Heart(y) news: clinical trial updates, Oct 29

No firm conclusions about HDL cholesterol can be drawn from JUPITER sub-analysis
The JUPITER trial (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) investigated the efficacy of the anti-cholesterol drug rosuvastatin in preventing cardiovascular disease. Based on the JUPITER results, a paper has been published that claims that “a normal, healthy individual has level of low density lipoprotein (LDL), known as “bad cholesterol”, substantially lowered with a potent statin, then the level of HDL “good cholesterol” in that person no longer bears any relation to the remaining cardiovascular risk.”
However, the European Society of Cardiology (ESC) has expressed concerns about the paper’s claims and interpretations that might be easily misinterpreted as raising HDL levels having no beneficial cardiovascular effects.

RENEW: Intense diet/exercise improves weight, CV risk factors, in severely obese
More and more clinical trials on lifestyle-based interventions are being conducted. One such trial is the Re-Energize with Nutrition, Exercise and Weight Loss (RENEW) which studied the effect of intensive lifestyle interventions in the extremely obese. The results were very encouraging and will be discussed in detail in another post.

NIH blood pressure trial expands to include more older adults
The Systolic Blood Pressure Intervention Trial (SPRINT) trial is enrolling more elderly adults, e.g. an additional 1,750 study participants aged above 75. The trial is investigating how blood pressure range in is related to cardiovascular and kidney diseases, age-related cognitive decline, and dementia. According to Dr. Susan B. Shurin:

“No large-scale clinical trial has examined the impact of aggressively lowering systolic blood pressure among older adults. The SPRINT study and the senior expansion address four of the 10 common causes of death and disability in adults over 75 years: heart disease, stroke, kidney failure, and dementia. The addition of these participants promises to provide useful scientific and public health information on a large and growing segment of the population.”

FDA stopped enrolment in TIDE trial
The enrolment for Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial which compared the cardiovascular effects of long-term treatment with rosiglitazone vs. pioglitazone was stopped in July by the US FDA in connection with safety issues regarding rosiglitazone (Avandia). After postmarketing data review, European drug authorities suspended rosiglitazone from the EU market. In the US, Avandia remains but increased warnings.

Liraglutide in nondiabetics: Weight and BP improve at two years in extension trial
Finally, a drug-based trial with encouraging results. The diabetes drug liraglutide (Victoza) seems to be also effective as a weight loss drug in non-diabetic patients. Furthermore, it is helps in blood pressure control. However, liraglutide still has to overcome the hurdle of strict regulations on cardiovascular safety so that it doesn’t go the way of sibutramine.