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zoom RSS 睡眠薬服用する人の死亡リスクが増大/米国

<<   作成日時 : 2012/03/03 09:33   >>

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 米国での研究によると、睡眠薬により死亡リスクが増大するという。テマゼパムのような睡眠薬を服用する10,000人とそういった薬剤を服用しない23,000人を比較したところ、死亡リスクが約4倍高かった。このリスク増加は心肺疾患や喫煙・飲酒とは関連はなかった。
 英国では2010年にテマゼパムが530万、ゾピクロンが280万、ゾルピデムが72万処方された。

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28 February 2012 Last updated at 02:17 GMT
Sleeping pills 'linked to increased death risk'
By Michelle Roberts
Health reporter, BBC News

画像Sleeping pills used by thousands of people in the UK appear to be linked with a higher death risk, doctors warn.

The American study in BMJ Open compared more than 10,000 patients on tablets like temazepam with 23,000 similar patients not taking these drugs.

Death risk among users was about four times higher, although the absolute risk was still relatively low.

Experts say while the findings highlight a potential risk, proof of harm is still lacking.

They say patients should not be alarmed nor stop their medication, but if they are concerned they should discuss this with their doctor or pharmacist.

UK guidelines for NHS staff say hypnotic drugs should only be used for short periods of time because of tolerance to the drug and the risk of dependency. But they make no mention of an associated death risk, despite other studies having already reported this potential risk.

The Medicines and Healthcare products Regulatory Agency said it would consider the results of this latest study and whether it has any implications for current prescribing guidance.

Continue reading the main story

Start Quote

The study needs to be replicated in a different sample and I think we need to hold judgement until we have further studies”

Malcolm Lader
Professor of clinical psychopharmacology at the Institute of Psychiatry at King's College London
Millions prescribed
In 2010 in England, there were 2.8 million prescriptions dispensed for temazepam and almost 5.3 million for another common sleeping pill called zopiclone.

There were also more than 725,000 prescriptions dispensed for zolpidem and more than 9,400 for zaleplon, two other drugs in this same family.

The latest study looked at a wide range of sleeping pills, including drugs used in the UK, such as benzodiazepines (temazepam and diazepam), non-benzodiazepines (zolpidem, zopiclone and zaleplon), barbiturates and sedative antihistamines.

The investigators, from the Jackson Hole Centre for Preventive Medicine in Wyoming and the Scripps Clinic Viterbi Family Sleep Centre in California, found that people prescribed these pills were 4.6 times more likely to die during a 2.5-year period compared to those not on the drugs.


Overall, one in every 16 patients in the sleeping pill group died (638 out of 10,531 in total) compared to one in every 80 of the non-users (295 deaths out of 23,674 patients).

This increased risk was irrespective of other underlying health conditions, such as heart and lung diseases, and other factors like smoking and alcohol use, which the researchers say they did their best to rule out.

The researchers say it is not yet clear why people taking sleeping tablets may be at greater risk.

The drugs are sedating and this may make users more prone to falls and other accidents. The tablets can also alter a person's breathing pattern as they sleep and they have been linked to increased suicide risk.

'Meagre benefits'
In this latest study, those taking the highest doses of sleeping tablets also appeared to be at greater risk of developing cancer.

The researchers say: "The meagre benefits of hypnotics, as critically reviewed by groups without financial interest, would not justify substantial risks."

They say even short-term use may not be justifiable.

But Malcolm Lader, professor of clinical psychopharmacology at the Institute of Psychiatry at King's College London, said people should not panic as a result of the findings.

"The study needs to be replicated in a different sample and I think we need to hold judgement until we have further studies.

"What we don't want is people stopping sleeping tablets and then going through a very disturbing period of insomnia.

"People should discuss this with their GP but should not under any circumstances stop taking their medication."

Nina Barnett, of the Royal Pharmaceutical Society, said: "This is an important study and although it is unlikely to radically change prescribing in the immediate term, it should raise awareness and remind both patients and prescribers to the potential risks of sedative use for insomnia.

"The association between mortality and sedation is not new and this research tells us that people who took these medicines were more likely to die than people who didn't take them.

"However it does not mean that the deaths were caused by the medicine."

A spokesman for the Association of the British Pharmaceutical Industry said the safety of medicines was closely monitored and continued even after regulatory approval.


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BMJ Open 2012;2:e000850 doi:10.1136/bmjopen-2012-000850
Pharmacology and therapeutics
Hypnotics' association with mortality or cancer: a matched cohort study
OPEN ACCESS
Daniel F Kripke1, Robert D Langer2, Lawrence E Kline1
+ Author Affiliations

1Scripps Clinic Viterbi Family Sleep Center, La Jolla, California, USA
2Jackson Hole Center for Preventive Medicine, Jackson, Wyoming, USA
Correspondence to
Dr Daniel F Kripke; kripke.daniel@scrippshealth.org
Received 9 January 2012
Accepted 20 January 2012
Published 27 February 2012
Abstract
Objectives An estimated 6%?10% of US adults took a hypnotic drug for poor sleep in 2010. This study extends previous reports associating hypnotics with excess mortality.

Setting A large integrated health system in the USA.

Design Longitudinal electronic medical records were extracted for a one-to-two matched cohort survival analysis.

Subjects Subjects (mean age 54?years) were 10?529 patients who received hypnotic prescriptions and 23?676 matched controls with no hypnotic prescriptions, followed for an average of 2.5?years between January 2002 and January 2007.

Main outcome measures Data were adjusted for age, gender, smoking, body mass index, ethnicity, marital status, alcohol use and prior cancer. Hazard ratios (HRs) for death were computed from Cox proportional hazards models controlled for risk factors and using up to 116 strata, which exactly matched cases and controls by 12 classes of comorbidity.

Results As predicted, patients prescribed any hypnotic had substantially elevated hazards of dying compared to those prescribed no hypnotics. For groups prescribed 0.4?18, 18?132 and >132 doses/year, HRs (95% CIs) were 3.60 (2.92 to 4.44), 4.43 (3.67 to 5.36) and 5.32 (4.50 to 6.30), respectively, demonstrating a dose?response association. HRs were elevated in separate analyses for several common hypnotics, including zolpidem, temazepam, eszopiclone, zaleplon, other benzodiazepines, barbiturates and sedative antihistamines. Hypnotic use in the upper third was associated with a significant elevation of incident cancer; HR=1.35 (95% CI 1.18 to 1.55). Results were robust within groups suffering each comorbidity, indicating that the death and cancer hazards associated with hypnotic drugs were not attributable to pre-existing disease.

Conclusions Receiving hypnotic prescriptions was associated with greater than threefold increased hazards of death even when prescribed <18 pills/year. This association held in separate analyses for several commonly used hypnotics and for newer shorter-acting drugs. Control of selective prescription of hypnotics for patients in poor health did not explain the observed excess mortality.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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