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Ceftaroline fosamil (Teflaro, Forest), an injectable antibiotic, has been approved to treat adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA).
Ceftaroline is a cephalosporin, which acts by interfering with the bacterial cell wall. The drug’s safety and effectiveness were evaluated in four phase 3 clinical trials in patients 18 years of age and older. Adverse effects included diarrhea, nausea, and rash.
Source: FDA, October 29, 2010
An orphan drug designation has been approved for Discovery’s KL4 surfactant for patients with cystic fibrosis (CF). CF is caused by a genetic mutation that can cause life-threatening lung infections and premature death. Previous studies had suggested that a surfactant might improve mucociliary clearance, perhaps with the potential to prevent further compromise of lung function.
Discovery completed a double-blind, randomized crossover phase 2a study in which the aerosol surfactant was generally safe and well tolerated. Patients experienced improved mucociliary clearance, and no associated serious adverse events were reported.
Source: Drug Discovery Dev, November 2, 2010
Lurasidone HCl tablets (Latuda, Sun-ovion) have been approved for the treatment of schizophrenia in adults. Like other atypical antipsychotic agents, lurasidone carries a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older adults with dementia-related psychosis. Lurasidone is discussed in this month’s Pharmaceutical Approval Update on page 693.
Source: FDA, October 28, 2010
The FDA has approved tesamorelin injection (Egrifta, Theratechnologies, Inc./EMD Serono) to treat HIV patients with lipodystrophy. This condition, in which excess fat develops around the liver, stomach, and other abdominal organs, is associated with many antiretro-viral drugs.
Tesamorelin is a growth hormone–releasing factor that is administered once daily. In two clinical trials, patients receiving tesamorelin experienced greater reductions in abdominal fat, compared with patients receiving placebo. Some patients also reported an improved self-image.
Adverse effects included joint, stomach, and muscle pain; erythema and pruritus at the injection site; swelling; and worsening blood glucose control.
Source: FDA, November 10, 2010
Eribulin mesylate (Halaven, Eisai) has been approved to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
Eribulin, a microtubule inhibitor, is a synthetic form of a compound derived from the sea sponge Halichondria okadai. Before therapy, patients should have received prior anthracycline-based and taxane-based chemotherapy for early or late-stage breast cancer.
In a randomized study of 762 women, median overall survival rates were 13.1 months with eribulin and 10.6 months with a different agent. Adverse effects included neutropenia, anemia, leukopenia, hair loss, fatigue, nausea, peripheral neuropathy, and constipation.
Source: FDA, November 15, 2010
CNS Therapeutics has announced the FDA’s approval of Gablofen (baclofen) injection for use in the management of severe spasticity. This movement disorder affects more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke.
Originally developed in the 1920s as a potential antiepileptic drug, baclofen was also found to be safe and effective for reducing spasticity. In the early 1980s, the drug was noted to be more effective when delivered intrathecally. Baclofen intrathecal injection was first approved in 1992 as an orphan drug and is now considered the standard of care for patients with severe spasticity of spinal and cerebral origin.
Gablofen is administered in the same standard concentrations as Lioresal Intra-thecal (Novartis): 50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL. It is sold with ready-to-use vials and pre-filled syringes offering clear advantages over glass ampules, including a faster refill preparation time and a lower risk of product contamination.
The company’s research was partly funded by a grant from the Michael J. Fox Foundation.
Lisdexamfetamine dimesylate capsules (Vyvanse, Shire) have been approved for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents 13 to 17 years of age. Vyvanse was previously approved for treating ADHD in adults and children 6 to 12 years of age. The new approval was based on results from a randomized study of 314 adolescents.
Vyvanse is a federally controlled substance (CII) because it can be abused or may lead to dependence. It is available in six once-daily dosage strengths of 20, 30, 40, 50, 60, and 70 mg.
Sources: FDA and Shire, November 15, 2010
Dasatinib (Sprycel, Bristol-Myers Squibb) has been approved for patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. This slowly progressing blood and bone marrow disease is linked to a genetic abnormality.
An oral kinase inhibitor, dasatinib is believed to block the activity of proteins responsible for the growth of cancer cells so that the bone marrow can start reproducing normal red and white blood cells.
In 2006, the FDA granted accelerated approval for dasatinib to treat adults with CP–CML with disease that was resistant to previous therapy, including imatinib (Gleevec, Novartis). In 2009, formal approval was granted.
Bristol-Myers Squibb has launched My Sprycel Support to help patients learn more about the drug. Patients also have access to a care counselor 24 hours every day.
Source: FDA, October 28, 2010
Everolimus (Afinitor, Novartis) is now approved to treat subependymal giant cell astrocytoma, a benign brain tumor that is associated with tuberous sclerosis. Tuberous sclerosis is a rare genetic disorder in which tumors grow in the brain, eyes, lungs, liver, heart, skin, and kidneys. Signs may include learning disabilities, skin abnormalities, seizures, and lung and kidney disease.
Everolimus tablets were first approved in March 2009 to treat kidney cancer patients who were not responding to sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer). Everolimus is also approved as Zortress (Novartis) for preventing organ rejection after kidney transplantation.
Source: FDA, November 1, 2010
The FDA has approved duloxetine HCl (Cymbalta, Eli Lilly) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Duloxetine is also indicated for major depressive disorder, diabetic peripheral neuropathy and fibromyalgia, generalized anxiety disorder, and maintenance treatment of major depression.
The FDA assessed the drug’s efficacy in four randomized clinical trials. At the end of the study period, patients taking duloxetine had a significantly greater pain reduction compared with those taking placebo.
The recommended dose is a 60-mg capsule taken once daily without regard to meals.
Source: FDA, November 4, 2010
The FDA has expanded the indication for trastuzumab (Herceptin, Genentech) to include the initial treatment of HER-2− positive (HER-2+) metastatic cancer of the stomach or gastroesophageal junction in combination with chemotherapy.
Trastuzumab has improved outcomes in women with HER-2+ breast cancer. HER-2 protein is also overexpressed in some stomach cancers. The drug blocks HER-2 and is used to treat early-stage and advanced HER-2+ breast cancer.
The drug was evaluated in the phase 3 ToGA study. Half of the patients received chemotherapy alone, and half received chemotherapy plus trastuzumab. Chemotherapy comprised a fluoropyrimidine (capecitabine [Xeloda, Roche]) or 5-fluorouracil (5-FU) and cisplatin (Platinol, Bristol-Myers Squibb). Overall survival rates were 13.8 months with chemotherapy plus trastuzumab and 11.1 months with chemotherapy alone.
Sources: Reuters and Genentech, October 20, 2010
The RANK ligand inhibitor deno-sumab (Xgeva, Amgen) has been approved to prevent skeletal-related events in patients with bone metastases from solid tumors. Denosumab was approved in the U.S., the European Union, and Canada earlier this year as Prolia for post-menopausal women with osteoporosis who were at a high risk of bone fractures.
The approval of the new indication followed a six-month review based on three pivotal head-to-head trials that compared the drug with zoledronic acid (Zometa, Novartis). Denosumab is given as a single subcutaneous injection every four weeks, whereas zoledronic acid is administered as a monthly infusion and must be dose-adjusted to allow for renal function.
Results showed significant benefits of denosumab therapy over zoledronic acid in preventing skeletal-related events among patients with breast or prostate cancer and bone metastases. Denosumab was also non-inferior to zoledronic acid in patients with bone metastases resulting from other solid tumors or bone lesions caused by multiple myeloma.
Source: Gen Eng Biol News, November 19, 2010
Pfizer has recalled an additional 38,000 90-count bottles of the 40-mg dose of atorvastatin (Lipitor) because of reports of an uncharacteristic musty, moldy odor related to the product’s packaging. This was the third recall of the drug since August for the same complaint, bringing the total number of bottles to 369,000 at the end of October.
The odor was a result of a chemical called 2,4,6-tribromoanisole, used as a preservative in wood pallets for storing and shipping the drugs. The same chemical was cited in Johnson & Johnson’s recall of Tylenol and other over-the-counter drugs earlier this year. No injuries or illnesses have been reported. Consumers may return the affected bottles to the pharmacy for a replacement.
Sources: Drug Disc Dev and WebMD, October 29, 2010
Xanodyne Pharmaceuticals. Inc., has agreed to withdraw the pain medication propoxyphene (Darvon, Darvocet) from the U.S. market at the request of the FDA. The FDA has also informed generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and has requested that they voluntarily remove their products as well.
The FDA sought the withdrawal after receiving data showing that the opioid was putting patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result, the agency concluded that the risks of the medication outweighed the benefits.
The FDA is advising health care professionals to stop prescribing propoxyphene to patients. Those who are taking the drug should discuss switching to another therapy with their physician.
Propoxyphene is used to treat mild to moderate pain. First approved by the FDA in 1957, the drug has been sold alone (Darvon) or combined with acetaminophen (Darvocet).
Since 1978, the FDA has received two requests to remove propoxyphene from the market. In June 2009, the European Medicines Agency recommended that marketing authorizations for propoxyphene be withdrawn in the European Union.
In July 2009, the FDA required that a new boxed warning be added to alert physicians and patients about the risk of a fatal overdose. A study at that time also showed that even at recommended doses, propoxyphene was affecting the electrical activity of the heart.
Source: FDA, November 19, 2010
The diuretic eplerenone (Inspra, Pfizer) may be able to lower the risk of death and hospitalization in patients with mild heart failure, according to a study from France. The drug, already used to treat advanced heart failure, also has value for people with mild disease.
In a phase 3 trial (EMPHASIS–HF), which included 2,737 patients 55 years of age and older with New York Heart Association class II heart failure, eplerenone reduced the risk of cardiovascular death or heart failure hospitalization by more than one-third, compared with placebo, after two years.
Approximately 13% of patients receiving eplerenone died, compared with 16% of patients given placebo. Further, 12% of patients taking eplerenone were hospitalized for heart failure, compared with almost 19% of those taking a placebo.
The study was stopped early because of eplerenone’s benefits. However, this medication can raise potassium levels, which must be monitored.
Sources: N Engl J Med, November 14, 2010; WebMD Health News, November 15, 2010; American Heart Association.
Many women who are taking teratogenic medications, which pose risks in pregnancy, might not be adhering to their prescribed oral contraceptive regimen.
Researchers from Medco Health Solutions evaluated prescription medication claims and refill patterns for more than six million women 18 to 44 years of age. Of the 2,355,790 women who were taking one or more long-term medications to treat a chronic disease, 146,758 (6%) were taking one classified as Category X and 26,136 were also taking an oral contraceptive. Nearly all of the Category X prescriptions (97%) were sedative–hypnotics, antineoplastics, retinoids, or statins. More than two-thirds of the women were receiving five or more medications during the study period.
About 40% of the women who received prescriptions for Category X agents and oral contraception had refill patterns suggesting suboptimal adherence to their birth control drugs—a percentage that was no better than that of the general population.
The greater the number of prescriptions, the less likely the women were to use the contraceptive. Adherence rates were highest among women taking statins and women whose contraceptive had been prescribed by a primary care provider. Women whose prescribers were obstetrician/gynecologists were about as adherent as the general population; those whose prescribers were dermatologists were the least adherent. Older, better-educated women were more adherent than single and lower-income patients.
As for why adherence rates might have been low, the Centers for Disease Control and Prevention found that only 20% of women correctly interpreted the teratogen warning symbol to mean that they should not become pregnant while taking the drug; however, it’s possible that women receiving Category X drugs were not advised about risks to the fetus. Research suggests that physicians do not routinely counsel patients who are taking certain agents about the need for contraception. In one study, 50% of women who filled a Category X drug prescription had no documentation of counseling.
The researchers suggest improving compliance by including electronic reminders for physicians at the time of prescribing and alerts for pharmacists when women are late in filling their oral contraceptive prescription.
Source: Am J Med 2010;123:929–934
In a pilot study of 88 patients, heating topical anesthesia patches helped lower pain intensity scores by 37%. The findings spurred a larger study of 250 healthy adults, with a similar reduction of 31%. The patches, which have an air-activated heating element, warm the skin and make it easier to deliver local anesthetics.
Researchers randomly assigned participants to eight groups, some receiving a heated patch and some receiving an unheated patch. The duration of application also varied (20 minutes vs. 30 minutes), as did catheter size (16 gauge, or 5 French vs. 18 gauge, or 3.8 French).
In the larger study, the aim was to test the impact of controlled heat on local dermal analgesia prior to vascular access. Using the pilot study findings, the researchers randomly assigned subjects to receive either the heated or unheated patch, 20 minutes before vascular access, using a 16 G catheter in the antecubital space of the arm. The heated lidocaine/tetracaine patch (Zars Pharma) is multilayered, and an inner heating element is activated when it is hit by air. The heat generated by the element increases the local temperature of the skin to about 39°C for approximately two hours. It also increases the flux of tetracaine and lidocaine, leading to more rapid and effective anesthesia.
More participants testing the heated patch reported adequate anesthesia, compared with those testing the unheated patch (71% vs. 53%, respectively). However, five patients who tested the heated patch and two who tested the unheated patch had an adverse reaction. Mild skin reactions and slight bruising were unrelated to the study medication.
Source: J Pain Symptom Manage 2010; 40:510–519
Although Helicobacter pylori infection is very common among older patients, this population is not screened proportionately. Researchers from Italy have proposed a test-and-treat strategy that can eradicate H. pylori as well as prevent peptic disease, gastric cancer, and even death. Older patients are at high risk of death because of peptic ulcer disease and its complications.
In the study, 140 of 195 older patients had positive results on the carbon-13 (13C)-urea breath test. The incidence of erosive or micro-erosive gastritis, duodenitis, and gastroduodenitis; gastric or duodenal ulcer; and reflux esophagitis was similar among subjects with and without dyspeptic symptoms. The symptoms were not linked to any specific organic pathology. Micro-erosive and peptic lesions were associated with both nonspecific symptoms and various combinations of symptoms. Symptoms were also variable and nonspecific in patients without any lesion at gastric endoscopic exploration.
It was not possible to formulate an accurate differential diagnosis between organic pathology and functional disorders of the upper gastrointestinal (GI) tract based only on symptoms in older patients. None of the patients with specific symptoms, with or without organic pathology, responded differently to H. pylori–eradicating treatment. Even the asymptomatic group had a high rate of organic pathology, similar to that of the symptomatic group. Thus, H. pylori positivity may indicate cellular damage even in the absence of clinical manifestations.
All patients who tested positive for H. pylori received 20 mg of omeprazole (Prilosec, AstraZeneca) twice daily, 500 mg of clarithromycin (Biaxin, Abbott) twice daily, and 1 g of amoxicillin (Amoxil, GlaxoSmithKline) twice daily for one week. After four weeks, the 13C-urea breath test was given again. In both the symptomatic and asymptomatic groups, H. pylori infection was eradicated in 88% of patients with minimal secondary effects. Seven patients withdrew from the study for nonmedical reasons.
These findings suggest that this well-tolerated treatment, with its high rate of H. pylori eradication, can be initiated promptly and safely in older patients, regardless of the endoscopic diagnosis.
Source: Arch Gerontol Geriatr 2010; 51:237–240
Methicillin-resistant Staphylococcus aureus (MRSA) bacteria seem to be thriving to a greater extent in the U.S. than in the United Kingdom. Americans appear to be more than six times as likely as Britons to contract the infection in the community, but rates of hospital infections are about the same—even though MRSA was first discovered in the U.K.
Almost 29 per 100,000 people in the U.S. contract a MRSA bloodstream infection every year, compared with 11 out of 100,000 Britons. For infections presumed to be acquired outside of hospitals, there were 22 cases per 100,000 in the U.S. and 3.5 per 100,000 in the U.K.
Most Americans with community-onset MRSA had been in recent contact with the health care system and were twice as likely as Britons to have been on dialysis, to have had diabetes, or to have needed a central IV line more often. The type of medical care and the patient’s condition may help to explain the difference.
Source: Clin Infect Dis, October 15, 2010; Reuters Health, October 20, 2010
An FDA advisory panel voted 15–1, with one abstention, that patients with kidney failure can keep taking anemia drugs if they do not yet need dialysis, even though these agents have the potential to increase the risk of stroke.
The erythropoiesis-stimulating agents (ESAs)—epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp)—boost oxygen-carrying red blood cells, reducing the need for blood transfusions. In 2007, however, the FDA added the first of several safety warnings to the drugs, based on evidence that the drugs could cause tumor growth. These drugs are no longer used in patients with certain cancers.
The current labeling advises hemoglobin levels to be maintained between 10 and 12 g/dL. Most panelists voted against lowering this level to 9 g/dL because of concerns that patients would have a higher rate of anemia (a side effect of kidney failure and chemotherapy) and would need more blood transfusions.
Deciding when to give ESAs depends on whether dialysis is needed. Patients receiving dialysis tend to have more severe anemia than those not on dialysis. The meta-analysis might have highlighted problems because studies tend to include older patients, who might not show as much improvement because of their age.
Sources: Associated Press; U.S. News & World Report LP; Health Day News, October 19, 2010
The benefits of using antibiotics to treat newly diagnosed ear infections in children might not always outweigh the costs in adverse effects and dollars spent, suggests a new study.
Researchers from the Southern California Evidence-Based Practice Center examined published data about the diagnosis and treatment of acute ear infections among children. The American Academy of Pediatrics had requested the review as part of its effort to update practice guidelines on otitis media treatment.
Children in the U.S. receive antibiotics for acute ear infections more often than for any other illness, costing almost $2.8 billion dollars, or $350 per child, spent each year to treat the condition.
In the study, antibiotics offered a modest benefit in treating the infection, were somewhat more effective than no treatment, and worked quickly; however, they were also associated with an increased risk of side effects, such as rash and diarrhea, in 4% to 10% of the children.
No evidence was found that using newer, name-brand products to treat uncomplicated acute ear infections in normal-risk children offered an advantage over generic antibiotics, namely amoxicillin, even though higher-priced antibiotics are often prescribed for these infections.
The investigators concluded that a less aggressive approach to prescribing antibiotics, such as using amoxicillin, might lead to considerable cost savings.
Sources: JAMA 2010;304(19):2161–2169; Rand Corp., November 17, 2010, retrieved from Science Daily
A six-week treatment with teriparatide injections (Forteo, Eli Lilly), which stimulate bone remodeling, improved alveolar bone formation in patients undergoing periodontal surgery. The findings, from the University of Michigan, are important, as gum disease is the leading cause of tooth loss in adults.
Bone gain in the osseous defects of the 20 patients who received daily teriparatide was detectable early after treatment began and continued to improve during 12 months of follow-up. These patients also had better periodontal probing depth and attachment.
Teriparatide, a recombinant agent, contains the first 34 amino acids of parathyroid hormone (PTH), which stimulates the formation of pre-osteoblast cells, which form bone. Treated patients also experienced better resolution of periodontal bone defects at six, nine, and 12 months, compared with patients receiving placebo. Teriparatide is approved only for treating osteoporosis but scientists hope that it might also be used to grow bone around dental implants.
Sources: N Engl Med J (online), Internal Medicine News, October 16, 2010
Some day a simple blood test may be able to detect clogged arteries. Until now, angiograms, usually performed in hospitals, have been used. Angiograms, however, involve radiation, are often inconclusive, and can cost more than $30,000.
The Corus CAD test (CardioDx) costs about $1,200, and it is covered by some insurers. Results take three days. The goal is to determine whether a patient has heart disease. The test does not look for genes or mutations; it measures how active 23 key genes are. In one study comparing Corus CAD with the leading method, the test improved diagnoses for 16% more patients.
One drawback of the test is the high rate of false-positive and false-negative results. Physicians hope that as the test is perfected, it might enable them to order fewer angiograms as “defensive medicine.”
Source: Ann Intern Med 2010;153(7): 425–434
More than 200,000 people in the U.S. die each year because of sepsis, an uncontrolled reaction to infection. Hospitals are now being encouraged to become more aggressive in offering care at the first hint of trouble.
Sepsis is the body’s overreaction to fighting infection; it causes injury to the body’s own tissues and results in shock and organ failure. Sepsis is more common in the elderly, the very young, and recent surgical patients.
A new alliance, formed to treat sepsis more aggressively, calls for giving antibiotics and IV fluids to counter shock or low BP within an hour if sepsis is suspected. Many hospitals do not begin care for four or even six hours.
Scientists from Portugal have uncovered a culprit that may identify which sepsis patients are at highest risk of death. In sepsis, red blood cells can become injured and leak an iron-based substance, heme (part of the hemoglobin). If heme leaks into the bloodstream at the same time the patient is experiencing inflammation, as during sepsis, heme becomes toxic to organs. In a study of infected mice, extra heme led to more deaths.
Although the body makes a molecule (hemopexin) to dispose of leaky heme, as heme levels rose in the mice, levels of the molecule declined. When the mice were given extra hemopexin, more survived.
In blood samples from 56 patients in a Brazilian hospital, those who survived had higher natural hemopexin levels than those who died. The data might help explain why people who require blood transfusions seem have a higher risk for sepsis.
Sources: Sci Translat Med 2010;2(51); Associated Press, October 4, 2010
After chemotherapy, many patients experience remissions that can last for months or years. In some cases, however, tumors grow back and may be resistant to the drugs that had worked earlier.
In a study of mice with lymphoma, biologists at Massachusetts Institute of Technology (MIT) discovered that some cancer cells are not affected by chemotherapy; they can “hide out” in the thymus, where immune cells mature. In the thymus, these cancer cells are bathed in growth factors that protect them from the drugs’ effects. These cells are likely to be the source of relapse.
The researchers plan to test mice with drugs that interfere with one of these protective factors. These drugs were originally developed to treat arthritis.
For cancer therapy to succeed, a component that kills tumor cells as well as a component that blocks pro-survival signals must be present. Current therapies have not been able to target this survival response. In the new study, mice were given doxorubicin (Adriamycin). During treatment, cells that line the blood vessels release cytokines, small proteins that affect immune responses and cell development.
The researchers think that chemotherapy-induced DNA damage provokes these blood-vessel cells to launch a stress response that is normally intended to protect progenitor cells (immature cells that can evolve into different types of blood cells). That response includes the release of cytokines such as interleukin-6 (IL-6), which promotes cell survival.
It is unclear whether the results can be applied to humans. This protective effect was seen only in the thymus, but there might be other protected areas where tumor cells hide, such as bone marrow.
Sources: MIT, http://web.mit.edu; Cell, October 29, 2010
Amyloid beta proteins, which are thought to cause Alzheimer’s disease (AD), block the transport of vital cargoes inside brain cells. Scientists at the Gladstone Institute of Neurological Disease have discovered that reducing the level of tau protein can prevent amyloid beta from causing such “traffic jams.”
Suppressing tau can prevent amyloid beta from causing memory deficits and other abnormalities in mice. The scientists explored whether this rescue might be caused by improvements in axonal transport.
Neurons from normal mice or from mice lacking one or both tau genes were exposed to human amyloid beta, which slowed down axonal transport of mitochondria and growth factor receptors—but only in neurons that produced tau and not in neurons that lacked tau. In the absence of the amyloid beta challenge, reducing tau had no effect on axonal transport.
Tau reduction looks promising, but more work is needed before such an approach can be explored in humans.
Sources: Science Daily, September 9, 2010, retrieved October 15; Gladstone Institutes via EurekAlert!
A vasodilator that was used in the 1970s and 1980s to treat hypertension may improve learning in mouse models of AD. Diazoxide stabilizes nerve cells in the mouse brain and slows the development of the neurodegenerative disorder.
Researchers observed that diazoxide prevented a biological cascade in the mice that could cause the destruction of nerve cells. The drug also improved blood flow in the brain and prevented the harmful accumulation of beta-amyloid and tau proteins. Diazoxide is now used to treat patients with hypoglycemia.
The scientists studied two groups of mice with AD. The brain tissue of the treated group showed fewer amyloid and tau deposits, less damage resulting from oxidative stress, and better blood flow. Diazoxide activated and opened channels in the cell that enhanced potassium movement, thereby calming the electrical activity of nerve cells in parts of the brain involved in learning and memory. The drug also lowered the excessive calcium often found in nerve cells in brains affected by AD.
The dose of diazoxide is low enough to prevent a major decrease in blood pressure.
Sources: NIH and J Alz Dis, November 15, 2010
A medication that has been used for diabetes may be able to be used to treat patients with Parkinson’s disease (PD) and some inflammatory conditions. Pioglitazone (Actos, Eli Lilly) decreases inflammation associated with neurological diseases, and unlike steroids, it carries few side effects. It does not lower glucose levels if diabetes is not present.
Scientists now think that PD may stem from an “energy crisis” in the brain, years before symptoms appear, and that malfunctioning mitochondria play a role in degenerative brain disease. Ten sets of genes work at abnormally low levels in PD, and they are sluggish in people with presymptomatic PD. Each gene set is controlled by a master regulator gene named PGC1-alpha. Pioglitazone is known to activate part of that PGC1-alpha pathway.
If blocking a “brain energy drain” is to succeed, pre-symptomatic PD must be detected early in the process.
Sources: Translat Med 2010;2:52ra73; Nature online, October 6, 2010; Associated Press, November 2, 1010
Three cardiac resynchronization therapy defibrillators, made by Boston Scientific Corp., have new indications. The devices are used to treat left bundle branch block in patients who have either mild heart failure or heart failure with no apparent symptoms.
Implantable defibrillators sense arrhythmias and attempt to shock the heart back into a normal rhythm, enabling blood to be pumped more effectively. The devices are used with, but do not replace, drug therapy.
Source: FDA, September 16, 2010
Name: Advanix Biliary Plastic Stents
Manufacturer: Boston Scientific Corp., Boston, Mass.
FDA Approval Date: October 21, 2010
Purpose: The stent is used to treat biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. Endoscopic therapy, specifically with stent placement, has gained acceptance as a first-line therapy for biliary strictures and is less invasive than surgery.
Description: The stent accommodates variations in anatomy. The NaviFlex RX Delivery System offers physicians the flexibility of using both long and short guide wires during access and stent placement. The visible guide wire exit port allows for easier manipulation during the stenting procedure.
Benefit: In a study of patients with postoperative benign bile duct strictures, stenting was associated with long-term success rates and lower early complication rates. The design offers precise control for surgeons when they must navigate tight strictures in the bile ducts, and it facilitates stent placement and removal. The stent’s thin wall and increased inner diameter increase duct patency, resulting in improved outcomes.
Name: Zerona Low-Level Body-Sculpting Laser
Manufacturer: Erchonia Medical, Inc., McKinney, Tex.
FDA Approval Date: September 9, 2010
Purpose: This noninvasive aesthetic device is used to reduce the circumference of the patient’s waist, hips, and thighs.
Description: An Erchonia laser scanner targets fat cells with cold energy, emulsifying adipose tissue. The tissue is then released into the interstitial space and passed naturally through the body. Treatment consists of 40-minute sessions three times per week. The laser is applied to the front and back of target areas on the waist, hips, or thighs. Because no heat is applied to cause discomfort, patients can resume normal activities immediately.
Benefit: The FDA’s approval of the low-level laser was based on data from a placebo-controlled, randomized, double-blind, multicenter study of 67 patients. The cold laser decreased the total circumference of the waist, hips, and thighs by 3.64 inches in as little as two weeks, compared with 0.5 inch in patients receiving a placebo treatment. The trial set a precedent for evaluating aesthetic devices, because there were no dietary restrictions or exercise requirements. No equivalent device had previously been granted clearance by the FDA.
Name: Talent Thoracic Stent Graft with Captivia Delivery System
Manufacturer: Medtronic, Inc., Minneapolis, Minn.
FDA Approval Date: November 3, 2010
Purpose: Approximately 60,000 people in the U.S. have a thoracic aortic aneurysm (TAA), but only about 50% of these are diagnosed because patients have no symptoms. The Talent system is used to repair TAAs, which can rupture and cause death if left untreated. The device is used in the endovascular repair of fusiform aneurysms, saccular aneurysms, and penetrating ulcers of the descending thoracic aorta in patients with the appropriate anatomy.
Description: A tip-capture mechanism enables precise placement of the implantable stent graft. The device is inserted into the femoral artery in the patient’s groin and is moved up through blood vessels to the aorta. With the device at the site of the aneurysm, the physician expands the stent graft within the aorta, creating a new path for blood flow, reducing pressure on the bulge and decreasing the risk of rupture.
Benefit: The clinician has excellent control of the device during deployment to ensure that blood flow isn’t occluded into the nearby arteries, and the surgery is minimally invasive.