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 



Statins users with existing coronary artery disease have a 15% increased risk of another heart attack

This study was published in Circulation Journal 2004 Jan;68(1):47-52

Study title and authors:
Insulin resistance and fasting hyperinsulinemia are risk factors for new cardiovascular events in patients with prior coronary artery disease and normal glucose tolerance.

Yanase M, Takatsu F, Tagawa T, Kato T, Arai K, Koyasu M, Horibe H, Nomoto S, Takemoto K, Shimizu S, Watarai M.
Division of Cardiology, Cardiovascular Center, Anjo Kosei Hospital, Aichi, Japan. yanase@kosei.anjo.aichi.jp

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/14695465

This study investigated risk factors for further cardiovascular event in patients with existing coronary artery disease. The study lasted three years and included 102 patients with coronary artery disease.

Regarding statins, the study found that patients who took statins had a 15% increased risk of a further cardiovascular event than patients who did not take statins.

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.



Statin treatment increases cardiovascular diseases in diabetics by 31%

This study was published in Diabetes 2009 Apr;58(4):926-33

Study title and authors:

C-reactive protein and 5-year survival in type 2 diabetes: the Casale Monferrato Study.

Bruno G, Fornengo P, Novelli G, Panero F, Perotto M, Segre O, Zucco C, Deambrogio P, Bargero G, Perin PC.

Department of Internal Medicine, University of Torino, Torino, Italy. graziella.bruno@unito.it

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19074985

The objective of the study was to determine to what extent various diabetic risk factors and diabetic treatments influence 5-year cardiovascular death rates and total death rates in type 2 diabetic individuals. The study lasted for 5 years, with 11,717 years of observation on 2,381 subjects with type 2 diabetes.

The study found after 5 years:

• Those with C-reactive protein levels above 3 mg/l had an increase of 51% in total death rates and an increase of 44% in death from cardiovascular diseases compared to those with C-reactive protein levels below 3 mg/l. High fat diets can reduce dangerous C-reactive protein levels see here.
• Those with high blood sugar levels (HbA1-C) had an increase of 10% in total death rates and an increase of 19% in death from cardiovascular diseases compared to those with lower blood sugar levels. High fat diets can reduce dangerous high blood sugar levels see here.
• Those with LOW levels of high density lipoprotein (HDL) cholesterol had an increase of 8% in total death rates and an increase of of 1% in death from cardiovascular diseases compared to those with higher levels of HDL cholesterol. High fat diets raise the levels of the good HDL cholesterol see here.
• Those who were been treated with anti-diabetic drugs had an increase of 9% in total death rates and an increase of 24% in death from cardiovascular diseases compared to those who were not treated with anti-diabetic drugs.
• Those who were receiving insulin treatment had an increase of 81% in total death rates and an increase of 129% in death from cardiovascular diseases compared to those who were not receiving insulin treatment.
• Those who were taking statins had an increase of 2% in total death rates and an increases of 31% in death from cardiovascular diseases.

This study reveals many health risk factors linked with diabetes and higher death rates including high levels of C-reactive protein and blood sugar, and treatment with anti-diabetic drugs and statins.

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".

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.

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.

End of the road for the diet-heart theory?

This post includes a summary of a paper published in the Scandinavian Cardiovascular Journal 2008 May 9:1-6 and a recipe for roast pork and taro.

Study title and author:

Books:

End of the road for the diet-heart theory?

Werko L

This paper can be accessed at: http://www.unboundmedicine.com/medline/ebm/record/18609049/abstract/End_of_the_road_for_the_diet_heart_theory
 
In this review Werko describes how the diet-heart theory is flawed. He points out that;
(a) Having a heart attack is NOT synonymous with clogged arteries.
(b) Shenanigans with the data has been used  to obscure the negative results of randomized multifactorial trials.
(c) Side effects of the statin group of medicines have been more or less been neglected in the large amount of clinical trials.

More information on this subject: Books : Scientific Studies : Other Websites : Videos : Food Mall

Recipe of the day

Roast Pork and Taro

Ingredients:
1-1/4 to 1-1/2 pounds taro (2-3 inches long)

Food Mall: Pork Shoulder

1 piece boned and tied pork butt or shoulder (2to2-1/2 pounds)

1 onion (1/2 lb.), peeled and chopped
2 tablespoons chopped fresh ginger
2 cups chicken or beef broth
4 cups chopped washed spinach leaves

Instructions:
In a 4 or 5 quart ovenproof pan over high heat, bring 2 quarts water to a boil. Add taro and cook 5 minutes.

Drain and let cool.

With a knife, peel taro and cut away any bruised or decayed spots. Cut taro into 1 inch chunks.

Rinse pan.

Rinse pork and set, fatty side up, in pan. Add taro, onion, ginger, and broth.

Cover and bake in a 375F oven until meat is very tender when pierced, about 2-1/2 hours.

Uncover and stir spinach into juices. Bake until meat is lightly browned, about 30 minutes more.

Then broil about 8 inches from heat until meat is richly browned, about 5 minutes longer.

Cut strings from pork, slice meat (it tends to tear apart), and serve with taro mixture and juices.

Season to taste.

Are all the early statin trials a sham?

This post includes a summary of a paper published in the Journal of Lipid Nutrition Vol. 19 (2010) , No. 1 pp.65-92

Study title and authors:
Recent cholesterol-lowering drug trials: New data, new questions
Michel de Lorgeri and Patricia Salen
Laboratoire Cœur & Nutrition, Université Joseph Fourier

This paper can be accessed at: http://www.jstage.jst.go.jp/article/jln/19/1/19_65/_article

Books:

The french cardiologist Dr Michel de Lorgeril investigated the outcome of recent cholesterol-lowering drugs trials.

He found:
(a) The cholesterol-lowering drug trials published in 2008-2009 were either negative (ENHANCE, SEAS, GISSI-HF, AURORA) or obviously biased and therefore not credible (JUPITER).
(b) It is also noteworthy that most cholesterol-lowering drug trials published between 2005 (the year of the Vioxx affair and of enforcement of new clinical trial regulations) and 2007 were also negative or ambiguous.
(c) Taken together, these trials strongly suggest that the results of previous, highly positive trials with statins - particularly in the secondary prevention of coronary heart disease - published between 1994 and 2004 and that were used to issue guidelines for medical practitioners should be carefully re examined by experts independent from the pharmaceutical industry.
(d) The positive results from trials published between 1994 and 2004 were before the Vioxx affair and of enforcement of new clinical trial regulations. (Vioxx was a drug that was supposed to greatly relieve the pains of arthritis sufferers, the problem was that it caused heart attacks and strokes and three-fold increase in death rates. The company that manufactured the drug (Merck) tried to hide these side effects by manipulating data. Eventually the drug was withdrawn and now, in an attempt to prevent pharmaceutical companies hiding or manipulating evidence, the US Food and Drug Administration require that all pharmaceutical companies file any and all trial results to a federal registry within one year of the completion of the trial).

Dr de Lorgeril concludes: "The next question would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality".

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