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Medical Forum / General / Cardiology / March 2005Pfizer HDL Drug Linked to Hypertension in Some
NEW YORK (Reuters) - Pfizer Inc.'s experimental drug to raise "good" HDL cholesterol was effective and well tolerated in two small mid-stage trials, but appeared to cause a small increase in blood pressure among some patients, according to industry analysts. "Investors should note that even minor elevations in blood pressure could partially offset the cardiovascular benefits of elevated HDL," Merrill Lynch analyst David Risinger said in a research report about the drug, called torcetrapib. Complete data on the studies of torcetrapib, the most important medicine in Pfizer's drug pipeline, will be formally presented Monday at the annual scientific meeting of the American College of Cardiology in Orlando, Florida. But Wall Street analysts, including JP Morgan's Chris Shibutani and Lehman Brothers' Anthony Butler, this week issued research reports that analyze brief descriptions of the studies already provided by the cardiology group. Pfizer aims to combine torcetrapib in a single tablet with the company's widely marketed Lipitor, which works instead by lowering levels of "bad" LDL cholesterol. Pfizer has said the combination product, if approved, has the potential to outstrip Lipitor's current $10 billion in annual sales. It could do so, Pfizer believes, by better preventing heart attacks and stroke through its dual method of action. In a highly publicized different trial described last April in the New England Journal of Medicine, volunteers who took daily 120-milligram doses of torcetrapib had a 46 percent increase in HDL. When Lipitor was added to the mix, the good cholesterol rose 61 percent. Analysts said the latest mid-stage trials involved 162 subjects who took torcetrapib alone at various doses up to 90 milligrams, or who took placebos. Patients in the other 174-person trial took the same doses of torcetrapib, while also taking Lipitor. HDL levels rose from 9 percent to 54.5 percent in those taking torcetrapib alone, and rose between 8.3 percent to 40.2 percent in those also taking Lipitor. Risinger said researchers reported "small increases in systolic and diastolic blood pressure" in some treated patients. The analyst questioned whether the hypertension findings might help explain why Pfizer has decided to keep doses of torcetrapib down to 60-milligrams in far larger late-stage trials now being conducted. "Is there an adverse hypertension signal?" Risinger asked in his report, adding that U.S. regulators can be expected to focus on the problem, if it is truly worrisome. Lehman Brothers' Butler said neither study showed an increase in overall side effects with increasing dosages of torcetrapib. "However, we expect further details on the significance (or insignificance) of the observed hypertension in the treatment groups during the American College of Cardiology" meeting, Butler said. Butler said Pfizer officials commented that hypertension seems to be observed "mostly with higher dosages of torcetrapib." But Pfizer spokeswoman Kate Robins told Reuters she could not comment on the studies until they were officially presented in their entirety on Monday. "We prefer to comment on data that we know is accurate and look forward to discussing the full information," she said. What were the screening parameters? Early drug trials typically screen out anyone with hypertension and strive for healthy people. If that was the case in these trials, what effects will there be on the natural candidate for this latest Pfizer statin, who will commonly have established hypertension issues? > NEW YORK (Reuters) - Pfizer Inc.'s experimental drug to raise "good" HDL > cholesterol was effective and well tolerated in two small mid-stage [quoted text clipped - 65 lines] > "We prefer to comment on data that we know is accurate and look forward > to discussing the full information," she said. the way I read it....these were not folks hypertensive to start with...and they do not define "small increases" in b/p could be only a few mm there ARE some meds that can cause my b/p to rise just a tad...but since my systolic is usually around 100...it has never been an issue... as for what to do with hypertensives who have high cholesterol?? hmmm...well they have two risk factors for CAD going in... goes to the risk benefit ratio again... in my h.o. > What were the screening parameters? Early drug trials typically screen > out anyone with hypertension and strive for healthy people. If that was [quoted text clipped - 71 lines] >> "We prefer to comment on data that we know is accurate and look forward >> to discussing the full information," she said. Exactly my point. The screening that takes place early on in drug trials ensures that the population most likely to suffer adverse effects is excluded before the study starts. Then, people drop out of the study if adverse effects are experienced. Thus, the best possible results are achieved - in this case the adverse effect of elevated bp was actually still evident. The methodology for drug approval is one reason why the average time before adverse effects are evident enough for warnings to the general public for an approved drug is approximately 7 1/2 years. Women are frequently negatively affected, because they are included in so few studies. As we know from yesterday's news, Asians were evidently not included in early statin/Crestor studies, or the fact that the drug remains at double strength in their bodies would have been known long ago. It isn't just the larger population taking the drug that makes the adverse effects evident, it is the population of people who NEED the drug - typically, not as robust and healthy as the heavily-screened drug trial volunteers. This particular finding of an adverse effect so early in the game - one that is explicitly dangerous for the target population of the drug - is a fluke. Fortunate, but rare, that it was discovered so early. > the way I read it....these were not folks hypertensive to start with...and > they do not define "small increases" in b/p [quoted text clipped - 87 lines] >>> "We prefer to comment on data that we know is accurate and look forward >>> to discussing the full information," she said. > Exactly my point. > [quoted text clipped - 115 lines] > >>> "We prefer to comment on data that we know is accurate and look forward > >>> to discussing the full information," she said. "This particular finding of an adverse effect so early in the game...rare, that it was discovered so early." Rarer still that we learned about it pre-market. Thank you David Graham whose courageous act will reverberate through pharma corridors for some time to come. Zee Re: In a highly publicized different trial described last April in the New England Journal of Medicine, volunteers who took daily 120-milligram doses of torcetrapib had a 46 percent increase in HDL. When Lipitor was added to the mix, the good cholesterol rose 61 percent. HDL levels rose from 9 percent to 54.5 percent in those taking torcetrapib alone, and rose between 8.3 percent to 40.2 percent in those also taking Lipitor. ?????? How did they arrive at the results in the 1st paragraph ? It appears the 61 percent should be for taking torcetrapib alone, NOT taking torcetrapib with Lipitor. [as described in paragraph 2]. Frankie "Frankie" <birm47@gmail.com> wrote in part: >Re: In a highly publicized different trial described last April in the >New [quoted text clipped - 15 lines] > >Frankie There's no inconsistency. The range of individual responses is extremely variable. That's why means and medians and other group measures are used. -- Jim Chinnis Warrenton, Virginia, USA "Sharon Hope" <shope@anet.net> wrote in part: >The screening that takes place early on in drug trials ensures that the >population most likely to suffer adverse effects is excluded before the >study starts. Then, people drop out of the study if adverse effects are >experienced. Thus, the best possible results are achieved - in this case >the adverse effect of elevated bp was actually still evident. How did they screen people so as to exclude those whose blood pressure would rise from taking torcetrapib? -- Jim Chinnis Warrenton, Virginia, USA > "Sharon Hope" <shope@anet.net> wrote in part: > [quoted text clipped - 7 lines] > pressure would rise from taking torcetrapib? > -- Didn't mean to imply that at all. I assumed that they screened out all hypertensives from the study - those in whom an increase in bp would be a much more serious problem - because that kind of screening would be typical of any early study. Thus, based on that unfounded assumption, I concluded that the bp elevation was a real and significant adverse effect finding. Also, I speculate that it would be more of an issue for the target population than it was for the study volunteers, because the target population would likely include many hypertensives. If anyone has the actual screening criteria, speak up, as that would allow us to see how much of these hypotheses can be verified. > Jim Chinnis Warrenton, Virginia, USA > What were the screening parameters? Early drug trials typically screen out > anyone with hypertension and strive for healthy people. If that was the case > in these trials, what effects will there be on the natural candidate for > this latest Pfizer statin, who will commonly have established hypertension > issues? Do not be concerned Sharon: "...U.S. regulators can be expected to focus on the problem, if it is truly worrisome." Apparently new policies have been implemented at the FDA since the recent and third POST MARKET edit to Crestor's growing WARNING list. Zee > > NEW YORK (Reuters) - Pfizer Inc.'s experimental drug to raise "good" HDL > > cholesterol was effective and well tolerated in two small mid-stage [quoted text clipped - 65 lines] > > "We prefer to comment on data that we know is accurate and look forward > > to discussing the full information," she said. >> What were the screening parameters? Early drug trials typically > screen out [quoted text clipped - 8 lines] > Do not be concerned Sharon: "...U.S. regulators can be expected to > focus on the problem, if it is truly worrisome." That quote sounds like the reporter had a dry sense of ironic humor. "IF it is truly worrisome" to give people with hypertension and high cardiac risk a drug that exacerbates the hypertension....... Going for the readership response of, "gee, I'm no doctor and I don't play one on tv, but even I know that this is obviously a very very bad idea." Kinda like the general public shaking their heads in disgust when the early reports that the new trend is to find a way to supress CRP - once it was found that CRP was indicative of cardiac risk. The same readership then read that CRP is the indicator of an infection or inflammation, and that instead of addressing the cause of the inflammation or infection, the drug companies were going to try to find a drug that blocked the CRP, and responded "gee, I'm no doctor and I don't play one on tv, but even I know that this is obviously a very very bad idea. That would be like 'fixing' a car that overheats by disconnecting the idiot light that said the engine was hot." > Apparently new policies have been implemented at the FDA since the > recent and third POST MARKET edit to Crestor's growing WARNING list. [quoted text clipped - 96 lines] > forward >> > to discussing the full information," she said. Sharon... I just read "somewhere" that there are two assays for CRP...one is specific for cardiac...sorry...cannot remember where I read it.. But I agree that simply treating a high CRP is spitting in the wind...as the increase could be due to inflammation elsewhere in the body..such as rheutomoid arthritis..etc.... However...statins do result in a lowering of CRP in many ..if not most patients who take statins Not that statins alone should be used...in my h.o.....for those with ONLY CRP elevations... the hypertension link...according to what I have read...including what has been posted here...poorly define WHAT the risk of elevation is...a few mm of elevation should not be an issue.. as many things..meds,,lifestyle..stress..etc also can cause a few mm of elevation...and no one jumps on that.. >>> What were the screening parameters? Early drug trials typically >> screen out [quoted text clipped - 128 lines] >> forward >>> > to discussing the full information," she said. |
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