Estimating Numbers Of Older US Adults Who May Benefit From Statin Therapy

Ruzanna Harutyunyan's picture
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Researchers estimate more than 11 million older Americans may be newly eligible for statin therapy if findings from a recently published large clinical trial are adopted into clinical practice guidelines, according to a new analysis of the trial data. The analysis is published online in Circulation: Cardiovascular Quality and Outcomes.

Using data from the 1999–2004 National Health and Nutrition Examination Survey, researchers found that 33.5 million older Americans (men age 50 years and older and women age 60 years and older) are currently taking a statin (24.4 percent) or have risks that would indicate a need for statin therapy based on current guidelines but do not take a statin (33.5 percent).

They estimated that an additional 19.2 percent of older adults could be considered eligible for statin therapy based on their matching the inclusion criteria used in a recently published clinical trial, Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER), presented in November at the American Heart Association’s Scientific Sessions 2008 in New Orleans, La.

“Based on our analysis, more than 44.7 million older Americans might have an indication for statin therapy when you consider those who already meet current guidelines for statin therapy and those who might be eligible based on the criteria proposed in JUPITER,” said the study’s lead author Erica S. Spatz, M.D., an internist and fellow in the Robert Wood Johnson Clinical Scholars Program at Yale University, New Haven, Conn. “That’s nearly 80 percent of this segment of the population who could potentially be recommended a statin therapy if those criteria were adopted into guidelines.”

The study is a numerical analysis rather than an endorsement of using statins to aggressively lower cholesterol and high sensitivity C-reactive protein (hsCRP) in people not currently considered candidates for that therapy, as was done in JUPITER. Additionally, the exclusion criteria for study participants in the JUPITER trial may make it difficult to generalize those findings. While statins are also known to cut the risk of a few types of cancers.

“Certainly the JUPITER findings were intriguing and they will be evaluated as any future revisions are considered for treatment guidelines for reducing cardiovascular risk,” said American Heart Association president Timothy Gardner, M.D. “This additional analysis of that data provides useful information about how many individuals would meet the JUPITER inclusion criteria. A more in-depth study of further implications, including cost-analysis, will be critical in future decision-making processes about preventive measures for the population as a whole. All of this will need to be carefully considered in the context of available resources and the most effective ways to make the most positive impact possible in reducing heart disease and stroke.”

Spatz, who was not involved in the JUPITER trial, said her analysis does highlight an important challenge for healthcare providers and systems: Even under current treatment guidelines, fewer than half (42 percent) of older Americans who qualify for statin therapy actually get it. Although there are many possible reasons for this lack of treatment, many patients who could benefit are being missed – and this problem is likely to increase if the size of the population eligible for statins increases, she said.

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“We must reduce risk, both with lifestyle changes and when indicated, with medications,” said Gardner. “Clearly, as a nation, we are not adequately reducing the risk of those who, even under current guidelines, already need statin treatment but are not receiving it. Determining the most effective ways to do that is paramount.”

In JUPITER, researchers explored whether statin use reduced heart attacks, strokes and death in patients who did not have cholesterol levels that would dictate cholesterol-lowering treatment, but had elevated levels of hsCRP, an inflammatory marker. Elevated levels of hsCRP have been associated with the development of coronary artery disease.

“That trial was terminated early after an interim analysis showed greater benefits in people taking statins than in those taking a placebo,” Spatz said. “Our suspicion was that the findings from JUPITER might potentially impact a sizeable number of older adults in the United States; the question for us was how many more people might now have an indication to take a statin medication under these criteria.”

Spatz used information from the 1999–2004 National Health and Nutrition Examination Survey (NHANES), a periodic survey conducted by the federal government that is statistically representative of the U.S. population. Her study examined data from a subset of 2,322 older men and women who answered the NHANES survey questionnaires and also allowed researchers to take a fasting blood sample to test for a variety of cardiovascular risk factors, including cholesterol level and level of hsCRP.

Using those data, Spatz and her co-authors estimate that another 13.9 percent (8 million) of the older population would be candidates for statin therapy under the strictest JUPITER trial criteria – hsCRP at or above 2 milligrams per liter (mg/L) and low-density lipoprotein cholesterol (LDL) under 130 milligrams per deciliter (mg/dL), Spatz said.

She estimated that another 3 million people, or 5.3 percent of the older population, would qualify for statins under an expanded, but still plausible, treatment criteria of hsCRP at or above 2 mg/L and LDL cholesterol between 130 and 160 mg/dL.

Overall, the people who may now qualify for a statin based on JUPITER’s findings share many characteristics with those who already qualify for a statin medication. The two groups were similar in age, race and socioeconomic status and had equal degrees of high blood pressure and abdominal obesity, both of which are risk factors for heart disease. Compared to people who have no indication for a statin medication, the JUPITER group was distinguishable in that they were more likely to be female and older, and to have obesity, high blood pressure and the metabolic syndrome.

“This further suggests we may be missing a group of people who in addition to having an elevated hsCRP, have other features that put them at risk for heart disease, and for whom a statin medication may be beneficial,” Spatz said.

Spatz hopes her study will help provide important information for the development of future guidelines about using statin medications to reduce cardiovascular disease by providing some of the information necessary to determine whether the number of people who would get statin therapy under JUPITER criteria would be cost-effective from a public health standpoint.

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Comments

What Is Believed To Be Qualities Of All Statin Medications: Statins are a class of medications specifically prescribed to lower LDL- one of five lipid parameters of a person’s lipid profile, which is alto the name of the blood test to measure these parameters. They are known as statins, as all of these types of medications end with the letters, statin. There are about 6 available statins to choose for lipid management as needed- with three that are combination drugs that have a statin included in these drugs. There are other classes of medications for lipid management, such as bile acid sequestrants and nicotinic acid, which is known as niacin. Yet the side effect profile is more unfavorable of these classes of medications compared with the statin class of drugs. One’s cholesterol level is primarily due to how they produce cholesterol in their liver, which is overall genetically determined. This level is also determined by one’s lifestyle and diet as well. If a person has too much cholesterol in their blood, it can lead to hardening and narrowing of their arteries as well as the formation of coronary plaques in the coronary arteries. If these plaques break off of the arterial wall, this leads to a myocardial infarction, or heart attack. Statins are believed to stabilize coronary plaques so this does not occur. To measure one’s cholesterol, a blood test called a lipid profile is obtained from a person after they have fasted for at least 12 hours. The test should also be performed only if the person is free of any acute illness, as this may affect true lipid measures. If the results prove to be abnormal, lipid altering medicinal therapy may be initiated- according to the discretion of the person’s health care provider. This therapy usually involves a statin medication. Adverse events associated with the statin class of pharmaceuticals are thought to occur more often than they are reported- with high doses of statins prescribed to patients in particular at times that may not be necessary to control their dyslipidemia based on their lipid profile. Side effects may include muscle pain, or possible damage to the patient’s liver. However, since this class of statin drugs has existed for use for over 20 years, statins are considered to be overall safe and effective for enhancing the clearance of LDL noted to be elevated in the lipid profiles of patients. Also, they have proven to reduce cardiovascular mortality with one who is treated with a statin that has dyslipidemia. In addition to lowering LDL by up to about 60 percent- depending on the choice of the statin prescribed for the patient, and how high the LDL cholesterol is in a patient. This class of drugs also has the ability to raise their HDL lipid parameter as well as lower to their benefit their triglyceride parameter of their lipid profile. Both of these additional effects in addition to lowering the LDL parameter from taking a statin drug is ultimately beneficial for the patient on a statin drug for lipid management. Statin therapy is also recommended for those patients who have a greater than twenty percent risk of developing cardiovascular disease, or those patients that have clinical evidence of this disease. Additionally, there appears to be no comparable reduction in cardiovascular morbidity or mortality, as well as a difference in the increase of one’s lifespan, if one is on any particular statin medication for their lipid management over another, others have concluded. So caution should perhaps be considered if one chooses to prescribe a statin for a patient if they are absent of, or have only mild dyslipidemia to a significant degree. Furthermore, research should be done by the health care provider if they are under the belief that one statin medication provides a greater cardiovascular benefit over another. In other words, the health care provider should be assured that any choice of statin therapy for their patients is considered reasonable and necessary if the LDL in their patients need to be reduced, and the statin selection should be determined by the results that have been shown with a particular statin. There exist abstract etiologies for health care providers at times to choose to prescribe statin drugs on occasion for reasons not indicated with the medicinal treatment of these statin drugs. Examples include the speculated benefits associated with statins- such as reducing CRP levels, or for Alzheimer’s treatment, or other reasons not directly related to cholesterol management. Statin therapy for such patients may not be considered appropriate, reasonable, or necessary prophylaxis at this point for any patient who does not have the indications for which statins are approved for to treat patients with dyslipidemia. All other benefits that appear to have favorable effects in such areas not involved with a patient's cholesterol are suggested at this point due to minimal research in these other variables aside from lipid management. Other reasons for placing a patient on a statin drug at this time require further research for these disease states and dysfunctions that may exist with a patient aside from dyslipidemia. Statins as a class of drugs seem to in fact decrease the risk of cardiovascular events significantly, it has been proven. Statins also decrease thrombus formation as well as modulate inflammatory responses (CRP) as additional benefits of the medication. For those patients with dyslipidemia who are placed on a statin, the effects of that statin on reducing a patient’s LDL level can be measured after about five weeks of therapy on a particular statin drug. Liver Function blood tests are recommended for those patients on continued statin therapy, and most are chronically taking statins for the rest of their lives to manage their lipid profile in regards to maintaining the suitable LDL level for a particular patient presently. Patients should be made aware of potential additional side effects as well, such as myopathy and muscular dysfunctions that occur on occasion when one is on statin therapy. Yet some have said that about half of all strokes and heart attacks that do occur are not because of increased cholesterol levels of these patients. So it appears clear that high cholesterol may not be an absolute for cardiovascular events for them to occur. Others believe that it is oxidized cholesterol that causes vulnerable plaques to form on coronary arterial walls, which is the catalyst for a heart attack, and that there is no medicinal treatment for the formation or stabilization of these plaques to prevent heart attacks or strokes. Some who support statin medicinal therapy for their clinically appropriate patients claim that these drugs, do, in fact, stabilize these plaques as an added benefit, and therefore are beneficial. As stated previously, in regards to other uses of statins besides just primarily LDL reduction, there is some evidence to suggest that statins have other benefits besides lowering LDL, but not enough evidence yet. These other disease states include aside from what has been stated already, such as those patients with neurological disease, as well as statins being beneficial for certain cancer patients. Some have suggested that statins interfere with cancer treatment with bladder cancer patients as well. Yet again, these other roles for statin therapy have only been minimally explored and researched, comparatively speaking. Because of the limited evidence regarding additional benefits of statin medications, the drug should again be prescribed for those with dyslipidemia only at this time involving elevated LDL levels as detected in the patient’s bloodstream. Yet overall, the existing cholesterol lowering recommendations or guidelines should possibly be re-evaluated. The cholesterol guidelines that presently exist may be over-exaggerated possibly due to tacit suggestions from the makers of statins to those who create these current lipid lowering guidelines. This is notable if one chooses to compare these cholesterol guidelines with the other guidelines that have existed in the past. The cholesterol guidelines that exist now are considered by many health care providers and experts to be rather unreasonable and unnecessary, as well as possibly have the potential to be detrimental to a patient’s health. Yet statins are beneficial medications for those many people that exist with elevated LDL levels that can cause cardiovascular events to occur because of this abnormality. What that ideal LDL level is may have yet to be empirically determined. Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and this may prevent them from being candidates for statin therapy now and in the future, regarding the high cholesterol issue. Treating children with a statin drug for dyslipidemia is controversial presently. Dietary management should be the first consideration in regards to correcting lipid dysfunctions that may exist in patients. Dan Abshear