Maybe you should take a look at some of the data analysis in the link in post #118. You will see that the number needed to treat (by using statins to try to prevent one premature death in cardiac low-risk categories) is infinity; in other words, NOT ONE DEATH will be prevented by treating low risk patients with statins. Even for moderate-to-high cardiac risk patients who have not yet had a coronary event, the NNT is 50 (to prevent one premature death); that means 49 other people are taking statins but derive no benefit from it. Actually that's not quite true; one other non-fatal MI will be prevented.
Not on cholesterol meds? New guidelines may change that
- Thread starter steve williams
- Start date
I did broach the recent article on statins with one of my cardiologist clients vis a vis prevention. He said that the most recent data is not so much that statins can reverse the plaque accumulation but that the drugs change the nature of the plaque making it less susceptible to breaking off and causing a clot/stroke/heart attack.
But really the question is whether that translates to any clinical benefit. One striking recent example (in cardiovascular medicine) is that of Nesiritide (BNP) which improved all physiologic parameters in CHF compared to standard treatment, but had a lower survival rate. Go figure...
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Lot cheaper too but how soon until see GSK selling heart enhanced apples?
http://www.sciencedaily.com/release...Top+News+--+Top+Science)&utm_content=FaceBook
http://www.sciencedaily.com/release...Top+News+--+Top+Science)&utm_content=FaceBook
The 'Real' Side-Effect Cost of Statins: Sorting Fact from Fiction
Michael O'Riordan
March 13, 2014
LONDON, UK — For patients treated with statins, only a very small minority of side effects reported can be directly attributed to the drugs, according to the results of a new study[1]. In primary prevention, the risk of developing diabetes with statins is real, but just one in five cases of new-onset diabetes suspected to be caused by statins is likely caused by the drugs, while the risk of developing diabetes in secondary prevention is offset by the reduction in cardiovascular deaths, report investigators.
Speaking with heartwire , the researchers, including lead and senior authors Dr Judith Finegold and Dr Darrel Francis (National Heart and Lung Institute, London, UK), said that in clinical practice, patients frequently report side effects such as muscle aches, fatigue, and gastrointestinal distress when started with statin therapy, and this poses a problem for doctors looking to keep patients on the drugs.
However, Francis said the rationale for the analysis stems from the problem that physicians have in communicating the true risk of side effects to their patients. The package insert for statins lists a multitude of possible side effects, a list that contains nearly every side effect reported in clinical trials, including those reported in the placebo arms, but physicians have no way to determine whether those side effects are caused by the medication, would have happened anyway, or are derived from the nocebo effect, a term given to side effects experienced by patients if they anticipate a medication might be harmful.
"It was frustrating to have no reliable information to give to patients quite rightly asking about side effects from statins," said Francis. "If the patient has a side effect, how can I tell them that it's probably not from the tablet? I know from reading the trials, but how is the patient supposed to know? All the patient has is the strip of paper that comes with the tablets and lists every imaginable side effect. Having read that, why would anyone in their right mind take the tablet for an asymptomatic condition? How is the patient supposed to know which of those are significantly increased by the drugs, decreased by drugs, or left unchanged?"
The study is published online March 13, 2014 in the European Journal of Preventive Cardiology.
Side Effects Equally Common in Placebo Arm
To address the proportion of symptomatic side effects in statin-treated patients caused by the medication, the researchers analyzed randomized, controlled clinical trials that compared statin therapy with placebo for primary and secondary cardiovascular disease prevention. In total, 14 primary-prevention studies with 46 262 participants and 15 secondary-prevention studies with 37 618 participants were included in the analysis. To calculate the risk for symptomatic side effects, the absolute increase in risk observed in the placebo arm was subtracted from the risk observed in the statin arm.
In primary prevention, statin therapy increased the absolute risk of diabetes by 0.5% and decreased the risk of mortality by 0.5%. In secondary prevention, treatment with statin therapy decreased the risk of death by 1.4%. In both primary and secondary prevention, statin therapy was associated with an asymptomatic, 0.4% absolute increase in liver enzymes.
"We found that the majority of side effects in primary- and secondary-prevention patients were as common in the placebo arm as in the statin arm, with the exception of asymptomatic liver enzyme elevations and an increase in diabetes in the primary-prevention population," Finegold told heartwire .
In calculating the proportion of symptoms that were not attributable to the statin, the researchers estimated 80% of the new diagnoses for diabetes were not attributed to the medication. As Finegold pointed out, even though one in five cases of new-onset diabetes is attributed to the drug, there has been no clinical trial to date where the use of statins in diabetic patients caused harm. In fact, statins in this patient population have always been shown to save lives. For Francis, he points out that the absolute increase in new-onset diabetes in primary prevention was 0.5%, the same as the absolute reduction in the number of deaths.
"To express this in a simplistic but memorable way, for every primary-prevention patient in whom we cause diabetes, we save one life, prevent two heart attacks, and half a stroke," said Francis. "To me, that is a good deal. But a patient may feel otherwise, and we must respect their preference and just focus on making sure we have given them correct information."
Information from Industry
To heartwire , Finegold and Francis said they would like to see the side-effect profile of drugs, including statins, written in a way patients can understand. If the package insert listed commonly reported side effects, as well as the likelihood that such events were caused by the drugs, patients might be more likely to choose to persist with medication rather than give up.
"If you're a patient and you feel any new symptom, the first thing you do is open the drug box and look at the side effects," said Finegold. "And that, to be honest, seems to list every symptom that has ever been reported in the statin and placebo arms of the clinical trials. There is very little reliable side-effect information given to patients. If you read that leaflet you would assume it was due to the medication." For physicians, they face the same problem, with little information to rely on in terms of determining real vs fictitious side effects reported in the clinical trials.
"We think it's very important that just as we calculate benefit using scientific randomized controlled trials, we should be equally careful to make only true statements about side effects. Ultimately, patients should decide using genuine information," said Finegold.
Michael O'Riordan
March 13, 2014
LONDON, UK — For patients treated with statins, only a very small minority of side effects reported can be directly attributed to the drugs, according to the results of a new study[1]. In primary prevention, the risk of developing diabetes with statins is real, but just one in five cases of new-onset diabetes suspected to be caused by statins is likely caused by the drugs, while the risk of developing diabetes in secondary prevention is offset by the reduction in cardiovascular deaths, report investigators.
Speaking with heartwire , the researchers, including lead and senior authors Dr Judith Finegold and Dr Darrel Francis (National Heart and Lung Institute, London, UK), said that in clinical practice, patients frequently report side effects such as muscle aches, fatigue, and gastrointestinal distress when started with statin therapy, and this poses a problem for doctors looking to keep patients on the drugs.
However, Francis said the rationale for the analysis stems from the problem that physicians have in communicating the true risk of side effects to their patients. The package insert for statins lists a multitude of possible side effects, a list that contains nearly every side effect reported in clinical trials, including those reported in the placebo arms, but physicians have no way to determine whether those side effects are caused by the medication, would have happened anyway, or are derived from the nocebo effect, a term given to side effects experienced by patients if they anticipate a medication might be harmful.
"It was frustrating to have no reliable information to give to patients quite rightly asking about side effects from statins," said Francis. "If the patient has a side effect, how can I tell them that it's probably not from the tablet? I know from reading the trials, but how is the patient supposed to know? All the patient has is the strip of paper that comes with the tablets and lists every imaginable side effect. Having read that, why would anyone in their right mind take the tablet for an asymptomatic condition? How is the patient supposed to know which of those are significantly increased by the drugs, decreased by drugs, or left unchanged?"
The study is published online March 13, 2014 in the European Journal of Preventive Cardiology.
Side Effects Equally Common in Placebo Arm
To address the proportion of symptomatic side effects in statin-treated patients caused by the medication, the researchers analyzed randomized, controlled clinical trials that compared statin therapy with placebo for primary and secondary cardiovascular disease prevention. In total, 14 primary-prevention studies with 46 262 participants and 15 secondary-prevention studies with 37 618 participants were included in the analysis. To calculate the risk for symptomatic side effects, the absolute increase in risk observed in the placebo arm was subtracted from the risk observed in the statin arm.
In primary prevention, statin therapy increased the absolute risk of diabetes by 0.5% and decreased the risk of mortality by 0.5%. In secondary prevention, treatment with statin therapy decreased the risk of death by 1.4%. In both primary and secondary prevention, statin therapy was associated with an asymptomatic, 0.4% absolute increase in liver enzymes.
"We found that the majority of side effects in primary- and secondary-prevention patients were as common in the placebo arm as in the statin arm, with the exception of asymptomatic liver enzyme elevations and an increase in diabetes in the primary-prevention population," Finegold told heartwire .
In calculating the proportion of symptoms that were not attributable to the statin, the researchers estimated 80% of the new diagnoses for diabetes were not attributed to the medication. As Finegold pointed out, even though one in five cases of new-onset diabetes is attributed to the drug, there has been no clinical trial to date where the use of statins in diabetic patients caused harm. In fact, statins in this patient population have always been shown to save lives. For Francis, he points out that the absolute increase in new-onset diabetes in primary prevention was 0.5%, the same as the absolute reduction in the number of deaths.
"To express this in a simplistic but memorable way, for every primary-prevention patient in whom we cause diabetes, we save one life, prevent two heart attacks, and half a stroke," said Francis. "To me, that is a good deal. But a patient may feel otherwise, and we must respect their preference and just focus on making sure we have given them correct information."
Information from Industry
To heartwire , Finegold and Francis said they would like to see the side-effect profile of drugs, including statins, written in a way patients can understand. If the package insert listed commonly reported side effects, as well as the likelihood that such events were caused by the drugs, patients might be more likely to choose to persist with medication rather than give up.
"If you're a patient and you feel any new symptom, the first thing you do is open the drug box and look at the side effects," said Finegold. "And that, to be honest, seems to list every symptom that has ever been reported in the statin and placebo arms of the clinical trials. There is very little reliable side-effect information given to patients. If you read that leaflet you would assume it was due to the medication." For physicians, they face the same problem, with little information to rely on in terms of determining real vs fictitious side effects reported in the clinical trials.
"We think it's very important that just as we calculate benefit using scientific randomized controlled trials, we should be equally careful to make only true statements about side effects. Ultimately, patients should decide using genuine information," said Finegold.
DURHAM, NC – The new American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for the treatment of cholesterol would increase the number of individuals eligible for statin therapy by nearly 13 million people, an increase that is largely driven by older patients and treating individuals without cardiovascular disease, according to a new analysis[1].
Among older adults, those aged 60 to 75 years old, 87.4% of men would now be eligible for the lipid-lowering medication, which is up from one-third under the old Adult Treatment Panel (ATP) III guidelines. For women of the same age, the percentage of those now eligible for statins would increase from 21.2% under ATP III to 53.6% with the new 2013 clinical guidelines.
The increase, say investigators, is the result of more patients being eligible based on their 10-year risk of cardiovascular disease.
"The real change is particularly in older individuals," senior investigator Dr Eric Peterson (Duke Clinical Research Institute, Durham, NC) told heartwire . "The guidelines add 13 million new people to treatment or who would be recommended to get treatment. If you look at where those patients are, the vast majority are the older population, those aged 60 to 75 years old. In that age group, we estimate that almost 80% of people would be recommended to be on a statin based on the new risk-based algorithm. That's a big change."
To heartwire , lead investigator Dr Michael Pencina (Duke Clinical Research Institute), a biostatistician, said the relative impact of age vs other risk factors is greater in the new risk-assessment model when compared with the Framingham risk score used in ATP III.
"Because we're treating more and more older people, what it does is increase the sensitivity of the guidelines, which means we're going to catch more people who would have developed cardiovascular disease and prevent more events," said Pencina. "But the price to pay for it is that we will be treating more people. So, increased sensitivity and decreased specificity."
The analysis, which applied the new clinical guidelines to an estimate of the US population using data from the National Health and Nutrition Examination Surveys (NHANES), is published March 19, 2014 in the New England Journal of Medicine.
Big Changes Merged Last Year
Presented and published last November, the new cholesterol guidelines caused quite a stir given their departure from previous iterations. As reported by heartwire previously, the guidelines abandoned the LDL- and non–HDL-cholesterol targets that recommended physicians treat patients with cardiovascular disease to a target of less than 100 mg/dL (or the optional goal of less than 70 mg/dL).
Instead of these targets, which the guideline authors said were not grounded in randomized, controlled clinical-trial data, the new guidelines identify four groups of primary- and secondary-prevention patients for physicians to focus their efforts to reduce cardiovascular disease events. And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in achieving relative reductions in LDL cholesterol.
These four groups include individuals with clinical atherosclerotic cardiovascular disease, individuals with LDL-cholesterol levels >190 mg/dL, diabetic patients without cardiovascular disease aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL, and those without evidence of cardiovascular disease, an LDL cholesterol level 70–189 mg/dL, and a 10-year risk of atherosclerotic cardiovascular disease >7.5%.
To heartwire , Pencina said there was a lot of media hype and speculation last November as physicians and the general public grappled with the changes. Rather than "guess" at what the guidelines would look like in the general population, the researchers extrapolated eligibility for statin therapy using data from 3773 patients enrolled in NHANES.
Of the 115 million adults aged 40 to 75 years old in the US, approximately 43 million (37.5%) could receive or be eligible to receive a statin using the ATP III guidelines. When the ACC/AHA cholesterol guidelines were applied, however, this number increases to 56 million (48.6%). The researchers estimate that 14.4 million adults would be newly eligible for statin therapy.
Although the new guidelines increase the number of eligible statin users across all four of the new treatment categories, the largest increase in use would be in primary prevention. Of the 12.8 million additional people treated if the ACC/AHA guidelines were applied, 10.4 million of these would be adults without evidence of atherosclerotic cardiovascular disease (but with a 10-year risk >7.5%), the primary-prevention population. The increase in statins for primary prevention is largest among men, although the number of female primary-prevention patients also increases.
The researchers also looked at patients aged 40 to 59 years and those aged 60 to 75 years old without cardiovascular disease and noted a substantial difference in statin eligibility between ATP III and the ACC/AHA guidelines. While the number of adults aged 40 to 59 years old eligible for primary-prevention therapy is similar between the two guidelines, 77% of adults aged 60 to 75 years would be treated with a statin under the ACC/AHA guidelines. This percentage is up from the 48% of older adults who would be treated with ATP III.
Among older adults, those aged 60 to 75 years old, 87.4% of men would now be eligible for the lipid-lowering medication, which is up from one-third under the old Adult Treatment Panel (ATP) III guidelines. For women of the same age, the percentage of those now eligible for statins would increase from 21.2% under ATP III to 53.6% with the new 2013 clinical guidelines.
The increase, say investigators, is the result of more patients being eligible based on their 10-year risk of cardiovascular disease.
"The real change is particularly in older individuals," senior investigator Dr Eric Peterson (Duke Clinical Research Institute, Durham, NC) told heartwire . "The guidelines add 13 million new people to treatment or who would be recommended to get treatment. If you look at where those patients are, the vast majority are the older population, those aged 60 to 75 years old. In that age group, we estimate that almost 80% of people would be recommended to be on a statin based on the new risk-based algorithm. That's a big change."
To heartwire , lead investigator Dr Michael Pencina (Duke Clinical Research Institute), a biostatistician, said the relative impact of age vs other risk factors is greater in the new risk-assessment model when compared with the Framingham risk score used in ATP III.
"Because we're treating more and more older people, what it does is increase the sensitivity of the guidelines, which means we're going to catch more people who would have developed cardiovascular disease and prevent more events," said Pencina. "But the price to pay for it is that we will be treating more people. So, increased sensitivity and decreased specificity."
The analysis, which applied the new clinical guidelines to an estimate of the US population using data from the National Health and Nutrition Examination Surveys (NHANES), is published March 19, 2014 in the New England Journal of Medicine.
Big Changes Merged Last Year
Presented and published last November, the new cholesterol guidelines caused quite a stir given their departure from previous iterations. As reported by heartwire previously, the guidelines abandoned the LDL- and non–HDL-cholesterol targets that recommended physicians treat patients with cardiovascular disease to a target of less than 100 mg/dL (or the optional goal of less than 70 mg/dL).
Instead of these targets, which the guideline authors said were not grounded in randomized, controlled clinical-trial data, the new guidelines identify four groups of primary- and secondary-prevention patients for physicians to focus their efforts to reduce cardiovascular disease events. And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in achieving relative reductions in LDL cholesterol.
These four groups include individuals with clinical atherosclerotic cardiovascular disease, individuals with LDL-cholesterol levels >190 mg/dL, diabetic patients without cardiovascular disease aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL, and those without evidence of cardiovascular disease, an LDL cholesterol level 70–189 mg/dL, and a 10-year risk of atherosclerotic cardiovascular disease >7.5%.
To heartwire , Pencina said there was a lot of media hype and speculation last November as physicians and the general public grappled with the changes. Rather than "guess" at what the guidelines would look like in the general population, the researchers extrapolated eligibility for statin therapy using data from 3773 patients enrolled in NHANES.
Of the 115 million adults aged 40 to 75 years old in the US, approximately 43 million (37.5%) could receive or be eligible to receive a statin using the ATP III guidelines. When the ACC/AHA cholesterol guidelines were applied, however, this number increases to 56 million (48.6%). The researchers estimate that 14.4 million adults would be newly eligible for statin therapy.
Although the new guidelines increase the number of eligible statin users across all four of the new treatment categories, the largest increase in use would be in primary prevention. Of the 12.8 million additional people treated if the ACC/AHA guidelines were applied, 10.4 million of these would be adults without evidence of atherosclerotic cardiovascular disease (but with a 10-year risk >7.5%), the primary-prevention population. The increase in statins for primary prevention is largest among men, although the number of female primary-prevention patients also increases.
The researchers also looked at patients aged 40 to 59 years and those aged 60 to 75 years old without cardiovascular disease and noted a substantial difference in statin eligibility between ATP III and the ACC/AHA guidelines. While the number of adults aged 40 to 59 years old eligible for primary-prevention therapy is similar between the two guidelines, 77% of adults aged 60 to 75 years would be treated with a statin under the ACC/AHA guidelines. This percentage is up from the 48% of older adults who would be treated with ATP III.
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