New Statins Labeling Update: Risk Of Increased Blood Sugar Levels And Diabetes
Report a Concern Health Canada is informing Canadians of a labelling update for all cholesterol-lowering drugs (also known as statins) regarding the risk of increased blood sugar levels and a small increased risk of diabetes among patients already at risk for the disease. Based on the review of all available data, Health Canada concluded that the risk of diabetes appears to be mainly in patients with pre-existing risk factors for diabetes, such as high levels of glucose or triglycerides, obesity or high blood pressure. Health Canada continues to believe the overall cardiovascular benefits of statin drugs in reducing blood cholesterol outweigh their risks. Diabetes is a condition where the body is unable to use blood sugar, due to decrease in body insulin production or insulin sensitivity. Diabetes is a complex condition with a number of risk factors, and a small increase in blood sugar will not necessarily increase the risk of diabetes in all patients. A new warning about the increased blood sugar levels and the risk of diabetes, including information on how to identify high-risk patients, has been added to the drug labels for the six statins currently marketed in Canada: atorvastatin (Lipitor and generics), lovastatin (Mevacor and generics), rosuvastatin (Crestor and generics), simvastatin (Zocor and generics), pravastatin (Pravachol and generics), fluvastatin (Lescol and generics). The new labels recommend that healthcare professionals carefully monitor the use of statins in patients at a high risk of future diabetes. What patients should do If you are taking statins and are at risk of diabetes, or are unsure of whether you are at risk, please consult your healthcare professional. You should not stop taking your statin drug without first speaking to your healthcare pr Continue reading >>
What is Lipitor? Lipitor is a prescription drug manufactured by pharmaceutical giant Pfizer and used to control high cholesterol levels. By lowering cholesterol, the drug aims to prevent dangerous blockages in blood flow and thereby reduce the risk of heart attack and stroke. The U.S. Food and Drug Administration (FDA) approved Lipitor in 1996. The drug’s active ingredient is atorvastatin calcium. This class of medications is generally well-tolerated; however, it has been associated with multiple risks, including: Lipitor belongs to a popular class of cholesterol-lowering drugs called statins, which represent the most widely prescribed class of drugs in the U.S. Lipitor is the most popular of all statins. Patients take statins to lower levels of cholesterol and other fatty substances in the blood that, if left unchecked, can increase the risk for heart attack, stroke and other related health complications. The liver makes most of the cholesterol found in blood. Statins reduce the amount of cholesterol made by the liver and help the liver remove cholesterol that’s already in the blood. How Lipitor Works Cholesterol plays a crucial role in several bodily processes that are essential to our health, but unhealthy levels of cholesterol can lead to buildup (plaque) on the walls of arteries. This can block blood flow to the brain and heart and put people at higher risk for stroke and heart disease. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both men and women in the U.S. Lipitor prevents heart attack and stroke by lowering cholesterol in the blood. It slows the production of cholesterol in the body therefore decreasing the amount of plaque buildup that may block the flow of blood to the heart and brain. Stat Continue reading >>
Controlling Cholesterol With Statins
Whether you’re taking a statin or not, the following tips can help keep your cholesterol in check: Talk with your healthcare provider about how often you should have your cholesterol checked. Maintain a healthy weight. Exercise regularly. When buying groceries, use the Nutrition Facts Label to choose foods lower in saturated fat, trans fats, and calories. Eat more fruits and vegetables. And remember, you should not stop taking any cholesterol-lowering medication you may be on without first talking to your healthcare provider. Subscribe: FDA Consumer Health Information You go to the gym faithfully, and try to watch your diet. But after your annual physical, you find out that your blood cholesterol is surprisingly high. Your doctor calls you back to discuss taking a medication known as a statin. Here are some commonly asked questions about cholesterol and statins. 1. What are statins? How do they work? Statins are a class of medicines used to lower cholesterol in the blood. Most of the cholesterol in your blood is made by the liver. Statins work by reducing the amount of cholesterol made by the liver and by helping the liver remove cholesterol that is already in the blood. According to James P. Smith, M.D., M.S., deputy director of the Division of Metabolism and Endocrinology at the U.S. Food and Drug Administration (FDA), “An important first step is to have a discussion with your healthcare provider about your risk of having heart disease or a stroke, how a statin would reduce that risk, and any side effects that you should consider.” 2. Why is it important to keep cholesterol levels in the blood low? Your body needs cholesterol, but too much of it in your blood can lead to buildup on the walls of your arteries (this buildup is called “plaque”), putting you at Continue reading >>
Playing The Odds With Statins: Heart Disease Or Diabetes?
Last year my cholesterol shot up despite living nowhere near a decent barbeque joint. I was totally stressed. I wasn't overweight. But I was pretty sedentary. My doctor prescribed a high dose of Lipitor, a powerful statin. For women of a certain age, statins are supposedly the best thing since Lycra for keeping wayward bodies in check. Statins interfere with the synthesis of low-density lipoprotein, the "bad" cholesterol. LDL is a prime suspect in heart disease, the top killer of women. The statin cut my cholesterol like buttah. But statins can also increase the risk of developing Type 2 diabetes, muscle and/or liver damage. Heart trouble and diabetes run in my family. Was I trading a heart attack for diabetes? "We give statins to people with diabetes," was all my doc said. That didn't answer my question. I knew from an unrelated test that I did not currently have coronary artery disease, so I decided to investigate the statin situation. In 2012 the Food and Drug Administration slapped a black box warning on statins, saying that they could raise blood glucose levels in people at high risk of Type 2 diabetes. That meant an increase of anywhere from 9 to 27 percent in relative risk – in absolute terms about 0.3 excess cases of diabetes for every 100 people who are treated for a year with high-intensity statins (which lower cholesterol by 50 percent or more) and 0.1 excess cases of diabetes for every 100 people treated with moderate-intensity statins (which lower cholesterol by 30 to 50 percent.) Because doctors disagree on who should get statins, in 2013 the American College of Cardiology and the American Heart Association issued guidelines advising doctors not to treat to a cholesterol target, but to prescribe statins if patients fit into one of four risk categories an Continue reading >>
Statin Use Linked To Heightened Type 2 Diabetes Risk In Susceptible Individuals
Long term use of statins to lower blood fats and stave off cardiovascular disease is associated with a 30 per cent heightened risk of developing type 2 diabetes in susceptible individuals, suggests a large study published in the online journal BMJ Open Diabetes Research & Care. The findings held true irrespective of the criteria used to determine the need for treatment, suggesting that these factors weren't major contributors to diabetes risk, say the researchers. They base their findings on 3234 participants in the US Diabetes Prevention Program Outcomes Study (DPPOS). This is a long-term follow up study to a randomised clinical trial which looked at whether modest weight loss through lifestyle changes or treatment with metformin could reduce or delay development of type 2 diabetes in people at high risk. The trial participants were given standard advice on healthy eating and exercise and were randomly assigned to either an intensive lifestyle programme, treatment with metformin, or a dummy drug (placebo). At the end of the trial they were invited to take part in DPPOS, during which their blood fats and blood pressure were measured annually. Blood glucose was measured twice a year, at which point new statin treatment was recorded. At the start of DPPOS fewer than 4 per cent of participants were taking statins, but use of these drugs gradually increased until after 10 years around a third of the participants were taking them. The most commonly prescribed statins were simvastatin (40%) and atorvastatin (37%). The likelihood of a prescription rose substantially after a diagnosis of diabetes. However, statin use was itself associated with a heightened risk of being diagnosed with diabetes, irrespective of which treatment group the participants had been in during the trial. Continue reading >>
Statins Warning: Cholesterol-lowering Drug Found To Raise Risk Of Diabetes By 50 Percent In Older Women
(Natural News) Elderly women who take statins have an increased risk of developing type-2 diabetes, an Australian study found. Researchers at the University of Queensland examined more than 8,000 elderly female pensioners and found that those who took the cholesterol-lowering drug had a 33% increased risk of diabetes. The experts also found that taking higher doses of statins further elevated the increased risk to more than 50%. “Statins are highly prescribed in this age group but there are very few clinical trials looking at their effects on older women. What is most concerning was we found a ‘dose effect’ where the risk of diabetes increased as the dosage of statins increased. Over the ten years of the study most of the women progressed to higher doses of statins. Those elderly women taking statins should be carefully and regularly monitored for increased blood glucose,” said Dr. Mark Jones of the University of Queensland. The findings were published in the journal Drugs and Ageing. More studies link statins to higher diabetes risk A 2015 study in Diabetologia showed that statin treatment was associated with a 46% increased risk of type-2 diabetes, even when other risk factors were taken into account. The researchers have also noted a dose-dependent effect on those taking atorvastatin and simvastatin. The study was based on a respondent population of more than 8,700 nondiabetic men aged 45 to 73 years old. Senior author Markku Laakso of the University of Eastern Finland and Kuopio University Hospital suggested that patients with preexisting risk factors such as obesity and a family history of diabetes should try to lower their statin doses if possible. Another study looked into the effects of statin therapy on nearly 7,000 middle-aged men and women. Research d Continue reading >>
Statin Side Effects: Weigh The Benefits And Risks
Statin side effects can be uncomfortable, making it seem like the risks outweigh the benefits of these powerful cholesterol-lowering medications. Doctors often prescribe statins for people with high cholesterol to lower their total cholesterol and reduce their risk of a heart attack or stroke. While statins are highly effective, they have been linked to muscle pain, digestive problems and mental fuzziness in some people and may rarely cause liver damage. Statins include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor). Having too much cholesterol in your blood increases your risk of heart attacks and strokes. Statins block a substance your liver needs to make cholesterol. This causes your liver to remove cholesterol from your blood. If you think you're experiencing side effects from statins, don't just stop taking the pills. Talk to your doctor to see if a change of dosage or even a different type of medication might be helpful. What are statin side effects? Muscle pain and damage One of the most common complaints of people taking statins is muscle pain. You may feel this pain as a soreness, tiredness or weakness in your muscles. The pain can be a mild discomfort, or it can be severe enough to make your daily activities difficult. Oddly enough, most randomized controlled studies of statins indicate that people taking statins develop muscle pain at the same rate as people taking placebo. But up to 29 percent of the people who start taking statins report muscle pain and many discontinue statins because of it. Many of these people do well when they are switched to a different variety of statin. Very rarely, statins can cause life-threatening muscle damage call Continue reading >>
Statin Use Raises Diabetes Risk
A A A Liam Davenport Long-term statin use is associated with an increased risk of type 2 diabetes of approximately 30% in individuals at high-risk of the disease, even after taking into account known risk factors and potential confounders, say US researchers. They looked at the development of diabetes among statin users in the Diabetes Prevention Program (DPP), which included more than 3200 participants. Over 10 years, statin use was linked to a 36% increased risk of being diagnosed with type 2 diabetes, falling to 27% after taking into account baseline risk factors and clinical criteria used to determine the need for statins. The findings are consistent with previous studies suggesting that statin use substantially increases the risk of type 2 diabetes. The new study was published online October 23 in BMJ Open Diabetes Research & Care by lead author Jill P Crandall, MD, department of medicine and diabetes research center, Albert Einstein College of Medicine, New York, New York, and colleagues. As previously reported by Medscape Medical News, a study of more than 8700 Finnish men aged 45 to 73 years showed that over 6 years statins were linked to a 46% increased risk of type 2 diabetes — more than double prior estimates. This was followed by recent data from the Australian Longitudinal Study on Women's Health, which indicated that, among almost 8400 women aged 76 to 82 years, the risk of new-onset diabetes ranged from 17% with the lowest statin doses to 51% with the highest doses. Despite accumulating evidence, the current researchers still maintain that the overall healthcare advice remains unchanged — the benefits of statins outweigh the risks. "For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consisten Continue reading >>
Do Statins Raise Odds For Type 2 Diabetes?
HealthDay Reporter TUESDAY, Oct. 24, 2017 (HealthDay News) -- Cholesterol-lowering medications known as statins may lower your risk of heart disease, but also might boost the odds you'll develop type 2 diabetes, new research suggests. "In a group of people at high risk of type 2 diabetes, statins do seem to increase the risk of developing diabetes by about 30 percent," said the study's lead author, Dr. Jill Crandall. She's a professor of medicine and director of the diabetes clinical trials unit at Albert Einstein College of Medicine in New York City. But, she added, that doesn't mean anyone should give up on statins. "The benefits of statins in terms of cardiovascular risk are so strong and so well established that our recommendation isn't that people should stop taking statins, but people should be monitored for the development of diabetes while on a statin," she explained. At least one other diabetes expert agreed that statins are still beneficial for those at risk of heart trouble. Dr. Daniel Donovan Jr. is professor of medicine and director of clinical research at the Icahn School of Medicine at Mount Sinai Diabetes, Obesity and Metabolism Institute in New York City. "We still need to give statins when LDL (bad) cholesterol isn't under control. A statin intervention can lower the risk of a cardiovascular event by 40 percent, and it's possible the diabetes may have been destined to happen," he said. The new study is an analysis of data collected from another ongoing study. More than 3,200 adults were recruited from 27 diabetes centers across the United States for the study. The research goal was to prevent the progression of type 2 diabetes in people with a high risk of the disease, Crandall said. All of the study participants were overweight or obese. They also all Continue reading >>
Fda Adds Diabetes Warning To Statin Label
WASHINGTON -- The FDA said today that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems, but at the same time the agency removed a standing recommendation for routine liver function tests for patients taking the cholesterol-lowering drugs. The FDA said the label changes apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). Despite the additional warnings, the FDA said it "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks." Rather than regular monitoring of liver function, the agency said that clinicians should now simply order a liver function test before starting a patient on a statin. Although the drugs do carry a risk of liver damage, the agency has judged the risk to be "rare and unpredictable in individual patients." The diabetes warning has been rumored as a possibility since the findings from the JUPITER trial of rosuvastatin revealed an unexpected 27% increase in new onset diabetes among patients randomized to the statin. That finding was especially perplexing because JUPITER was a study of statins in patients who had no history of cardiovascular disease, the so-called healthy patient trial. Moreover, based on the JUPITER results, the FDA approved rosuvastatin for primary prevention. The FDA said hyperglycemia was also observed among patients treated with 40-mg atorvastatin in a substudy of PROVE-IT TIMI 22, and a meta-analysis of data from 13 statin trials "reported that statin therapy was associated with a 9% increased risk for incident diabetes." The cognitive data are a Continue reading >>
Warning! Read These Before Taking Cholesterol Drugs
Statins are the most popular cholesterol drugs and the second most commonly prescribed drug class in the US. Yet their benefits are in question and there are strong concerns about their side effects. Even the FDA recognizes these side effects and mandates certain warnings on the labels of statin drugs. Which statin side effects are so serious to warrant repeated FDA warnings? Who benefits from statins? Read on to find out the answers to these questions and also why Big Pharma’s next moves should warn you off statins. Statins are the most popular drugs used to lower blood cholesterol levels. They are still commonly prescribed for people with hypercholesterolemia even though the first statin drugs were released over 20 years ago. The sales of statin drugs is quite huge. Lipitor, the most popular statin drug, earned Pfizer over $12 billion in 2008 and has been determined to be the best-selling drug in history. Since the release of Lipitor (atorvastatin), newer generations of statins have been introduced as well as combinations with other cholesterol-lowering agents. As cholesterol-lowering agents, statins inhibit the liver enzyme known as HMG-CoA reductase. This enzyme is involved in the early stages of the mevalonate pathway. This is the synthetic pathway used for synthesizing cholesterol in the liver. Statins are effective cholesterol-lowering drugs. They are especially effective for lowering LDL (low-density lipoprotein or “bad”) cholesterol levels. However, they are not as effective for reducing triglyceride levels or raising HDL (high-density lipoprotein or “good”) cholesterol as supplements such as niacin (vitamin B3). Although they are commonly prescribed, statins are also controversial drugs with serious adverse effects and questionable benefits for reduc Continue reading >>
Could Statins Raise Diabetes Risk?
THURSDAY, May 23 (HealthDay News) -- Certain statins -- the widely used cholesterol-lowering drugs -- may increase your chances of developing type 2 diabetes, a new study suggests. The risk was greatest for patients taking atorvastatin (brand name Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor), the study said. Focusing on almost 500,000 Ontario residents, researchers in Canada found that the overall odds of developing diabetes were low in patients prescribed statins. Still, people taking Lipitor had a 22 percent higher risk of new-onset diabetes, Crestor users had an 18 percent increased risk and people taking Zocor had a 10 percent increased risk, relative to those taking pravastatin (Pravachol), which appears to have a favorable effect on diabetes. Physicians should weigh the risks and benefits when prescribing these medications, the researchers said in the study, which was published online May 23 in the journal BMJ. This does not, however, mean that patients should stop taking their statins, the experts said. The study also showed only an association between statin use and higher risk of diabetes; it did not prove a cause-and-effect relationship. "While this is an important study evaluating the relationship between statins and the risk of diabetes, the study has several flaws that make it difficult to generalize the results," said Dr. Dara Cohen, a professor of medicine in the department of endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City. "There was no data regarding weight, ethnicity and family history -- all important risk factors for the development of diabetes." Cohen added that there was no information on the patients' cholesterol and blood sugar levels, and that higher-risk patients might automa Continue reading >>
Statins | Lipitor | Diabetes | Lawsuit
Studies Link Lipitor to an Increased Risk of Diabetes A number of studies have linked statins including Lipitor (atorvastatin), Crestor (rosuvastatin), as well as Zocor (simvastatin, produced by Merck) to an increased risk of diabetes. In fact, an FDA warning was required to be included on the Lipitor label following a safety announcement on February 28, 2012, that warned of the diabetes risk as well as other side effects. A study published in BMJ on May 23, 2013 confirmed the FDA warning and earlier research when it concluded that statins, such as Lipitor, had a higher incident of diabetes risk than pravastatin. The study analyzed patients in Ontario, Canada were treated with Lipitor, Crestor and Zocor. The team of researchers examined the healthcare records of more than 1.5 million patients aged 66 or older without diabetes who started statin treatment between August 1997 and March 2010. Overall, a 10-22% increased risk of diabetes was found. The BMJ study follows a Women’s Health Initiative study published on January 23, 2012, which found a nearly 50% increase in new onset diabetes for postmenopausal women with statins compared with a placebo. In addition to the risk of diabetes, a BMJ research paper published on March 19, 2013, noted that users of “high potency statins” (including Lipitor) were 34% more likely to be hospitalized with acute kidney injury within 120 days after starting treatment, again confirming the need for the FDA warning. Lipitor Diabetes Litigation Moves Forward On March 25, 2013, a South Carolina woman spoke to a Lipitor diabetes lawyer and filed a complaint against Pfizer claiming that Pfizer promoted and marketed Lipitor as safe and effective. (U.S. District Court of South Carolina Civil Action No. 2:13-cv-796-CWH). Evalina Smalls, the p Continue reading >>
Statins Warning: Cholesterol-lowering Drug Found To Raise Risk Of Diabetes By 50 Percent In Older Women
Elderly women who take statins have an increased risk of developing type-2 diabetes, an Australian study found. Researchers at the University of Queensland examined more than 8,000 elderly female pensioners and found that those who took the cholesterol-lowering drug had a 33% increased risk of diabetes. The experts also found that taking higher doses of statins further elevated the increased risk to more than 50%. “Statins are highly prescribed in this age group but there are very few clinical trials looking at their effects on older women. What is most concerning was we found a ‘dose effect’ where the risk of diabetes increased as the dosage of statins increased. Over the ten years of the study most of the women progressed to higher doses of statins. Those elderly women taking statins should be carefully and regularly monitored for increased blood glucose,” said Dr. Mark Jones of the University of Queensland. The findings were published in the journal Drugs and Ageing. More studies link statins to higher diabetes risk A 2015 study in Diabetologia showed that statin treatment was associated with a 46% increased risk of type-2 diabetes, even when other risk factors were taken into account. The researchers have also noted a dose-dependent effect on those taking atorvastatin and simvastatin. The study was based on a respondent population of more than 8,700 nondiabetic men aged 45 to 73 years old. Senior author Markku Laakso of the University of Eastern Finland and Kuopio University Hospital suggested that patients with preexisting risk factors such as obesity and a family history of diabetes should try to lower their statin doses if possible. Another study looked into the effects of statin therapy on nearly 7,000 middle-aged men and women. Research data showed that Continue reading >>
Statins And Diabetes -- Is There Really A Risk?
First, let me say that I have a tremendous respect for Dr. Eric Topol. He is a world renowned cardiologist whose contributions to medicine far outstrip any that I will ever make. Having said that, I think that he is off-base in his recent New York Times Op-Ed entitled “The Diabetes Dilemma for Statin Users” (March 4). Dr. Topol’s view is that “We’re overdosing on cholesterol-lowering statins, and the consequence could be a sharp increase in the incidence of Type 2 diabetes.” Indeed, Dr. Topol isn’t just making this up. Last week, the FDA added warnings in the labels of all statins warning of the risk of developing diabetes. What drove the FDA to do this? Dr. Topol accurately states the results on which this label change was based. The pooling of multiple clinical studies for more than 90,000 patients randomly assigned to take either statins or placebo showed that the risk for developing diabetes was one in every 255 patients. He then goes on to say that this figure could even be an underestimate of the problem since “It is only with the more potent statins — Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) — particularly at higher doses, that the risk of diabetes shows up.” I have two issues with this statement. First of all, Zocor’s potency really doesn’t differ that much from its parent drug, Mevacor. Indeed, Merck only brought Zocor to market because of better patent protection for the latter. Thus, the situation isn’t so simple as statin potency. But more important is that the trials that the FDA is basing its warning on are retrospective and observational in nature. That is, these are relatively uncontrolled situations from which observations are being made. Retrospective analyses of clinical trials ser Continue reading >>