Ladies: No need to feign a headache - just give your man a statin!

This study was published in Drug Safety 2009;32(7):591-7

Study title and authors:

Statins and erectile dysfunction: results of a case/non-case study using the French Pharmacovigilance System Database.

Do C, Huyghe E, Lapeyre-Mestre M, Montastruc JL, Bagheri H.

Université de Toulouse, UPS, Unité de Pharmacoépidémiologie EA 3696, Toulouse, France.

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19530745

The object of this study was to investigate the association between exposure to drugs such as statins and the occurrence of erectile dysfunction. Over a 20 year period the researchers extracted data about 110,685 men aged 13 - 80 years old who had reported an incidence of erectile dysfunction to see if they had being taking statins, fibrates or other drugs.

The study found:
(a) Statins users had a 275% increase in erectile dysfunction.
(b) Erectile dysfunction usually started to occur within 1 month.
(c) Just over half of these men recovered if they stopped taking the statins.
(d) Erectile dysfunction happened no matter what the dose or duration of the statin therapy.
(e) Fibrate users had a 260% increase in erectile dysfunction.
(f) Men on beta-adrenergic receptor antagonists (beta blockers) had 50% increased rates of erectile dysfunction.
(g) Those taking tricyclic antidepressants had double the risk of erectile dysfunction.
(h) Men having finasteride (used for male pattern baldness) were over 14 times more likely to suffer from erectile dysfunction.

This study reveals that statins and other drugs are a major risk factor in erectile dysfunction.

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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.

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Statins cause a massive rise in constipation

This study was published in the Journal of the American Medical Directors Association 2010 Oct;11(8):572-8

Study title and authors:

Risk factors associated with stool retention assessed by abdominal radiography for constipation.

Gau JT, Walston S, Finamore M, Varacallo CP, Heh V, Kao TC, Heckman TG.

Department of Geriatric Medicine/Gerontology, Ohio University College of Osteopathic Medicine (OU-COM), Athens, OH 45701, USA. gau@oucom.ohiou.edu

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/20889093

One of the aims of the study was to identify risk factors associated with constipation. 122 adults aged 65 or over with constipation were included in the study.


The study found that the use of statins was significantly associated with constipation, with statin users having a 286% increased risk of constipation.

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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. 

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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.

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High fat diets reduce dangerous C-reactive protein levels by 52.6%

This study was published in Diabetologia 2005 Jan;48(1):8-16

Study title and authors:

Comparison of high-fat and high-protein diets with a high-carbohydrate diet in insulin-resistant obese women.

McAuley KA, Hopkins CM, Smith KJ, McLay RT, Williams SM, Taylor RW, Mann JI

Edgar National Centre for Diabetes Research, Medical and Surgical Sciences, University of Otago, PO Box 56, Dunedin, New Zealand. kirsten.mcauley@stonebow.otago.ac.nz

This study can be accessed at: http://www.springerlink.com/content/1abv5hablr8veyrm/fulltext.html

High levels of C-reactive protein and triglycerides are associated with an increased risk of heart disease. See here and here.

This study investigated the effects of 3 diets on diabetes and heart disease risk factors, such as weight, triglyceride levels and C-reactive protein levels in 96 overweight insulin-resistant women.

The diets were either:
(i) High-carbohydrate, high-fibre diet
(ii) High-protein diet
(iii) High-fat diet

The study found:
(a) When compared with the high carbohydrate diet, the high fat and high protein diets were shown to produce significantly greater reductions in weight loss.
(b) When compared with the high carbohydrate diet, the high fat and high protein diets were shown to produce significantly greater reductions in triglyceride levels.
(c) All diets reduced C-reactive protein levels. The high carbohydrate diet reduced them by 14.8% and the high protein diet by 17.3%. However by far the largest decrease in the dangerous C-reactive protein levels was on the high fat diet, with a 52.6% reduction.

This study reveals how a high fat diet is effective in reducing the risk of heart disease, with weight loss and the reduction of heart disease risk factors such as triglyceride and C-reactive protein levels.

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Professor says the cholesterol hypothesis is false and should be buried

This paper was published in the Scandinavian Cardiovascual Journal 2011 Dec;45(6):322-3

Study title and author:

The cholesterol hypothesis: time for the obituary?

Scherstén T, Rosch PJ, Arfors KE, Sundberg R.

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/22070401

Dr. Schersten is a professor of Vascular Surgery, University of Göteborg and was previously Principal Secretary of the Swedish Medical Research Council.

Professor Schersten finds that the cholesterol hypothesis that links cholesterol intake and blood cholesterol levels to cardiovascular disease has little or no scientific backing that is relevant for the human species.

He concludes that the hypothesis is false and should be buried.

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