A summary of the latest clinical research in the news. This issue covers studies on cardiovascular health, diabetes, and influenza.
Almonds for Cardiovascular Health
A study conducted at Aston University in Birmingham, UK, has shown that including almonds in your diet helps to keep blood vessels healthy, thereby reducing the risk of heart disease. During the study, participants included 50 grams of almonds per day, for one month, as a part of their diet, while a control group did not consume almonds. The study participants consisted of healthy men, as well as men who had cardiovascular risk factors such as high blood pressure. The results showed that participants who consumed almonds had higher levels of antioxidants in their blood stream compared to participants who did not consume almonds. In addition, participants who included almonds in their diet had improved blood flow, and reduced blood pressure. This study demonstrated that even moderate consumption of almonds, for a short period of time, can have beneficial cardiovascular effects.
Press release available from: http://www.alphagalileo.org/ViewItem.aspx?ItemId=143254&CultureCode=en Last Accessed: July 1, 2014.
Type 2 Diabetes
A recent phase 3 clinical trial has investigated empagliflozin and glimepiride as an addition to metformin in type 2 diabetes patients. The trial included participants who were 18 years or older, who had type 2 diabetes, and increased levels of HbA1c while being treated with metformin. The participants were randomized to treatment groups of either empagliflozin (25mg per day) or glimepiride (1-4mg per day), in addition to their metformin treatment. The study found that empagliflozin was effective and well tolerated, and may be a beneficial second-line treatment option for patients who fail to achieve glycaemic control with metformin. There is currently a 104 week extension period of the study being conducted.
Martin Ridderstråle, Knut Robert Andersen, Cordula Zeller, Gabriel Kim, Hans J Woerle, Uli C Broedl, on behalf of the EMPA-REG H2H-SU trial investigators. “Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial”Original TextThe Lancet Diabetes & Endocrinology, Early Online Publication, 16 June 2014. doi:10.1016/S2213-8587(14)70120-2
ClinicalTrials.gov “Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes” Available from: http://clinicaltrials.gov/ct2/show/NCT01167881?term=NCT01167881&rank=1 Last Accesssed: July 2, 2014.
A recent phase 2b/3 clinical trial was carried out to determine the safety and efficacy of nitazoxanide, as a novel treatment for influenza. The study was conducted in the USA in primary care clinics, and included patients who were aged between 12 and 65 years old, who presented with fever, at least one respiratory symptom, and one symptom of influenza. A total of 624 people participated in the study, and were randomized to either nitazoxanide 600mg, 300mg, or a placebo group. The treatment was given twice a day for 5 days. Symptoms lasted for a median time of 116.7 hours for participants in the placebo group. Patients who were taking 600mg of nitazoxanide had a median duration of symptoms of 95.5 hours, while for patients taking 300mg of nitazoxanide, symptoms lasted for a median of 109.1 hours. Overall the study demonstrated a favourable effect of nitazoxanide, associated with a significant reduction in length of influenza symptoms.
Jason Haffizulla, Aaron Hartman, Melanie Hoppers, Harvey Resnick, Steve Samudrala, Christine Ginocchio, Matthew Bardin, Jean-François Rossignol, for the US Nitazoxanide Influenza Clinical Study Group. “Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial” The Lancet Infectious Diseases, Volume 14, Issue 7, Pages 609 – 618, July 2014. doi:10.1016/S1473-3099(14)70717-0
Written by Deborah Tallarigo, PhD