By Dr. Ed Hendricks on March 30, 2009
Arena Pharmaceuticals released today the first report of their initial 2-year phase 3 clinical trial for Lorcaserin. Although Wall Street analyists generally issued pessimistic opinions, careful analysis reveals that the new drug meets or exceeds FDA standards for approval. Furthermore the weight loss results are robust with nearly 50% of patients losing 5% of initial weight and nearly 25% losing 10%. Typically there is a marked genetic variation in patient response to obesity treatment, something FDA trials tend to obscure. A high percentage of patients who lose more than 5 and 10% suggests a very large population of obese patients will respond with impressive weight loss with Lorcaserin. The drug triggers specific brain serotonin receptors known to diminish carbohydrate cravings and diminish food intake. Patients receiving agents known to stimulate these receptors often comment on how easy it is to diet and lose weight. This factor alone should make this drug a very popular one with patients. Serotonin precursors have been used for weight management for decades and are known by obesity treatment specialists to be both safe and effecetive for seleced patients. A new report published online in the journal Obesity indicates that about 20% of bariatric specialists are now treating some patients with 5-Hydroxytryptophan and Carbidopa, a combination known to trigger the same serotonon receptors as Lorcaserin.
Drop-out rates, typically at 50% at six months in lengthy obesity drug trials, were extraordinarily low indicating the patients who responded were highly satisfied with their results. This is a critical factor with any obesity drug since high drop-out rates generally mean patients won’t stick with a drug long enough to achieve success.
Also impressive was the paucity and lack of severity of adverse events. Early headache on nausea were the most frequent and were mild since evidently no patients dropped out because of such events. Intensve cardiac monitoring over the two years revealed absolutely no significant cardiac adverse reactions.
From the perspective of a medical weight management specialist, Lorcaserin appears to be a very promising new drug. Arena intends to report results of two more clinical trials this fall before applying for FDA approval for Lorcaserin. Check back here for updates as new information becomes available.
By Paula Hendricks - Nutritionist on March 10, 2009
Thank you Dr. Hendricks and Staff – It is such a nice feeling to be thin again!
by Trenton and Barbara Bahr
As an approaching 40 yr old male, I have never really been on a diet, nor felt I needed one until I saw myself in some family snapshots. ”All my life I was thin and now I have a belly on me!” I thought to myself. Since my wife was on a national-branded weight loss plan, I thought I would copy her plan for awhile – no success for either of us. I remember Barbie coming home being all happy about losing 3 ounces. I do not know why I thought copying her would make me successful in losing weight. I was frustrated.
Then I remembered hearing about The Center for Weight Management and Dr. Hendricks through one of my portrait clients and how excited she was to take a family portrait 30 lbs lighter then the last portrait. I thought maybe this was the place for us. When I called Dr. Hendricks’ clinic in Roseville, the staff was friendly and helpful and very understanding… Remember – I’m a man and men don’t ask for help or go to the doctor unless our arm is falling off.
During the free consultation, Dr. Hendricks explained to me the different programs and options and what I should expect. I ask him if I would have to take “Diet Pills” and that I’d rather not. He had several options that did not include diet pills. I started the program the next day. I lost 21 lbs. in 5 weeks. My wife started the next week. She was so mad that I could do it so fast and easily, but in less than a year, Barbie lost over 40 lbs. That was six years ago.
Today, Barbie still looks awesome. We continue to schedule regular maintenance appointments to keep on track and use the products, vitamins and supplements which have helped us maintain our weight over the years.
Both of us love Dr. Hendricks and his wonderful staff and the amazing change he has made in our lives. He’s the best.
Trenton Bahr Portrait Art, Granite Bay, CA
Patient since January 2002
By Dr. Ed Hendricks on March 9, 2009
New Obesity Drug?
Something which could cause a great deal of excitement is on the horizon in obesity treatment. Arena Pharmaceuticals, a San Diego biotech firm, has an anti-obesity drug in development. The drug, named Lorcaserin, activates specific brain serotonin receptors which suppress appetite, reduce food intake, and produce weight loss. This late-stage developmental drug is still several years away from possible FDA approval. Arena has it on the FDA approval track and has big event scheduled to occur in late March, 2009 when the company will first report results of a Phase 3 clinical trial. The company hasn’t revealed any details of the 2-year Phase 3 trial as yet, but if the results are as impressive as those of the Lorcaserin Phase 2 trials, and if Phase 3 trials raise no safety issues then Lorcaserin may be the drug everyone has waiting for.
The two-drug combination of phentermine and fenfluramine or, “Phen/Fen,” activated these same serotonin receptors. For many patients Phen/Fen was a magical combination, which made food cravings, especially carbohydrate cravings, disappear and produced almost effortless weight loss. Unfortunately, a small number of patients developed cardiac valve leakage caused by the fenfluramine because fenfluramine activates all serotonin receptors including the 5-HT 2B receptors on cardiac valves. The fenfluramines were withdrawn from the market. Although the FDA was suspicious for a while that phentermine could have played a part in causing the heart valve problem, it is well documented now that phentermine has no adverse cardiovascular effects. Phentermine was exonerated and remains the most frequently prescribed anti-obesity drug.
Lorcaserin should be cardiac-safe because it activates one and only one specific serotonin receptor, the 5-HT 2C receptor but does not activate the cardiac 5-HT 2B receptor. Patients in the Phase 3 trial were monitored with echocardiograms and Arena will be announcing the analysis of that data along with the efficacy data in late March. The results of the 12-week Phase 2 trial were recently published in the medical journal Obesity (Smith SR, Prosser WA, Donahue DJ, Morgan ME, Anderson CM, Shanahan WR. Lorcaserin (APD356), a Selective 5-HT2C Agonist, Reduces Body Weight in Obese Men and Women. Obesity 2008;17:494-503.). Adverse effects were limited to headaches, nausea, and dizziness. Headaches usually started on day one, lasted a few hours and were mild. Nausea was also typically a drug start up effect and then disappeared. Dizziness occurred in about 7% of the patients in the trial. There were no significant cardiac or psychiatric adverse effects.
Weight loss appeared at 2 weeks and was progressive throughout the 12-week trial. The weight loss achieved at 12 weeks was comparable to the weight loss at 12 weeks of other weight loss drugs such as sibutramine. The non-responder rate was very low with nearly all patients losing weight in the Phase 2 trial. This is interesting because in the Phase 2 trial the patients were not put on diets and did not receive even advice on changing behaviors. In other words, nearly all the patients lost weight by merely taking the drug and doing nothing else. If the Phase 3 trial results in about 3,000 patients confirms and extends the Phase 2 trial results in about 400 patients, Lorcaserin could be the next blockbuster obesity drug. This preliminary Phase 2 report show results for 12 weeks only but a crucial question is what happens in the next 12 weeks of therapy and thereafter. This is why the Phase 3 trial results are eagerly awaited.
Even if it is eventually approved by the FDA, the earliest date Lorcaserin might be available at pharmacies will likely be 2012. The FDA has been very slow to act on new drug applications lately and the agency has always been extremely slow in approving new obesity drugs. Overweight patients shouldn’t wait for a new drug before dealing with this illness.
It looks like Lorcaserin alone produces an average 3% weight loss at 12 weeks or about one third the weight loss our patients get on our Very Low Carbohydrate Diet program which includes a great deal of attention to behaviors and behavior modification without any weight loss drug. Our patients who have phentermine added, experience on average a 15% weight loss at 6 months. Although a 3% weight loss at the highest dosage at 12 weeks may seem low, one should remember this is in patients who aren’t even trying to lose weight – they just took the drug. I would expect Lorcaserin will be like any other drug in that it will do much better combined with a comprehensive weight loss program. Will Lorcaserin be a better drug than phentermine? We’ll see. It will most certainly be much more expensive than phentermine.
I’ll continue to watch for news on this exciting developmental drug and will post new information here in this Blog as it becomes available. Check back often.
By Paula Hendricks - Nutritionist on March 2, 2009
Chile Verde Stew – Makes Ten 1 ½ cup Servings
Craving something warm and spicy? Try this delicious winter stew that warms you up on those rainy winter nights. It’s easy to make, low-calorie, and makes a perfect left-over meal for lunch, too. Just pull out the slow cooker or crock pot, put the ingredients in at morning time and let it simmer all day for a delicious evening meal. If you are on the maintenance diet, enjoy a low-carb quesadilla on the side. Enjoy on any of the Key Diets.
Ingredients you will need:
All ingredients below can be found at most grocery stores -
- Two pounds lean pork tenderloin, cut into 1 inch cubes
- One pound lean pork shoulder, cut into 1 inch cubes (all visible fat cut off)
- One 32 oz container fat free chicken broth
- One 28 oz can La Victoria green chile enchilada sauce
- One 14 oz can Hunts fire roasted diced tomatoes
- Two 7 oz cans Ortega fire roasted whole green chiles*, diced
- One medium onion, diced, about 1 cup
- 3 garlic cloves, diced
- 2 tsp. Mexican seasoning, dried
- Fresh cilantro. diced
- Knudsen’s Light Sour Cream
Instructions:
1. Put first 9 ingredients into a 6-quart slow cooker.
2. Turn cooker setting to high and set timer for 2 hours. After 2 hours, turn setting to low and cook for 4-6 more hours. If you are going to be away from home, turn setting to low and set timer for 8-10 hours.
3. When stew is ready (meat will be very tender), put a 1 ½ cup serving of stew in a soup bowl.
4. Garnish with fresh diced cilantro and 1 teaspoon of light sour cream.
Nutritional Analysis: Per 1 ½ cup serving; approximately 212 calories, 28 grams of protein, 10 grams of carbohydrates, and 7 grams of fat.
Variations: *Replace canned Ortaga chiles with 4 fresh Pasilla chiles. To prepare, place chiles in oven and broil until skin is blackened, i.e. fire-roasted, or place chiles directly on gas stove top – turn frequently. Slice open; remove seeds and stem. Dice – makes about 1 ½ cups.
Side Dish: Add a low-carb quesadilla to your meal. You will need one package of Mission brand carb balance tortillas, fajita size (80 calories – 8 grams of dietary fiber, or 32 calories, 48 effective calories each), and one package Kraft 2% shredded Mexican style four cheese, 2 T per tortilla (40 calories). Total calories = 88/serving.
By Paula Hendricks, Nutritionist
By Paula Hendricks - Nutritionist on March 2, 2009
PRODUCTS & SPECIALS
· Special Protein of the Month: Chicken Noodle soup is back on the shelves and on sale this month! Pick up a box or two at 10% off the regular price. Sale price $9.90 for a box of 7.
· Special Supplement of the Month: Buy a bottle of Super Omega-3 EPA/DHA with Sesame Lignans and Olive Fruit Extract on sale for $27, 15% off original price of $32. (EPA 350 mg/DHA 250 mg per capsule, 120 capsules per bottle). Take advantage of this great price and stock up. Read below about the benefits of omega-3s.
· New Protein Product: Chicken with Pasta. Come into the office and ask for a sample of our new soup today. 90 calories and always 15 grams of protein. It is delicious!
· New Patient Special: Know someone who wants to start our program? For the month of March, we are offering a discounted office visit, $150, to get started in addition to a free EKG! (A $95 value savings) If the patient already has an EKG, we will apply the $60 EKG value in credit towards any products purchased. Spread the word. We always offer a $50 credit towards product purchases for any patient who refers someone to our office. It is our way of saying, “Thank you for believing in us and cheers to your health!”
· Voluntary Recall: Product vendor, Robard Corporation, has requested that we remove their product, Peanut Crisp ‘N Crunch Bar, for sale in our office. The company hopes to have it available for sell again in May. There is no need to worry about consuming any of these bars that you may have already purchased; however if you feel uncomfortable consuming them, please bring them back to our office for a full refund.
FROM THE NUTRITIONIST
· Pick up a copy of the following today in our office or at the blog section of our website, download:
* Recipe of the Month – Chile Verde Stew. A delicious comfort food that warms you up on these cold winter nights; it’s easy to make, low-calorie, and a great left-over meal too. Just pull out the slow cooker or crock pot, put the ingredients in and let it simmer for the day. Great meal for a family/friend gathering.
* Did You Know? hand-out on Goal Setting. Studies show that people who set goals for weight loss and exercise are twice as likely to reach them. Read how.
· New Supplement: Resveratrol Capsules. What is it? It is a health-promoting compound (potent antioxidant) found in grapes, thought to increase life span and reduce the toxic effects of a high-fat diet. Scientists believe resveratrol may be the key component in the French Paradox; high intakes of red wine coupled with a high-fat diet and a reduced incidence of heart disease among those who follow this common French eating style. Why should you take it in supplement form? With the wide-spread use of pesticides today, the amount found in grapes has diminished greatly. And while on the VLCD, it is recommended that you NOT drink red wine or eat fruit, where resveratrol is found. Other benefits may include: improved insulin sensitivity, enhanced cell mitochondrial function (aids in fat burning), reduced expression of inflammatory factors seen in arthritis, Alzheimer’s disease, and other neurodegenerative conditions. We recommend taking up to 250 mg daily. Special introductory price of $30 (100 mg. per capsule, #60 per bottle)
· Supplement with Omega-3s. Consuming a healthy diet with a lower intake of saturated fats (butter, fatty beef, etc.), a higher intake of certain monounsaturated fats (olive oil, nuts, etc.), and supplementing with marine-based omega-3 fatty acids provides huge cardio-protective benefits. In addition, studies indicate that people with inflammatory diseases (arthritis, allergies, asthma, etc.), attention deficit disorder, depression, and compromised immune systems have reduced symptoms when using this supplement. It is recommended that at least 2 servings of omega-3 rich fish (salmon, etc.) be consumed each week in addition to supplementing with marine lipids to provide your body with at least 1400 mg EPA/1000 mg DHA daily ( i.e. 4 capsules daily but you can skip the supplements on the days you consume omega-3 rich fish).
COMPANY NEWS
· Testimonials from patients are on our blog. Scroll down and read how one patient succeeded on our program and continues to maintain his healthy lifestyle.
· Would you like to be on our email list? Already are? Forward this email to a friend. You will receive updates on upcoming specials, the recipe of the month, what’s new in medical research, and other information. Please fill out the email form for us at the front counter to get you on the list.
· Questions? Email us at info@hendricksforhealth.com. 2009
By Paula Hendricks - Nutritionist on March 1, 2009
Goal setting is a habit that successful people use in everyday life.
What are your goals for 2009?
If you are reading this, chances are one of your goals this year is to get healthy and fit. When it comes to getting healthy, being fit, and sound nutrition, goal setting can help you reach your potential. It need not be complicated – one only needs the mindset to get started. The body will follow and soon goal setting will become second nature. So, get a pen and paper (or your computer) and get started. Remember, goals that are not written down are just wishes. Written goals provide a concrete reminder of what you want to do so you can plan how to achieve it.
Develop goals that are specific, achievable and measurable. Your goals should be 1) specific (concrete, measurable and observable), 2) realistic (small changes), 3) stated positively (no negative wording), and 3) under your control (not depend on another person). For example, you may have a list: lose weight, save money, get off my diabetic medication, take an educational course, exercise more, take a trip, lose 15 lbs, etc. Don’t be overwhelmed by your list – these are goals to work towards, one step at a time.
Next, organize your goals by categorizing them into anticipated results (or outcomes), broad goals and specific goals. For example, an anticipated result may be to decrease blood sugar levels and get diabetes under control, so a broad goal might be to reduce intake of processed foods and high sugar carbohydrates. A specific goal, a more concrete goal, could be to eliminate starch from diet for two weeks and incorporate 2 servings of nutrient-rich vegetables into lunch and dinner each day. Look at the examples on table below.
|
Anticipated Results – Outcome (Observable Goals) |
Broad Goals – Plan (not specific enough to be achievable) |
Specific Goals – Action (concrete, measurable, positive) |
|
Lose 15 pounds |
Reduce caloric intake for one month. |
Start the VLCD Diet for one month. |
|
Maintain/increase bone density |
Start strength training program and increase calcium intake. |
Strength train with free weights at home on Weds and Sats. Take calcium supplements and eat leafy green vegetables every day. |
|
Take a trip after weight loss
|
Save money for trip. |
Put $30/week in trip savings account by NOT stopping for coffee in the morning or NOT eating out for lunch. |
|
Decrease LDL (bad) cholesterol levels and increase HDL (good) cholesterol levels |
Consume vegetables, lean meat and fish to decrease LDL and start aerobic exercise to increase HDL. |
Eat salmon twice/week, take marine lipid supplements, eat a high fiber vegetable at night (broccoli, etc.) Walk, jog or run 3 x times this week. |
|
Eliminate junk food from diet |
Buy nutrient-dense foods (not calorie-dense). Quit snacking on empty calories. |
Throw out ALL junk food in house on Saturday and make a grocery list to restock with healthy whole foods. |
By Paula Hendricks - Nutritionist on March 1, 2009
Read how one patient succeeded on our weight loss program and how he continues to maintain his new healthy lifestyle!
To all who want to lose weight…
by Robert Ramm
I first heard about the Key Diet from my wife. There was an associate who had some success losing a considerable amount of weight in a short time, and that they had a back up program for maintaining the weight loss. For people who need to lose weight, this is an important part of trying to diet – seeing results fast, and having support in maintaining the weight loss.
I had a hip replacement two years prior. My weight at time of surgery was 367 lbs.; my doctor told me that I would be more mobile if I lost weight. A year later, on my first return check up, I had lost 3lbs. He was not impressed with my efforts. Well, needless to say I was “not ready” to make the decision to lose weight. My wife had been very patient with my weight and hid the worry about my overall health. I had been telling her that “When I am ready,” I will make the decision to lose weight.
Well, one morning in early July 2007, I sat on the side of my bed, knee’s both hurting, ankles aching, and I decided that it was time. I had read about studies on weight loss, that if a person can lose the weight and then keep it off for two years after, the chances of regaining are single digit. I contacted Dr. Hendricks office for a free consultation.
I found out that the program made sense, since I had tried hi-protein diets before with some success. The difference this time was that there was a staff of people to help you through the diet in addition to the fact that vitamin supplements taken with protein keep your energy levels up. I also contacted my general practitioner doctor about the diet program, and he agreed that it has been proven successful with others.
I started on the program on July 25, 2007 at about 345lbs. (my scales weighted heavier than his) and after 12 months, have lost over 100lbs. When I began the diet, I told everyone I knew that I was going on a program for 3 years. It is amazing how many people watch you, some people support and some try to sabotage by saying, “How much more are you going to lose?” They mean well, but don’t understand your goals.
Set a weight you want and don’t change it because of others, only change it due to your decision. My wife has been very supportive, and has even enrolled in the program and lost over 50lbs. She feels great and looks terrific. The same is true for me. I feel great and have the ability to do more things I like to do, instead of watching others have fun doing them. There are some down sides, like your wife wanting you to do more jobs around the house and yard.
This has been, and continues to be, a great program for losing and maintaining the weight loss. The term “Key Diet” has a special meaning for me, I see myself as being “The Key” in making the decision to lose, and keep off the weight.
I hope you too have success in your decision.
Call me anytime, and I will answer your questions about my progress… Phone 530-867-2104
Patient since July 2007
Contact our non–surgical weight loss clinic, which serves Sacramento, Roseville, and surrounding areas, to schedule an appointment.
2310 Professional Dr., St. 200
Roseville, California 95661
Phone:916.773.1191
Fax: 916.773.0498
click for map & directions
2621 Capitol Ave.
Sacramento, California 95816
Phone: 916.551.1999
Fax: 916.551.1998
click for map & directions