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Arena Pharmaceuticals, Inc. Message Board

jeremiahthirtythreeone 1565 posts  |  Last Activity: Feb 6, 2015 3:00 PM Member since: Feb 16, 2010
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  • jeremiahthirtythreeone jeremiahthirtythreeone Feb 6, 2015 12:55 PM Flag

    This was updated 2 months ago and literature was checked through Jan 2015.
    Literature review current through: Jan 2015. | This topic last updated: Dec 03, 2014

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Feb 6, 2015 12:16 PM Flag

    The resource is called My UpToDate. I am pretty sure he already has it. This is used in all residency programs and most medical centers subscribe to and is used by their staff physicians.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Feb 6, 2015 12:14 PM Flag

    The source is called My UpToDate. He can google it but I am sure he is already using it. Most medical centers subscribe to it and is used by the physicians on staff.

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Feb 6, 2015 12:05 PM Flag

    wwwdotuptodatedotcom/contents/obesity-in-adults-drug-therapy?source=see_link&anchor=H4029763#H46

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • Uptodate is a resource available to all MD's and is the most widely used source of information for the practicing clinician
    It has been utilized by physicians for over 20 years as the primary resource for medical knowledge.
    The knowledge contained in this program is up to date and is evidence based and continuously uptdated. Recommendations can be acted on at the point of care. It is written by accomplished authors and editors, renowned leaders in their specialties.

    I use this resource on a daily basis whenever I want to know the most current treatments available for my patients.

    On the topic: Obesity
    in Adults: Drug Therapy these are the recommendations that are given to physicians interested in treating obesity:
    1. We do not suggest combination bupropion-naltrexone as first-line pharmacologic therapy. Owing to the uncertainty about cardiovascular effects, we prefer to use lorcaserin.
    2. Combination bupropion-naltrexone is also an option for obese patients who cannot tolerate orlistat or lorcaserin. It produces similar weight loss as orlistat and lorcaserin, but it has more side effects and contraindications.

    Authors:
    Author
    George A Bray, MD
    Professor of Medicine
    Louisiana State University
    Section Editor
    F Xavier Pi-Sunyer, MD, MPH
    Section Editor — Obesity
    Professor of Medicine
    Columbia University College of Physicians and Surgeons
    Deputy Editor
    Jean E Mulder, MD
    Deputy Editor — Endocrinology
    Instructor in Medicine
    Harvard Medical School

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • The CAMELLIA study is ongoing in the United States and Canada with 12000 patients sponsored by Eisai, Inc and in the EEA sponsored by Eisai Limited, United Kingdom (735 subjects from Poland and 2320 from the EEA (European Economic Area) . The EEA allows movement of goods and services through 27 of 28 member states of the EU. It appears that the trial in the EEA was approved in September 2014 and the trial is ongoing however the record of the trial was entered in the EU Clinical Trials Register in July of 2014.

    The preparation for the trial has been going on since 2013. It is interesting the EEA trial has an additional sub-study that includes:
    1. Pharmacogenetic Research – one of the things they will be looking at is response/resistance to the effects of the drug on obesity
    2. Biomarker Research - this study will look at effect of Belviq on changes in biomarkers of adiposity and metabolic dysregulation, dysglycemia and its complications, CV Risk (atherosclerosis, ischemia, inflammation, thrombosis, hemodynamic stress and lipid dysregulation) – IN EFFECT, THE METABOLIC SYNDROME

    In short, Belviq will be the most studied drug with regard to obesity, type 2 diabetes, and the metabolic syndrome.

    Though its frustrating to see the current PPS, this drug will be one the most innovative drugs to be approved for the treatment of the some deadly diseases that afflict us. It is just a matter of time when the studies will explode and Belviq will become a household name.

    I also noticed that there were several other countries listed on the CAMELLIA update – I presume they are targeted to be included in this study.

    You can get all the info on the EEA Trial from the European Union Clinical Trials Register
    Just google 2013-000324-34 and open the site titled PL-Clinical Trials Register

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • From todays Medscape:

    A committee of the European Medicines Agency (EMA) has recommended suspending the sale of roughly four dozen generics for conditions such as diabetes, depression, and hypertension because their approvals were based on flawed clinical studies conducted in India, the agency announced today. The US Food and Drug Administration (FDA) has not yet taken action on the issue.

    Familiar names on the list include candesartan, donepezil, escitalopram, esomeprazole, and metformin. The list extends more than 120 pages because the drugs are marketed individually in multiple European Union (EU) nations in various dosages, and therefore appear over and over.

    Abbott Laboratories, Actavis, Dr Reddy's Laboratories, Mylan Pharmaceuticals, Sandoz, and Takeda Pharmaceuticals are some of the many manufacturers involved.

    The EMA recommendation to suspend the drugs would apply across the entire EU. Drug regulators in France, Germany, Belgium, and Luxembourg have already acted to stop the sales of 25 drugs.

    The clinical studies in question were conducted by GVK Biosciences, a contract research organization in Hyderabad, India.

    FYI
    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 14, 2014 4:08 PM Flag

    Johnrambo,

    In fact, a study by Charlton et al etimates that the rising prevalence of NAFLD in the US will soon lead to large numbers of patients with decompensating cirrhosis from NASH and that it will soon become the leading indication for liver transplants in the US.

    Charlton MR, Burns JM, Pedersen RA, Watt KD, Heimbach
    JK, Dierkhising RA. Frequency and outcomes of liver transplantation
    for nonalcoholic steatohepatitis in the United
    States. Gastroenterology 2011; 141: 1249-1253

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 14, 2014 1:27 PM Flag

    It would not be off label for diabetes, high blood pressure, or even high cholesterol.
    Remember Belviq is indicated for obesity and also with those patients that have at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes.

    So when I said no it would not be off-label in patients with NASH it is because a significant number of patients with NASH, and especially with more severe NASH, they will have one or more of the weight related medical conditions that make it possible to prescribe Belviq for this indication.

    Docs are increasingly becoming aware of the benefits. Arena has to be more aggressive in dispelling the myth that lorcaserin has minimal weight loss and this has been the major obstacle.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 14, 2014 1:15 PM Flag

    I appreciate your post however I certain that Arena is aware of the same info I posted. They cannot promote what I posted because there are no specific studies performed to demonstrate its benefit for metabolic syndrome directly However, since treatment of both NASH and metabolic syndrome is primarily weight loss then it is clear that Belviq is a therapeutic option for both of theses diseases. It is more important that physicians are aware of the potential uses of Belviq. And most physicians will understand the benefits of Belviq in both these cases. With time this will become more evident.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 14, 2014 1:01 PM Flag

    Yes to your first question. Regarding off label use, which is perfectly acceptable, the answer is yes and no. No because most patients are obese and that would be primary reason for prescribing however it NASH provides a more compelling reason to prescribe Belviq to patients who are obese and have NAFLP. An excellent medical indication (in addition to prediabetes) and not for weight loss alone will provide an impetus to prescribe Belviq. And yes, if your only indication is NASH, however this would be much less common. The vast majority of NASH patients have obesity.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 14, 2014 12:53 PM Flag

    This is too funny if not creepy

    tnorman61 seems to be assigned as a personal watchman over me. I only occasional post over the past year but as soon as I do within 5 minutes tnorman posts his famous Professor Fakir lines. There could be a month lapse between posts, and usually with hundreds and hundreds of posts on this board in between but it is guaranteed that tnorman61 will immediately respond to one of my posts.

    Did someone hire you to keep watch over me?

    I don't usually respond to bashers but this special affinity that tnorman has for me necessitated a comment.

    Don't bother to comment because I will not respond to useless and futile attempts to discredit me.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone Nov 14, 2014 12:08 PM Flag

    In order to understand why Belviq is the ideal drug we need to know some pertinent information regarding NASH epidemiology and causes.

    NAFLD is the presence of hepatic steatosis with no other causes for secondary fat accumulation present. NAFLD may progress to cirrhosis and hepatocellular carcinoma.

    NAFLD includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH). NASH is associated with hepatic inflammation. Cirrhosis develops when steatosis becomes steatohepatitis and then fibrosis.

    Hepatocellular carcinoma risk in NASH with cirrhosis ranged from 2.4 percent over seven years to 12.8 percent over three years with a five year cumulative incidence of 8%.

    Prevalence
    NAFLD is the most common disorder in Western industrialized countries where the major risk factors are CENTRAL OBESITY, T2DM, DYSLIPIDEMIA, AND METABOLIC SYNDROME.
    Prevalence in the US is 10-46% - accounting for 75 percent of chronic liver disease
    Worldwide prevalence is 6-35 percent (median 20 percent)
    In one study in the US NASH was present 32 percent.

    NAFLD in the US has been increasing over time.

    Metabolic syndrome is a known risk factor for cardiovascular disease and is common in NASH

    NASH is also associated with increases in cholecystectomy - 2x as many patients had NASH

    Many different therapies have been attempted but most have either serious adverse effects or not efficacious.

    Weight loss is the only therapy that is both safe and efficacious - Belviq is both safe and efficacious
    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone Nov 14, 2014 11:40 AM Flag

    Patients with NAFLD (nonalcoholic fatty liver disease) and especially those with NASH frequently have one or more components of the metabolic syndrome:
    Obesity – in particular central obesity
    - In the BLOOM trial in year 1, lorcaserin use was associated with a significant decrease in waist circumference (baseline 109.6 cm) of 6.8 cm versus a decrease of 3.9 cm in the placebo arm and a decrease in BMI of 2.09 versus 0.78.
    - Treatment with belviq alone or with phent can decrease weight significantly
    Systemic hypertension
    - BLOOM trial: reduction in sys and dia BP
    Dyslipidemia
    - BLOOM trial: reduction in total cholesterol/LDL and cholesterol/triglyceride

    Insulin Resistance or overt diabetes
    - In the BLOOM trial, fasting blood glucose, insulin, and glycated hemoglobin (HBA1C) levels and insulin resistance also all decreased significantly more during year 1 in the lorcaserin group than in the placebo arm.
    In summary, BLOOM study demonstrated significantly reduced waist circumference (abdominal obesity), reduced fasting blood sugar, reduced A1C, reduced systolic anf diastolic blood pressure (hypertenssion), reduced total cholesterol/LDL cholesterol/triglycerides (dyslipidemia).

    The association was demonstrated in a study of 304 patients with NAFLD but without overt diabetes
    Liver biopsies were done in 163 patients and revealed NASH in 120 (74%)
    - Metabolic syndrome present in 53% who did not undergo biopsy
    - Metabolic syndrome in 67% with those with simple steatosis
    - Metabolic syndrome in 88% of those with NASH on biopsy

    Furthermore, metabolic syndrome was associated with increased risk of severe fibrosis, a risk factor for cirrhosis and hepatocellular carcinoma (HCC) – in one report of 137 patients with NASH and advanced fibrosis, the five year incidence of HCC was 8 percent.

    Multiple therapies have been investigated for treatment of NASH. Weight loss is THE ONLY THERAPY with reasonable evidence with beneficial and safe results.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 5, 2014 12:10 PM Flag

    Works Cited
    1 Prospective Studies Collaboration, Whitlock G, Lewington S, et al. Body-mass index and cause specific mortality in 900 000 adults: collaborative analysis of 57 prospective studies. Lancet 2009; 373: 1083
    2 Van Dam RM, Willett WC, Manson JE, Hu FB. The relationship between overweight in adolescence and premature death in women. Ann Intern Med 2006; 145:91
    3 Nguyen NT, Magno CP, Lane KT, et al. Association of hypertension, diabetes, dyslipidemia, and metabolic syndrome with obesity: findings from the National Health and Nutrition Examination Survey, 1999 to 2004. J Am Coll Surg 2008; 207: 928
    4 Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as risk factor for clinical diabetes mellitus in women. Ann Intern Med 1995; 122:481
    5 Klein S, Burke LE, Bray GA, et al. Clinical implications of obesity with specific focus on cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation 2004; 110: 2952
    6 Rexrode KM, Hennekens CH, Willett WC, et al. A prospective study of body mass index, weight change, and risk of stroke in women. JAMA 1997; 277:1539
    7 Deslypere JP. Obesity and cancer. Metabolism 1995; 44:24
    8. Visceral obesity and breast cancer risk in Cancer 1994, 74, p 632.
    9 Association of obesity and cancer risk in canada in the american journal of epidemiology 2004 vol 159 p 259.
    10 obesity and incidence of cancer, a large cohort study of over 145000 adults in austria in the british journal of cancer 2005 vol 93 p1062. and finally number
    11 Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults in the new england journal of medicine 2003 vol 348 p 1625.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 5, 2014 12:09 PM Flag

    Continued

    MORBIDITY

    - Overweight and obese people have a higher relative risk of hypertension, dyslipidemia, and diabetes mellitus in individuals with BMIs ranging from 25-40 kg/m2 [3]

    - Diabetes Mellitus: 80% of cases of type 2 DM can be attributed to obesity [4]

    - Heart Disease: Obesity is associated with increased risks of coronary disease, heart failure, and cardiovascular and all-cause mortality
    -Weight loss (achieved through lifestyle interventions, medication, or surgery) is associated with improvement in CVD risk factors [5]
    - Stroke: Nurses Health Study found that increased BMI ( 27) and weight gain after age 18 were associated with increased risk of stroke [6]

    CONCLUSION

    Obesity is associated with increased risk of cardiovascular complications, type 2 diabetes mellitus, and several different neoplasms
    -The pooled phase 3 data analyses showed that lorcaserin caused significant improvements in blood pressure, lipid profiles, and insulin resistance

    Arena monitored for neoplasia in clinical trials and no excess neoplasia was observed in clinical trial participants.

    Lorcaserin is used to treat obesity and therefore may be used to help prevent obesity complications without the associated adverse effects

    We must start thinking in terms of prevention rather than cure since prevention is safer and more effective

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • When we look at overall benefits we tend to look at only a weight loss as a percentage and nothing else and we only see the forest through the trees - that is, we can't see the big picture because we are so focused on this detail. What gets lost is that we don't see the tremendous impact PREVENTION of disease has which saves more lives and saves much more money than treatment. Lorcaserin is the ideal for the dictum that an ounce of prevention is worth a pound of cure - a very appropriate pun, by the way.

    - Morbidity and mortality associated with obesity have been known to medical professionals for more than 2000 years

    - Obesity is associated with an excess risk of many disorders, including diabetes mellitus, insulin resistance, hypertension, dysplipidemia, heart disease, stroke, sleep apnea, cancer, and many others

    MORTALITY

    - Large epidemiologic studies have shown that being overweight and obese is associated with increased death from all causes and from cardiovascular disease (CVD) [1]

    - Overweight in adolescence may also increase the risk of premature death as an adult [2

    CANCER MORTALITY

    - Cancer: Obesity is not only associated with increased frequency of certain cancers in both men and women it also increases the likelihood of dying from cancer [7-10]

    - For both men and women, increasing BMI was associated with higher death rates due to the following cancers: Esophagus, colon and rectum, liver, gallbladder, pancreas, kidney, non-Hodgkin lymphoma, multiple myeloma,

    - Women had increased risk of death from cancers of the breast, uterus, cervix, and ovary

    - Based on upon the associations in the previous slide the authors came to the following conclusion:

    Overweight and obesity in the US accounts for 14 percent of all cancer deaths in men and 20 percent of those in women [11]

    Continued

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone by jeremiahthirtythreeone Nov 4, 2014 11:47 AM Flag

    Research firm IMS compiled a rolling 12-month history (October 2013 to September 2014) of the top 100 drugs by total prescriptions and total sales in the United States.

    wwwdotmedscapedotcom/viewarticle/834273?src=wnl_edit_newsal&uac=80075FN#vp_1

    Chantix is in top 50 with 2,165,904 prescriptions in the 12 months listed above.

    Belviq, if one year data demonstration significant continuous abstinence (chantix is 23% vs 10% placebo), will be able to penetrate this market given its superior safety profile.

    The advantage is that Belviq also decreases weight. This is important because obesity may soon surpass tobacco as the leading preventable cause of cancer.

    The American Society of Clinical Oncologists (2014) said obesity is now implicated in as many as 1 in 5 cancer deaths — about the same rate as cancers linked to smoking.

    Having said that, we have sufficient data to demonstrate the safety of Belviq and this should encourage physicians to begin prescribing it off label for tobacco cessation.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Nov 4, 2014 11:41 AM Flag

    Den1man,
    Cannot make direct comparisons with Chantix until long term randomized trials are performed.
    A randomized trial by Pfizer demonstrated a 23% continuous abstinence after one year but placebo was 10%.

    At the present time we cannot make direct comparisons other than safety. Belviq's safety profile has been sufficiently demonstrated.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

ARNA
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