PCP’s instrumental to weight loss

On February 2, 2010, in Uncategorized, by Andrea

As much as docs (and, well, us) may not want to admit it, our PCP’s can be instrumental in helping with weight loss in the morbidly obese — and I don’t just mean in signing that Letter of Medical Necessity for surgery, either.  Let’s face it — not everyone is ready for surgery yet – maybe this is a step in helping some get ready for it.

From Medscape:

Primary Care Practice Intervention Can Prompt Weight Loss in Morbidly Obese

Nancy Fowler Larson

February 2, 2010 — Primary care practices can be instrumental in helping patients who are morbidly obese to lose weight and keep it off, according to a study published January 25 in the Archives of Internal Medicine.

“Other therapeutic techniques for treating obesity, besides surgery, including diet, exercise, behavior therapy, and pharmacotherapy, might be applied, but there are few data on applying them in cases of extreme obesity, despite it being commonly encountered,” write Donna H. Ryan, MD, from the Pennington Biomedical Research Center, Baton Rouge, Louisiana, and colleagues. “We developed the Louisiana Obese Subjects Study (LOSS) to test the hypothesis that primary care physicians could effectively implement intensive medical management to treat patients with extreme obesity, with a goal of weight loss at year 2 significantly better than usual care.”

LOSS, a randomized controlled pragmatic clinical trial, took place from July 2005 through January 2008. Volunteers, 83% of whom were women, had body mass indexes of 40 to 60 kg/m2 and a mean age of 47 years. They were divided into 2 groups: intensive medical intervention (IMI; n = 200) and usual care condition (UCC; n = 190). The UCC group was directed to an Internet weight loss program. The IMI faction was counseled by primary care practices to follow these recommendations:

  • Maintain a 900-kcal liquid diet for up to 12 weeks.
  • Attend group behavioral counseling, follow a standardized diet and exercise program, and take weight-loss medications (choice of sibutramine hydrochloride, orlistat, or diethylpropion hydrochloride) during months 3 through 7.
  • Continue medications and adhere to maintenance methods for months 8 through 24.

The retention rate was 51% for the IMI group and 46% for the UCC group (P = .30). Those who attended the final study visit received a $100 gift card.

Physician Support Results in Long-Term Weight Loss

After 2 years, the study authors reported that the IMI group had lost more weight and maintained their weight loss better than the UCC segment:

  • In the IMI group, 31% achieved a weight loss of 5% or more, and 7% achieved a 20% or greater weight loss vs 9% and 1%, respectively, in the UCC group.
  • A weight loss of −4.9% ± 0.8% in IMI and −0.2 ± 0.3% in UCC was demonstrated by the mean ± SEM baseline observation carried forward.
  • A weight loss of −8.3% ± 0.79% for IMI and −0.0% ± 0.4% for UCC was shown by the last-observation-carried-forward analysis.
  • The 101 IMI subjects who completed the study lost −9.7% ± 1.3% (−12.7 ± 1.7 kg); the 89 remaining UCC participants lost −0.4% ± 0.7% (−0.5 ± 0.9 kg).

The results were significant (P < .001) at year 2 for all group differences, according to the study authors, given that most of the morbidly obese population will not have weight loss surgery.

“Recently, the SOS [Swedish Obese Subjects] study demonstrated that surgery for obesity is associated with reduction in mortality,” the authors write. “Still, surgery is currently not an option for most patients with extreme obesity because of reimbursement issues and individual preference.”

In an interview with Medscape, John Morton, MD, director of bariatric surgery at Stanford University in Stanford, California, pointed out that, of the 12 million candidates for weight-loss surgery in the United States, fewer than 175,000 undergo such procedures each year. Dr. Morton noted several limitations to the Pennington study, including small sample size, modest weight loss, and high dropout rate. Still, he applauded the results as a forward step in obesity treatment.

“Obesity is a chronic disease and just like any chronic disease it requires a lot of different modalities, including surgery and other medical intervention,” Dr. Morton said. “Even a modest amount of weight loss is going to result in some significant health benefits.”

Physicians See Weight Loss Intervention as “Daunting”

An editorial, published in the same issue of the Archives, said primary care practices are in dire need of a boost to their confidence regarding obesity treatment. In his commentary, Robert F. Kushner, MD, from the Northwestern University Feinberg School of Medicine, Chicago, Illinois, said that obesity intervention is often seen by physicians as a “daunting or even futile task.”

“There are few other examples in medicine where stigmatization of the patient, feelings of being ill equipped, perceived treatment ineffectiveness, and even reluctance to engage in obesity care prevail as major barriers,” Dr. Kushner said.

However, primary care practices can play a valuable role in weight loss and control among morbidly obese patients, the study authors concluded.

“Primary care practices can initiate effective medical management for extreme obesity; future efforts must target improving retention and weight loss maintenance,” the authors write.

The Office of Group Benefits (OGB) for the State of Louisiana funded the study. Abbott Laboratories donated a portion of the sibutramine used in the study. The authors disclosed that OGB’s primary contractee, Pennington Biomedical Research Center, has received research funding from pharmaceutical companies including Abbott Laboratories, Roche, GlaxoSmithKline, Amylin, Johnson & Johnson, Arena, Hollis Eden, Eli Lilly and Co, Merck & Co, Pfizer, Sanofi-Aventis, Shionogi, Takeda Pharmaceutical Co, and Vivus. At the study’s onset, Dr. Kaj Stenlof was an employee of Pennington Management of Clinical Trials, which monitored the research. Fifteen of the 20 study authors receive, have received, or will receive health insurance from the OGB. Several of the study authors have been paid consultation and/or service fees, received grant money from, or hold stock in, Abbott Laboratories, Arena, Johnson & Johnson, Merck & Co, NutriSystem, Sanofi-Aventis, Shionogi, Vivus, Amylin Pharmaceuticals, Orexigen Pharmaceuticals, GlaxoSmithKline, Takeda, Bristol-Myers Squibb, AstraZeneca, Hoffmann-La Roche, Ethicon, Biovitrum, BMS, Global Health Partners, Lenimen, and/or NovoNordisk, all of which manufacture medicines involved in the study. Several of the authors have received salaries from the OGB-sponsored project. A full list of disclosures is available in the original article.

Arch Intern Med. 2010;170:124-125, 146-154.

Fast Food Diets – That Work?

On February 2, 2010, in General Nutrition, by Andrea

Well.  Maybe.  Sorta.  Kinda.

Qualified answer  is that these are BETTER choices when going out to eat.  Given smaller stomachs, and these are even better choices for us.

Thought even those of us with rerouted guts could use this info.

Video from MSNBC.com:

Visit msnbc.com for breaking news, world news, and news about the economy

Lo Carb vs Diet/Drug Combo

On January 26, 2010, in Uncategorized, by Andrea

In the world of non-surgical weight loss (and let’s face it, we’ve all been there), there’s a new study out that proves that medications raise BP.  Especially in light that Meridia should not be used in heart patients, here’s even more proof that low carb diets are better for one’s heart health than medication and diet combos.

From Medscape:

Same Weight Loss, Better BP With Low-Carb Diet vs Drug/Diet Combo

Shelley Wood

January 25, 2010 (Durham, North Carolina) — A new randomized trial comparing a low-carbohydrate diet with a low-fat diet in combination with the weight-loss drug orlistat has found that both strategies produced meaningful weight loss among hospital outpatients over a one-year period [1]. Strikingly, however, the low-carb diet appeared to produce significant improvements in blood pressure.

According to Dr William S Yancy Jr (Duke University, Durham, NC), lead author on the study, this is the first time the low-carb diet has been pitted against a diet drug in combination with a different diet. It is also one of the first studies to compare weight-loss strategies in patients who also have other known medical problems, including high blood pressure, diabetes, arthritis, etc.

Yancy et al’s findings are published in the January 25, 2010 issue of the Archives of Internal Medicine.

Almost 10% Weight Loss at One Year

Yancy et al’s study randomized 146 overweight or obese outpatients (mean age 52, mean body-mass index [BMI] 39.3) to either a low-carbohydrate, ketogenic diet, or to orlistat (120 mg, three times daily) and a low-fat diet over 48 weeks, with regular group meetings to boost diet adherence. At the end of the study period, weight loss was similar in both groups, at roughly 10% (approximately 20 to 25 pounds). Of note, almost 80% of the low-carb group and almost 90% of the orlistat/low-fat group completed the full 48-week follow-up.

Improvements in HDL and triglycerides were seen in both groups, LDL levels improved in the orlistat/low-fat diet group only, while glucose, insulin, and HbA1c levels improved in the low-carb group only, although none of these differences were statistically meaningful. By contrast, both systolic and diastolic blood-pressure levels declined in the low-carb group only, a statistically significant difference between weight-loss groups.

“It’s not surprising that the blood pressure improved,” Yancy told heartwire , adding that improvements in blood pressure are common in weight-loss trials. “But it was surprising that, with similar weight loss, blood pressure would improve more in one group than the other.”

While there are a number of explanations for the blood-pressure differences between weight-loss strategies, Yancy speculated that it might be related to the known diuretic effect of low-carb diets.

“We’ve looked at that in the past, and it seems to occur in the first couple weeks of the diet and doesn’t seem to be a big factor after that, but that could contribute to the differences seen here. The other thing is that low-carb diets are thought to reduce insulin levels more so than a high-carb diet. There are several different mechanisms that insulin has with the vascular system that might cause increased blood pressure, so if you decrease insulin your blood pressure might decrease as well.”

No Significant Differences in Lipid Changes

Other low-carb diet studies have also reported improvements in lipid parameters compared with low-fat diets: something that was not seen in the current study to a statistically significant degree. Yancy attributes this in part to an aggressive attempt on the part of investigators to include as many patients as possible at the 48-week follow-up.

“A big criticism of other weight-loss trials is there are a lot of lost or missing data,” he explained. “We tried to avoid that as much as possible, and as a result, some of these folks who came back for their final measurements who hadn’t really been following their diets kind of watered down the results.”

For example, in the paper, the authors report differences in heart-disease risk factors at interim time points and note that, out to 36 weeks, the two interventions “appeared to have differential effects on fasting serum lipid and lipoprotein levels over the first 36 weeks,” but that “these differences converged by 48 weeks.”

In another important finding, Yancy et al point out that while a small number of study participants initiated hypertension or diabetes medications over the course of the study in both diet groups, a much higher number actually decreased or discontinued their dosages, with a higher proportion of patients discontinuing or lowering their dosages in the low-carb group.

Referring to the blood-pressure effects of the low-carb diet, Yancy pointed out that investigators “don’t really know the full effect of the diet intervention because patients were actually taking less medication.”

Options for Patients

The key message from the paper is not that one diet is superior to another, Yancy concluded. “Different interventions appeal to different people,” he told heartwire . “We have a big weight problem in our society, and this study gives us two different options, both of which worked quite well. And if you happen to have blood-pressure problems and you are trying to kill two birds with one stone, the low-carb option might be a better option than the orlistat option.”

Of note, he added, orlistat is not associated with increases blood pressure, although other diet drugs are, including sibutramine, for which the FDA recently released an updated warning on CVD risks.

Yancy, as well as second author Dr Eric C Westman (Duke University Medical Center) disclosed having received clinical research grants from the Robert C Atkins Foundation.

Heart problems and Meridia don’t mix

On January 21, 2010, in Uncategorized, by Andrea

Not that heart patients and surgical options always mix, either.  However, hypertension is a common co-morbidity that is used as a reason FOR WLS.   But here’s a mark against Meridia, a popular prescription diet pill that several of us have tried in the past before going the WLS path.

From MSNBC.com:

Heart patients shouldn’t use diet pill, FDA says

Meridia can increase risk of heart attack in patients with previous history

WASHINGTON – Federal health regulators on Thursday added new warnings to weight loss pill Meridia about the increased risk of heart attack and stroke in patients with a history of heart problems.

The Food and Drug Administration’s labeling announcement came on the same day the European Medicines Agency advised doctors and pharmacists to stop using the drug. The agency said “the risks of these medicines are greater than their benefits,” and recommended that Meridia’s marketing license be suspended.

The group’s recommendation must be adopted by the European Commission to take effect.

The FDA’s new label states only that the drug should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.

In a statement posted online, the FDA urged patients to talk to their doctors about whether they should continue taking the drug.

“Health care professionals should regularly monitor the blood pressure and heart rate of patients using,” Meridia, the FDA stated.

Meridia is marketed by Abbott Laboratories, which agreed to add the FDA’s contraindication language. The company, based in North Chiacgo, previously stressed that the drug is only approved for patients with no previous history of heart disease.

Consumer advocacy group Public Citizen petitioned the FDA to pull Meridia off the market late last year, based on new data about heart risks.

The group’s health care specialist, Dr. Sidney Wolfe, blasted the FDA on Thursday for not taking a harder line against the drug.

“The FDA has once again copped out,” said Wolfe, who directs the group’s Health Research Group

Public Citizen reported there had been a total of 84 deaths associated with Meridia reported to FDA as of June last year. Regulators previously rejected a 2002 petition from Public Citizen to withdraw Meridia, saying they wanted to wait for the findings of a 10,000-patient study.

Preliminary findings from that study released in November showed a slightly higher risk of heart-related problems in patients taking Meridia, also called sibutramine, compared with a dummy pill. Patients in the study were older than 55 and overweight with a history of heart disease or diabetes.

The drug was prescribed to about quarter million patients in the U.S. last year, according Public Citizen.

FDA approved Meridia in 1997 as a weight loss aid alongside diet and exercise. The drug is related to the amphetamine family of stimulants.

Fake Alli on web

On January 21, 2010, in Uncategorized, by Andrea

While this is a WLS-centric blog, there may be some out there that MAY be considering using the drug Alli to help lose weight.

For the few of you who have had WLS and are considering trying to use it, btw, it’s not a helpful tool.  It really only works if you eat a higher threshold of fat — and considering we limit our fat consumption (or are supposed to at least…) it’s fairly useless.

In any case, in case there are any out there that are considering buying Alli out on the web, be forewarned — there be fakes out there.

From myalli.com:

Online Auction Sites Selling Fake Weight Loss Products

GlaxoSmithKline Consumer Healthcare alerts consumers that a small quantity of fake weight loss product, falsely packaged and labeled as alli® has been sold on online auction websites, such as eBay. The falsely packaged and labeled products are the 60mg, 120ct refill packs only. The products are sold on online auction sites directly to consumers and are falsely represented as the genuine alli product. We do not have any evidence that counterfeit alli products have penetrated other distribution channels.

Preliminary testing confirms that the counterfeit products do not contain the active ingredient orlistat, which is found in the authentic alli product. The prescription drug sibutramine has been detected in the fake product. Sibutramine is the active ingredient in the prescription drug, Meridia. Sibutramine could potentially interact with other medications the consumer may be taking and there are dosing differences between alli (three times a day) and Meridia (once a day).

While many of these counterfeit products may look similar to GSK’s products, they are illegal and have no connection with GSK or FDA. GSK Consumer Healthcare, along with FDA has initiated efforts to identify those responsible for counterfeit products.

HOW TO IDENTIFY THE FAKE PRODUCT:

  • The LOT code information is missing from the top of the box
  • The expiration date includes month, day and year (example: 06162010); The authentic alli expiration date includes only the month and year (example: 05/12)
  • The seal on the bottle should read “SEALED FOR YOUR PROTECTION” in white ink on the GSK alli bottle; This statement is not present on the fake product
  • The capsule size is slightly larger in the counterfeit and the content inside of the capsule is different – the counterfeit content is powdery and the genuine product is more of a pellet shape.

WHAT CONSUMERS SHOULD DO:

  • Buy alli only from reputable retailers or from their branded online websites. When purchased from these reputable retailers, consumers can have confidence the product is genuine and they should continue use.
  • Consumers who suspect they have purchased counterfeit alli are urged to contact the FDA at http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
  • Consumers can visit www.myalli.com for more information.

VISUALS WITH SIDE BY SIDE COMPARISONS:

From Medscape:

Fake Alli Sold on Internet

Daniel J. DeNoon

January 19, 2010 — Fake, “potentially harmful” versions of the weight loss drug Alli are being sold on Internet auction sites such as eBay, the FDA and GlaxoSmithKline warn.

The counterfeit Alli looks a lot like the real thing. But the pills are filled not with orlistat — the main ingredient in GSK’s Alli and in Roche’s Xenical. Instead, they are filled with sibutramine.

Sibutramine, the main ingredient in the prescription weight loss drug Meridia, affects chemical signals in the brain and should not be used without a doctor’s oversight. The drug should not be used by certain people.

Moreover, Alli is taken three times daily while Meridia is meant to be taken only once a day.

So far, the fake Alli has been sold only in 60 milligram, 120-count refill packs. They are falsely being sold as the real thing.

To date, GlaxoSmithKline says it has received no word that the fake Alli has been sold in retail stores or anyplace other than on the Internet.

Here’s how to identify the fake product, according to GSK:

  • The LOT code information is missing from the top of the box.
  • The expiration date includes month, day, and year (example: 06162010). The authentic Alli expiration date includes only the month and year (example: 05/12).
  • The seal on the bottle should read “SEALED FOR YOUR PROTECTION” in white ink on GlaxoSmithKline’s Alli bottle; This statement is not present on the fake product.
  • The capsule size is slightly larger in the counterfeit pills and the contents of the capsules are different — the counterfeit content is powdery and the genuine product is more of a pellet shape.

Pictures of the real and fake product can be seen on GlaxoSmithKline’s myalli.com web site and on the FDA web site.

If you think you may have purchased the fake Alli, the FDA would like to hear from you at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm or by calling 800-551-3989.

SOURCES:

News release, FDA.

News release, GlaxoSmithKline.

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