Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Devices for Lowering Blood Pressure

The British Hypertension Society (BHS) issued a statement earlier this year regarding the use of medical devices to lower blood pressure. This statement was made following several queries about a new product listed in the Drug Tariff.

The statement refers to a systematic review and meta-analysis that was published in the Journal of Hypertension. This study identified 8 trials involving 494 patients using the RESPeRATE® device.

Collectively these trials demonstrated statistically significant reductions in systolic and diastolic blood pressure of 3.67mmHg (95% CI −5.99 to −1.39; P=0.002) and 2.51mmHg (95% CI −4.15 to −0.87; P=0.003) respectively. However, when 5 trials that were sponsored by or involved the manufacturers of the device were removed from the analysis no overall effect on blood pressure was evident.

The authors of the paper conclude that, "longer term, independent trials are required to validate this intervention". The BHS note that the longest trial duration was 9 weeks and that no effect was seen on pulse rate or quality of life. They advise that, "such small effects over very short durations of time do not provide sufficient evidence for this equipment to be recommended".

Action: Clinicians should be aware of the availability of this product. Such devices cannot be recommended based on the currently available evidence.

Thanks to Kevin Ashworth for spotting this article

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$3 billion fine for GSK

GlaxoSmithKline has reached an agreement to pay a $3 billion fine (£1.9billion) after promoting drugs for unapproved uses and withholding safety data in the USA. This has been reported in the general media (BBC).

The settlement covers both civil and criminal liabilities for activities ranging from off-label promotion of anti-depressants, including promoting use in children and adolescents and direct payments to physicians, to withholding safety data and making unsupported safety claims for the now withdrawn diabetes drug rosiglitazone (Avandia®).

A statement issued by the company states that fundamental changes have been made throughout the American business to their procedures for compliance, selling and marketing. Government officials will continue to closely monitor the company for the next 5 years as part of the settlement.

A statement from the Deputy Attorney General in the US Department of Justice noted that this is the "largest health care fraud settlement in United States history".

Action: Clinicians should be aware of this fine and the resulting media reports. Such reports risk undermining public confidence in the pharmaceutical industry and, by proxy, healthcare organisations.

Thanks to Kevin Ashworth for spotting this article

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Games4Life

Games4Life is the latest campaign from the Department of Health's Change4Life public health policy. In a summer which will see over 1,200 hours of sport being aired on television it is hoped that the excitement these events generate will encourage people to get involved and get active.

The Games4Life website allows visitors to complete a brief questionnaire and then receive a free personalised activity plan. These plans can be tailored to accommodate activities for children and adults.

The site also provides access to a Fun Generator which provides a rapid way to identify fun activities for indoors and outdoors and for individuals or groups. There are over 100 different activities available so there should be something for everyone. It is also available for mobile devices running iOS and Android.

Action: Clinicians should be aware of this new campaign. It may be a useful resource for patients who are motivated to increase their activity levels.

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