Intensive blood pressure (BP) control does not reduce the rate of cardiovascular (CV) events in patients with Type 2 diabetes and high CV risk, reveals research presented at the 59th Annual Scientific Sessions of the American College of Cardiology in Atlanta, Georgia, USA.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure trial found that targeting therapy in such patients to achieve a systolic blood pressure (SBP) below 120 mmHg did not significantly reduce the annual rate of a composite of nonfatal myocardial infarction, nonfatal stroke, or death from CV causes, compared with a standard blood pressure target of below 140 mmHg.

A total of 4733 patients aged an average of 62.2 years with Type 2 diabetes were randomly assigned to intensive BP control (n=2362) or standard BP control (n=2371). The patients had an average baseline SBP of 139 mmHg, ranging from 130 to 180 mmHg, and had stable diabetes for at least 3 months, with a HbA1c of 7.5% to 11.0%. Also, 33.7% of patients had CV disease (CVD), while the remainder had subclinical CVD or at least two risk factors.

Patients in the intensive group were initiated on a two-drug therapy, typically a thiazide-type diuretic plus ACE inhibitor, angiotensin receptor blocker, or beta blocker. Drugs were then added and/or titrated at monthly visits to achieve the target SBP of 120 mmHg. In the standard group, therapy was intensified if SBP was 160 mmHg or above at the first visit or 140 mmHg or above at the second visit.

William Cushman, from the Veterans Affairs Medical Center in Memphis, Tennessee, USA, noted that “the SBP separated very early.”

He reported that BP from a year onward averaged at about 134 mmHg for the standard therapy group and at about 119 mmHg for the intensive therapy group.

This meant that, on average, a delta difference in BP of 14 mmHg was achieved from 1 year to the end of the 4.7-year study, which Cushman said was “certainly far greater” than the 10 mmHg minimum that they had set out to achieve.

Patients in the intensive treatment group took more drugs over the course of the study than did those in the standard treatment group, at an average number of 3.4 versus 2.1. Despite the difference in SBP, the patients receiving intensive BP-lowering therapy had a similar risk for the primary outcome as patients receiving standard therapy, at rates of 1.87% and 2.09%, respectively, and a hazard ratio of 0.88 (p=0.20).

The findings, published simultaneously advance online by the New England Journal of Medicine, did show about a 40% reduction in the risk for stroke in the intensive therapy group compared with the standard therapy group, however. And although this finding is consistent with meta-analyses summarizing the impact of a 10-mmHg reduction in SBP on stroke in observational studies, Cushman pointed out that the overall rate of stroke was very low, at about 0.5% per year.

“Therefore, although intensive management did significantly reduce total stroke and nonfatal stroke, assuming that this finding is real… the number needed to treat to lower the SBP to prevent one stroke over 5 years was 89.”

Cushman cautioned that patients receiving intensive therapy were also at increased risk for complications attributed to antihypertensive treatment compared with those receiving standard therapy, with occurrences seen in 3.3% versus 1.3% of patients. But overall serious adverse events were of a low order.

He concluded: “The results find no conclusive evidence that the intensive BP control strategy reduces the rate of a composite of major CV events, which was all-cause or fatal CV events plus nonfatal myocardial infarction and nonfatal stroke in high-risk adults with Type 2 diabetes.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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Combination therapy with fenofibrate and simvastatin does not provide additional protection against cardiovascular disease (CVD) in high-risk patients with Type 2 diabetes compared with simvastatin alone, according to findings from the ACCORD lipid trial.

Presenting the findings at the 59th Annual Scientific Session of the American College of Cardiology, in Atlanta, Georgia, USA, Henry Ginsberg (Columbia University College of Physicians and Surgeons, New York, USA) said that the findings “provide physicians with important new information regarding the treatment of a common lipid abnormality affecting many of their patients with Type 2 diabetes”.

The findings were also simultaneously published online in the New England Journal of Medicine.

For the ACCORD (Action to Control CardiOvascular Risk in Diabetes) lipid trial, 5518 people who had Type 2 diabetes and either pre-existing CVD or at least two additional CV risk factors and who were already taking simvastatin were randomly assigned to additional treatment with fenofibrate 54??”160 mg/day or placebo.

At baseline, the average total cholesterol level was 175 mg/dl (4.5 mmol/l), and the average high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglyceride levels were 101 mg/dl (2.6 mmol/l), 38 mg/dl (0.98 mmol/l), and 162 mg/dl (1.83 mol/l), respectively.

After a mean follow-up of 4.7 years, there was no significant difference between the two groups in the annual rate of the primary outcome (CV death, nonfatal heart attack, or nonfatal stroke) at 2.2% in patients taking fenofibrate and simvastatin and 2.4% in patients taking simvastatin and placebo. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group.

The researchers also compared rates of the primary outcome in 10 prespecified subgroups based on baseline characteristics. Of these, there appeared to be a difference between men and women taking combination therapy, “with the data for women suggesting potential harm and the data for men suggesting potential benefit,” Ginsberg reported. But the results did not reach statistical significance for either group.

There was also a trend toward benefit of fibrate treatment in a prespecified subgroup of patients with particularly high triglyceride levels of at least 204 mg/dl (2.30 mmol/l) and low HDL levels of 34 mg/dl (0.88 mmol/l). In these patients, the primary outcome rate was 12.4% in those taking fenofibrate plus simvastatin versus 17.3% in the simvastatin plus placebo arm. This compared with a rate of 10.1% in both study groups for all other participants.

“This dyslipidemia group outcome, which was prespecified, is concordant with several post hoc analyses from prior lipid trials,” Ginsberg noted.

He cited the Helsinki Heart Study (HHS) of gemfibrozil, which had a positive result for the primary outcome in the whole cohort and a greater benefit in a dyslipidemia subgroup, similar to that reported here. Other trials included the Bezafibrate Infarction Prevention (BIP) study and the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, which despite having negative results for the whole cohort showed significant findings for subgroups with severe dyslipidemia.

Ginsberg concluded: “ACCORD lipid does not support use of the combination of fenofibrate and simvastatin compared to simvastatin alone, to reduce CV events in the majority of patients with Type 2 diabetes mellitus who are at high risk for CVD.”

He added: “Subgroup analyses suggesting heterogeneity in response to combination therapy by gender or by the presence of significant dyslipidemia require further investigation.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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If you have already developed the habit of self-monitoring your blood sugar levels several times a day, this is something to celebrate. Checking your blood sugars regularly is imperative for everyone diagnosed with type 1 diabetes. Those with type 2 diabetes who self-monitor their blood sugars are way ahead of the game compared to those who do not. When you know what your sugar level is, it’s possible to make changes and adjustments in what you are doing for the rest of the day.

Maintaining tight control of your sugar levels… that is keeping them as near as possible to normal… significantly reduces your risk of complications.

The question is when should blood sugar levels be checked?

• these levels should be checked on fasting
• knowing this level gives you an indication of how your day is going to be
• when your fasting level is high… you may be eating less and/or exercising more

Many diabetics want to know when specifically they should take the fasting blood sugar level:

The best time is before your activities of the day get started. This includes before:

• shaving
• cleaning
• showering

The next time of the day to take a glucometer reading is:

• one to two hours after you eat a meal

If you take the reading one hour after you eat:

• this will provide you with valuable information about how well your meal was constructed.

How high did your blood sugar go? Is it normally 150 mg/dL (8.3 mg/dL) and after a pasta meal, your blood sugar shot up to 175 mg/dL (9.72 mmol/L)? If so, it would be wise to analyze the meal and see what nutrients were off kilter… what caused this issue? The protein, fat or carbohydrates?

Usually in a pasta meal, there is not enough protein. People often think that eating pasta noodles with tomato sauce, bread and butter and maybe a small glass of wine is a great meal. However, this type of meal doesn’t have enough protein in it! There may be about 4 or 5 grams but what you need is at least 25 grams. That’s a deficit of about 21 grams. The meal is predominantly carbohydrate, in other words it’s carbohydrate rich and those carbohydrates will, of course, cause a blood sugar spike. This will then create a burst of insulin so that this spike can be lowered. You are then left with a blood sugar level that will go up and down, up and down for the rest of the day.

As well, if you have more glucose in your body than your cells need, insulin takes the extra blood glucose and transports it into fat storage. This step is important because having abnormally high blood sugar levels is called type 2 diabetes and is very damaging to your body. Self-monitoring is one of the best ways to help you overcome your type 2 diabetes.