HPS2-THRIVE: Niacin therapy not beneficial for vascular disease.


Niacin, in combination with laropiprant, appears to provide no benefit and may have harmful effects in patients with vascular disease, researchers reported.

The 4-year HPS2-THRIVE study tested a combination of extended-release niacin 2 g plus laropiprant 40 mg (Tredaptive, Merck) compared with placebo in 25,673 patients at risk for CV events. In addition, all patients received simvastatin (Zocor, Merck), with or without ezetimibe (Zetia, Merck).

According to results presented at a late-breaking clinical trials session, the study did not meet the primary endpoint of reducing risk for a major vascular event, defined as a composite of nonfatal MI or CV-related death, stroke, or need for angioplasty or bypass surgery. Patients assigned extended-release niacin/laropiprant had a similar number of major vascular events compared with patients assigned placebo (13.2% vs. 13.7%; P=.29).

The extended-release niacin/laropiprant had increased rates of excess bleeding (2.5% vs. 1.9%) and infections (8% vs. 6.6%). In addition, serious adverse events were more prevalent with combination therapy, including new-onset diabetes (9.1% vs. 7.3%), diabetic complications (11.1% vs. 7.5%), indigestion and diarrhea (4.8% vs. 3.8%) and rashes (0.7% vs. 0.4%).

Data by the HPS2-THRIVE Collaborative Group published in European Heart Journal in early March revealed that by the end of the study 25% of patients assigned combination therapy had stopped treatment compared with 17% of patients assigned placebo.

“A striking finding from the study was a significant excess [in adverse events] among people who were allocated the niacin preparation. The excess represents a 3% absolute excess, which means 30 patients for every 1,000 treated patients had at least one side effect,” Jane Armitage, FFPH, FRCP,professor at the University of Oxford, United Kingdom, said at a press conference.

“It was a disappointing result but, nevertheless, these are clear and reliable results from a large study.”

 

PERSPECTIVE

 

Christie M. Ballantyne

  • We confirmed that using niacin in well-treated patients on statins with low LDL does not have a benefit. That was a very common use for this medicine. The other important point this study nails down is that the adverse effects of niacin in extended release were considerable. If we are going to use the drug in patients with high LDL, we have to think about the modest benefits and risks.
  • Christie M. Ballantyne, MD
  • Professor of Medicine
    Baylor College of Medicine

    • Source: Endocrine Today.

 

People can be fat yet fit, research suggests.


People can be obese yet physically healthy and fit and at no greater risk of heart disease or cancer than normal weight people, say researchers.

The key is being “metabolically fit”, meaning no high blood pressure, cholesterol or raised blood sugar, and exercising, according to experts.

Looking at data from over 43,000 US people they found that being overweight per se did not pose a big health risk.

The results are published in the European Heart Journal.

In the study at the University of South Carolina, more than a third of the participants were obese.

Of these 18,500, half were assessed as metabolically healthy after a physical examination and lab tests.

This subset of metabolically healthy obese people who did not suffer from conditions such as diabetes, high cholesterol or high blood pressure, were generally fitter and exercised more than the other obese people.

And their risk of developing or dying from cardiovascular disease or cancer was identical to people of ideal weight and was half that of “metabolically less fit” obese people.

These studies remind us that it is not always your weight that’s important, but where you carry fat and also how it affects your health and fitness”

Amy Thompson British Heart Foundation

Lead researcher Dr Francisco Ortega, who currently works at the University of Granada in Spain, said the findings show that getting more exercise can keep you healthier, even if you still carry a bit of extra weight.

“This research highlights once again the important role of physical fitness as a health marker.”

Most of the men and women in the study came from a similar background, meaning the results may not apply to everyone. They were mostly Caucasian, well educated, and worked in executive or professional positions.

Amy Thompson, of the British Heart Foundation, said: “In the majority of cases, obesity is an undeniable risk factor for developing coronary heart disease. However, these studies remind us that it is not always your weight that’s important, but where you carry fat and also how it affects your health and fitness.

“It is particularly important to be aware of your weight if you are carrying excess fat around your middle. The fat cells here are really active, producing toxic substances that cause damage which can lead to heart disease.

“Maintaining a healthy diet with lots of physical activity can help to slim you down as well as reduce your risk of heart health problems.

“But don’t get too caught up on the numbers on the scale. Calculating your body mass index and measuring your waist are great ways to keep on track. If you are concerned about your weight and want to make changes to your lifestyle, make an appointment with your GP to talk it through.”

  • Source: BBC.