Source Type: blogs

Could Statins Be Protective Against H1N1 Flu?
In a retrospective study, it's a definite maybe:Of the patients studied, 801 were taking statins anyway and continued taking them while hospitalized. Seventeen patients who were taking statins died while in the hospital or within a month afterward, compared to 64 who were not taking statins, Vandermeer said.Overall, 2.1 percent of patients taking statins died, compared to 3.2 percent of patients not taking statins. That means patients taking statins were just under 50 percent less likely to die.Turns out this is from a press release regarding reports being presented this weekend at the annual meeting of the Infectious Dise...
Source: Dr. Wes - October 30, 2009 Category: Internists and Doctors of Medicine Tags: lovastatin rosuvastatin pravastatin influenza simvastatin H1N1 Source Type: blogs

Fallout from New Healthcare Plans ... Yet Again?!
Last year, I lamented (see here and here) about a new healthcare provider, and many people commented. As I may have mentioned, on June 1, 2009, my employer switched healthcare plans and providers for the third time in the past 3 years. That's why I laugh at President Obama's speeches where he says if you like your doctor, you won't have to change with healthcare reform. He can't make such claims, because it's not necessarily true. Anyway, I can't really blame my employer's decision to switch again this year, as the company has done it's best to contend with healthcare costs which have consistently risen much faster than th...
Source: Scott's Web Log - October 1, 2009 Category: Diabetes Authors: Scott Source Type: blogs

Letters from Grassley: Are Statins Safe? Is the Sky Blue?
Simple questions deserve simple answers.   So when Senator Grassley (R-IA) recently sent a letter to the Food and Drug Administration (FDA) asking them to review the safety of cholesterol-lowering drugs (statins).   The response will be a straight forward statins are safe.  But preparing that answer will probably cost the taxpayers thousands of dollars and lost staff time at the FDA. Statins are drugs which reduce LDL Cholesterol (the Bad Cholesterol), they include branded and non branded products such as (pravastatin, atorvastatin, simvastatin, rosuvastatin, fluvastatin, lovastati...
Source: Policy and Medicine - September 27, 2009 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Approval of Effient, a Plavix Rival, Boosts Japanese Drug Maker
The FDA just approved Effient, a blood thinner that will compete against the megablockbuster Plavix. The initial approval is for patients who undergo angioplasty (and typically get a stent) to unclog one or more arteries around the heart. Effient will carry a boxed warning alerting doctors and patients to the risk of serious bleeding associated with the drug. The FDA’s approval isn’t just a big win for Eli Lilly. It’s also a boost for Daiichi Sankyo, which discovered the drug and will co-market it in the U.S. with Lilly. Japanese companies have been responsible for several big cardiovascular drugs. Sankyo, one of ...
Source: WSJ.com: Health Blog - July 10, 2009 Category: Health Medicine and Bioethics Commentators Authors: Peter Landers Tags: Drugs Source Type: blogs

Statins do not protect against dementia
Bernadette McGuinness and her colleagues analyzed the findings of two large clinical trials probing the health effects of statins: one study investigated the effects over five years of simvastatin (Zocor) in 20,536 patients; a second study followed 5,804 patients taking pravastatin (Pravachol) for an average of 3.2 years. Participants in these trials ranged in age from 40 to 82. In both studies, the odds of developing Alzheimer's and other forms of dementia were about the same among patients taking statins and not taking statins.Subscribe to The Alzheimer's Reading Room--via EmailStatins do not protect against dementiaChol...
Source: Alzheimer's Reading Room, The - April 15, 2009 Category: Dementia Tags: clinical trial alzheimer statins zocor research dementia pravachol Source Type: blogs

FDA Halts Imports of Many Ranbaxy Drugs, but Reassures Consumers
Mounting concerns about the quality of drugs manufactured by the big generics supplier Ranbaxy came to a head today, as the FDA took the tough step of blocking imports into the U.S. of more than 30 drugs from two of Ranbaxy’s manufacturing plants in India. The FDA is also refusing to approve any new drugs manufactured at the two plants until Ranbaxy fixes the problems with the factories. Here’s the FDA’s press release, and here are its letters to Ranbaxy pertaining to the two plants, this one in Dewas and this one in Paonta Sahib. The FDA’s concerns include inadequate prevention of potential cross-...
Source: WSJ.com: Health Blog - September 18, 2008 Category: Health Medicine and Bioethics Commentators Authors: Sarah Rubenstein Tags: Drugs Generics FDA Source Type: blogs

Abstract: Clinical drugs that interact with St. John's wort and implication in drug development
Curr Pharm Des. 2008;14(17):1723-42.Clinical Drugs that Interact with St. John's Wort and Implication in Drug Development Di YM, Li CG, Xue CC, Zhou SF. Divison of Chinese Medicine, School of Health Sciences, RMIT University, Bundoora, Victoria 3083, Australia. St. John's wort (Hypericum perforatum, SJW) is one of the most commonly used herbal antidepressants for the treatment of minor to moderate depression. A major safety concern about SJW is its ability to alter the pharmacokinetics and/or clinical response of a variety of clinically important drugs that have distinctive chemical structure, mechanism of action and metab...
Source: Latest entries from www.anxietyinsights.info - August 9, 2008 Category: Psychiatrists and Psychologists Authors: Anxiety Insights Tags: st johns wort Source Type: blogs

Bad News About "Good" Cholesterol Adds to Need for DTC Education
"'Good' cholesterol that scientists have thought helped unclog arteries had no effect on heart disease in a study, casting doubt on a theory drugmakers have spent more than $1 billion pursuing," says an article on Bloomberg.com (see "Why Pfizer Flopped: Good Cholesterol, not so good, says study").Add this to results from the Vytorin/Zetia study that failed to prove that lowering 'bad' cholesterol does not seem to lessen buildup of plaque on arteries and you seem to have a "perfect storm" that may eventually sink the whole anti-cholesterol drug market!Maybe I am not a good focus group of one, but in response to all this bad...
Source: Pharma Marketing Blog - June 4, 2008 Category: Pharma Commentators Tags: Vytorin Lipitor Pfizer Cholesterol DTC Advertising Crestor Source Type: blogs

Yes, Statins do everything - even lower BP
What could be crazy enough to end a 4 month hibernation of CTE? Archives Int Med 4/08 - The UCSD Statin study yielded further evidence that statin treatment reduces blood pressure (although not by much) The RCT enrolled over 900 subjects without known CVD or diabetes. The idea was to independently assess the effect on BP. There was no inclusion / exclusion criteria regarding baseline BP. Subjects were randomized to pravastatin, simvastatin, or placebo. Treatment with a statin resulted in about a 2-2.5 point drop in SBP and DBP. The treatment was stopped at 6 months, and the blood pressures returned to baseline by month 8 -...
Source: Consider The Evidence: Med/Peds Journal Roundup - April 17, 2008 Category: Internists and Doctors of Medicine Authors: medblog Tags: archives of internal medicine hypertension Source Type: blogs

Yes, Statins do everything – even lower BP
What could be crazy enough to end a 4 month hibernation of CTE? Archives Int Med 4/08 – The UCSD Statin study yielded further evidence that statin treatment reduces blood pressure (although not by much) The RCT enrolled over 900 subjects without known CVD or diabetes. The idea was to independently assess the effect on BP. There was no inclusion / exclusion criteria regarding baseline BP. Subjects were randomized to pravastatin, simvastatin, or placebo. Treatment with a statin resulted in about a 2-2.5 point drop in SBP and DBP. The treatment was stopped at 6 months, and the blood pressures returned to baseline by mon...
Source: Consider The Evidence: Med/Peds Journal Roundup - April 17, 2008 Category: Internists and Doctors of Medicine Authors: medblog Tags: archives of internal medicine hypertension Source Type: blogs

And here's another hard reality, Fred
This study was developed by experts.Whether the incremental lowering of LDL by this drug had an effect on the progression of atherosclerosis was an open question – worthy of study. As is the question of what effect the drug has on our patients – it is an open question – worthy of study. We do not know.Remember that this is a new drug – with a novel mechanism – first in class – we do not have outcomes studies.But you might say, but the drug lowers LDL, isn’t that a good thing? Shouldn’t that be associated with benefit? Wasn’t that enough for the FDA?Well, although LDL is an important risk factor for cardio...
Source: PharmaGossip - April 3, 2008 Category: Pharma Commentators Tags: Vytorin Schering Plough Merck Fred Hassan ezetemibe Source Type: blogs

Liver Warning with Prezista
Tibotec Dear Healthcare Professional:IMPORTANT DRUG WARNINGMarch 2008Dear Healthcare Professional:Tibotec Therapeutics, in cooperation with the U.S. Food and Drug Administration, would like to inform you of an important update to the prescribing information for PREZISTA TM (darunavir) tablets regarding addition of a Warning on Hepatotoxicity.In clinical trials and postmarketing experience, drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported in patients receiving combination therapy with PREZISTA/rtv. Given the clinical relevance of this adverse reaction, the following information on hepato...
Source: Nelson Vergel's HIV Blog - March 11, 2008 Category: HIV AIDS Source Type: blogs

KIF6, Jarvik and You
This study demonstrates a certain population at risk AND a benefit of therapy provided to that group. This is the essence of what pharmacogenomics and personalized medicine will bring to the table.Carriers and noncarriers of KIF6 719Arg received significantly different benefit from high-dose atorvastatin therapy compared with standard-dose pravastatin therapy. Specifically, in carriers of the 719Arg allele, high-dose atorvastatin therapy 80mg, compared with standard-dose pravastatin therapy, reduced the risk of death or major cardiovascular events by 41% (adjusted HR 0.59, 95% confidence interval [CI] 0.45 to 0.77; p This ...
Source: Gene Sherpas: Personalized Medicine and You - February 5, 2008 Category: Geneticists and Genetics Commentators Tags: helix health mitt romney hillary clinton DNA direct barack obama 23 and me democratic party super tuesday drudgereport republican party navigenics john mccain Source Type: blogs

More Questions on the Value of Statins
Statins, (technically known as HMG-CoA reductase inhibitors) form a class of lipid-reducing drugs which are prescribed to reduce the so-called "bad" low-density lipoprotein (LDL) cholesterol levels in the blood of people with or who are believed to be at risk of cardiovascular disease. Cardiovascular disease is the single biggest killer of all people with diabetes (type 1 and type 2), so as a group, patients with diabetes have long been assumed to have the same risk as someone who has already had a heart attack.For those of you who aren't familiar with them (or having been living in a cave for the past decade), statins are...
Source: Scott's Web Log - January 23, 2008 Category: Diabetes Tags: Lancet statins type 1 diabetes meta-analysis 2008 Source Type: blogs

Pravastatin use in patients with liver disease
Statin use in patients with liver disease is controversial but the concerns are diminishing. Now a RCT demonstrates that pravastatin in high doses can be safely used. From Hepatology. (Source: Notes from Dr. RW)
Source: Notes from Dr. RW - January 5, 2008 Category: Internists and Doctors of Medicine Source Type: blogs

Some Statins May Disrupt Sleep
This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication. Simvastatin modestly but significantly reduced sleep quality and increased sleep problems compared with pravastatin (Pravachol), according to a large study of subjective sleep measures reported at the American Heart Association meeting.   “This provides tentative corroboration for long-standing concerns that lipophilic statins may affect sleep in some individuals,” said Beatrice Golomb, ...
Source: Renegade Neurologist - A Blog by David Perlmutter, MD, FACN - November 10, 2007 Category: Neurologists Authors: Dr. Perlmutter Tags: Heads Up Source Type: blogs

Can't Sleep? Check Your Cholesterol Meds
Seems that people taking Merck & Co. (NYSE:MRK) Zocor, or any one of the many generic versions (simvastatin), are getting significantly worse sleep quality than those taking Bristol-Myers Squibb (NYSE:BMY) Pravochol (pravastatin).A study by Beatrice Golomb, lead author and an associate professor of medicine at the University of California, San Diego, found that three times as many patients on simvastatin found their sleep quality decreased once started on the drug as compared to those on pravastatin. The study followed 1,016 patients for 6 months who were taking either 20 mg of simvastatin, 40 mg of prav...
Source: PharmaGazette - November 8, 2007 Category: Pharmacists and Pharmacologists Tags: Research and Development Insomnia Pravachol Statins Zocor MRK BMY Source Type: blogs

Merck’s Zocor May Keep You Up At Night
This calls for a development deal with one of those companies that sells a sleeping pill. A government-funded study finds that the cholesterol pill may cause insomnia and disrupt sleep patterns, Bloomberg News reports. Patients taking Zocor, which is also available in generic form, had significantly worse sleep quality compared with those on Bristol Myers Squibb’s Pravachol, sold generically as pravastatin. “A significantly greater number of individuals taking simvastatin (Zocor) reported sleep problems than those taking either pravastatin or the placebo,” says Beatrice Golomb, the study’s lead aut...
Source: Pharmalot - November 7, 2007 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Bristol Myers Squibb Insomnia Merck Pravachol Zocor Source Type: blogs

Statins and Heart Disease: Look Behind the Curtain
I noticed that Ed Silverman picked up on a statin study published in the New England Journal of Medicine (NEJM) that suggests statins such as Pravachol -- the drug used in the study -- help prevent heart attacks for at least a decade after people stop taking them.This caught my attention because I recently stopped taking Pravachol, a Bristol-Myers Squibb (BMS) product, after about 12 years because I started getting leg cramps at night. Since I stopped, no cramps. I wondered if my risk for heart attack would increase because I stopped taking the drug, so I was pleasantly surprised to read this story, especially because it w...
Source: Pharma Marketing Blog - October 11, 2007 Category: Pharma Commentators Tags: Pharma Marketing Talk Pravachol BMS Source Type: blogs