Stroke victims taking statins have increased risk of death and a 140% increased risk of infection

This study was published in the European Journal of Neurology 2008 Jan;15(1):82-90

Study title and authors:
Simvastatin in the acute phase of ischemic stroke: a safety and efficacy pilot trial.

Montaner J, Chacón P, Krupinski J, Rubio F, Millán M, Molina CA, Hereu P, Quintana M, Alvarez-Sabín J.
Neurovascular Research Laboratory, Neurovascular Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain. 31862jmv@comb.es

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18070096

This study was a double-blind, randomised, multicentre clinical trial to study the effects of simvastatin in patients the first 90 days after a cortical stroke. The study included 60 patients with cortical strokes (a cortical stroke occurs when the blood supply to the outside, or cortex, of the brain is reduced or blocked, which results in brain damage) who were given either simvastatin or placebo at three to12 hours from symptom onset.

The study found:
(a) More patients taking simvastatin died compared to patients taking placebo.
(b) Patients taking simvastatin had a 140% increased risk of infection compared to patients taking placebo.

Links to other studies:
Patients taking statins after a stroke have a 68% increased risk of suffering another stroke
Statins increase the incidence of liver damage
Statins associated with increased bleeding in the brain in patients with intracerebral haemorrhage

Statins associated with 30% increased risk of death in kidney transplant patients

This paper was published in the Cochrane Database of Systemic Reviews 2009 Apr 15;(2):CD005019

 

Study title and authors:

HMG CoA reductase inhibitors (statins) for kidney transplant recipients.

Navaneethan SD, Perkovic V, Johnson DW, Nigwekar SU, Craig JC, Strippoli GF.

Department of Nephrology and Hypertension, Glickman Urological and Kidney institute, Cleveland Clinic, Cleveland, OH 44195, USA. navanes@ccf.org

 

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19370615

This paper assessed the effects of statin therapy on kidney transplant recipients. The paper analysed the results of 14 studies with 3,045 participants that compared death rates of patients.

The analysis found that kidney transplant patients that received statins had a 30% increased risk of death compared to patients who did not take statins. 

Cardiac surgery patients taking statins have a 24% increased risk of death

This study was published in Clinical Infectious Diseases 2009 Apr 1;48(7):e66-72

Study title and authors:
Preoperative statin use and infection after cardiac surgery: a cohort study.

Mohamed R, McAlister FA, Pretorius V, Kapoor AS, Majumdar SR, Ross DB, Norris CM
Department of Medicine, Division of General Internal Medicine, University of Alberta, Edmonton, Alberta, Canada.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19228110

This study explored the effects of preoperative statin use in adults who had undergone cardiac surgery. The study included 7,733 nontransplant cardiac surgery patients who were followed for 30 days.

The study found:
(a) Patients taking statins had a 24% increased risk of death compared to patients not taking statins.
(b) Patients taking statins had an 11% increased risk of death due to infection compared to patients not taking statins.
(c) Patients taking statins had an 8% increased risk of any infection compared to patients not taking statins.

 

 

Links to other studies:

Statin treatment increases the risk of death by 301% after balloon angioplasty

Statins should not be given to patients with heart failure

Statin use is associated with an 80% higher risk of multiple organ failure in severely injured blunt trauma patients

Cardiac surgery patients taking statins have a 42% increased risk of death

This study was published in the Journal of Cardiothoracic Surgergy 2012 Jul 13;7:39

Study title and authors:
Hemodynamic effects of peri-operative statin therapy in on-pump cardiac surgery patients.

Hinz J, Gehoff P, Schotola H, Hosseini MT, Didilis VN, Jebran AF, Gehoff A, Wiese CH, Schulz EG, Schoendube FA, Popov AF.
Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/22533985

This study set out to investigate the effect of statin therapy on patients undergoing cardiac surgery with cardiopulmonary bypass. (Cardiopulmonary bypass is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body). The study included 478 patients who stayed in hospital for an average of 25 days. They were divided into (i) statin taking group (ii) non statin group.

The study found:
(a) Patients taking statins had a 42% increased risk of death whilst in hospital compared to patients not taking statins.
(b) The statin taking group had a significant 16% lower Systemic Vascular Resistance Index compared to the non statin group. (A decrease of Systemic Vascular Resistance Index is evidence for systemic inflammation).

  

Links to other studies:

Statin treatment is associated with a higher death rate and a higher risk of heart attack in angioplasty patients

Statins can damage the lining of blood vessels

Statin major adverse effects have been under-reported and the way in which they withheld from the public, and even concealed, is a scientific farce 



Review reveals statins only extend life by 3 or 4 days. Closer analysis finds they may actually shorten life.

This study was published in the BMJ Open 2015 Sep 24;5(9):e007118

Study title and authors:
The effect of statins on average survival in randomised trials, an analysis of end point postponement.

Kristensen ML, Christensen PM, Hallas J.
Department of Clinical Pharmacology, University of Southern Denmark, Odense, Denmark.

This can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/26408281

The objective of the study was to estimate the average postponement of death by statin users in statin trials. The study included an analysis of 11 trials that were defined by being randomised, having at least 1000 patients included, comparing a statin with no treatment or placebo, having at least two years of follow-up. Six of the studies were for primary prevention and five for secondary prevention with a follow-up between 2.0 and 6.1 years.

The analysis found:
(a) In primary prevention trials statin users lived an extra 3.2 days.
(b) in secondary prevention trials statin users lived an extra 4.1 days.

So the results show that - with the massive expense of buying the drugs, with the plethora of debilitating side effects, such as diabetes, muscle damage, heart failure, suicide, homicide, accidental death, cognitive impairment, Alzheimer's, dementia, birth defects, cancer, cataract, erectile dysfunction, fatigue, liver damage, lung disease, memory loss, pancreatitis, peripheral neuropathy, rhabdomyolysis, and many, many more - with all these toxic side effects statins may (supposedly) increase your life by only three of four days.

However, do they even prolong life by this paltry amount?

Clinical trials with statins are performed in highly selected populations. Most statin trials have exclusion criteria that screens out a significant percentage of people because of health and toxicity concerns. This has the effect of making the statin drugs look better than they actually are.

In the real world, few people are discouraged from using statins by the medical profession, so many people who would not be allowed in the clinical trials are taking statin drugs. This is why clinical trials show that side effects are suffered by about 5% of participants, yet in reality the figure can be anything from a fifth to over two thirds (or even more) of all statin users. 

The begs the question, that if more people suffer toxic side effects than the clinical trials portray, then do people who are taking statin drugs also have a shorter life?

In trying to determine an answer to this question it may be helpful to look at the exclusion criteria in the eleven trials in this study.

The eleven trials were:
ALLHAT
ASCOT
CARDS
JUPITER
MEGA
WOSCOPS
4S
GISSI-HF
GISSI-P
LIPID
CORONA

(1) Exclusion criteria for the ALLHAT trial:
(i) People intolerant of statins: It's anyone's guess what this number is.
(ii) Those with liver or kidney disease.
(iii) Other contraindications for statin therapy: This may include hypothyroidism; pregnancy; lactation; excess alcohol intake; use of drugs such as: amiodarone, verapamil, diltiazem, erythromycin, clarithromycin, ciclosporin, itraconazole, ketoconazole, HIV protease inhibitors, nefazodone and ciclosporin; consumption of grapefruit or grapefruit juice; use of warfarin; patients at risk of haemorrhagic stroke.
(iv) Secondary cause of hyperlipidemia: This may include patients with diabetes; hypothyroidism; nephrotic syndrome; renal failure; use of drugs such as; adrenal steroids, isotretinoin, thiazides, anticonvulsants, oral contraceptives and alcohol; those who have obstructive liver disease, hepatitis, gaucher disease, von Gierke disease, acute intermittent porphyria, anorexia nervosa, systemic lupus erythematosus; the obese and those who smoke cigarettes. 

(2) Exclusion criteria for the ASCOT trial:
(i) Patients who had had a previous heart attack.
(ii) Those with angina.
(iii) A stroke within the previous 3 months.
(iv) Fasting triglycerides higher than 4·5 mmol/L.
(v) Heart failure.
(vi) Uncontrolled arrhythmias.
(vii) Anyone with a haematological (blood) or biochemical (chemical substances and vital processes) abnormality. 

(3) Exclusion criteria for CARDS:
(i) Any past history of myocardial infarction, angina, coronary vascular surgery, cerebrovascular accident, or severe peripheral vascular disease.
(ii) Abnormal kidneys.
(iii) High blood sugar.
(iv) Those who take their drugs less than 80% of the time.

(4) The JUPITER trial:
(i) 89,890 patients were screened for the study; (only 17,802 patients were finally entered into the trial.)
(ii) 37,611 patients were excluded because their LDLcholesterol was more than 130 mg/dL.
(iii) 25,993 because their C-reactive protein was less than 2.0 mg/L.
(iv) 957 patients for diabetes.
(v) 349 patients for hypothyroidism.
(vi) 305 patients for liver disease.
(vii) Many others for hypothyroidism, hypertriglyceridemia, concurrent use of hormone replacement therapy, or cancer in the last 5 years before enrolment
(viii) Additionally, 3,948 patients withdrew consent.
(ix) An additional 1,521 patients were excluded later after a 4-week placebo run-in for poor compliance.
(x) Despite all the scrutiny in choosing patients for the JUPITER trial, at the time of study termination, only 75% of study participants were still taking their study medication.

(5) The MEGA trial:
(i) 15,210 patients entered a 4-week run in phase, but 7,201 (48%) were excluded and only 8,009 finally participated in the trial.
(ii) Reasons for exclusion included: lack of effect on cholesterol, kidney and liver disease: and because "the patient had little probability of complying with the treatment".

(6) Exclusion Criteria for the WOSCOPS trial:
(i) History of treated heart attack.
(ii) Hospitalization for angina within prior 12 months.
(iii) Electrocardiogram abnormalities,.
(iv) Arrhythmia.
(v) Frequent premature ventricular contractions.
(vi) More than 2nd degree atrioventricular Block.
(vii) High blood pressure.
(viii) History of rheumatic heart disease.
(ix) Congenital heart disease.
(x) Cor pulmonale, chronic bronchitis, emphysema, or kyphoscoliosis associated with EKG changes.
(xi) Cardiomegaly, congestive cardiac failure, or significant valvular heart disease.
(xii) Other suspected serious physical illness.
(xiii) Psychiatric illness.
(xiv) Laboratory exclusions.

(7) 4S trial exclusion criteria:
(i) Premenopausal women of childbearing potential.
(ii) Secondary hypercholesterolaemia (see ALLHAT (iv)).
(iii) Unstable or Prinzmetal angina, tendon xanthomata.
(iv) Planned coronary artery surgery or angioplasty.
(v) Heart attack during the preceding six months.
(vi) Antiarrhythmic therapy.
(vii) Congestive heart failure requiring treatment.
(viii) Persistent atrial fibrillation.
(ix) Cardiomegaly.
(x) Haemodynamically important valvular heart disease.
(xi) Stroke.
(xii) Impaired liver function.
(xiii) Partial ileal bypass.
(xiv) History of drug or alcohol abuse.
(xv) Poor mental function.
(xvi) Other serious disease.
(xvii) Intolerant of statins.

(8) The GISSI-HF exclusion criteria:
(i) Heart attack, unstable angina or revascularization procedure within 1 month.
(ii) Planned cardiac surgery, expected to be performed within 3 months.
(iii) Congenital or primary valvular etiology.
(iv) Intolerant of statins.
(v) Liver disease.
(vi) Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
(vii) Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol.
(viii) Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy.
(ix) Kidney abnormalities.

(9) GISSI-P trial was an open trial on secondary coronary heart disease prevention: 4,271 recent acute heart attack patients with total blood cholesterol more than 200 mg/dl (5.1 mmol/L) were randomised to pravastatin 20 mg daily or no treatment.

(10) Exclusion criteria for the LIPID trial:
(i) Clinically significant medical or surgical event within three months before study entry.
(ii) Heart failure.
(iii) Kidney or liver disease.

(11) CORONA exclusion criteria.
(i) Prior statin-induced myopathy or hypersensitivity.
(ii) Decompensated chronic heart failure or need for inotropic support.
(iii) Heart attack within past 6 months.
(iv) Unstable angina or stroke within past 3 months.
(v) Coronary artery bypass graft (or similar), pacemaker within past 3 months or plan to implant.
(vi) Prior heart transplant.
(vii) Significant uncorrected primary valvular heart disease.
(viii) Malfunctioning prosthetic valve.
(ix) Hypertrophic cardiomyopathy.
(x) Acute endomyocarditis/myocarditis.
(xi) Pericardial disease.
(xii) Systemic disease (eg, amyloidosis).
(xiii) Liver disease.
(xiv) Chronic muscle disease.
(xv) Prior cyclosporine.
(xvi) Life-limiting condition (cancer etc).
(xvii) Suspected poor compliance to protocol.

This investigation of the exclusion criteria and run-in phases of statin trials reveals the reasons that the large significant percentage of people are excluded from entering the statin studies.
(a) Most trials weed out people who are intolerant of statins.
(b) Subjects with liver or kidney problems are normally excluded.
(c) Women of child bearing age are routinely not allowed.
(d) Patients are often barred who have had surgical procedures.
(e) Most studies don't allow patients with a wide range of heart conditions.
(f) People who use drugs or alcohol are not included in statin studies.
(g) Up to 80% of screened potential subjects are rejected from the trials.
(h) Patients with various concomitant illness are invariably excluded from the trials.
(i) Patients taking a wide range of pharmaceutical drugs are not allowed into the studies.
(j) Poor mental function patients are screened out.
(k) Many of the trials weed out potential subjects who they suspect will have poor compliance in taking the statin drugs.

 

A couple of the studies have a 'run-in' phase where potential subjects are weeded out through various criteria. These trials have amounted to about a 50 to 80% exclusion rate before the trial begins. Nearly all the trials have a whole plethora of exclusion criteria and although it is very difficult to quantify how many people have been excluded, it may be argued that the 50 to 80% exclusion rate may be broadly similar.

 

How can we answer the question "do people taking statins have a shorter life?" 

 

The above eleven statin trials included 92,135 subjects. If we take the lower exclusion rate of 50%, then potentially about another 46,000 statin intolerant or statin incompatible people could have been included in the trials.

 

This would dramatically reduce the already paltry "three or four days statins add to life".

 

How can an accurate revised death rate figure can be calculated? I don't know if it's possible. But with data from an extra 46,000 statin intolerant people to be crunched there would be an exponential rise in side effects with a concomitant rise in deaths.

 

So, even if the actual exclusion rate figure is less than the estimated 50% exclusion rate figure, I suspect that this closer analysis of clinical trials reveals that statins may actually shorten life in the real world.

 

Statins do not prevent cardiovascular and all-cause deaths

This paper was published in the Journal of Clinical Lipidology Volume 7, Issue 3 , Pages 222-224, May 2013
 
Study title and authors:
Point: Why statins have failed to reduce mortality in just about anybody
Eddie Vos, Colin P. Rose, Pierre Biron
127 Courser Road, Sutton, QC, Canada J0E 2K0

Department of Medicine, McGill University, Montreal, QC, Canada H3H 1V6

 

This paper can be accessed at: http://www.lipidjournal.com/article/S1933-2874(13)00052-4/abstract

 

This paper reviewed the scientific evidence regarding statins and death rates.

 

(i) In JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial), a trial involving 17,802 participants randomised to rosuvastatin or placebo found for all participants the cardiovascular mortality was not reduced.

(ii) All published trials with placebo controls conclusively establish that statins do not reduce mortality in women.

(iii) There are no mortality figures suggesting a positive effect for people taking statins for more than five or six years.

(iv) In the PROSPER (PROspective Study of Pravastatin in the Elderly at Risk) study, in patients older than 70 years of age, there appeared to be arising increased rate of cancer, which may indicate that longer intervals of statin therapy may have other costs in the elderly.

(v) For both genders, the lack of all-cause mortality benefit is also illustrated by all published studies using atorvastatin vs. placebo, including the summary of 49 in-house studies including 14,236 individual patients.

(vi) The secondary prevention study SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) ended with five more deaths on highdose atorvastatin than on placebo.

(vii) To date, there are no placebo-controlled studies showing a mortality benefit when patients used lovastatin, fluvastatin, cerivastatin, or pitavastatin.

(viii) No mortality benefit from statins has ever been shown in patients older than 70 years of age.

(ix) No mortality benefit from statins has ever been shown in patients with heart failure.

(x) No mortality benefit from statins has ever been shown in patients with kidney failure.

(xi) Patients believing consciously or subliminally that ‘‘their cholesterol is under control’’ because they take a statin may postpone embarking on lifestyle changes, such as stopping smoking and abandoning eating habits that produce obesity and diabetes.

(xii) There is evidence that statins themselves promote diabetes, a life-long health risk.

 

Vos advises: "Because the lack of circulating statins is not the cause of atherosclerosis and their benefit on mortality is highly questionable, we should concentrate on lifestyle changes. Exercise, no smoking, and a healthy diet are well demonstrated in population studies to reduce the high mortality seen in so many economically developed countries".

 

He concludes that statins: "do not prevent cardiovascular and all-cause deaths".

 



Statins increase the risk of serious adverse cardiovascular events

This study was published in the Journal of the American Medical Association 2007 Mar 28;297(12):1344-53

 

Study title and authors:

Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial.

Crouse JR 3rd, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Bots ML; METEOR Study Group.

Department of Medicine, Wake Forest University, Winston-Salem, NC 27157, USA. jrcrouse@wfubmc.edu

 

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/17384434

This study investigated the effects of statins in participants with a low risk of heart disease. The two year study was a randomised, double-blind, placebo-controlled trial of 984 individuals, average age 57 years. The participants received either a daily 40-mg dose of rosuvastatin or placebo.

The study found:
(a) Cholesterol levels reduced by 33% in the statin users and remained the same in those on placebo.
(b) Low density lipoprotein (LDL) cholesterol levels reduced by 49% in the statin users and remained the same in those on placebo.
(c) Statin users had a 21% increased risk of death compared to placebo.
(d) Statin users had a 423% increased risk of a serious adverse cardiovascular event compared to placebo.
(e) Statin users had a 4% increased risk of any adverse event compared to placebo.
(f) Statin users had a 5% increased risk of developing cancer compared to placebo.
(g) Statin users had a 5% increased risk of muscle pain compared to placebo.
(h) Statin users had a 121% increased risk of elevated liver enzymes compared to placebo.
(i) Statin users had a 56% increased risk of developing arthritis compared to placebo.



Low LDL cholesterol levels are associated with reduced survival in elderly patients with heart failure

This study was published in Cardiology 2014;127(1):45-50

Study title and authors:
Low levels of low-density lipoprotein cholesterol: a negative predictor of survival in elderly patients with advanced heart failure.

Charach G, Rabinovich A, Ori A, Weksler D, Sheps D, Charach L, Weintraub M, George J.
The Department of Internal Medicine 'C', Tel Aviv Sourasky Medical Center, Affiliated to the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/24217704

This study aimed to examine the impact of statins and low-density lipoprotein (LDL) cholesterol levels on survival rates in elderly patients with moderate and severe heart failure. The study included 212 patients, average age 77 years, who were followed for 3.7 years. The patients were divided into three groups according to LDL cholesterol levels:
(i) Group one had LDL cholesterol levels less than 90 mg/dL (2.32 mmol/l).
(ii) Group two had LDL cholesterol levels between 90-115 mg/dL (2.32-3.00 mmol/l).
(iii) Group three had LDL cholesterol levels above 115 mg/dL (3.00 mmol/l).

The study found:
(a) The total cholesterol levels of group one patients was 31% lower than group three patients.
(b) Group one patients were over twice as likely to be on statins than group three patients.
(c) Only 34% of group one patients survived longer than 50 months whereas 58% of group three patients survived longer than 50 months.

Charach concluded: "Low LDL cholesterol levels are associated with a reduced survival in elderly patients with clinically controlled moderate and severe heart failure. Statins were independently and significantly associated with a higher risk of mortality".

Statin treatment increases the risk of death from cancer

This study was published in the Journal of the American Medical Association 2002 Dec 18;288(23):2998-3007

Study title and authors:

Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).

ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. 

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/12479764

This study, which lasted for 6 years, was designed to determine whether pravastatin compared with patients usual medical care, reduces death rates in patients aged 55 or older who have high cholesterol and blood pressure and other heart disease risk factors. 10,355 participants were enrolled in the study and were assigned into 2 groups where they received either 40 mg of pravastatin a day or their usual medical care.

The researchers found at the end of the 6 year study:
(a) Heart disease death rates were virtually identical in both groups.
(b) Those who took statins had an 11% increased risk of death from cancer compared to those who did not take statins.
(c) Those who took statins had an 7% increased risk of suicide/homocide/accidental death compared to those who did not take statins.

The results of this study suggest that statin treatment increases the risk of death from cancer.



Links to other studies:
Statins may promote cancer in certain segments of the population
Statins raise prostate cancer risk of obese men
Young women who are treated with statins may be at increased risk for the development of breast cancer

Statins should not be given to patients with heart failure

This study was published in the Lancet 2008 Oct 4;372(9645):1231-9

Study title and authors:

Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.

Gissi-HF Investigators, Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/18757089?dopt=Abstract

The study investigated the effects of rosuvastatin in patients with heart failure. The study included 4,574 patients aged 18 years or older with chronic heart failure were assigned to either rosuvastatin 10 mg daily (2,285) or placebo (2,289) and followed up for 3.9 years.

The study found:
(a) Statin users had a 4% decreased risk of death from cardiovascular reasons compared to placebo.
(b) Statin users had a 12% increased risk of sudden cardiac death compared to placebo.
(c) Statin users had a 23% increased risk of fatal and non fatal stroke compared to placebo.
(d) Statin users had a 2.5% increased risk of death compared to placebo.

Tavazzi said: "In conclusion, results from the GISSI-HF trial might help physicians in taking the following decisions. First, not prescribing statins to patients with heart failure of non-ischaemic cause. Second, stopping statins in patients with heart failure of ischaemic cause".

Statins double the risk of stroke

This study was published in the New England Journal of Medicine 2005 Jul 21;353(3):238-48

Study title and authors:

Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis.

Wanner C, Krane V, März W, Olschewski M, Mann JF, Ruf G, Ritz E; German Diabetes and Dialysis Study Investigators.

Division of Nephrology, Department of Medicine, University of Würzburg, Würzburg, Germany. wanner_c@medizin.uni-wuerzburg.de

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/16034009?dopt=Abstract

This study investigated the effects of statin (atorvastatin) treatment in diabetic patients receiving hemodialysis. The study included 1,255 subjects with type 2 diabetes who were receiving hemodialysis who were assigned to receive either 20 mg of atorvastatin per day or matching placebo.

The study found:

• Those receiving atorvastatin had twice the risk of a fatal stroke.
• Death rates were similar in both groups.

This study found that atorvastatin increased stroke risk and had no effect on total death rates.  

Analysis of 13 studies finds that statins offer no health benefits for women

This paper was published in the Journal of the American Medical Association 2004;291(18):2243-2252

Study title and authors:

Drug Treatment of Hyperlipidemia in Women

Judith M. E. Walsh, MD, MPH;Michael Pignone, MD, MPH

Division of General Internal Medicine and Department of Epidemiology and Biostatistics, University of California, San Francisco.

This paper can be accessed at: http://jama.ama-assn.org/content/291/18/2243.abstract

The aim of this analysis of 13 studies (which included 19,707 women) was to determine if cholesterol lowering drugs such as statins have any effect on heart disease rates and death rates in women. The study investigated results for both women with cardiovascular disease and without cardiovascular disease.

The study found:

(a) For women with heart disease statins marginally lower heart disease rates, however death rates from all causes remained the same.

(b) For women without heart disease statins marginally raise heart disease death rates, however death rates from all cause again remained the same.

This analysis of 13 studies found that statins offer no health benefits for women.

JUPITER statin trial a biased sham

This paper was published in the Archives of Internal Medicine 2010;170(12):1032-1036

Study title and authors:
Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy
A Critical Reappraisal
Michel de Lorgeril, MD; Patricia Salen, BSc; John Abramson, MD; Sylvie Dodin, MD; Tomohito Hamazaki, PhD; Willy Kostucki, MD; Harumi Okuyama, PhD; Bruno Pavy, MD; Mikael Rabaeus, MD


This paper can be accessed at: http://archinte.ama-assn.org/cgi/content/full/170/12/1032#REF-IOI05093-1


Dr. de Lorgeril notes that the results of cholesterol-lowering drug trials show no evidence that statin drugs lower the disease rates or death rates of people with or without coronary heart disease with one exception, and that is the JUPITER (Justification for the Use of Statins in Primary Prevention) trial. JUPITER reports a substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels. 


The results of the JUPITER study were met with a massive media fanfare proclaiming the benefits of statin drugs. This enthusiastic recommendation has no doubt persuaded many people with normal cholesterol levels to start long term statin treatment.


The JUPITER trial tested the effects of rosuvastatin in patients without heart disease and with normal or low cholesterol levels but relatively high levels of C-reactive protein, a marker of inflammation. The study spanned 1,315 sites in 26 countries and included 17,802 people who were assigned either 20 mg/d of rosuvastatin or placebo.


3 recent trials with rosuvastatin (with the acronyms CORONA, GISSI-HF and AURORA) had been conducted, and all had failed to provide evidence that rosuvastatin therapy reduces heart disease complications.


The JUPITER trial was prematurely terminated on the grounds that it had generated evidence that the statin treatment had definitely reduced heart disease rates.


However the evidence shows otherwise:
(a) If you include people who had fatal and nonfatal heart attack and stroke - the trial was stopped after only 240 incidents. 
(b) There was no difference in the incidence of serious adverse events (total hospitalizations, prolongations of hospitalizations, cancer, and permanent disability) between the 2 groups.
(c) There was hardly any difference in death rates when the trial was ended, and the trend was showing that the statin groups death rate was increasing compared to the placebo group.


An "unequivocal reduction in cardiovascular mortality" was announced in March 2008 as the main justification for the premature trial termination.


However the actual facts again beg to differ:
(d) Fatal heart attacks were 9 in the statin group and 6 in the placebo group.
(e) Stroke death was 3 in the statin group compared to 6 taking the placebo.
So there was 12 cardiovascular deaths in each group. Hardly an "unequivocal reduction in cardiovascular mortality" as the JUPITER study authors concluded.


So why was the trial stopped early?


As stated earlier JUPITER was hailed in the media as a ringing endorsement for us all to start statin therapy. This was achieved by the authors of the study only highlighting some results of the trial and completely ignoring other, less favourable data. It also raises the suspicion that if the trial had continued then the results would have shown statins in an even more unfavourable light.


Rosuvastatin (sold under the brand name Crestor) is marketed and distributed by AstraZeneca Pharmaceuticals.


The JUPITER trial involved multiple conflicts of interest: 
(f) It was conducted by Astra Zeneca  with their obvious commercial interests. 
(g) Nine of 14 authors of the JUPITER article have financial ties to the Astra Zeneca. 
(h) The principal investigator has a personal conflict of interest as a co-holder of the patent for the C-reactive protein test.
(i) Astra Zenecas own investigators controlled and managed the raw data which increases the chance of bias appearing in the data.


Dr. de Lorgeril concludes:
(i) The results of the JUPITER trial are clinically inconsistent and therefore should not influence medical practice or clinical guidelines. 
(ii) The results of the JUPITER trial show that commercially sponsored clinical trials are at risk of poor quality and bias. 
(iii) The failure of the JUPITER trial to demonstrate a protective effect of rosuvastatin confirms the results of  more than 12 other cholesterol-lowering trials published in recent years, which all provided no evidence of protection against heart disease by cholesterol lowering. 
(iv) These failed trials strongly suggest that the presumed preventive effects of cholesterol-lowering drugs have been considerably exaggerated.


Dr.de Lorgeril ends by saying that the time has come for a critical reappraisal of cholesterol-lowering and statin treatments for the prevention of heart disease, and the emphasis on pharmaceuticals for the prevention of heart disease has diverted individual and public health attention away from other proven methods of prevention such as a healthy lifestyle, exercise and diet. 

Statins offer no benefit to the elderly

This study was published in the Lancet 2002 Nov 23;360(9346):1623-30

Study title and authors:

Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.

Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, Ford I, Gaw A, Hyland M, Jukema JW, Kamper AM, Macfarlane PW, Meinders AE, Norrie J, Packard CJ, Perry IJ, Stott DJ, Sweeney BJ, Twomey C, Westendorp RG; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk.

University Department of Pathological Biochemistry, University of Glasgow, Royal Infirmary, Scotland, Glasgow, UK. jshepherd@gri-biochem.org.uk

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/12457784

The aim of the trial was to ascertain the effects of pravastatin treatment in elderly men and women aged 70-82. The study involved 2,804 men and 3,000 women (total 5804) with a history of, or risk factors for, vascular disease. They were assigned into groups of either a statin (pravastatin) or placebo and the study lasted for just over 3 years. Total deaths and adverse events of heart attack, stroke, cancer etc were measured.

The results of the study revealed:
(a) Total serious adverse events were the same in both groups.
(b) Heart disease was 19% higher in the placebo group.
(c) Stroke risk was 3% higher in the pravastatin group.
(c) Cancer risk was 25% higher in the pravastatin group.
(d) Total death rates were 6% higher in the pravastatin group.

The results show that 3 years of statin treatment did not add one day to the life of the participants of the trial.

Women should not be prescribed statins as they fail to provide any overall health benefit

This article was published in the British Medical Journal 2007 May 12; 334(7601): 983 Study title and author:

Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No

Malcolm Kendrick, general practitioner

24 Prestwick Close, Tytherington, Macclesfield, Cheshire SK10 2TH

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1867901/?tool=pubmed

Dr. Kendrick believes there is little or no evidence of health benefits for women taking statins.

 

He makes the following observations:

(a) To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women.

(b) The primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women.

(c) Women should not be prescribed statins. Not only do statins fail to provide any overall health benefit in women, they represent a massive financial drain on health services. This money could be diverted to treatments of proved value.

(d) Statins carry a substantial burden of side effects.

(e) Mass medicalisation is a dangerous road with many psychological and societal consequences.

(f) In the Scandinavian simvastatin survival study three more women died taking statins than the women who took the placebo.

(g) In the studies of primary prevention neither total mortality nor serious adverse events have been reduced.

(h) A meta-analysis published in the Lancet found that statins even failed to reduce coronary heart disease events in women.

(i) Another meta-analysis of statins in primary prevention suggested that overall mortality may actually be increased by 1% over 10 years (in both men and women).

(j) Data from 124,814 women in 19 studies and trials found that cholesterol levels had no impact on total death rates and heart disease.

(k) Studies have suggested that side effects from statins may be much more common than is recognised.

(l) One study found that 80% of athletes could not tolerate statins.

(m) Research by Golomb and McGraw found that doctors often dismiss most (probable) statin related events. Patients who met the criteria for definite or probable adverse events reported that their doctors tended to dismiss symptoms, deny specific statins adverse events, and failed to appreciate the effect of the adverse reaction on their quality of life.

(n) More evidence comes from the US Food and Drug Administration adverse event reporting system. Between November 1997 and May 2004 simvastatin was reported as a direct cause of 49,350 adverse events and 416 deaths.Adverse events are greatly under-reported, so the actual figures are likely to be much higher.

(o) Of further concern, as statins are increasingly prescribed to younger women, is the potential for birth defects, with severe neurological abnormalities reported. Spending millions on a treatment that has no proved benefit and may cause serious harm goes against the rationale of evidence based prescribing.

 

Women should not be prescribed statins as they fail to provide any overall health benefit.

Cardiologist questions the benefits of statins

This post includes a synopsis of a paper published in the Canadian Medical Association Journal November 8, 2005; 173 (10) and a recipe for huevos rancheros.

Study title and authors:
Questioning the benefits of statins

Books:

Eddie Vos* and Colin P. Rose

*Sutton, Que.; Cardiologist, McGill University, Montréal, Que.

This paper can be accessed at: http://www.cmaj.ca/cgi/content/full/173/10/1207-a

Vos a cardiologist at McGill University, Montréal, notes that:
(a) Statins have failed to deliver in reducing all cause mortality
(b) There are no statin trials with even the slightest hint of a mortality benefit in women.
(c)  In patients over 70 years old evidence shows no mortality benefit of statin therapy.
(d)  In the ALLHAT study says it best: "trials [primarily in middle-aged men] demonstrating a reduction in [coronary artery disease] from cholesterol lowering have not demonstrated a net reduction in all-cause mortality." What is the point of decreasing the number of "events" without decreasing overall mortality, when the harm caused by the side effects of statin therapy is factored in?

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Recipe of the day

Huevos Rancheros

Ingredients:

◦1 lb. link sausage

◦6 eggs

Food Mall: Sausage

◦1 green onion, chopped

◦1 avocado, chopped
◦Salsa

Method:
For the sausage, use a knife to split the link 3/4 of the way through and use your fingers to split it flat. Cook the sausages in a saute pan, that’s on medium high heat, with the casing side down. Why? Because the casing needs to render out otherwise the sausage will curl up, won’t crisp up and will taste oddly chewy.

While the sausage is browning, whisk together the eggs with a bit of salt. Remember, the salt helps keep the eggs tender. After the sausage is done, scramble the eggs in the sausage renderings, however you like–runny, slightly runny, hard and rubbery.

To serve, lay a few sausage links down on your plate, top with eggs, spoon with salsa and then sprinkle the green onions and avocado on top.

The elderly die earlier when taking statins

This post contains a summary of a study published in Age Ageing 2010 39 (6): 674-680 and a recipe for braised beef with madeira sauce.

Study title and authors:
Lipid-lowering treatment to the end? A review of observational studies and RCTs on cholesterol and mortality in 80+-year olds

Books:

Line Kirkeby Petersen1, Kaare Christensen1 and Jakob Kragstrup2

1Research Unit of Epidemiology, Danish Aging Research Center and
2Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark

This paper can be accessed at: http://ageing.oxfordjournals.org/content/39/6/674.abstract
 
The author reviewed a total of 12 studies regarding the relationship of cholesterol levels and all-cause mortality. This corresponded to 13,622 participants: 3,789 aged 80 and above in eight studies and 9,833 aged 71–103 (average age 78 years) in four studies.

The review found:
(a) Regarding all-cause mortality in the 80+-year olds, low cholesterol levels did not seem beneficial in any study and low cholesterol levels (less than 5.5 mmol/l or 212 mg/dL) is associated with increased mortality among 80+-year olds.
(b) There was no evidence that statins decrease all-cause mortality in elderly people without known vascular disease, on the contrary, it was even possible that statins increased all-cause mortality.

This finding of the review show that low cholesterol and possibly statin treatment increases the death rate in the elderly.

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Recipe of the day

Braised Beef with Madeira Sauce

Ingredients:

Food Mall: Beef Brisket

1.3kg/3lb brisket

Salt and freshly milled black pepper

75g/3oz bacon, roughly chopped or bacon lardons

6 shallots, peeled and finely chopped

2 garlic cloves, peeled and crushed

45ml/3tbsp olive oil

1 small bunch fresh herbs

3 parsnips, peeled and chopped

4 celery sticks, chopped

450ml/¾pint good, hot beef stock

450ml/¾pint Madeira wine

Method:

1.Place the joint on a chopping board and season.

2.Heat a large non-stick frying pan and cook the bacon, shallots and garlic for 3-4 minutes. Transfer to a large ovenproof casserole dish.

3.In the same frying pan heat the oil and brown the joint on all sides for 4-5 minutes and transfer to the dish.

4.Add the remaining ingredients, cover the dish with 2 sheets of greaseproof paper or foil and secure with a lid.

5.Bring to the boil, reduce the heat and cook on the hob for the calculated cooking time until the beef is tender.

6.Remove the joint from the pan, transfer to a warm plate, cover and rest for 10 minutes before slicing. Meanwhile add olive oil to the sauce and stir gently.

Statins increase the death rate

This post contains a summary of a paper published in the British Journal of Clinical Pharmacology 2001 October; 52(4): 439–446 and a recipe for devilled lamb cutlets.

Books:

Study title and authors:

Statins for primary prevention: at what coronary risk is safety assured?

Peter R Jackson, Erica J Wallis, Ifti U Haq, and Lawrence E Ramsay
Section of Clinical Pharmacology and Therapeutics, University of Sheffield, Floor L, Hallamshire Hospital, Sheffield S10 2JF

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014585/

This paper reviewed the randomised placebo controlled clinical trials that assessed death rates and statin use. The authors searched the scientific literature and found five trials, namely: 4S, WOSCOPS, CARE, AFCAPS/TEXCAPS and LIPID.

The review found that statin use could be associated with an increase in mortality of 1% in 10 years.

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Recipe of the day

Devilled Lamb Cutlets

Ingredients:

Food Mall: Lamb Chops

4 lean lamb cutlets or chops

10ml/2tsp English mustard

Pinch cayenne pepper

5ml/1tsp lemon juice

30ml/2tbsp tomato ketchup

Method:

1.Cook the cutlets or chops under a preheated grill for 12-16 minutes, turning occasionally.

2.Meanwhile make up the devilled mixture; in a small bowl mix together the mustard, cayenne, lemon juice and tomato ketchup.

3.Brush each side of the chops with the mixture a couple of times during the last 2-3 minutes of the cooking time.