Statin is one of the world's biggest selling drug for lowering LDL cholesterol, a new research suggests using more potent doses of statin could prevent thousands more heart attacks and strokes.
40,000 high-risk patients were assessed for major vascular events after one year of randomisation to either regular or intensive treatment statin. The results, published in The Lancet, found that stronger treatments reduced major heart attacks and strokes by 15%. This included a 13% cut in heart-related death or non-fatal heart attacks, a 19% drop in bypass and other coronary treatments, and a 16% drop in strokes.
However, the study warned that simply raising the dose of simvastain might lead to health problem as muscle weakness and muscle damage are some of the known side effects.
Source: "Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12 064 survivors of myocardial infarction: a double-blind randomised trial". The Lancet, Early Online Publication, 9 November 2010 (full text via Athens)
Showing posts with label myocardial infarction. Show all posts
Showing posts with label myocardial infarction. Show all posts
Tuesday, November 09, 2010
Thursday, September 09, 2010
The Avandia scandal
An investigation by the BMJ published this week calls for the withdrawal of the daibetes drug, Avandia, immediately from the market because of the concerns that it may increase the risk of myocardial infarction and the paucity of good evidence to support its use.
Rosiglitazone, also known as Avandia, was GSK's second biggest selling drug, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes. It was approved by the EMA in 2000 despite concerns over its safety.
In 2007, several studies found Avandia having harmful effects and issued serious health warnings. The researchers questioned why Avandia is still available on the market and why physicians would prescribe it to diabetic patients when there are other drugs without these side effects. They called for Avandia to be withdrawn from the market. Since then, the sales of Avandia fell sharply.
The BMJ investigators found that in July, the UK Commission on Human Medicines advised the MHRA to withdraw Avandia as the risks of Rosiglitazone outweigh its benefits. This has raised a lot of questions about the quality of the data used in the studies and the lack of trial results made available to the public. The investigators also ask why the regulators accept such poor evidence on benefit and safety, why patients in the UK and Europe are not make aware of the concerns about this drug and whether the current regulatory body is doing its job properly. They said that doctors are advising that no new patients shoud use this drug, existing diabetic patients should review their options and those at high risk of heart disease should stop taking it.
In the accompanying editorial, the authors said that clinicians had focused on the wrong endpoint and lost sight of the main reason for treating this disease, "which is not to reduce glycaemia but to prevent complications". They went on to say that clinicians need to be "absolutely certain that the long term treatment for type 2 diabetes are not causing the harm they are meant to prevent" and should insist on robust evidence of benefits and harms.
Professor Freemantle noted in the accompanying commentary that the Avandia studies were hindered by inadequate data due to high levels of loss to follow-up. He wrote "In order to learn from our mistakes, we must improve the quality of safety data from clincal trials on all new healthcare interventions, not just antidiabetic drugs" and an overhall in the standards of regulatory trials is needed.
Sources : free f/t
Rosiglitazone: what went wrong? BMJ 2010; 341:c4848 (Published 6 September 2010) Editorial - Licensing drugs for diabetes BMJ 2010; 341:c4805 (Published 6 September 2010)
Commentary: What can we learn from the continuing regulatory focus on the thiazolidinediones?BMJ 2010; 341:c4812 (Published 6 September 2010)
Rosiglitazone, also known as Avandia, was GSK's second biggest selling drug, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes. It was approved by the EMA in 2000 despite concerns over its safety.
In 2007, several studies found Avandia having harmful effects and issued serious health warnings. The researchers questioned why Avandia is still available on the market and why physicians would prescribe it to diabetic patients when there are other drugs without these side effects. They called for Avandia to be withdrawn from the market. Since then, the sales of Avandia fell sharply.
The BMJ investigators found that in July, the UK Commission on Human Medicines advised the MHRA to withdraw Avandia as the risks of Rosiglitazone outweigh its benefits. This has raised a lot of questions about the quality of the data used in the studies and the lack of trial results made available to the public. The investigators also ask why the regulators accept such poor evidence on benefit and safety, why patients in the UK and Europe are not make aware of the concerns about this drug and whether the current regulatory body is doing its job properly. They said that doctors are advising that no new patients shoud use this drug, existing diabetic patients should review their options and those at high risk of heart disease should stop taking it.
In the accompanying editorial, the authors said that clinicians had focused on the wrong endpoint and lost sight of the main reason for treating this disease, "which is not to reduce glycaemia but to prevent complications". They went on to say that clinicians need to be "absolutely certain that the long term treatment for type 2 diabetes are not causing the harm they are meant to prevent" and should insist on robust evidence of benefits and harms.
Professor Freemantle noted in the accompanying commentary that the Avandia studies were hindered by inadequate data due to high levels of loss to follow-up. He wrote "In order to learn from our mistakes, we must improve the quality of safety data from clincal trials on all new healthcare interventions, not just antidiabetic drugs" and an overhall in the standards of regulatory trials is needed.
Sources : free f/t
Rosiglitazone: what went wrong? BMJ 2010; 341:c4848 (Published 6 September 2010) Editorial - Licensing drugs for diabetes BMJ 2010; 341:c4805 (Published 6 September 2010)
Commentary: What can we learn from the continuing regulatory focus on the thiazolidinediones?BMJ 2010; 341:c4812 (Published 6 September 2010)
Thursday, July 08, 2010
Diabetes drug linked to higher heart attack risk
Avandia and competitor drug, Actos, are commonly used diabetes drugs. Avandia has been found having harmful effects since 2007 while Actos seems safer apparently.
2 studies published last week reported serious health warnings. One study, published in June 28 issue of JAMA, reviewed the data of 227,000 patients takng either Avandia or Actos, found that Avandia increased the risk of heart attack, stroke or death by 17%.
The second study, published in the Archive of Internal Medicine, analysed 56 clinical trials involving 35,000 patients confirmed these findings. The reserachers questioned why Avandia is still available on the market and why physicians would prescribe it to diabetics when there are other drugs without these side effects. They called for Avandia to be withdrawn from the market.
However, some doctors said that the evidence is inconclusive.
Source:
1). David Juurlink. "Rosiglitazone and the Case for Safety Over Certainty". JAMA. 2010;304(4):(doi:10.1001/jama.2010.954). free f/t
Friday, June 13, 2008
4 cups of tea a day cuts heart disease risk
Newspapers reported a review of several studies on tea consumption and its effects that found drinking more than three cups of tea a day cuts the risk of heart attack due to the natural plant antioxidants, polyphenols, in tea. The researcher also found that adding milk to tea made no difference to the effect of tea. The study was funded by the Tea Advisory Panel and the Tea Council.
Although the evidence indicates a positive role for tea in human health, critics say that there are many risk factors that contribute to the development of heart disease, people should not rely on drinking tea for protection from heart attacks.
Source: "Black tea and health." Nutrition Bulletin 2008; 33 91-101
Although the evidence indicates a positive role for tea in human health, critics say that there are many risk factors that contribute to the development of heart disease, people should not rely on drinking tea for protection from heart attacks.
Source: "Black tea and health." Nutrition Bulletin 2008; 33 91-101
Higher heart attack risk in men with vitamin D deficiency
News source reported that researchers at Harvard analyzed medical records and blood samples from 454 men who had a heart attack or disease and compared them to 900 men who had no history of cardiovascular disease.
They found that men with a vitamin D deficiency (15 nanograms or less per ml of blood) had a higher risk of heart attack than those with a sufficient amount of vitamin D (30 nanograms per ml of blood or more). They concluded "the results further support an important role for vitamin D in myocardial infarction risk"
Source :"25-Hydroxyvitamin D and Risk of Myocardial Infarction in Men - A Prospective Study"
Archieve of Internal Medicine. 2008;168(11):1174-1180.
They found that men with a vitamin D deficiency (15 nanograms or less per ml of blood) had a higher risk of heart attack than those with a sufficient amount of vitamin D (30 nanograms per ml of blood or more). They concluded "the results further support an important role for vitamin D in myocardial infarction risk"
Source :"25-Hydroxyvitamin D and Risk of Myocardial Infarction in Men - A Prospective Study"
Archieve of Internal Medicine. 2008;168(11):1174-1180.
Red yeast rice extract may be good for the heart
Newspapers reported that a large randomised placebo-controlled trial of 5000 patients showed that the extract of Chinese red yeast rice, XZK, that gives Peking duck its red colour, reduces bad cholesterol that subsequently lowers cardiovascular events in Chinese people who have already experienced a heart attack.
Critics say that although the study provides good evidence of the beneficial effect of the extract, the finding is not surprising because one of the cholesterol-lowering drugs, lovastatin, was originally extracted from yeast rice. They also say that people who are concerned about their risk of heart attack or their cholesterol levels should talk to their GP, who may prescribe them a statin.
Source: "Effect of Xuezhikang, an Extract From Red Yeast Chinese Rice, on Coronary Events in a Chinese Population With Previous Myocardial Infarction." American J of Cardiology 2008; Apr 11 [Epub ahead of print]
Critics say that although the study provides good evidence of the beneficial effect of the extract, the finding is not surprising because one of the cholesterol-lowering drugs, lovastatin, was originally extracted from yeast rice. They also say that people who are concerned about their risk of heart attack or their cholesterol levels should talk to their GP, who may prescribe them a statin.
Source: "Effect of Xuezhikang, an Extract From Red Yeast Chinese Rice, on Coronary Events in a Chinese Population With Previous Myocardial Infarction." American J of Cardiology 2008; Apr 11 [Epub ahead of print]
Friday, October 19, 2007
Aspirin - men's drug?
Aspirin has been linked to many health benefits, but a study which analysed 23 previously published clinical trials for the effect of aspirin in heart attack prevention, involving more than 113,000 patients found that women may be less responsive to aspirin than men for heart protection.
The researchers believe that gender may be one of the main influences on aspirin's protective powers. One UK expert said the finding is "potentially misleading" and that "taking aspirin in the months and years after a heart attack delivered equal benefits to men and women".
Source: "The influence of gender on the effects of aspirin in preventing myocardial infarction"
BMC Medicine 2007, 5:29 ( This is an open access journal article with full text )
The researchers believe that gender may be one of the main influences on aspirin's protective powers. One UK expert said the finding is "potentially misleading" and that "taking aspirin in the months and years after a heart attack delivered equal benefits to men and women".
Source: "The influence of gender on the effects of aspirin in preventing myocardial infarction"
BMC Medicine 2007, 5:29 ( This is an open access journal article with full text )
Wednesday, June 20, 2007
Avandia and pharmacovigilance
An interim analysis published by NEJM added new data to the previous meta-analysis and found that Avandia (Rosigilitazone) is associated with an increased risk of myocardial infarction.
BMJ published an editorial, "Rosiglitazone and implications for pharmacovigilance: postsurveillance data should be systematically collected and publicly available." Kazi D. BMJ 2007; 334: 1233-4 (16 June) and concluded that "the ongoing use of rosiglitazone merits careful deliberation." ( You can access the full text with an Athens password).
The author said that pharmacovigilance is the weakest in the regulatory processes of drug safety on both sides of the Atlantic and called for a radical change in the culture of existing regulatory agencies.
BMJ published an editorial, "Rosiglitazone and implications for pharmacovigilance: postsurveillance data should be systematically collected and publicly available." Kazi D. BMJ 2007; 334: 1233-4 (16 June) and concluded that "the ongoing use of rosiglitazone merits careful deliberation." ( You can access the full text with an Athens password).
The author said that pharmacovigilance is the weakest in the regulatory processes of drug safety on both sides of the Atlantic and called for a radical change in the culture of existing regulatory agencies.
Wednesday, June 06, 2007
Avandia - an interim analysis
Following the concerns raised about the drug Avandia's heart risk, NEJM has published a report online on 5 June 2007 "Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis " with new data that come from the RECORD trial, sponsored by the drugmaker Glaxo, designed to assess the drug's effect on the heart.
The authors concluded that the interim findings from this study were inclusive, "Rosiglitazone was associated with an increased risk of heart failure", but "the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."
The authors concluded that the interim findings from this study were inclusive, "Rosiglitazone was associated with an increased risk of heart failure", but "the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."
Friday, May 25, 2007
Avandia and myocardial infarction
A leading cardiologist, Steven Nissen, found that Avandia (generic name: rosiglitazone), a diabetes drug, "was associated with significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance."
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
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