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ACEi/diuretic combination shown to lower death in type 2 diabetes

Routine administration of a blood pressure-lowering drug to people with diabetes – a fixed combination of perindopril (an ACE inhibitor) and indapamide (a diuretic), known as Coversyl Plus (Servier, Wexham), significantly reduces risk of death and cardiovascular events, irrespective of initial blood pressure status or other diabetes related treatments. This is according to results of the blood pressure-lowering arm of the 5-year study, ADVANCE (Action in Diabetes and Vascular Disease), presented at the European Society of Cardiology and published online in The Lancet.

The relative risk reduction of cardiovascular-related death was reduced by 18% (3.8% active versus 4.6% placebo) and death from any cause was reduced by 14% (7.3% active versus 8.5% placebo). In absolute terms, one death could be avoided for about 80 patients treated with Coversyl Plus over five years. In addition to this, the relative risk reduction of renal events was reduced by 21%.

Dr George Kassianos (a GP in Bracknell and a Fellow of the European Society of Cardiology) commented: ‘This study is genuinely exciting because it provides a rationale for considering such treatment routinely for patients with type 2 diabetes. It can save lives and reduce cardiovascular complications, regardless of whether patients have hypertension to start with or not – which has never been proven before. For doctors, this demonstrates that the therapeutic targets for blood pressure should actually be in line with levels suggested in the British Hypertension Society Guidelines and supported by the Joint British Societies Guidelines.’

ADVANCE is the first and largest trial ever performed with a fixed combination antihypertensive in people with type 2 diabetes. The multicentre, randomised, placebo controlled study involved a total of 11140 normotensive and hypertensive people with type 2 diabetes.

A second arm of the ADVANCE study, that aims to assess the risks and benefits of intensive glucose lowering using a modified-release gliclazide based regimen will report at a later date.

DPP-4 inhibitor class of drugs shown to lower HbA1c
New data presented at the American Diabetes Association (ADA) 67th Annual Scientific Sessions suggest that the recently-approved DPP-4 inhibitor, sitagliptin (Januvia; MSD, Hoddesdon), provides improvement in glycaemic control and a favourable tolerability profile as add-on therapy over one year.

Sitagliptin became available in April as add-on therapy to metformin or a thiazolidinedione (TZD) in people with type 2 diabetes when the single agent alone plus diet and exercise do not provide adequate glycaemic control. Approval of 100mg once-daily sitagliptin was based, in part, on a 24-week Phase III study in which sitagliptin was compared to placebo as an add-on to metformin monotherapy. The data presented at the ADA is an extension of this study out to 54 weeks. The mean change in HbA1c from baseline was -0.7% for sitagliptin-treated participants at week 54, the incidence of hypoglycaemia was <1% and there was a mean weight loss of 0.9kg. Corresponding values for patients in a comparative sulphonylurea arm (glipizide) were -0.9%, 16% and +1.5kg.

Other new data about the gliptin class presented at the ADA showed that HbA1c fell a further 0.6% when 50mg q.d. vildagliptin (Galvus; Novartis, Camberley) was added to a sulphonylurea compared to the sulphonylurea alone (P<0.001). A multi-dose study of Takeda’s investigational DPP-4 inhibitor, alogliptin, showed that after 14 days of treatment, statistically significant decreases from baseline in mean 4-hour plasma glucose levels were observed for 25, 100, and 400mg once-daily doses compared to placebo.

New real-time continuous glucose monitoring system launched
Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including diabetic retinopathy, kidney disease, diabetic foot problems, impotence and heart disease. In order to help patients maintain tight blood glucose control a new real-time continuous glucose monitoring (CGM) system was developed.

In addition to standard high and low glucose alerts, the system incorporates predictive and rate-of-change alarms that warn the patient before their blood glucose reaches preset thresholds.

This system includes a relatively small rechargeable, waterproof transmitter. This transmitter sends readings every 5 minutes to a monitor capable of displaying up to 288 such readings.

The Guardian REAL-Time System is a doctor-prescribed personal CGM system manufactured by Medtronic (Watford).

Rosuvastatin loses its {kcalb}
Following a comprehensive analysis of the pre- and post-marketing data by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) the risk–benefit profile for rosuvastatin (Crestor; AstraZeneca, Luton) has been confirmed and its black triangle status has been removed.

In line with other established medicines, healthcare professionals are now only required to report suspected serious adverse drug reactions (and are no longer required to report non-serious adverse drug reactions) through the yellow card system.

Routine administration of a blood pressure-lowering drug to people with diabetes – a fixed combination of perindopril (an ACE inhibitor) and indapamide (a diuretic), known as Coversyl Plus (Servier, Wexham), significantly reduces risk of death and cardiovascular events, irrespective of initial blood pressure status or other diabetes related treatments. This is according to results of the blood pressure-lowering arm of the 5-year study, ADVANCE (Action in Diabetes and Vascular Disease), presented at the European Society of Cardiology and published online in The Lancet.

The relative risk reduction of cardiovascular-related death was reduced by 18% (3.8% active versus 4.6% placebo) and death from any cause was reduced by 14% (7.3% active versus 8.5% placebo). In absolute terms, one death could be avoided for about 80 patients treated with Coversyl Plus over five years. In addition to this, the relative risk reduction of renal events was reduced by 21%.

Dr George Kassianos (a GP in Bracknell and a Fellow of the European Society of Cardiology) commented: ‘This study is genuinely exciting because it provides a rationale for considering such treatment routinely for patients with type 2 diabetes. It can save lives and reduce cardiovascular complications, regardless of whether patients have hypertension to start with or not – which has never been proven before. For doctors, this demonstrates that the therapeutic targets for blood pressure should actually be in line with levels suggested in the British Hypertension Society Guidelines and supported by the Joint British Societies Guidelines.’

ADVANCE is the first and largest trial ever performed with a fixed combination antihypertensive in people with type 2 diabetes. The multicentre, randomised, placebo controlled study involved a total of 11140 normotensive and hypertensive people with type 2 diabetes.

A second arm of the ADVANCE study, that aims to assess the risks and benefits of intensive glucose lowering using a modified-release gliclazide based regimen will report at a later date.

DPP-4 inhibitor class of drugs shown to lower HbA1c
New data presented at the American Diabetes Association (ADA) 67th Annual Scientific Sessions suggest that the recently-approved DPP-4 inhibitor, sitagliptin (Januvia; MSD, Hoddesdon), provides improvement in glycaemic control and a favourable tolerability profile as add-on therapy over one year.

Sitagliptin became available in April as add-on therapy to metformin or a thiazolidinedione (TZD) in people with type 2 diabetes when the single agent alone plus diet and exercise do not provide adequate glycaemic control. Approval of 100mg once-daily sitagliptin was based, in part, on a 24-week Phase III study in which sitagliptin was compared to placebo as an add-on to metformin monotherapy. The data presented at the ADA is an extension of this study out to 54 weeks. The mean change in HbA1c from baseline was -0.7% for sitagliptin-treated participants at week 54, the incidence of hypoglycaemia was <1% and there was a mean weight loss of 0.9kg. Corresponding values for patients in a comparative sulphonylurea arm (glipizide) were -0.9%, 16% and +1.5kg.

Other new data about the gliptin class presented at the ADA showed that HbA1c fell a further 0.6% when 50mg q.d. vildagliptin (Galvus; Novartis, Camberley) was added to a sulphonylurea compared to the sulphonylurea alone (P<0.001). A multi-dose study of Takeda’s investigational DPP-4 inhibitor, alogliptin, showed that after 14 days of treatment, statistically significant decreases from baseline in mean 4-hour plasma glucose levels were observed for 25, 100, and 400mg once-daily doses compared to placebo.

New real-time continuous glucose monitoring system launched
Improved glucose control has been shown to significantly reduce the likelihood of certain long-term complications, including diabetic retinopathy, kidney disease, diabetic foot problems, impotence and heart disease. In order to help patients maintain tight blood glucose control a new real-time continuous glucose monitoring (CGM) system was developed.

In addition to standard high and low glucose alerts, the system incorporates predictive and rate-of-change alarms that warn the patient before their blood glucose reaches preset thresholds.

This system includes a relatively small rechargeable, waterproof transmitter. This transmitter sends readings every 5 minutes to a monitor capable of displaying up to 288 such readings.

The Guardian REAL-Time System is a doctor-prescribed personal CGM system manufactured by Medtronic (Watford).

Rosuvastatin loses its {kcalb}
Following a comprehensive analysis of the pre- and post-marketing data by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) the risk–benefit profile for rosuvastatin (Crestor; AstraZeneca, Luton) has been confirmed and its black triangle status has been removed.

In line with other established medicines, healthcare professionals are now only required to report suspected serious adverse drug reactions (and are no longer required to report non-serious adverse drug reactions) through the yellow card system.

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