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Arena Pharmaceuticals, Inc. Message Board

jeremiahthirtythreeone 16 posts  |  Last Activity: Jan 25, 2015 10:48 PM Member since: Feb 16, 2010
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  • 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 โ€“ 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) โ€“ 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 โ€” 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

  • jeremiahthirtythreeone jeremiahthirtythreeone Oct 31, 2014 11:29 AM Flag

    Thank you Sharon. This will be a very significant addition to the treatment of this devastating disease. If studies confirm safety and efficacy this will be a leader in the treatment of PAH - the present therapies are very expensive, route of administration problems with complications and compliance.
    Keep us updated.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

  • jeremiahthirtythreeone jeremiahthirtythreeone Oct 30, 2014 9:21 PM Flag

    Forgot to mention date of article - October 2014.

    Sentiment: Strong Buy

  • IV nicotine self-administration in rats using a consummatory operant licking response: sensitivity to serotonergic, glutaminergic and histaminergic drugs.
    Cousins V, et al. Prog. Neuropsychopharmacol. Biol. Psychiatry - ; 54; 200-5

    Abstract
    Tobacco smoking is characterized by repeated self-administration of nicotine by placing the cigarette in the mouth. The repeated hand-to-mouth self-administration is essentially a consummatory act. We recently developed a paradigm in which rats lick one of two spouts to trigger intravenous (IV) delivery of nicotine, which combines a consummatory act with rapid delivery of nicotine to model the act of tobacco smoking. We have found that rats will lick hundreds of times per nicotine infusion. In the current study, using the operant licking nicotine self-administration model with young adult Sprague-Dawley rats, we tested the effect of antagonists of H1 histamine receptors pyrilamine, serotonin (5HT) type 2 receptors ketanserin and NMDA glutamate receptors with d-cycloserine as well as an agonist of 5HT2c receptors lorcaserin, in dose ranges that we have found in previous studies to significantly reduce IV nicotine self-administration with the operant In contrast, the 5HT2A and C antagonist ketanserin did not show an effect of reducing nicotine self-administration in the same dose range we had found in a previous study to significantly reduce operant lever press nicotine self-administration. The 5HT2C agonist lorcaserin significantly decreased nicotine self-administration in the licking paradigm at the same dose threshold as with lever press responding.
    The rat model incorporating consummatory aspects of tobacco addiction can provide distinct and potentially more relevant information concerning possible new avenues of treatment to combat tobacco addiction.

    Daniel
    UCLA MD

    Sentiment: Strong Buy

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