Thursday, November 24, 2011

Long-term study proves statins benefit to some

Those studied were "high risk" individuals. There is therefore no warrant from the findings that statins are of benefit to the general population. Note also the oddity that there was no mortality benefit in women in the original study and the fact that substantial funding (over one hundred million pounds) for the study came from statin drug companies. The academic journal abstract follows the popular summary below

I have looked at the whole article and can see no coverage of possible sex differences. In view of the findings in the original study, that seems extraordinary. It makes one wonder what else they have left out


STATINS safely reduce the risk of cardiovascular illness even years after treatment is stopped, according to a probe into the popular cholesterol-busters published today.

Statins work by blocking a liver enzyme that makes fatty molecules, which line arterial walls and increase the danger of heart disease and strokes.

With worldwide annual sales of more than 20 billion dollars, the drugs have been dubbed "the aspirin of the 21st century" because of their benefit and wide use.

But lingering questions persist about their long-term safety for the heart, liver and cancer risk.

Researchers at the Heart Protection Study Collaborative Group in Oxford looked at 20,536 patients at risk of cardiovascular disease who were randomly allocated 40mg daily of simvastatins or a dummy look-alike over more than five years.

During this period, those who took the statins saw a reduction in "bad" LDL cholesterol and a 23 per cent reduction in episodes of vascular ill-health, compared to the placebo group.

The monitoring of the volunteers continued for a further six years after the trial ended.

The benefits persisted throughout this monitoring period among those volunteers who stopped taking the statins, the investigators found.

In addition, there was no emergence of any health hazard among those who had taken, or were continuing to take, the drugs.

A large number of cancers (nearly 3500) developed during this follow-up period, but there was no difference in cancer incidence between the statin and placebo groups.

"The persistence of benefit we observed among participants originally allocated simvastatin during the subsequent six-year post-trial period is remarkable," said one of the investigators, Richard Bulbulia.

"In addition, the reliable evidence of safety, with no excess risk of cancer or other major illnesses during over 11 years follow-up, is very reassuring for doctors who prescribe statins and the increasingly large numbers of patients who take them long-term to reduce their risk of vascular disease."

A previous investigation in November 2010 found that long-term use of statins was less risky than thought for people with non-alcoholic fatty liver disease (NAFLD), a common liver ailment.

SOURCE
The Lancet, Early Online Publication, 23 November 2011
doi:10.1016/S0140-6736(11)61125-2

Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20 536 high-risk individuals: a randomised controlled trial

Background

Findings of large randomised trials have shown that lowering LDL cholesterol with statins reduces vascular morbidity and mortality rapidly, but limited evidence exists about the long-term efficacy and safety of statin treatment. The aim of the extended follow-up of the Heart Protection Study (HPS) is to assess long-term efficacy and safety of lowering LDL cholesterol with statins, and here we report cause-specific mortality and major morbidity in the in-trial and post-trial periods.

Methods

20 536 patients at high risk of vascular and non-vascular outcomes were allocated either 40 mg simvastatin daily or placebo, using minimised randomisation. Mean in-trial follow-up was 5·3 years (SD 1·2), and post-trial follow-up of surviving patients yielded a mean total duration of 11·0 years (SD 0·6). The primary outcome of the long-term follow-up of HPS was first post-randomisation major vascular event, and analysis was by intention to treat. This trial is registered with ISRCTN, number 48489393.

Findings

During the in-trial period, allocation to simvastatin yielded an average reduction in LDL cholesterol of 1·0 mmol/L and a proportional decrease in major vascular events of 23% (95% CI 19—28; p<0·0001), with significant divergence each year after the first. During the post-trial period (when statin use and lipid concentrations were similar in both groups), no further significant reductions were noted in either major vascular events (risk ratio [RR] 0·95 [0·89—1·02]) or vascular mortality (0·98 [0·90—1·07]). During the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites (0·98 [0·92—1·05]) or any particular site, or in mortality attributed to cancer (1·01 [0·92—1·11]) or to non-vascular causes (0·96 [0·89—1·03]).

Interpretation

More prolonged LDL-lowering statin treatment produces larger absolute reductions in vascular events. Moreover, even after study treatment stopped in HPS, benefits persisted for at least 5 years without any evidence of emerging hazards. These findings provide further support for the prompt initiation and long-term continuation of statin treatment.

Funding

UK Medical Research Council, British Heart Foundation, Merck & Co, Roche Vitamins.





Regular sex key to happiness in middle age, US study says

Does this just mean that happy couples have more sex?

OLDER married couples who have regular sex are more likely to be happier with their lives than those who do not, according to US research.

Only 40 percent of those who had no sex in the past 12 months said they were "very happy with life in general," compared to 60 percent of those who said they had sex more than once a month.

Almost 80 percent of those who had sex more than once a month also said they were very happy with their marriage, compared to 59 percent who did not, according to the research presented at the Gerontological Society of America's conference in Boston.

"This study will help open the lines of communication and spark interest in developing 'outside the box' approaches to dealing with resolvable issues that limit or prevent older adults from participating in sexual activity," according to Adrienne Jackson, from Florida Agricultural and Mechanical University.

Jackson added, "Highlighting the relationship between sex and happiness will help us in developing and organizing specific sexual health interventions for this growing segment of our population."

Some 238 married individuals aged 65 and older took part in the study.

SOURCE

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