By Paula Hendricks - Nutritionist on April 9, 2010
PRODUCTS & SPECIALS
FROM THE DOCTOR – Ed J. Hendricks, M.D.
Phentermine Therapy in Obesity Treatment and its Effect on Blood Pressure
Shibboleths, ideas everyone knows are true but for which the evidence suggests the opposite concept, abound in modern society.
Medicine too has its shibboleths. One of these is that phentermine treatment produces increases in blood pressure. Almost any doctor will tell you to not take phentermine because it will make your blood pressure go up. However, our 20 years of experience has been that the opposite is true – we typically see decreases in blood pressure in our patients on phentermine.
Frustrated with the constant repetition of this conjecture, we undertook a research study to investigate whether phentermine treatment in an obesity treatment program had any impact on baseline blood pressure and heart rate in 300 consecutive patients, 269 of whom were treated with phentermine for as long as 13 years. Of the 300 patients, 32% had hypertension, 54% were pre-hypertensive and 14% had normal blood pressure.
Our findings:
We conclude that weight loss typically produces lowered blood pressures and that phentermine has no direct impact on blood pressure or heart rate. Phentermine treatment improves long-term success and therefore assists indirectly in lowering blood pressure. Dr. Hendricks intends to publish the study and present it at national medical meetings.
FROM THE NUTRITIONIST – Paula Hendricks, BS, Nutritionist-C
Recipe of the Month – Buttermilk Bleu Cheese Dressing.
This is a delicious dressing, especially when you make it one day ahead. I usually make this dressing at the beginning of the week and use it on salads or as a vegetable dip. I like to use Point Reyes Bleu Cheese found at Safeway and Raley’s or the Buttermilk Bleu Cheese from Whole Foods.
I like to use the remaining buttermilk for marinating chicken. I take thin-sliced chicken breasts, put them in a container, and cover them with 1-2 cups of buttermilk (depending on how many chicken breasts you have), the juice of a half of a lemon, some fresh minced garlic, and the Made in Napa Valley Meritage Blend. I let it marinade for about 20 minutes or even overnight. This marinade makes the chicken very tender and gives it a tangy taste that works well with a salad and the buttermilk bleu cheese dressing to make a complete meal. Enjoy on any of the Key Diet plans. Download from our website or pick up a copy in the office.
By Dr. Ed Hendricks on September 8, 2009
The following is excerpted from a memo to the staff at the Center for Weight Management dated September 8, 2009
Swine Flu or H1N1 Influenza:
Publication of research reports on vitamin D continues to accelerate with 545 papers published in the last 90 days. The CDC has announced that so far, Swine flu, H1N1, has killed thirty-six children in U.S. and analysis of CDC data indicates Vitamin D deficient children at higher risk of death. 75% of teenagers in the US are vitamin D deficient with levels below 26 ng/ml. Vitamin D deficiency in adults is also prevalent.
Vitamin D Dose Revised Recommendations:
John Cannell, M.D., of the Vitamin D Council, has revised his recommendations regarding Vitamin D dosages so I have revised our as well:
In the absence of flu symptoms or exposure:
1. Every adult and adolescent should take one 5,000 I.U. vitamin D capsule daily.
2. Children should take one 1,000 I.U. vitamin D capsule daily for each 25 pounds of weight. Thus a child weighing 75 pounds should take 3 capsules, etc.
If exposed to the flu increase the vitamin D dose as follows:
Adults, adolescents, and children should take 1,000 I.U. per pound of body weight daily for at least 3 days. If re-exposed during the 3 days add 3 more days.
If influenza symptoms develop (at any time):
Adults, adolescents, and children should take 1,000 I.U. per pound body weight for at least 10 days. If symptoms are present at day 10, continue for another 10 days.
These doses with 50,000 I.U. dose capsules of vitamin D are a prescription and must be prescribed and dispensed by a practitioner. Practitioners must explain such prescriptions to the patient (or to a parent if it is for a child or adolescent.) Since these high doses of vitamin D can lead to toxicity if continued for too long we will not sell the 50,000 I.U. vitamin D capsules as an over-the-counter supplement. Practitioners should document these prescriptions and the instructions and cautions in the patient record. We’ll also document these in our dispense log.
Patients must be informed of vitamin D toxicity and that no one should take the 50,000 continuously Patients should also be informed that vitamin D alone is not sufficient treatment for influenza and this too should be documented in the record.
Vitamin D Toxicity:
Be sure to inform patients that other physicians, especially pediatricians, are apt to be horrified by these doses for fear of toxicity. I’ll be happy to discuss these recommendations with anyone, including any doubting physicians.
So what about toxicity? Dr. Cannell has pointed out that between 1955 to 1990, all infants in East Germany received 600,000 IU of Vitamin D every three months for a total of 3,600,000 IU at age 18 months. At one time rheumatologists thought that arthritis might respond to high dose vitamin D. A 1948 paper from Johns Hopkins is remarkable for the dosage the doctors prescribed for arthritis and for the toxicity those doses sometimes caused. In their series of 10 toxic patients, the dose ranged from a low to 150,000 IU/day to a high of 600,000 IU/day and it took anywhere from 2 to 18 months for these daily doses to cause clinical toxicity. Clinical toxicity was manifested by weight loss, malaise and fatigue, followed by anorexia, nausea and vomiting. As Dr. Cannell writes, “if you have these symptoms, you are not vitamin D toxic unless you are taking at least 50,000 IU per day for many months, in which case you have not understood anything I have ever written.”
Worried about toxicity?
Serum calcium levels will be elevated in patients with vitamin D toxicity. If serum calcium is normal the patient is not toxic. Calcium levels are more reliable for checking for toxicity (and considerably less expensive) than are vitamin D levels.
By Dr. Ed Hendricks on August 13, 2009
The following went out to all staff at the Center for Weight Management today. In view of the intense interest in the Swine Flu I’m posting it here for our patients and others. Please post your questions and comments.
Swine Flu or H1N1 Influenza:
Classes at Granite Bay High School started on Monday, August 10, 2009. Yesterday parents of students were notified that “Swine Flu” had been diagnosed in three students on the second day of classes. The H1N1 flu is now among us and we should be prepared to deal with it among our patients, our staff and our families.
A visit to CDC web pages today yielded the following information. “When the novel H1N1 flu outbreak was first detected in mid-April 2009, CDC began working with states to collect, compile and analyze information regarding the novel H1N1 flu outbreak, including the numbers of confirmed and probable cases of disease. From April 15, 2009 to July 24, 2009, states reported a total of 43,771 confirmed and probable cases of novel influenza A (H1N1) infection. Of these cases reported, 5,011 people were hospitalized and 302 people died.” The mortality rate during that time was 0.7% and the hospitalization rate 11%. A mortality rate of 0.7% means about 7 persons die out of 1,000 infected. This mortality rate is lower than usual for an influenza epidemic but these data are for summer months when the mortality rate is typically lower.
Of interest is the “secondary attack rate” meaning the rate of infection following close contact with an infected person at home, at work or at school. The CDC reports “a secondary attack rate in household contacts for acute-respiratory-illness (ARI) was 18 % to 19% and 8% to 12% for influenza-like-illness (ILI). ARI is defined as two or more of the following four symptoms: fever, cough, sore throat, and rhinorrhea (runny nose). ILI is defined as fever and cough or sore throat. In general, these household secondary attack rates are slightly lower than what occurs in seasonal influenza.” The secondary attack rate in the household can be lowered by the use of antiviral medications for the infected family member to reduce viral shedding. Secondary infection rates can also be reduced by treating contacts with an antiviral drug as discussed below.
Also of interest is that obesity may be a risk factor for flu complications.
Prevention: What can one do to avoid this flu? Wash your hands often, avoid infected persons if possible, get the vaccine as soon as it becomes available, and take vitamin D. More information about vitamin D is written below.
Symptoms: The symptoms of H1N1 flu virus in people are similar to the symptoms of seasonal flu, although vomiting and diarrhea has been reported more commonly with H1N1 flu infection than is typical for seasonal flu. Symptoms include fever (93%), cough (83%), shortness of breath (54%), fatigue/weakness (40%), chills (37%) and myalgias (muscle soreness) (36%).
Treatment: The swine flu or H1N1 influenza virus is sensitive or susceptible to the neuraminidase inhibitor antiviral medications, zanamivir (Relenza Inhalation Powder) and oseltamivir (Tamiflu). It is resistant to the adamantane antiviral medications, amantadine (Symmetrel) and rimantadine (Flumadine). For treatment and prophylaxis to be effective it should be initiated as soon as possible after exposure. If time lapse between exposure and therapy or prophylaxis was 2 or more days, choose Relenza over Tamiflu. Each Relenza prescription comes with an inhalation device – no special inhalation equipment is necessary.
Relenza Inhalation Powder treatment for adults & children ≥ 7 years infected with H1N1 influenza: 10 mg (two 5mg inhalations) twice daily for 5 days. Relenza prophylaxis if exposed to an infected person: 10 mg (two 5mg inhalations) daily for up to 10 to 28 days.
Tamiflu treatment for adults and adolescents ≥ 13 years infected with H1N1 influenza: 75 mg twice daily for 5 days. Tamiflu prophylaxis if exposed to an infected person: 75 mg daily for 10 days to 6 weeks.
As the recommendations indicate, either of these drugs can be used for prophylaxis during an epidemic for any patient or member of their family even in the absence of known exposure. At this point in the emerging epidemic we should not hesitate to write prescriptions for either drug if any patient requests them. I plan to prescribe Tamiflu for my family and hold it for use if needed. Later on in the epidemic the drugs may be hard to find or unobtainable.
Vitamin D3:
Vitamin D is an extremely important defense mechanism against influenza. Although definitive randomized placebo controlled clinical trials (RCTs) have not been reported, there is anecdotal evidence and limited trial evidence strongly suggesting that taking supplementary vitamin D is protective and reduces both the risk of influenza infection and the risk of complications if infection does occur. Vitamin D can be used as a supplementary, experimental treatment for and prophylaxis against influenza – it should not be used as the only agent in treatment or prophylaxis.
Vitamin D is toxic only in high doses taken for long periods of time. Rather than wait for definitive evidence from RCTs I make the following recommendations. These recommendations are adapted after those of John J. Cannell, M.D. of the Vitamin D Council. Patients should be informed that their other physicians probably would disagree with these recommendations. since knowledge of the importance of Vitamin D supplementation is not stressed in mainstream medicine.
As a daily routine in the absence of flu symptoms or exposure:
1. Every adult should take one 5,000 I.U. vitamin D capsule daily.
2. Children should take one 1,000 I.U. vitamin D capsule daily for each 25 pounds of weight. Thus a child weighing 75 pounds should take 3 capsules, etc.
If exposed to the flu I recommend increasing the vitamin D dose as follows:
1. Adults and adolescents should take one 50,000 I.U. capsule daily for 10 days. If re-exposed during the 10 days add another 10 days. (Don’t continue this dose indefinitely since this dose can produce vitamin D toxicity, but only after several months).
2. Children should take 10,000 I.U. per 25 pounds body weight for 10 days. If re-exposed during the 10 days add another 10 days. (Don’t continue this dose indefinitely since this dose can produce vitamin D toxicity, but only after several months).
If influenza symptoms develop, I recommend increasing the vitamin D intake as follows:
Adults, adolescents, and children should take 2,000 I.U. per Kg body weight per day for 7 days.
Examples for different weights:
Vitamin D dose for a 250 pound patient
Dose = 250 lb X 1 Kg/2.2 lb X 2,000 I.U./1 Kg = 236,367 I.U.
I’d round up to 250,000 I.U. or five 50,000 I.U. capsules per day for 7 days.
Dose = 200 lb X 1 Kg/2.2 lb X 2,000 I.U./1 Kg = 181,182I.U.
I’d round up to 200,000 I.U. or four 50,000 I.U. capsules per day for 7 days.
Vitamin D dose for a 85pound patient
Dose = 85 lb X 1 Kg/2.2 lb X 2,000 I.U./1 Kg = 72,272 I.U.
The 50,000 I.U. dose of vitamin D is a prescription and must be prescribed and dispensed by a physician or other practitioner. Practitioners should explain carefully such prescriptions to the patient (or to a parent if it is for a child or adolescent.) Since these high doses of vitamin D can lead to toxicity if continued for too long we do not sell the 50,000 I.U. vitamin D capsules as an over-the-counter supplement. Practitioners should document these prescriptions and the instructions and cautions in the patient record.
Patients should be informed that vitamin D alone is not sufficient treatment for influenza and this too should be documented in the record.
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 Dr. Ed Hendricks on February 25, 2009
If you have read the “Latest in Obesity Research” page on this website you’ll recall that last year we conducted a nationwide survey of obesity treatment specialists under the auspices of the American Society of Bariatric Physicians (ASBP). The survey discovered that phentermine is the most favored anti-obesity drug of obesity treatment specialists; the drug is the first choice of 97% of these specialists. Dr. Hendricks presented the survey results at the ASBP’s 58th annual symposium in Tampa last fall (Hendricks EJ. ASBP Membership Survey of Prescribing Practices. In: 58th Annual Obesity & Associated Conditions Symposium. Tampa, Florida: American Society of Bariatric Physicians; 2008). The results were also presented in October 2008 as a scientific poster at the Obesity Society’s Annual Scientific Meeting in Phoenix (Hendricks EJ, Greenway FL, Westman EC, et al. A Survey of Prescribing Practices of Medical Bariatricians, Abstract 840P. In: Annual Scientific Meeting. Phoenix, AZ: The Obesity Society; 2008). A manuscript detailing the results together with some additional data from our patients prepared by Dr. Frank Greenway has been accepted for publication by the journal Obesity (Hendricks EJ, Rothman RB, Greenway FL. How Physician Obesity Specialists Use Drugs to Treat Obesity. Obesity 2008;Submitted November 20, 2008, Manuscript ID 08-0897-Orig.R1.)
Our study of phentermine’s effects on blood pressure is still in progress. Preliminary results with a limited number of subjects suggest that in patients with normal blood pressure given phentermine blood pressure remains unchanged. On the other hand, we see blood pressures go down in patients with high blood pressures or with borderline high blood pressures. (What was once termed “borderline” is now called “prehypertension). Some preliminry data was presented at a scientific poster session at the Obesity Society meeting last fall (Hendricks EJ, Westman EC. Phentermine Therapy in Obesity Treatment: Effect on Blood Pressure 582P. Obesity 2008;16, Supplement 1:S216).
Recently Dr. Rothman came across a letter-to-the-editor in the International Journal of Cardiology which incorrectly maligned phentermine. We wrote a rebuttal letter defending phentermine which has just been published online (Rothman RB, Hendricks EJ. Phentermine Cardiovascular Safety. International journal of cardiology 2009;doi:10.1016/j.ijcard.2008.12.205). Perhaps you are aware that the length of time from submittal of a paper to a scientific journal to acceptance is commonly many months and that there is often then a lag of more months before the paper is actually published. Evidently the editor of the International Journal of Cardiology liked our letter – it was accepted the same day it was submitted and published online a month after it was submitted. If anyone would like a copy, you can stop by either office and pick one up or email us and we’ll send you a copy.
What about our newest studies? We have 5 new studies in progress and 3 others in planning stages. New studies underway include:
New studies at the planning stage include:
I’ll discuss these new studies in more detail in up-coming blog entries.
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
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2621 Capitol Ave.
Sacramento, California 95816
Phone: 916.551.1999
Fax: 916.551.1998
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