Carole Jackson from Bottom Line's Daily Health News wrote the following article about statin side effects.
Sometimes it seems as if everyone over age 50 takes statins -- women and men, middle aged and elderly, and lots of people whose cholesterol levels are barely a blip over normal. In fact, lipid-regulating drugs are among the most common prescriptions in this country -- but their side effects are a troubling but seldom acknowledged issue, even by the doctors prescribing them. Beatrice A. Golomb, MD, PhD, at the University of California, San Diego, a leading researcher in this area, recently published a review analyzing nearly 900 studies on the many problems associated with statin use. Not only is this the most complete analysis ever published, her paper also explains why some people are at higher risk for problems than others.
SIDE EFFECTS
Based on patient reports, the number-one statin side effect, which is also the most recognized, concerns adverse effects on muscles including muscle pain, fatigue and weakness. (There is also an association with a rare but potentially devastating muscle condition called rhabdomyolysis, which causes severe muscle damage that can produce toxins that can eventually lead to renal dysfunction and possibly death.)
Second on the list is cognitive problems, including some that are dementia-like. Third place goes to peripheral neuropathy, which causes tingling, pain and numbness in the feet and hands. Other side effects are less frequent but wide ranging, from blood-glucose increases to sleep disruption and atrial fibrillation, as well as -- and this should get some attention -- sexual dysfunction.
It’s widely known that statins decrease coenzyme Q10, harming the mitochondria, which are the power producers in our cells. Dr. Golomb says this explains why people at highest risk for statin side effects are those who already have conditions that adversely affect mitochondria function -- high blood pressure, diabetes, thyroid problems or simply being older. CoQ10 is helpful in minimizing mitochondrial damage, which is obviously especially important for people with these pre-existing conditions -- but as noted, statins deplete this coenzyme. Dr. Golomb noted that this may be why statins aren’t as helpful for people who are over 70 or so.
Observational studies indicate that 10% to 30% of people taking statins will likely experience side effects, and that women seem to be at higher risk than men. Are you wondering why these problems aren’t frequently reported in clinical trials on statins? According to Dr. Golomb, one reason is because participants selected for such studies tend to exclude those most likely to have side effects -- such as people who take other medications along with those who have other health problems. Pharmaceutical companies pour millions of dollars into clinical trials, which are designed to, as Dr. Golomb puts it, "showcase the benefits" of the drugs. However, there are no corresponding interest groups to make sure that the other side also gets heard -- and people at higher risk for side effects are not excluded from taking the drugs once they are on the market. Keep in mind that one-fifth of all fully tested drugs put on the market are ultimately withdrawn or receive a black box warning. The reason: Once a larger and broader population takes a drug over a longer period of time, potential problems not shown in clinical trials will surface.
With so many people taking statins, it’s particularly important to be alert to problems that develop after you start taking these drugs. Side effects can become progressively worse, so it’s vital to investigate any possible ones immediately -- by stopping the drug to see if the problem reverses or stops. The good news is that many side effects are at least partially reversible, says Dr. Golomb. Potency of the statin increases the risk of side effects, so be especially suspicious if problems develop when you are taking a high dose. Taking less may be a solution, if you and your doctor feel you really need to be on statins.
Source(s): Beatrice Golomb, MD, PhD, University of California, San Diego.
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Showing posts with label statins. Show all posts
Showing posts with label statins. Show all posts
Wednesday, June 10, 2009
Tuesday, June 9, 2009
Statins and Diabetes: What the News Reports Aren't Saying
I received this interesting article in my email inbox from Bottom Line's Daily Health News about statin drugs. The article was written by Carole Jackson.
Statin use is so prevalent today that the brand names of these cholesterol-lowering drugs -- Lipitor, Crestor, Zocor -- seem almost as familiar as toothpastes. I worry this may make it hard to make good decisions as to whether the benefits of these "miracle drugs," as they’re too often called, outweigh the risks.
Harsh words? Perhaps, but they may be what we need to hear. The recently released results of the JUPITER trial (JUPITER stands for "Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin") singing the praises of Crestor helps prove my point... the public has become complacent about taking statins. The researchers claim that when patients with no evidence of pre-existing cardiovascular disease and low-to-normal LDL with elevated C-reactive protein (CRP), a marker of blood vessel inflammation that can be a sign of cardiovascular disease, were given 20 mg of Crestor once a day, it dramatically reduced their risk of major cardiovascular events such as heart attack and stroke.
The media took the bait -- hook, line and sinker.
Yes, the numbers appear to be dramatic: Published reports state that taking Crestor reduced the combined risk of heart attack, stroke or sudden cardiac death in the elevated-CRP population by 47%... cut the risk of heart attack by 54%... slashed the risk of stroke by 48%... and lowered total mortality by 20%. The trial was even halted early (after two years, although it was designed to go for five) so that those receiving the placebo could start taking Crestor. The problem: Media coverage of the study overlooked some of its key problems -- in a direction that is likely to the benefit of the drug’s manufacturer.
STEERING THE STATISTICS
When I read through the JUPITER study results as they were published in the New England Journal of Medicine, I immediately saw two red flags. First, the study was funded by AstraZeneca, the pharmaceutical company that makes Crestor. Second, the lead researcher is listed as a co-inventor on patents related to the test for elevated levels of high-sensitivity C-reactive protein, which the study puts forth as an indication for initiating statin therapy. I’m not saying either factor negates the quality of the research -- after all, somebody has to pay for these expensive studies -- but they do suggest possible bias on the part of the authors.
Indeed, when you look closely at the numbers, it does seem that they are spun to emphasize what’s positive for Crestor. What got everybody so excited about this report was that it looked like Crestor cut nearly in half the risk of a cardiac event (meaning myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina or death from cardiovascular causes) for the patients in the study. While that’s true... sort of... it’s far from the whole story.
Over the two-year period of research, .77% of the Crestor group experienced a cardiac event, compared with 1.36% of the placebo group. Take the math to the next level and you’ll see this means that more than 120 patients would need to take the drug for nearly two years for a single patient to benefit. Yes, it’s arguably true that Crestor cut the risk of a cardiac event nearly in half in this study (from 1.36% to .77%) but the risk was very small to begin with -- which makes it hard to justify the benefit of taking such an expensive drug.
Of even more concern... there are many known side effects associated with use of Crestor but this particular study uncovered an important and frightening one -- diabetes. News reports overlooked that physicians reported an increased incidence of diabetes with the Crestor group (270 Crestor patients developed diabetes over the course of the trial versus 216 in the placebo group). On his web site MedicationSense.com, Jay S. Cohen, MD, author of What You Must Know About Statin Drugs and Their Natural Alternatives, wrote, in a criticism of the study, "Imagine taking Crestor to prevent a heart attack and getting diabetes instead, which greatly increases the risks of heart attack and stroke." Scary, right?
LET COMMON SENSE PREVAIL
When I spoke with Dr. Cohen about this study and the role of statins in cardiac health, he emphasized that he is not against prescribing these medications for patients who need them. "There are two factors to consider when taking statins -- your cholesterol level and your medical history," Dr. Cohen said. "If you have a serious family history of heart attack or have diabetes, you may need a statin."
On the flip side, he points out, if you’re healthy, have no outstanding medical issues and have cholesterol that is "borderline high," you need to weigh the decision carefully. Do some research about statins and effective natural alternatives before you reach for the pills. One study, published in the Journal of the American College of Nutrition, showed that taking 515 mg of vitamin C each day was an effective way to reduce CRP. Also, exercising regularly, keeping your weight within a healthy range, and eating a plant-rich diet that’s low in animal products are helpful in improving or maintaining cardiovascular health... and, of course, not smoking.
Until we hear about follow-up studies that verify the "miracle drug" claims of statins (or any other drug, for that matter), don’t be a marketing victim -- always read the fine print. Learn as much as you can about all the options at your disposal, and then work with your doctor to arrive at the choice that makes sense for you.
Source(s):
Jay S. Cohen, MD, associate professor (voluntary) of family and preventive medicine, University of California, Del Mar. MedicationSense.com. Read more!
Statin use is so prevalent today that the brand names of these cholesterol-lowering drugs -- Lipitor, Crestor, Zocor -- seem almost as familiar as toothpastes. I worry this may make it hard to make good decisions as to whether the benefits of these "miracle drugs," as they’re too often called, outweigh the risks.
Harsh words? Perhaps, but they may be what we need to hear. The recently released results of the JUPITER trial (JUPITER stands for "Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin") singing the praises of Crestor helps prove my point... the public has become complacent about taking statins. The researchers claim that when patients with no evidence of pre-existing cardiovascular disease and low-to-normal LDL with elevated C-reactive protein (CRP), a marker of blood vessel inflammation that can be a sign of cardiovascular disease, were given 20 mg of Crestor once a day, it dramatically reduced their risk of major cardiovascular events such as heart attack and stroke.
The media took the bait -- hook, line and sinker.
Yes, the numbers appear to be dramatic: Published reports state that taking Crestor reduced the combined risk of heart attack, stroke or sudden cardiac death in the elevated-CRP population by 47%... cut the risk of heart attack by 54%... slashed the risk of stroke by 48%... and lowered total mortality by 20%. The trial was even halted early (after two years, although it was designed to go for five) so that those receiving the placebo could start taking Crestor. The problem: Media coverage of the study overlooked some of its key problems -- in a direction that is likely to the benefit of the drug’s manufacturer.
STEERING THE STATISTICS
When I read through the JUPITER study results as they were published in the New England Journal of Medicine, I immediately saw two red flags. First, the study was funded by AstraZeneca, the pharmaceutical company that makes Crestor. Second, the lead researcher is listed as a co-inventor on patents related to the test for elevated levels of high-sensitivity C-reactive protein, which the study puts forth as an indication for initiating statin therapy. I’m not saying either factor negates the quality of the research -- after all, somebody has to pay for these expensive studies -- but they do suggest possible bias on the part of the authors.
Indeed, when you look closely at the numbers, it does seem that they are spun to emphasize what’s positive for Crestor. What got everybody so excited about this report was that it looked like Crestor cut nearly in half the risk of a cardiac event (meaning myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina or death from cardiovascular causes) for the patients in the study. While that’s true... sort of... it’s far from the whole story.
Over the two-year period of research, .77% of the Crestor group experienced a cardiac event, compared with 1.36% of the placebo group. Take the math to the next level and you’ll see this means that more than 120 patients would need to take the drug for nearly two years for a single patient to benefit. Yes, it’s arguably true that Crestor cut the risk of a cardiac event nearly in half in this study (from 1.36% to .77%) but the risk was very small to begin with -- which makes it hard to justify the benefit of taking such an expensive drug.
Of even more concern... there are many known side effects associated with use of Crestor but this particular study uncovered an important and frightening one -- diabetes. News reports overlooked that physicians reported an increased incidence of diabetes with the Crestor group (270 Crestor patients developed diabetes over the course of the trial versus 216 in the placebo group). On his web site MedicationSense.com, Jay S. Cohen, MD, author of What You Must Know About Statin Drugs and Their Natural Alternatives, wrote, in a criticism of the study, "Imagine taking Crestor to prevent a heart attack and getting diabetes instead, which greatly increases the risks of heart attack and stroke." Scary, right?
LET COMMON SENSE PREVAIL
When I spoke with Dr. Cohen about this study and the role of statins in cardiac health, he emphasized that he is not against prescribing these medications for patients who need them. "There are two factors to consider when taking statins -- your cholesterol level and your medical history," Dr. Cohen said. "If you have a serious family history of heart attack or have diabetes, you may need a statin."
On the flip side, he points out, if you’re healthy, have no outstanding medical issues and have cholesterol that is "borderline high," you need to weigh the decision carefully. Do some research about statins and effective natural alternatives before you reach for the pills. One study, published in the Journal of the American College of Nutrition, showed that taking 515 mg of vitamin C each day was an effective way to reduce CRP. Also, exercising regularly, keeping your weight within a healthy range, and eating a plant-rich diet that’s low in animal products are helpful in improving or maintaining cardiovascular health... and, of course, not smoking.
Until we hear about follow-up studies that verify the "miracle drug" claims of statins (or any other drug, for that matter), don’t be a marketing victim -- always read the fine print. Learn as much as you can about all the options at your disposal, and then work with your doctor to arrive at the choice that makes sense for you.
Source(s):
Jay S. Cohen, MD, associate professor (voluntary) of family and preventive medicine, University of California, Del Mar. MedicationSense.com. Read more!
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