Articles filed under 'Heart Conditions'
The FDA recently approved a new amphetamine-based drug for hyperactivity disorder that will be harder to abuse than older stimulants, according to pharmaceutical company Shire. Vyvanse remains inactive until swallowed, after which it gradually releases its active ingredient d-amphetamine. It is activated after coming into contact with enzymes in the digestive tract.
Vyvase is expected to stop the potential for abuse by individuals who snort or inject crushed pills. The newly developed drug will be listed as a Schedule II drug, a category including cocaine, methadone, methamphetamines, and other ADHD medicines such as Adderall and Ritalin. Vyvanse will carry a “black-box” warning because of safety concerns related to amphetamine abuse, as well as the risk of sudden death in patients with heart defects.
The FDA approval of Vyvanse took place in the same week when the agency required manufacturers of other ADHD drugs to warn patients and parents of potential mental and heart problems associated with these medications in a small percentage of users.
FDA statistics indicate that ADHD affects about 3 to 7% of schoolchildren and 4% of adults. The principal symptoms are hyperactive behavior, difficulty paying attention, and problems with impulse control. Medications approved to treat ADHD have major benefits for many patients but for some, they can also pose serious risks.
New warning instructions required for ADHD medications will be included for Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera. It is hoped these new cautionary guidelines will not keep people who need these drugs from taking them.
Sources: Yahoo News; Medical News Today
February 27th, 2007
Pharmaceutical companies who make Ritalin, Adderall, Strattera and other ADHD drugs have been advised to give patients and parents additional warnings about the potential for serious psychiatric and heart problems. Patients would be given a 2-page medication guide with each new prescription.
Drug companies are expected to comply with the new requirement within 30 days. The announcement covers 15 drugs, including those offered in extended-release, patch and chewable versions.
Serious side effects for ADHD drugs are rare. However, the new warnings advise calling a physician immediately in case of chest pain, shortness of breath, fainting or hallucinations. A sudden change in behavior should also be noted and promptly reported.
Of the 3.3 million children taking ADHD medications, more than 2,500 went to emergency rooms in 2004. About a fourth of them had serious heart or blood pressure problems, according the Centers for Disease Control. Of the 25 deaths thought to be linked to the drugs, 19 involved children. In the 54 patients who experienced serious heart problems, some had prior heart conditions.
Proposed guidelines are to state that these amphetamine-based drugs have been linked to stroke and heart attacks in adults and sudden death in patients with heart problems or defects. A few children and teens reported hearing voices, growing suspicious or becoming manic while on ADHD medication. About 1 child in 1000 may experience hallucinations.
It is vital that patients give doctors a full history of cardiovascular or mental problems. In addition, they should make it known if they take antidepressants, seizure medications or blood thinners. The FDA emphasizes that persons with heart disease, blood pressure problems, hyperthyroidism or glaucoma should not take ADHD medications.
The FDA emphasizes that new requirement for expanded warnings is precautionary and should not discourage patients from taking these drugs, which are safe in appropriate patients.
Source: San Francisco Chronicle; Feb. 22, 2007 (article from Baltimore Sun)
CNN.com
February 24th, 2007
A simple blood test measuring the amount of a protein called NT-proBNP was recently shown to be highly predictive of cardiovascular events in patients with established coronary heart disease.
In a study of almost 1,000 heart patients believed to have stable heart disease, those with the highest blood levels of the protein were eight times more likely to have a heart attack, stroke or heart failure during the 3.7-year study than those with the lowest levels of NT-proBNP.
Among the study participants, patients with highest NT-proBNP level had the strongest association with heart failure. Eighty cases of heart failure were reported during the study, compared with only three cases among patients with the lowest protein levels. There were four times as many heart attacks and four times as many strokes in study patients with the highest NT-proBNP levels, compared to those with lower protein measurements.
The test is already in use in hospital emergency departments to assist ER doctors in identifying heart failure in patients presenting with shortness of breath and other established symptoms. In addition to echocardiograms, stress tests, and other protein biomarkers, the new blood test may be able help physicians to pinpoint heart patients with the highest risks.
Looking at other risk factors such as sex, age, smoking, and elevated cholesterol levels, this new maker provides additional information that other tests don’t reveal. It is still unclear, however, whether the test is valuable for predicting risk in asymptomatic heart patients thought to have stabilized their heart disease.
Also unknown is whether the test could prove useful for identifying heart disease risk in the general public. At this point, it is best utilized with patients with established heart disease. Its role in disease management is still not clear. Those with elevated NT-proBNP can be treated very aggressively, but most patients with serious heart conditions are already being treated in that manner.
More study is needed to determine the value of the NT-proBNP test, the subject of the study at the University of California, San Francisco and the San Francisco VA Medical Center.
Source: WebMD
January 11th, 2007
In early studies, an experimental device resembling a tiny pacemaker has been shown to control blood pressure more effectively than medications. For 10 to 15% of patients with high blood pressure, medications are not helpful.
High blood pressure consists of a reading of 140/90 mm Hg or higher. Also called hypertension, high blood pressure is a major risk factor for heart disease or stroke.
The new “pacemaker-type” device is currently being studied by the chief of vascular surgery at the University Hospital in Berne, Switzerland, in patients who do not respond to available medications.
Surgeons place electrodes outside the carotid artery and implant an internal pulse generator into the chest wall. Using electrical current to stimulate the carotid sinus, messages are sent to receptors in the brain. Preliminary results have shown remarkable results in a swift drop of blood pressure.
The first 16 patients experienced an average drop of 29 millimeters of mercury after receiving the new device. In patients taking drugs, reducing their blood pressure by
9 millimeters is considered an outstanding result. Researchers call the device, developed by Minneapolis-based CVRx, “very promising.”
Source: Oakland Tribune November 2006
November 24th, 2006
An inexpensive new test uses computer technology to gauge the risk of sudden cardiac death. The test of the heart’s electrical system in individuals with history of heart damage helps doctors decide who needs an implanted cardioverter defibrillator (ICD).
When a person with an ICD experiences dangerously abnormal cardiac rhythm, the device delivers an electrical jolt that shocks the heart back to normal rhythm. Sudden cardiac death kills about 325,000 adults in the U.S. each year – primarily persons who do not have the implanted device.
Until now, cardiac screening of large populations for risk of sudden cardiac death has been expensive and impractical. This new technology could make such screenings more affordable and feasible.
A study involving 500 patients with some heart damage using the more invasive electrophysiological screenings as well as the new, computerized technology came to a close recently. The new testing techniques proved to be just as accurate, according to a professor of medicine at the American Heart Association’s annual meeting.
In the older test, a catheter is inserted through a small incision in the vein and threaded to the heart to measure electrical activity. The new test, called the microvolt T wave alternans (MTWA), measures the electrical discharge of a person’s T-waves from one beat to the next. This individualized risk information allows doctors to determine which patients might benefit from an implanted ICD.
The predictive accuracy of both tests is comparable. The main difference is that the latest test is simple, noninvasive and cheap, while the other is invasive, expensive and risky. In complicated cases, some doctors use both tests. When both technologies confirm the need for an ICD, the surgery is performed.
Physicians hope that in the future, the newer technology may be able to replace electrophysiological screening altogether. At this point, two tests are still better than one.
Source: WebMD
November 22nd, 2006
Doctors were surprised at the results of a five-year study of over 2,000 patients in 27 countries. All had one blocked artery and received either an angioplasty or medications to reopen a closed artery within 3 to 28 days after a heart attack. The consensus reached was that angioplasty should be performed very early in the course of a heart attack, preferably within the first 12 hours, to be most effective.
Four years after the heart attack, in study participants who had a delayed angioplasty, 17% of them had died, suffered another heart attack or developed heart failure. Nearly 16% of the group taking drugs without the surgery had the same adverse effects as the group receiving angioplasty. Results could be considered statistically the same.
When angioplasty is performed during the first 72 hours of a heart attack, the procedure saves many lives, especially when clot-dissolving drugs are not effective. But angioplasty performed weeks or months after a vessel becomes blocked apparently produces results no better than taking standard medications.
Balloon angioplasty is done by threading a catheter through the groin to the blocked artery to reopen it and putting in place a mesh stent to keep the vessel open.
Nearly 1 million heart attacks occur in the U.S. annually. If you suspect a heart attack, don’t stay home and take antacids. Go immediately to emergency, and do not try to drive yourself there.
Source: WebMD
November 20th, 2006
A new study involving 1,500 persons found that patients who had taken beta blocker or statin drugs were more likely to experience only mild chest pain, rather than a full-blown heart attack. Statins such as Lipitor, Zocor and Pravachol reduce artery-clogging cholesterol, while beta blockers like Coreg help lower high blood pressure. The Kaiser Permanente study of men aged 42 to 74 and women aged 55 to 74 indicated that heart drugs can lessen severity of the first symptoms of the disease.
Previous studies have shown that statins cut heart disease risk overall. This recent clinical trial demonstrated that these drugs reduce chances of a heart attack without having previous warning symptoms. Twice as many of the patients experiencing only chest pain had been taking a beta blocker or a statin during the previous five months, compared to those who experienced a sudden heart attack and did not take these drugs.
Only statins and beta blockers lowered the risk of heart attack when looking at all medications used to prevent heart disease. This conclusion was reached by Dr. Alan Go, the study’s lead author and researcher at Kaiser Permanente of Northern California.
Mark Hlatky, professor of cardiovascular medicine at Stanford University and a study author explained that if a patient experiences angina while exercising, it’s an early warning that allows time to start on treatments to reduce risk. He emphasized that a heart attack may cause permanent damage even if you survive it.
Additional study is needed to confirm these findings. Patients’ health records did not indicate whether patients were taking aspirin as a heart-protective measure. This study, published in the Annals of Internal Medicine, was conducted jointly by Kaiser and Stanford researchers and also scientists at the University of California-San Francisco.
Source: MSNBC.com; 2/21/06
March 22nd, 2006
If your child has been labeled “hyperactive” by a teacher, you might think twice before resorting to a drug such as Ritalin to improve performance in class. Stimulants such as Ritalin, Concerta and Adderall are the most widely prescribed medications for childhood behavioral problems. Some 2.5 million children and 1.5 million adults are taking them for hyperactivity or attention deficit disorder (ADD or ADHD).
An FDA panel recently voted 8-7 to recommend written guides to patients and to require that prominent, “black box” warnings be placed on drug labels. Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and member of the panel voiced “grave concerns” about the harm these drugs may cause. The vote took place after FDA medical officers described reports of 25 sudden deaths, mostly children, among those taking these stimulants.
A biostatistician on the panel went so far as to say that stimulants might be more dangerous to the heart than the painkiller Vioxx, withdrawn from the market in recent years. Some physicians believe the drugs may increase risks of strokes and serious arrhythmias in children and adults, although the risk of heart disease is small in childhood. All panel members agreed that parents of children with known heart conditions should consult their physicians about the use of such drugs.
Ritalin has been marketed since 1955. Dozens of studies have shown it to be safe and effective, although these studies may not have continued long enough to determine risks of long-term use. The soaring popularity of these medications warrants close study as to their potential risks to the heart. Preliminary analysis suggests that heart risks may increase two-fold. With the increasing use of these medications in adults, this data may be more significant for them.
Panel members were deeply divided as to relative risks and benefits of stimulants. Psychiatrists and psychologists who treat patients with attention deficit disorder and hyperactivity disagreed on whether a strongly worded warning was warranted. The director of the Center for Children and Families at the State University of New York voiced the idea that a black-box warning might prompt families to explore behavioral treatments as alternatives to drugs – “a very good outcome for kids with ADHD and their families.” Other FDA officials expressed concern about scaring away many from needed treatment and minimizing the benefits of these drugs. They were unwilling to “sensationalize what is a very low-probability event.”
In March, the FDA will convene a committee made up primarily of pediatricians and psychiatrists on these issues. These clinicians are expected to voice support for continued use of stimulants and be reluctant to frighten patients with black box warnings. Pharmaceutical company representatives agreed to cooperate with the FDA on any label changes.
Sources: San Francisco Chronicle, 2/10/06, Gardiner Harris, New York Times reporter; New York Times editorial (2/12/06)
March 19th, 2006