rosuvastatin the triumph of marketing on the evidence

rosuvastatin the triumph of marketing on the evidence

sericos seae ecuador

There are weeks that blogueables items piled on the table. And this week is one of them. So we’re going to sting succulent starters before moving to the main course. And we begin with an interesting BMJ article, after reviewing the evidence supporting the use of alteplase in the treatment of ischemic stroke, a calm review of laidoneidad of this practice is requested. We continue with a complete review of the use of PPIs that leaves in the pipeline issues as important as short-term use, the downstream treatment GERD or safety aspects of these apparently inocuosmedicamentos. We finished the first block today with the publication of the Quality Criteria for prescription drugs and health products SSPA, work-reaching recommendations that extracted proper use of medicines in the Andalusian public health, similar to how does the NICE in the UK, and whose main weakness the lack of transparency, house brand, which we have criticized in public and in private.

But today we are going to translate, adapt and summarize an article entitled Rosuvastatin: winner in the statin wars, patients’ health notwithstanding whose devastating beginning reads: The United States spends more on rosuvastatin than any other statin, although evidence about its benefits health has always been weak and the evidence of its harmful side effects accumulate. Loans voice Reading Room Sidney Wolfe, a renowned member of the powerful Public Citizen who directly advocates the removal of this medicine today. Here are their arguments …

1.- Less evidence of its clinical benefits: when rosuvastatin was authorized in EE. UU. in 2003 as cholesterol-lowering and there were 3 statins on the market (simvastatin, pravastatin and lovastatin) approved by the FDA for reducing cardiovascular risk which then they add atorvastatin in 2004. Rosuvastatin was not authorized in this indication until 2010 and only primary prevention of heart attacks and stroke. This approval was based on the results of the JUPITER involving patients with low levels of LDL (With rosuvastatin time was authorized in primary prevention, as we have seen above, while the three most commonly prescribed statins were also allowed in secondary prevention based on the results of many studies involving patients with elevated LDL cholesterol (atorvastatin, 4 trials, pravastatin, simvastatin 3 and 2).

2.- Further evidence of risks: predefined variable result in JUPITER was the new cases of diabetes, because in a previous study, pravastatin had shown diminish. However, in the JUPITER a significantly higher incidence of new cases of diabetes (26%) in the rosuvastatin vs the recent placebo.Un treated group was recorded meta-analysis of 17 clinical trials involving 113 394 patients has confirmed these results and in a previous observational study of 240,000 patients, rosuvastatin was associated with the greatest increased risk for diabetes and pravastatin with the child, all of which has been reflected by the FDA in the data sheet. The differences are probably due to different metabolic effects of rosuvastatin and pravastatin. In another randomized, rosuvastatin significantly increased the levels of HbA1c and fasting plasma glucose and decreased insulin sensitivity, while pravastatin did the opposite. Before rosuvastatin it authorizes another serious problem was detected. Public Citizen opposed such authorization in 2003 and in 2004 asked the FDA to withdraw it from the market due to two serious adverse reactions: first, rhabdomyolysis, as rosuvastatin is the only statin that this undesirable effect has been detected in before comercialzacion clinical trials (even this happened with cerivastatin). In a recent study of 641 703 patients, those who took rosuvastatin had a significantly higher risk of having an increased activity of CPK than those taking other statins. The second concern revolves around kidney problems. Currently, rosuvastatin is the only statin that has been associated with proteinuria and hematuria and the FDA itself has recognized that

In addition, urine abnormalities, specifically proteinuria and hematuria, not previously noted in the review of other statin drug applications and not known to occur with this class, were observed sporadically in a small percentage of rosuvastatin-treated patients, with the highest incidence occurring at the 80-mg dose.”

¿Why is a bestseller? One answer may be found in an editorial in The Lancet accusing the executive director of AstraZeneca having bowed to do anything just to persuade doctors to prescribe rosuvastatin, including the launch of a promotional campaign of only $ 1,000 million in the first year. The editorial concludes that doctors should tell their patients the truth about rosuvastatin compared with its competitors which have less evidence base supporting its sure-use. AstraZeneca has forced their promotional machine too and it’s time to desist from an unprincipled campaign. After the uproar of the laboratory, later, in December 2004, the FDA sent a letter demanding that AstraZeneca immediately withdraw an ad in the Washington Post with false and misleading information about the risks of rosuvastatin. The announcement was responding to an article by Public Citizen against this medicine where shared security issues were discussed with the FDA. Rosuvastatin patent expires in 2016 and AstraZeneca need to promote it. But for the sake of public health we hope that the disadvantages of this drug cause a sharp drop in use in the coming years.

Colophon: the case of rosuvastatin is the living example of how marketing bends the will of many prescribers rather than evidence. With a pyrrhic record has sidoprofusamente criticized by the blogosphere homeland and whose evidence base is a clinical trial, the Jupiter, which bit dedicated a monograph that anyone interested in this estatinadebería know, rosuvastatin is, contrary to what one might wait a bestseller in our country, where the aim of LDL figures have served as an excuse to promote use of statins inadequate and in many cases opposed to the interests of patients. SSPA in the document that we reference in the intro criteria proper use of statins, among others, based on the best evidence currently available are shown. Among them, it is recommended to mention some objective reason sernunca figures which was endorsed by a randomized clinical trial. We do not know what impact all this in prescribing rosuvastatin. What we do know is that propaganda, sometimes crude and always deceptively in its many versions, is a worthwhile investment for any laboratory. And to address the emotions aroused, of little value wield the reasons. The painter Juan Gris that they prefer the excitement to the correct rules already said. In the art world, we see fit. In healthcare, has always found it reckless …

sociedad ecuatoriana de aterosclerosis y endotelio
Ecuadorian society of atherosclerosis and endothelium

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