Taking insulin to control type 2 diabetes may increase the risk of developing serious complications, a new study suggests.

An epidemiological study based on the UK Clinical Practice Research Datalink (CPRD) has shown that type 2 diabetes patients taking insulin are at higher risk of heart attack, stroke, cancer and retinopathy than those taking oral medications.

The study follows a population-based study that showed people with type 2 diabetes treated with insulin had a 50% higher mortality rate than people treated with a widely prescribed alternative.

Researchers from Cardiff University’s School of Medicine used CRPD data, which covers about 10% of the UK population, to compare the mortality rates of people whose type 2 diabetes is treated in different ways.

Lead study author Professor Craig Currie noted that the use of insulin to control blood glucose levels in people with type 2 diabetes has grown “markedly” in recent years. However, he noted, “By reviewing data from CPRD between 1999 and 2011 we’ve confirmed there are increased health risks for patients with type 2 diabetes who take insulin to manage their condition.”

Type 1 diabetes requires treatment with insulin, but type 2 diabetes – which often occurs in older and overweight people – can be treated in a number of ways depending on the patient’s characteristics.

“This study shows that we need to investigate this matter urgently, and the drug regulatory authorities should take interest in this issue,” Professor Currie added.

A previous study of UK patients taking insulin to control type 2 diabetes found a 50% higher mortality rate than with an oral drug therapy.

However, it should be noted that those patients with type 2 diabetes put on insulin are likely to have the worst diabetes control prior to insulin therapy.

An individual suffering a cardiac arrest in London is three times more likely to survive than somebody living in the Home Counties, new figures suggest.

Data from ambulance services across England found that almost a third (31.7%) of people who suffer a heart attack away from a hospital in the capital survive. Yet only 10.8% of people survive in the South Central region.

Fiona Moore, Medical Director of the London Ambulance Service, said the results were “fantastic”.

The London Ambulance Service started tracking its own survival rates from 1998 onwards. In its first year capturing data it found that only 4% of people who suffered a heart attack away from a hospital survived.

The national figures are the first time ambulance services across the country have pooled together their data to measure survival rates.

The East of England had the second best survival rate with just under a quarter (24.4%) of people surviving a heart attack. The North East followed closely behind, but the Isle of Wight (17.4%) and Great Western (15.1%) services recorded disappointing figures.

Undiagnosed or untreated chronic kidney disease (CKD) causes 45,000 premature deaths in England each year, according to a new report.

The study, commissioned by NHS Kidney Care, estimates that CKD costs the NHS £1.4bn per year – about half of which is spent on treating advanced CKD with dialysis or transplants.

Earlier diagnosis and intervention to address the condition – through behaviour changes and drug therapies – could prevent many severe cases and save many lives, the study concludes.

CKD is a progressive condition in which the kidneys become less effective at cleaning the blood, increasing the risk of cardiovascular events.

According to the report, 1.8m people in England have been diagnosed with CKD and another 1m may be undiagnosed.

“Chronic kidney disease has a much greater impact on people's lives, and on NHS costs, than is generally recognised,” said study author Marion Kerr.

“Most of the spending on CKD is for people with advanced disease. We hope this report will focus attention on the need for early detection and intervention.”

Dr Donal O’Donoghue, National Clinical Director for NHS Kidney Care, commented: “Putting the cost of care aside, for individuals the late identification of kidney disease means delays in diagnosis with a failure to manage risk factors including heart attacks, strokes and progressive kidney disease.”

Bristol-Myers Squibb’s anti-platelet therapy Plavix (clopidogrel) has become the latest blockbuster to lose patent protection in the US.

A mainstay of heart disease treatment since 1997, Plavix faces immediate generic competition from Cardinal Health.

BMS, who markets Plavix in partnership with Sanofi, has said it will cease promoting the drug immediately following patent expiry.

Used together with aspirin, Plavix is the standard blood-thinning therapy for people who have suffered a heart attack.

The product earned BMS $7.1bn in 2011, a third of the company’s revenue.

BMS has decided not to follow the example of Pfizer, who promoted Lipitor extensively for six months after its US patent expiry, because the usual six-month exclusivity to one generic supplier will not apply.

The reason is that the first authorised supplier of generic clopidogrel, Apotex, forfeited its exclusivity period due to unlicensed sales in 2006.

As a result, seven companies have already received tentative approval to sell generic clopidogrel in the US. Cardinal Health plans a next-day launch. A spokesman for Sun Pharmaceutical Industries said the company would lose no time: “I would not be surprised if there was a stopwatch involved.”

BMS’s 2011 annual report predicted “a rapid, precipitous and material decline in Plavix net sales” following expiry of its US patent.

The company has developed a new blood-thinning drug, Eliquis, in partnership with Pfizer. Its FDA approval for stroke prevention is expected in June.

The use of prescribed aspirin is not suitable for primary prevention of cardiovascular diseases, according to a new UK-led study.

The study found that a small reduction in heart attack risk achieved by regular aspirin doses was outweighed by a greater increase in the risk of serious internal bleeding.

The authors concluded that regular prescription of aspirin in people with no history of cardiovascular disease is not appropriate.

A research team at St George’s University of London analysed data from nine clinical trials with over 100,000 healthy people over six years to determine the effects of taking aspirin daily.

Regular aspirin doses reduced the total incidence of cardiovascular events by 10%, but this difference was entirely in non-fatal heart attacks and not in strokes or fatal heart attacks.

In addition, regular aspirin doses increased the incidence of severe or potentially fatal internal bleeding by 30%.

Aspirin, a mild anticoagulant, has been shown to reduce the risk of blood clotting. It is widely prescribed in both secondary and primary prevention of cardiovascular events.

The study authors concluded that since the risks outweigh the benefits, “routine use of aspirin for primary prevention is not warranted”.

Lead study author Dr Rao Seshasai emphasised that the use of aspirin in secondary prevention of cardiovascular disease (in people with a history of such disease) is undoubtedly worthwhile.

However, he noted, the benefits of aspirin to patients without a history of cardiovascular disease are “far more modest” and the risks greater than had been thought.

“It would be worthwhile to review the existing recommendations, such as the Joint British Societies' Guidelines, for the use of this agent in low-risk populations, and consider aspirin treatment more selectively on a case-by-case basis,” he said.

Bayer has submitted its oral anticoagulant Xarelto (rivaroxaban) to the European Medicines Agency for marketing authorisation for secondary prevention, after onset, of acute coronary syndrome (ACS).

The submission is based on clinical trial results that indicated a 34% relative risk reduction in cardiovascular mortality when the drug is used in combination with antiplatelet therapy.

Xarelto is the first oral direct factor Xa inhibitor, acting at a specific point in the clot formation process, and is the first anticoagulant other than vitamin K antagonists to be submitted in this indication.

ACS is the blocking of a coronary artery by a blood clot, and occurs as a complication of coronary heart disease. It can directly cause heart attack or unstable angina.

The global phase III ATLAS ACS 2-TIMI 51 study showed that adding twice-daily rivaroxaban to standard antiplatelet therapy reduced the incidence of cardiovascular death after a recent ACS by 34%.

The combination also reduced the incidence of stent thrombosis relative to standard therapy. It increased the incidence of major bleeding events, but not of fatal bleeding.

“The prevention of subsequent ACS episodes is a critically important clinical target and in rivaroxaban, we have a compound which offers a significant reduction in both CV death and all-cause mortality,” said Luis-Felipe Graterol, Medical Director, Bayer Healthcare UK.

Xarelto is currently approved in the UK for prevention of venous thromboembolism (VTE) after hip or knee replacement surgery; prevention of stroke in patients with non-valvular atrial fibrillation; and secondary treatment of deep vein thrombosis (DVT).

Rivaroxaban was discovered by Bayer Healthcare in Germany and is being jointly developed by Bayer and Janssen (a Johnson & Johnson company), who co-funded the ATLAS ACS 2-TIMI 51 study. The drug is marketed in the US by Janssen.

NICE has recommended Boehringer Ingleheim’s Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final draft guidance.

The positive recommendation follows the disclosure of further information from Boehringer that had been requested on a number of areas, including its cost effectiveness and use in clinical practice.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says the medication “represents a significant potential benefit for many people with AF”.

Questions were initially raised by NICE’s Independent Appraisal Committee over the cost to the NHS and a “more plausible set of assumptions” on Pradaxa’s use were required from Boehringer.

But NICE says it is “pleased” the additional information and analysis it received has enabled the Committee to recommend the treatment as a cost-effective use of NHS resources.

“The Independent Appraisal Committee accepted evidence that showed dabigatran 150mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110mg twice daily is as effective as warfarin. However, there were a number of uncertainties relating to the drug’s cost-effectiveness in the original evidence submission from the manufacturer which required clarification,” said Professor Longson.

Dr Charles de Wet, Medical Director at Boehringer Ingelheim, welcomed the revised decision by NICE. “Pradaxa is the first new oral anticoagulant in 50 years and we are committed to working closely with the NHS to ensure appropriate prescribing in suitable patients with AF who are at risk of stroke,” he said.

Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years with AF who have had a previous stroke, heart attack or systemic embolism.

It is also authorised for people with AF over 65 who have diabetes, coronary heart disease or hypertension.

Final guidance is now expected to be published next month.

The EMA has started a new review of the cardiovascular safety of non-selective NSAIDS (non-steroidal anti-inflammatory drugs).

The CHMP’s previous opinion of NSAIDs in 2006 was positive, but a small possibility of an increased risk of thrombotic events such as heart attack or stroke could not be excluded, particularly involving high doses and long-term treatment with NSAIDs.

The CHMP will update its opinion in light of recently published evidence from the independent research project Safety Of non-Steroidal anti-inflammatory drugs (SOS) funded by the European Commission.

NSAIDS have been subject to several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions since the CHMP’s 2006 opinion.

It will review the results thoroughly, together with other available clinical research data, to distinguish the need to update the CHMP’s 2006 opinion.

Popular painkillers or non-steroidal, anti-flammatory drugs (NSAIDs) can increase the risk of heart attack or stroke by a third, a study has found.

Researchers from the NHS, Hull York Medical School (HYMS), and the Institute for Clinical Evaluative Sciences in Canada found that patients with heart problems who used NSAIDs, including diclofenac and indomethacin, had a significantly higher risk of serious cardiovascular events compared to patients who did not.

Dr Patricia McGettigan, lead researcher of the study at HYMS said: “NSAIDs provide pain relief for millions of patients with chronic inflammatory disorders. The cardiovascular risk is well described but often overlooked.”

Even OTC drugs such as diclofenac were linked to serious cardiovascular risks, however, other common NSAIDs, including naproxen and low doses of ibuprofen do not appear to increase any risks.

The team of researchers based its results after reviewing 51 large scale studies of NSAIDs conducted in Europe, USA, Canada and Australia.

Dr McGettigan commented: “In choosing which one of the many available NSAIDs to use, patients and doctors would benefit from knowledge of the balance between benefit and harm for individual NSAIDs.”

Many people use NSAIDs in both OTC and prescription form for pain relief and for their anti-inflammatory effects to treat pains and aches.

In 2010, GPs prescribed 17 million NSAIDs in England alone, accounting for one in three people in the country. Of these, nearly 6 million were for diclofenac, 5 million were for ibuprofen and 3 million for naproxen, all of which can be bought without prescription.

The Medicine Company’s Angiox (bivalirudin) has been recommended by NICE for the treatment of a type of heart attack called ST-segment-elevation myocardial infarction (STEMI).

NICE’s independent Appraisal Committee concluded that the treatment is more effective and less costly than other options to treat the condition.

Dr Carole Longson, NICE Health Technology Evaluation Centre Director, says the NHS has been provided with “another important tool” to treat people more effectively.

Approximately 180,000 people in the UK are admitted to hospital after suffering a heart attack and nearly 30,000 people in England and Wales will die as a result.

STEMI is caused by the narrowing and blockage of the coronary artery that delivers blood to the heart. Current treatments aim to re-open the blocked artery and include primary PCI, a surgical procedure where either fine wires, balloons or stents are inserted to disrupt the blood clot.

Angiox is a type of anticoagulant that is given intravenously at the time of the PCI, together with aspirin and clopidogrel, to prevent blood from clotting during the procedure.

“The independent committee that advises NICE considered that, on the basis of the available evidence, bivalirudin, in combination with clopidogrel and aspirin, is both more effective and less expensive than treatment with a glycoprotein inhibitor plus heparin,” said Dr Longson.

“It is also associated with a lower incidence of major bleeding events compared with heparin and glycoprotein inhibitors.”