Friday, January 23, 2015

GLP-1 Analogue Liraglutide For Obesity Gets Positive Vote In Europe

novo_nordiskJust one month after the GLP-1 analogue liraglutide 3 mg received approval for obesity treatment by the US-FDA, liraglutide 3 mg, yesterday, also got a positive nod from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Here is how the Novo Nordisk press release describes the mode of action and indication for liraglutide 3 mg:

Saxenda®, the intended brand name of liraglutide 3 mg, is a once-daily glucagon-like peptide-1 (GLP-1) analogue, with 97% homology to naturally occurring human GLP-1, a hormone involved in appetite regulation. The CHMP positive opinion recommends that Saxenda® will be indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of >=30 kg/m2 (obese), or >= 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.”

Regular readers will be aware of the role that the incretin GLP-1 plays in the  regulation of glucose metabolism as well as satiety and appetite.

Data for this approval come from the Phase 3 SCALE trial program involving over 5,000 patients with overweight and obesity, the majority of who also had related comorbidities.

Given that this is an injectable drug that will be available only with a  doctor’s prescription and, as any anti-obesity medication, will need to be used in the long-term, it will be interesting to see how this new approach to obesity treatment will be accepted by doctors and their patients.

Although liraglutide 3 mg may not work for or be tolerated by everyone, I am confident that this much-needed addition to the obesity treatment tool-box will provide a new treatment option to some patients – especially those with obesity related health problems.

@DrSharma
Edmonton, AB

Disclaimer: I have received honoraria for consulting and speaking from Novo Nordisk

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Wednesday, January 14, 2015

Guest Post: Bariatric Foodie

Nikki Massie, Bariatric Foodie

Nikki Massie, Bariatric Foodie

Last year, at the Obesity Action Coalition’s annual conference, I met Nikki Massie, who underwent Roux-en-Y gastric bypass surgery seven years ago and writes a blog with recipes and other advice for people post bariatric surgery (“Bariatric Foodie“).

As I am always eager to hear the perspective of someone living with bariatric surgery, I invited Nikki to send me a guest post – here it is:

My name is Nikki Massie and seven years ago I underwent Roux-en-Y gastric bypass surgery in Baltimore, Md.

Last year I wrote an article on my journey in the National Inquiry of Bioethics and in it I described having weight loss surgery as, “stepping off the edge of the earth and trusting there’d be a soft place to land.” I had been overweight my entire life. I was over 9 lbs. at birth and trended above the top of the growth charts throughout my childhood.

The decision to have surgery came by way of motherhood. I was 31 years old and I had two daughters, aged 8 and 6. One day, watching them play at the playground I realized that if I didn’t do something soon, I would probably miss many moments in their lives due to lack of energy and the myriad health problems associated with obesity. At the time I was 340 lbs.

In January 2008, I had my surgery.

That was the start of my journey, and it’s where I’d like to start with a few things I’d like you to know from the patient perspective.

All the tests in the world can’t predict how a patient will react emotionally. I realized shortly after my surgery that I am a food addict. Restriction plunged me into a deep depression and anxiety. Some days the only way I knew how to cope was wandering supermarket aisles looking at food. Thankfully I found a great resource in Overeaters Anonymous and I’m working on my own recovery.

Bottom Line: Stress to your patients the importance of having mental health support. Encourage them to find a therapist, come to support group or utilize any other mental health tools at their disposal.

Weight and self-image vary from culture to culture. I think that’s important to note because within my own African-American culture, being a curvy woman is not stigmatized, but often celebrated. Being “skinny” is not necessarily a cultural value. I hear from many African-American women post-ops that they worry they will get too small and they work against losing past a certain amount. There is also familial and community pressure share in traditional foods and to look a certain way.

Bottom Line: It helps to ask about traditions and culture and how food plays into them and then help them find a healthier alternative!

In the long-term many post-ops feel abandoned. In a blog series I wrote for Obesity Action Coalition, I noted that many long-term post-ops felt alienated at their support groups. Many shared the feeling that they seemed more geared toward newer post-ops than long-termers. In addition, many weren’t sure what follow-up they needed after the two-year post-op mark.

Bottom Line: Does your office see patient’s long-term? If so, reach out to them and get them into the office. If not, make sure your patients know how to talk to their primary care physician about any issues that might arise and also make them aware of the existence of bariatricians!

The Bottom Line For Me

I recently celebrated the seven-year anniversary of my surgery. I’ve regained about 30 lbs. I continue many of the lifestyle habits I adopted: I go to the gym several times a week, I follow a high protein eating plan, but most of all I have more energy and I am in good health, even though I have regained.

These days I stay connected via my website, Bariatric Foodie, which encourages readers to reimagine their favorite foods in a healthier way, but also challenges them to make goals, practice accountability and think realistically and critically about their weight loss process.

If you have any questions I’m happy to answer them in the comments or via email at bariatricfoodie@yahoo.com

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Thursday, January 8, 2015

Hope For Hypothalamic Obesity And Beyond?

craniopharyngoma

Craniopharyngoma

Hypothalamic obesity, is a rare but serious condition that occurs in about 50% of individuals who have suffered injury to their hypothalamus (e.g. because of a craniopharyngoma or trauma).

Severe weight gain in these patients may not be all that surprising given that the hypothalamus plays a key role in the regulation of hunger, satiety and other aspects of energy balance.

Now, Zafgen, a US biopharmaceutical company, announces surprising early results of treating such patients with beloranib, an inhibitor of methionine aminopeptidase 2 (MetAP2), an enzyme that modulates the activity of key cellular processes that control metabolism. 

According to Zafgen, their small proof-of-principle trial (ZAF-221), conducted in 14 obese patients (nine women and five men) who were confirmed by magnetic resonance imaging (MRI) to have had hypothalamic injury, the results look most promising.

Here is the description of their findings taken from their press release:

“ZAF-221 was a randomized, double-blind, placebo controlled study of twice-weekly subcutaneous injections of 1.8 mg beloranib or placebo in patients with HIAO to evaluate weight reduction and safety over four weeks, followed by an optional four week open-label extension. Beloranib treatment resulted in mean weight loss of 3.4 kg and 6.2 kg in patients with HIAO after four and eight weeks of treatment with beloranib, respectively, in contrast to 0.3 kg mean weight loss in patients treated with placebo for four weeks (p = 0.01). Improvements in cardiovascular disease risk factors of lipids and inflammation (measured by C-reactive protein) were also observed. Beloranib 1.8 mg was well tolerated in this population, with no serious or severe adverse events reported. Safety measures such as laboratory, electrocardiogram, and vital sign measurements revealed no signals of concern, and all subjects randomized to beloranib completed the trial.”

What I find most surprising about these findings, is that this drug appears to work in people where key centres for appetite regulation are no longer intact. This points to the existence of a non-hypothalamic mode of action for this drug – an action that is powerful enough to work independently of the centres in the brain known to play a key role in energy regulation.

The company is also pursuing beloranib for individuals with Prader-Willi Syndrome, another hypothalamic form of obesity as well as patients with severe obesity.

Needless to say, this finding may well also hold promise for other forms of obesity, reason enough to closely watch the further development of this compound.

@DrSharma
Edmonton, AB

Disclaimer: I have served as a paid consultant to Zafgen.

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Wednesday, January 7, 2015

New Year’s Resolution: Use Chop Sticks?

rice-and-chop-sticksJust in time for the new year, a group of researchers from Singapore show that eating rice with chopsticks may reduce its glycemic index compared to using a spoon.

This randomised controlled trial, published in Physiology & Behaviour, involved eleven healthy volunteers, who came in on six non-consecutive days to the laboratory and evaluated three methods of eating white rice (spoon, chopsticks and fingers) once and the reference food (glucose solution) three times in a random order.

The three modes of eating were chosen to represent the most common eating habits of the various ethnic communities living in Singapore – chopsticks (Chinese), fingers (Malay and Indian) or spoon (Chinese, Malay and Indian).

Based on the glycemic response (GR) over 120 mins after ingestion of each test meal, the glycemic index of eating rice with chopsticks was 68 compared to 81 when eating the same amount of rice with a spoon was measured for the subsequent 120 min (eating with fingers fell in the middle).

The most likely explanation for this difference is the finding that the mode of eating significantly affected the number of mouthfuls, the number of chews per mouthful, the chewing time per mouthful, and the total time taken to consume the whole portion of rice.

Not surprisingly, these parameters were significantly correlated to the glycemic response.

If nothing else, this study should remind us that taking more time to eat and better chewing your food may affect the processing and metabolic response to what you eat – thus, it appears that when it comes to healthy eating – the “how” may well be as important as the “what”.

@DrSharma
Princeton, NJ

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Friday, December 5, 2014

Hypothalamic Inflammation In Human Obesity

sharma-obesity-astrogliosisRegular readers may recall the exciting body of work from animal models of obesity showing that hypothalamic inflammation involving microscarring (gliosis) may play an important role in appetite and energy regulation in obesity.

Now, a study by Josep Puig and colleagues from the University of Girona, Spain, published in the Journal of Clinical Endocrinology and Metabolism, provides evidence for a similar process in humans.

The researchers used an MRI technique called diffusion tensor imaging (DTI) to measure hypothalamic damage in 24 consecutive middle-aged obese subjects (average BMI 43) and 20 healthy volunteers (average BMI 24).

Not only did the obese participants show greater signs of hypothalamic inflammation but these changes were also strongly associated with higher BMI, fat mass, inflammatory markers, carotid-intima media thickness, and hepatic steatosis and lower scores on cognitive tests.

While these studies do not prove cause and effect, these findings are consistent with findings in animal models and point to the role of pro-inflammatory pathways in the areas of the brain known to be intimately linked to appetite and energy regulation.

Understanding what exactly triggers this inflammatory response (in animal models, one fact appears to be a high-fat diet) and how this process could be inhibited, may open new avenues for obesity prevention and treatment.

@DrSharma
Madrid, Spain

ResearchBlogging.orgPuig J, Blasco G, Daunis-I-Estadella J, Molina X, Xifra G, Ricart W, Pedraza S, Fernández-Aranda F, & Fernández-Real JM (2014). Hypothalamic damage is associated with inflammatory markers and worse cognitive performance in obese subjects. The Journal of clinical endocrinology and metabolism PMID: 25423565

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In The News

Diabetics in most need of bariatric surgery, university study finds

Oct. 18, 2013 – Ottawa Citizen: "Encouraging more men to consider bariatric surgery is also important, since it's the best treatment and can stop diabetic patients from needing insulin, said Dr. Arya Sharma, chair in obesity research and management at the University of Alberta." Read article

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