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Microsoft word - article 07-10 newman statin.doc

Carcinogenicity of Lipid-lowering Drugs
Journal of the American Medical Association
January 3, 1996;275(1):55-60
Newman TB, Hulley SB.
Department of Laboratory Medicine, School of Medicine, University of California,San Francisco, USA.
BACKGROUND INFORMATION:
Fibrates:
Bezafibrate (e.g. Bezalip)
Ciprofibrate (e.g. Modalim)
Gemfibrozil (e.g. Lopid)
Fenofibrate (e.g. TriCor)
Statin Brand
name Derivation
Pravachol, Selektine, Lipostat Fermentation-derived OBJECTIVETo review the findings and implications of studies of rodent carcinogenicity of lipid-lowering drugs.
DATA SOURCESSummaries of carcinogenicity studies published in the 1992 and 1994 Physicians'Desk Reference (PDR), additional information obtained from the US Food and DrugAdministration, and published articles identified by computer searching,bibliographies, and consultation with experts.
STUDY SAMPLEWe tabulated rodent carcinogenicity data from the 1994 PDR for all drugs listed as“hypolipidemics.” For comparison, we selected a stratified random sample ofantihypertensive drugs. We also reviewed methods and interpretation ofcarcinogenicity studies in rodents and results of clinical trials in humans.
DATA SYNTHESISAll members of the two most popular classes of lipid-lowering drugs (the fibratesand the statins) cause cancer in rodents, in some cases at levels of animal exposureclose to those prescribed to humans.
In contrast, few of the antihypertensive drugs have been found to be carcinogenicin rodents.
Evidence of carcinogenicity of lipid-lowering drugs from clinical trials in humans isinconclusive because of inconsistent results and insufficient duration of follow-up.
CONCLUSIONSExtrapolation of this evidence of carcinogenesis from rodents to humans is anuncertain process. Longer-term clinical trials and careful post-marketingsurveillance during the next several decades are needed to determine whethercholesterol-lowering drugs cause cancer in humans.
In the meantime, the results of experiments in animals and humans suggest thatlipid-lowering drug treatment, especially with the fibrates and statins, should beavoided except in patients at high short-term risk of coronary heart disease.
In the past decade (1985 – 1995) there has been a greater than 10-fold increase in the prescription of lipid-lowering drugs because they are beingaggressively promoted by their manufacturers.
Lipid-lowering drugs may be taken for 30 years or more, yet the FDA approved these drugs based upon clinical trial that lasted only a fraction of thistime.
“Thus, millions of asymptomatic people are being treated with medications, the ultimate effects of which are not yet known.” “Meta-analyses of randomized clinical trials have suggested that cholesterol- lowering drugs may increase noncardiovascular mortality.” “Drug companies are required to submit data from rodent carcinogenicity studies to the FDA. These studies are not generally published in scientific journalsbut are summarized in the Physicians’ Desk Reference (PDR).” These authorsevaluated the results of these carcinogenicity rodent studies in the PDR andcompared them to other classes of drugs.
“The product information for lipid-lowering drugs indicates that all the fibric acid derivatives and statins caused cancer in rodents.” “In most cases the rodent exposure at which carcinogenicity was observed was of the same order of magnitude as that observed with the maximum doserecommended for humans.” “Unlike the lipid-lowering drugs, most drugs for lowering blood pressure do “Almost all known human carcinogens have been found to be carcinogenic in “Why Were These Drugs Approved?”
These authors reviewed the minutes of the approval committee meeting, and found that representatives of the makers of these drugs downplayed the importanceof the rodent carcinogenicity studies. Additionally, for gemfibrozil, “only three of thenine members of the advisory committee believed that the potential benefit of usinggemfibrozil, for the prevention of coronary heart disease outweighed the potentialrisks associated with such use.” Sadly, such votes are only advisory, and the FDA approved gemfibrozil, when Low high-density lipoprotein cholesterol.
Elevated low-density lipoprotein cholesterol.
Inadequate response to weight loss, diet, and exercise.
“Unfortunately, the subsequent popularity of gemfibrozil suggests that its use hasnot been restricted to this small group.” “For patients not at high short-term risk of CHD death, especially patients with life expectancies of more than 10 to 20 years, pharmacologic treatmentprobably should be avoided.” It is possible that these drugs are not carcinogenic, but rather that it is the lower cholesterol levels they cause being responsible for the adverse effects.
“Persons with low cholesterol levels have higher cancer death rates in cohortstudies.” “It seems prudent to reserve the statins for people at high short-term risk of heart disease and to be wary about their long-term use.” “Most cholesterol-lowering drugs cause or promote cancer.” “Patients to whom these drugs are prescribed are exposed throughout many years to doses approaching those shown to be carcinogenic in animals.” Use of cholesterol-lowering drugs should be restricted to those at high risk of short-term CHD death, such as those with prior CHD, in whom the short-termbenefits of treatment are most likely to justify the long-term risks.
“Drug companies are required to submit data from rodent carcinogenicity studies to the FDA. These studies are not generally published in scientific journalsbut are summarized in the Physicians’ Desk Reference (PDR).” These authorsevaluated the results of these carcinogenicity rodent studies in the PDR andcompared them to other classes of drugs.
“The results of experiments in animals and humans suggest that lipid- lowering drug treatment, especially with the fibrates and statins, should be avoidedexcept in patients at high short-term risk of coronary heart disease.” Lipid-lowering drugs may be taken for 30 years or more, yet the FDA approved these drugs based upon clinical trials that lasted only a fraction of thistime.
“Millions of asymptomatic people are being treated with medications [lipid- lowering drugs], the ultimate effects of which are not yet known.” “Meta-analyses of randomized clinical trials have suggested that cholesterol- lowering drugs may increase noncardiovascular mortality.” “The product information for lipid-lowering drugs indicates that all the fibric acid derivatives and statins caused cancer in rodents.” “In most cases the rodent exposure at which carcinogenicity was observed was of the same order of magnitude as that observed with the maximum doserecommended for humans.” “Almost all known human carcinogens have been found to be carcinogenic in “For patients not at high short-term risk of CHD death, especially patients with life expectancies of more than 10 to 20 years, pharmacologic treatment [withlipid-lowering drugs] probably should be avoided.” It is possible that these drugs are not carcinogenic, but rather that it is the lower cholesterol levels they cause being responsible for the adverse effects.
“Persons with low cholesterol levels have higher cancer death rates in cohortstudies.” “It seems prudent to reserve the statins for people at high short-term risk of heart disease and to be wary about their long-term use.” “Most cholesterol-lowering drugs cause or promote cancer.” “All members of the two most popular classes of lipid-lowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animalexposure close to those prescribed to humans.” “Patients to whom these drugs are prescribed are exposed throughout many years to doses approaching those shown to be carcinogenic in animals.” Use of cholesterol-lowering drugs should be restricted to those at high risk of short-term CHD death, such as those with prior CHD, in whom the short-termbenefits of treatment are most likely to justify the long-term risks.

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