50% of heart attacks occur in people with high C-Reactive Protein levels
The JUPITER study showed that the benefits offered by the use of Statin in preventing and reducing the risk of heart attacks, strokes and death from cardiovascular problems, both in people with high cholesterol levels, and those who have normal cholesterol values but elevated ultra sensitive C-Reactive protein levels, outweigh the potential risks that those who use it may develop Type 2 Diabetes.
By Joe Cardozo
In the primary prevention study JUPITER, the results indicated that the risk of developing Type 2 Diabetes among people who use Statins, are solely limited to people who already have a high risk of developing it, such as people with impaired glucose tolerance, metabolic syndrome, severe obesity or elevated Hemoglobin A1c levels.
Dr. Paul Ridker of Brigham’s and Women’s Hospital in Boston, who’s head of the research group, said “This is a very important aspect to clarify, especially because of the coverage the media gave it earlier this year, where a growing concern was shown for patients under Statin therapy, who had a higher risk of developing Diabetes, and based on that, many patients stopped using it” and added “unfortunately at that time there wasn’t any information available that not only stressed the risks but also the benefits of Statin therapy. This is crucial because it is the “risk-benefit” relationship that both doctors and patients need to understand.”
Half of myocardial infarctions occur in people with normal Cholesterol levels
50% of all heart attacks occur in people whose blood lipid (LDL) values are normal, but have elevated high sensitivity C-reactive protein values or ultra-sensitive (hsCRP) values.
Determining high sensitivity C-reactive protein (hsCRP) values is therefore an important indicator of cardiovascular disease risk and it’s been observed that Statin use not only decreases cholesterol levels, but also high sensitivity C-reactive protein levels, greatly decreasing the incidence of myocardial infarction, stroke and death from cardiovascular events.
Determining hsCRP is done to predict the risk of cardiovascular disease in healthy people. When hsCRP concentration is on the upper limit of what’s normal, it’s considered that the risk of myocardial infarction is 1.5 to 4 times greater than in those at the lower limit.
The increased concentration of hsCRP only indicates that there’s an inflammation which is more severe than normal. Determining hsCRP doesn’t reflect the location of the inflammation. It can be located in the fatty cell deposits in the arterial walls, which would mean a case of atherosclerosis, but it can also be located in any other tissue.
Statins are a drug that block a liver enzyme, thereby inhibiting the production of Cholesterol in the liver. Statins are prescribed for people with high blood cholesterol levels or who are at risk of suffering from circulatory system diseases, particularly atherosclerosis, which is characterized by arterial blockage due to the formation of atherosclerotic plaques.
The JUPITER study showed that the benefits outweigh the risks
The JUPITER (Justification for the Use of Statins in Prevention: Assessing Rosuvastatins) study investigated whether treatment with Rosuvastatin (Crestor™) could reduce the rate of cardiovascular events in healthy people with normal LDL cholesterol but elevated high sensitivity C-reactive protein (hsCRP) values.
This study included 17,603 participants of both sexes who didn’t have any prior cardiovascular disease or Diabetes, who were randomly selected to be part of one of two groups. A group was treated with daily 20mg-doses of Rosuvastatin and the other received a placebo treatment.
Controls were first done on week 13 and then every 6 months until 60 months after treatment initiation. The semiannual controls included the following tests:
- Lipidic profile.
- High sensitivity C-reactive protein.
- Liver and kidney function.
- Glucose and Hemoglobin A1c
41.4% of all participants had metabolic syndrome. The average LDL cholesterol was 108 mg/dl and the average high sensitivity C-reactive protein (hsCRP) was 4.2 mg/l in the Rosuvastatin group and 4.3 mg/l in the placebo group. The average follow-up was of 1.9 years and the maximum follow-up was of 5 years.
At the end of the study, the group taking Rosuvastatin had an average LDL cholesterol of 55mg/dl and high sensitivity C-reactive protein was 2.2 mg/l. In comparison to the placebo, the group that took Rosuvastatin decreased their LDL cholesterol levels by 50% and high sensitivity C-reactive protein (hsCRP) by 37%.
Triglyceride levels decreased by 17% among the participants who got Rosuvastatin in comparison to the placebo group, and good cholesterol (HDL) levels were 4% higher in the Rosuvastatin group than in the placebo group.
Having the same number of participants in each group, there were 142 cardiovascular events in the group receiving Rosuvastatin, in comparison to the placebo group where 251 cardiovascular events occurred.
Higher Diabetes incidence in those at high risk of developing it
On the other hand, JUPITER was the first controlled clinical trial to formally document an increased risk of developing Type 2 Diabetes in people who used Statins, but who also had a high predisposition of developing it (people with metabolic syndrome, impaired glucose tolerance, Pre-Diabetes, severe obesity and abnormal A1c levels). This study found that among the participants treated with Rosuvastatin (Crestor ™), 270 new cases of Diabetes were diagnosed in comparison to the 216 new cases of Diabetes in patients with the placebo treatment, representing a 27% incidence increase for Type 2 Diabetes.
As a result of these findings, the FDA ordered modifying Statins labels to alert physicians that using this drug could increase blood glucose and Hemoglobin A1c levels.
Dr. Kausik Ray of St. George University of London, who’s been involved in multiple analyses of clinical trials which seek to find the relationship between Statin use and the risk of developing Diabetes, said that the JUPITER study results are consistent with previous studies which demonstrate the benefits of Statin therapy and offer more accurate information in the primary prevention population. The concern has been that the risks of developing Diabetes could outweigh the benefits of Statin use in patients with lower risk of cardiovascular disease.
“What this suggests is that in healthy people who don’t have diabetes yet but who are at risk of cardiovascular events, for any reason, the number of preventable cardiovascular events outweigh the risk of developing Diabetes”, added Dr. Ray.
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