A quick trip to belviq's website which I know very few of you have even researched that much. Show the studies of belviq's minimal efficacy. Only 37.5 - 47.1% of patients acheived 5% or greater weight loss(which is also the requirement to remain on treatment per FDA) in comparison to 16.1% and 22.6% in the placebo groups respectively. We all already knew the efficacy was minimal but the year two results are where things get interesting why do patients start gaining a significant amount of the weight back in the 2nd year of treatment? The 3.3% placebo adjusted weight loss isn't something shorts, adam f, etc have made up its right there on belviq's website, research it yourself.
Just a few things in response. First, this is not a "magical" pill where one is going to lose weight by sitting leading a sedentary lifestyle with an accompanying poor diet. The pill is part of a comprehensive plan. This is akin to the smoking cessation patches. Studies how that it works (I believe it is a combo of the physical and psychological) but only alongside psychological willpower and lifestyle changes. The patch isn't going to be for everyone and it isn't an expensive magical patch that I put on and then I stop smoking. Now the efficacy wears off and after one year there are statistics that vary but many say only 5% are not smoking at that point. Does that mean the patch didn't work? Does that mean that smokers who tried it to stop may try it again? Do you think those who did quit for good made some lifestyle changes which are required to stay off the nicotine? You can manipulate all of the statistics you want to support your stance but when I read posts like yours I can tell that you are not really understanding the fundamentals of the illness and are relying on the stats/technicals. I think instead of rushing to conclusions and making your own assumptions prior to the DEA making theirs, you should probably keep these sort of comments to discourse with other bashers and not waste the time of others.
The disturbingly low efficacy rate of 37.5% means the vast majority of patients will discontinue Belviq within 12 weeks. The 60% non responders of Belviq will then have the option of switching to the highly effective QSYMIA. treatment.
How dare you post facts that are contrary to arnatard deluded fantasies. The pied pipers pump and mislead the koolaid drinking retail longs and they delude themselves of riches they will never realize. Belcebo will fail, it is really not very good and extremely expensive. By the end of the year the truth will be apparent to all and the lying pumpers will disappear from this MB.
They have to report results on an MITT-LOCF basis to produce statistical analysis..... in real life there are no drop outs (totally different circumstances) and therefore it is better to look at the results the PATIENTS THAT ACTUALLY TOOK THE DRUG achieved. Makes sense, right?
Patients that look at a possible treatment don't usually ask "how much weight loss did the drop outs get?". Most patients want to know what they can expect IF THEY TAKE IT AS PRESCRIBED.
1775 patients completed the B+B clinical trials.... that's more than the minimum STARTING population recommended by the FDA and blows away the Q testing (titration games can backfire.... Lol).
I couldn't respond to your specific post in this thread, but you state that Q doesn't have the 5% 12 week restriction. Q's prescribing label states that after 12 weeks of taking the low dose and 3 percent weight hasn't been lost than double the dose for another 12 weeks and if 5% percent weight loss hasn't been obtained by then you should discontinue use gradually due to possibility of precipitating a seizure. Sounds fun! What happens if a woman becomes pregnant while taking the high dose? She can't immediately stop like the label directs without risk of seizure. The choice is there, ween off the drug and risk fetal harm or immediately discontinue and risk seizures.
Sentiment: Strong Buy
Your comments about valvulopathy totally false making you a certified liar.
Read and weep!!
"The most frequent lorcaserin-associated adverse events included headache, nausea, dizziness, fatigue and dry mouth. Headache was the only adverse event with an incidence that exceeded the placebo group by greater than 5%. In each trial, echocardiograms were performed at baseline and every six months to measure heart valve regurgitation. In the meta-analysis of the three trials, the proportion of patients who developed FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency) at Week 52 were as follows: lorcaserin 10 mg BID (2.37%), lorcaserin 10 mg QD (1.57%) and placebo (2.04%)." All below the general population % of 2.9%
The poster (not peer reviewed) methodology was incorrect in that they combined data from studies that excluded pre-existing vavlulopathy. You can't mix apples and oranges to make a conclusion, well you can and that conclusion was wrong.
All from the Arena website and Clinicaltrials website.
Most drugs are contradicted for pregnancy. Have you been living in a cave somewhere?
The poster that stated that higher dosage caused an increase in AR used the data incorrectly to come to that false conclusion.
In addition, regarding efficacy, patients taking lorcaserin are 3.6X vs. placebo to lose greater than 5% of their weight.
Now go back to your master, kiss his butt and ask for forgiveness for failing at your job as basher and spreader of FUD! Rtsos you are fired! Another CR dispensed with!
Sentiment: Strong Buy
Well it must have been a real quick trip because you for obvious reasons missed the data below. In the meantime, let's look at the different studies and the real facts.
1. Bloom - 2 year study. 3182 patients in the study. Categorical weight loss was that 47.5% in the drug arm lost greater than 5% of their weight. 68% of patients on Lorcaserin in year 2 that were on lorcaserin in year maintained greater than 5% weight loss. Thus your comments above are bogus!
2. Blossom - 1 year study. 4008 patients in the study. Categorical weight loss was that 47.2% lost greater than 5% of their weight vs. placebo. In addition 771 patients that were on 10mg QD, 41% of those patients lost greater than 5% of their weight.
3. Bloom-DM 604 patients in the study all with T2DM. 251 Patients on 10mg BID lost 37.5% greater than 5% weight loss. (note: T2DM patients are known to have a tough time losing weight); 94 patients on 10mg QD; 44% lost greater than 5% of their weight.
Now the Meta-Analyses of Phase 3 trials:
At one year, using Modified Intent-to-Treat with Last Observation Carried Forward analysis (MITT-LOCF) of the integrated results, 46.3% of lorcaserin 10 mg twice daily (BID) patients and 40.6% of lorcaserin 10 mg once daily (QD) patients achieved at least 5% weight loss, compared to 22.1% of patients on placebo, and 22.0% of lorcaserin 10 mg BID patients and 17.3% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 8.3% of patients on placebo. Of the patients completing year one of the trials, 62.3% of lorcaserin 10 mg BID patients and 52.8% of lorcaserin 10 mg QD patients achieved at least 5% weight loss, compared to 32.0% of patients on placebo, and 33.5% of lorcaserin 10 mg BID patients and 25.5% of lorcaserin 10 mg QD patients achieved at least 10% weight loss, compared to 13.8% of patients on placebo. Notably, this meta-analysis included approximately 600 patients enrolled with T2DM, a disease that typically makes weigh loss hard.
Sentiment: Strong Buy
bout2over...... Clinical trials have different characteristics than real life.... people drop out of tests for a variety of reasons and the fact is only 2% of B+B patients dropped out due to lack of efficacy and only 7.9% dropped out due to side effects (close to placebo)..... high drop out rates are common in weight loss drug testing because it is not an acute or rapidly life threatening disease.
In real life there are no drop outs..... only patients. Paper over the real picture.... paint it anyway you like, the true test is yet to come.....
Long as you are throwing out the Bloom, Blossom, and Bloom-DM statistics lets not forget that about 43% of the participants dropped out of the study. So 57% complete. That works out to about 27% of the original participants losing a whopping 5% of body weight over 2 years. Evan if insurance starts covering figure co-pay around $75. So here's the pitch...spend $900/yr- IF your insurance will pay for a 30% chance or less to lose 5% of your weight. Man I can't get to the Dr. soon enough!!!
But not good enough for the average person who want to lose weight and have better health. There are better products that are less expensive. There is NO DOUBT that belcebo will greatly disappoint.
63.9% of the patients that took Belviq reached AT LEAST 5% BW loss and were responders based on the FDA threshold level of 5% BW.
Your real fear is that once on the market you won't be able to distort the test data any more.
It was only good to the FDA for responders, not the total population of the study, the benchmark. That is why the severe restriction of lose 5 % in 12 weeks or you are done. Q does not have that restriction. That is a real Europe problem too. With ARNA giving 2 weeks free for all customers more than half of the expensively recruited customers will never pay more than 10 weeks and be gone forever.Some will move to Q to lose some real weight
Since you have such a handle on things, why don't you explain to the group how the placebo group is not just people popping sugar pills in this case. In the real world patients would not be able to afford what is considered placebo in the studies. Belviq looks down right inexpensive in comparison and with excellent efficacy, especially when considering real patients are not in a study and don't have the benefits that come from being in one. Also if you know science at all, you would know that you can't compare efficacy from two different studies. It is simply BS to do so....Bad Science. There are no head to head Q to B studies so any comparisons don't fly. Go run that study for 2 years and tell us how it turns out. Don't forget that Docs will have the patients come off of Q every few months because you cant just keep popping amphetamines. How is Q's efficacy when it cant be taken genius.
Sentiment: Strong Buy