Keppra helps brain-tumor patients
MIAMI BEACH, Florida
The antiepileptic drug (AED) levetiracetam (Keppra) significantly reduced seizures and was well tolerated in patients with brain tumors, according to research presented at the 57th annual meeting of the American Academy of Neurology (AAN) in April.
"Epilepsy in patients with brain tumors is common. The incidence of seizures varies from 20 to 70 percent with the highest incidence in low-grade gliomas," said Charles Vecht, neurologist-oncologist at the Department of Neurology, Medical Center, The Hague, The Netherlands. Noting that traditional AEDs interact with other medicines, he said the ultimate goal of treatment must be the elimination of seizures while avoiding any drug interactions.
Glen Stevens, a lead investigator of one of the studies and head of the section of adult neurooncology, Cleveland Clinic Foundation, Ohio, said the research team chose to assess Keppra in the study because it has no known clinically significant drug interactions.
The Cleveland Clinic retrospective study reviewed medical charts of 278 patients with varying types of brain tumors who were treated with Keppra for three years. "Keppra produced more than 50-percent reduction in seizure activity in 60 percent of the patients, and was well tolerated," said Stevens. Additionally, 70 percent of patients were maintained on Keppra as monotherapy. Somnolence and fatigue were the most frequently reported adverse experiences.
In a similarly designed study, researchers from Ohio State University showed that, in patients with brain tumors who had a median of one seizure a week, Keppra reduced seizure frequency in 88 percent of patients, with nearly 60 percent becoming seizure free over the treatment period. The most common side effect was somnolence.
"Keppra resulted in impressive reductions in seizure frequency and improvement in control among the patients in our study," said lead investigator Dr. Herbert Newton, director of the division of neurooncology, Ohio State University.
"The older, first-generation AEDs have been used the most in treating seizures in patients with brain tumors. However, because these AEDs are metabolized in the liver, they interact with steroids and many chemotherapy agents, also processed in the liver, reducing their cancer-fighting effectiveness. Many newer, second-generation AEDs, are not metabolized in the liver and have fewer drug interactions," he continued.
Therapharma launches new drugs
Therapharma Inc. recently launched three new antihypertensive drugs--Lifezar, Combizar, and Vascoride--to add to its growing line of cardiovascular products.
Lifezar is Therapharma's version of losartan, the first and most widely studied angiotensin-receptor blocker (ARB) that has been shown in many trials to be effective not only in lowering blood pressure, but more importantly in reducing the risks of death, stroke, and heart attack, and preventing organ damage. In the landmark Losartan Intervention for Endpoint Reduction (LIFE) trial that involved 9,000 patients showed that compared with atenolol, losartan was more effective in reducing the incidence of stroke and left ventricular hypertrophy. A post hoc analysis also indicated that losartan provided diabetic patients greater protection against sudden cardiac deaths.
Combizar is a fixed-dose combination of losartan and hydrochlorothiazide, a diuretic. An ARB-diuretic combination is regarded as a highly effective agent for both short- and long-term blood-pressure control, owing to the drugs' complementary mechanisms of action, enhanced antihypertensive activity, potential for target-organ protection, better tolerability, and simplicity of regimen.
A double-blind, placebo-controlled study by J. H. MacKay et al. showed that the combination achieves greater reduction in blood pressure than either losartan or hydrochlorothiazide alone in patients with essential hypertension.
The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure of the United States National Institutes of Health considers the use of combination therapy, notably a diuretic in combination with an ARB or ACE inhibitor, as an appropriate initial therapy.
Vascoride is a combination of the ACE inhibitor imidapril (10 mg) and hydrochlorothiazide (12.5 mg) approved by the Bureau of Food and Drugs (BFAD) in September 2003.
ACE inhibitors and diuretics are widely used in combination for the treatment of hypertension. The combination has been showed effective because the ACE inhibitor enhances the natriuretic effect of the diuretic and blocks the renin stimulation and potassium loss brought about by the diuretic. The combination also prevents or reverses the diuretic's adverse effects on serum glucose, lipids, and potassium.
A study by T. Saruta et al. showed that the imidapril-diuretic combination achieved higher efficacy rates than imidapril alone across a range of doses (54.8 v. 40.3 percent at 5 mg, 72.6 v. 65.5 percent at 10 mg, and 77.4 v. 76.5 percent at 20 mg).
Once-monthly Boniva gets okay
The United States Food and Drug Administration (FDA) approved ibandronate sodium (Boniva), the first and only once-a-month oral medicine for the treatment of postmenopausal osteoporosis. The drug, available in 150 mg tablets, was developed by Roche and GlaxoSmithKline (GSK).
Boniva is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With Boniva, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments.
"Boniva is the first and only once-monthly osteoporosis medication that maintains and actually builds bone density," said Dr. Ronald Emkey, clinical-trial investigator and medical director of Radiant Research in Reading, Pennsylvania. "The approval of this medication is significant because it offers patients a new treatment option that is effective and easy to take."
Developed in response to patient need, Boniva was approved based on a supplemental-new-drug application. It is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva.
Once-monthly oral Boniva was approved based on results of the Monthly Oral Ibandronate in Ladies (MOBILE) study, a randomized, double-blind, multinational, noninferiority trial in 1,602 women with postmenopausal osteoporosis showing that the monthly dose was at least equivalent to the daily dose in increasing bone-mass density (BMD) after one year at lumbar spine and other skeletal sites.
Osteoporosis affects an estimated 75 million people in Europe, US, and Japan. Studies show that one-third of women over 50 will experience osteoporotic fractures.
Cannabis-based Sativex approved
LONDON
Britain's GW Pharmaceuticals' pain-relief drug Sativex, the world's first containing cannabis, has been approved for use in Canada. Sativex is designed to alleviate the pain individuals suffering from multiple sclerosis. The drug, jointly marketed by GW and Bayer, is taken via a spray into the mouth.
"This first regulatory approval has been obtained by GW in just over six years since the company's development program commenced, a highly significant achievement," said GW chair Geoffrey Guy.
A recent five-week trial involving 66 patients found that Sativex significantly reduced pain and pain-related sleep disturbance, according to GW and Bayer. Half of multiple-sclerosis patients suffer from chronic pain, which occurs spontaneously or can be provoked by touch, temperature, or movement, and causes sensations of freezing or burning.
The British government has licensed GW Pharmaceuticals to research and develop nonsmoked cannabis-based prescription medicines. Health regulators in Britain are expected to complete their review of the treatment by August.
AFP
Herceptin cuts cancer recurrence
WASHINGTON
Use of the drug trastuzumab (Herceptin) cuts recurrence of certain types of breast cancer by half when used postoperatively with chemotherapy.
The United States National Cancer Institute said two clinical trials showed that breast-cancer recurrence was 52-percent lower in women treated with Herceptin combined with standard chemotherapy following surgical removal of a tumor. The figure compared with a 33-percent lowering of recurrence in women treated solely with chemotherapy.
NCI director Andrew von Eschenbach said the finding was significant. "This is a major advance for many thousands of women with breast cancer," he said, adding that the new findings emphasize that "we are at a major turning point in the use of targeted therapies to eliminate suffering and death from cancer."
Produced by Genentech, Herceptin appears to help the 20 to 30 percent of women whose breast cancer is characterized by a genetic mutation that causes overproduction of a protein known as HER-2. The protein is found on the surface of cancerous cells. This type of tumor tends to grow more quickly and reappear more often after surgery than other types of breast cancer, according to researchers.
The trials were conducted between February 2000 and April 2005 on 3,300 women who had an operable HER-2-type tumor.
In the United States, more than 211,000 women will be diagnosed with breast cancer in 2005. About 30 percent of those affected will have HER-2-type tumors. Around 40,000 people will die of breast cancer this year in the United States--15 percent of total cancer deaths among Americans.
AFP
Inhaled insulin available soon
LONDON
Diabetics in Europe could soon be using inhaled insulin rather than injectable ones as test results show it to be safe and effective in controlling blood sugar levels. Pfizer and Sanofi Aventis have already applied for licenses to market inhaled insulin throughout Europe and the United States. It could be available throughout Europe in a year or two.
Test results---announced at the Diabetes UK annual conference in April in Glasgow---showed that for people with type 2 diabetes already on tablets, inhaled insulin gave better blood-glucose control than taking more tablets as treatment. Among patients with type 1 diabetes, four years of inhaled insulin treatment, combined with a daily long-lasting insulin injection, was shown to be effective with no serious side effects.
"Our hope is that inhaled insulin will provide more choice, making it easier for people with diabetes to stay healthy."
Douglas Smallwood, chief executive of Diabetes UK, said: "Since insulin was discovered in the 1920s injections have been the only option. That can be difficult for some people. Many attempts have been made to come up with new treatments and at last we appear to be close to success. While it will not be suitable for everyone this could make a real difference to the daily lives of many people with diabetes."
Pfizer said Exubera is being developed for patients with type 1 and type 2 diabetes through a collaboration between Pfizer and Sanofi-Aventis. The two companies have entered into a global agreement to codevelop, copromote, where permitted by local law, and comanufacture inhaled insulin.
Pfizer said that Exubera, a dry, powder form of insulin that is inhaled into the lungs prior to a meal, using a specially designed inhalation device, has been studied in more than 3,500 patients for over seven years.
Naltrexone helps fight alchoholism
WASHINGTON
A monthly injection of naltrexone, a drug used to fight opiate addiction, combined with psychotherapy, can significantly reduce alcohol dependence.
A study in the Journal of the American Medical Association in April showed that a person who habitually drank heavily 19 days a month could, after six months of treatment, cut their binges to three days a month. Tests of the naltrexone-and-therapy cocktail were tried on 627 alcoholics by researchers at 24 US university hospitals, led by the University of Pennsylvania.
"Alcoholism is a serious disease that destroys lives. As we learn more about how the brain is affected by alcohol, we are discovering how best to provide treatment," said Helen Pettinati, leader of the University of Pennsylvania research team.
Alcoholism is the fourth-leading cause of physical and mental incapacitation around the world, according to World Health Organization statistics. In the United States, it causes 100,000 avoidable deaths each year.
Naltrexone is one of a class of drugs called opioid antagonists that can tame an addict's "need" for narcotics. Researchers found it can help with alcohol addiction as well. While the drug has been used in pill form for several years, the researchers found it more effective when injected, combined with 12 psychotherapy sessions in the six-month period, to help alcoholics.
Vytorin shown superior to Lipitor
ORLANDO, Florida
Results from a clinical trial conducted in 1,902 patients with high cholesterol showed that ezetimibe/simvastatin (Vytorin) provided greater reduction in low-density lipoproteins (LDL) across the dosing ranges compared with Lipitor. At the most commonly used starting doses of these two therapies, Vytorin 10/20 mg decreased LDL cholesterol by 51 percent compared with 36 percent for Lipitor 10 mg (p < 0.001). The results were presented at the American College of Cardiology's annual scientific session in March in Orlando, Florida.
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In a subgroup of high-risk patients, significant differences in LDL cholesterol reductions at these starting doses resulted in more patients achieving a goal of less than 100 mg/dL with Vytorin compared with Lipitor. Eighty-two percent of high-risk patients on Vytorin 10/20 mg achieved LDL cholesterol goal of less than 100 mg/dL compared with only 47 percent for those on Lipitor 10 mg (p < 0.001). High-risk patients in the study with a goal of less than 100 mg/dL who were taking Vytorin 10/20 mg had a baseline LDL cholesterol of 166 mg/dL, against patients taking Lipitor 10 mg who had a baseline of 169 mg/dL.
"There has been a good deal of discussion about achieving even lower LDL-cholesterol goals especially in higher-risk patients," said Dr. Christie Ballantyne, director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, Texas, and lead investigator of the study. "This study demonstrated that more high-risk patients taking Vytorin 10/40 mg achieved the NCEP ATP III goal of less than 100 mg/dL compared with Lipitor 40 mg. The study also showed that a greater percentage, 57 percent, of these high-risk patients on Vytorin 10/40 mg also achieved an LDL-cholesterol level of less than 70 mg/dL compared to 23 percent of patients taking Lipitor."
Results showed that Vytorin 10/40 mg decreased LDL cholesterol by 59 percent vis-à-vis 49 percent for Lipitor 40 mg in the subgroup of high-risk patients.
Vytorin was approved by the US Food and Drug Administration on July 23, 2004 for the treatment of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Vytorin is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food. It was developed by Merck/Schering-Plough Pharmaceuticals, a joint venture between Merck & Co. and Schering-Plough Corporation formed to develop and market in the United States new prescription medicines in cholesterol management.
MabThera relieves arthritis
BASEL, Switzerland
Rituximab (MabThera) successfully met its primary end point in patients with the most difficult-to-treat rheumatoid arthritis (RA) in a pivotal phase-III study. These patients had an inadequate response or were intolerant to prior treatment with one or more anti-TNF therapies. The study showed that a greater proportion of patients treated with MabThera achieved a significant relief of disease symptoms after 24 weeks compared with placebo.
"These data suggest that MabThera may offer new hope to patients who have explored all existing therapies. We are pleased that MabThera's value has now been demonstrated in this group of patients with the most-difficult-to-treat rheumatoid arthritis and for whom there are currently no adequate treatment alternatives," commented William M. Burns, chief executive officer of Roche's Pharmaceutical Division.
MabThera was developed by Roche, Genentech, and Biogen Idec.
The Randomized Evaluation of Long-term Efficacy of Rituximab in RA (REFLEX) was conducted in Canada, Europe, and the United States and involved 520 adult patients with active rheumatoid arthritis. In this multicenter, double-blind, placebo-controlled study, patients received either two infusions of MabThera two weeks apart or placebo infusions in combination with continuing methotrexate (MTX) and a two-week course of glucocorticoids. Patients in the MabThera and MTX group had a statistically significant relief of symptoms compared with patients given placebo and MTX. A preliminary analysis of the data did not reveal any unexpected safety signals. The most common side effects in the MabThera arm included headache, upper-respiratory-tract infection, and nasopharyngitis.
Roche said the REFLEX data also complement the excellent results from earlier phase-II studies in less refractory patients, supporting the belief that MabThera has the potential to play a major role for a broad population in the future treatment of rheumatoid arthritis.
MabThera is a therapeutic antibody that selectively targets B cells, which play a key role in the inflammatory cascade of RA. By doing so, MabThera aims to break the inflammatory cascade of RA--a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion.
MabThera is Roche's leading cancer medicine and has been used for over seven years for the treatment of non-Hodgkin's lymphoma. Over 380,000 patients have been treated to date worldwide with the drug.
RA affects more than six million people worldwide, two million in Europe.
Merck's HPV vaccine tests okay
WHITEHOUSE STATION, New Jersey
Gardasil, the investigational vaccine against the human papillomavirus (HPV) from Merck and Co., significantly reduced the combined incidence of persistent HPV 6, 11, 16, or 18 infection and related diseases, including new cervical precancers and genital warts compared with placebo in a phase-II study published for the first time in The Lancet Oncology.
"The level of protection in this study against infection with these four HPV types, including precancerous lesions, was significant," said lead investigator Luisa Villa, head of the Virology Group at the Ludwig Institute for Cancer Research, São Paulo, Brazil.
This phase-II, randomized, double-blind, placebo-controlled study evaluated the efficacy of Gardasil in preventing infection from the types of HPV responsible for 70 percent of all cases of cervical cancer and 90 percent of all cases of genital warts. In the study, 552 women in the United States, Europe, and Brazil between the ages of 16 and 23 were randomized to receive vaccine or placebo at day 1, month 2, and month 6. The primary end point was to assess the efficacy of the investigational vaccine in reducing the combined incidence of persistent HPV 6, 11, 16, and 18 infections and related diseases, including cervical precancers (cervical intraepithelial neoplasia or CIN), cervical cancer, and/or external genital lesions (genital warts).
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Over the two and a half years of follow-up, Gardasil reduced the combined incidence of persistent infection from HPV 6, 11, 16, or 18 and related genital disease including new cervical precancers and genital warts by 90 percent compared with placebo among women who were naïve to the relevant HPV types at baseline (p < 0.001). Thirty-six cases of either disease, persistent infection, or detection of HPV on the last visit on record were seen in the placebo group compared to four in the group who received Gardasil. Of the four cases seen in the group who received Gardasil, one was confirmed as persistent infection; in the other three cases, HPV was detected on the last study visit but was not later confirmed as a persistent infection.
"This study evaluated the effectiveness of Gardasil in reducing the combined incidence of persistent HPV infections and related diseases, including new cervical precancers and genital warts caused by HPV 6, 11, 16 and 18," said Dr. Kevin Ault of the University of Iowa Carver College of Medicine. "Although the study was not originally designed or powered to assess vaccine efficacy on the disease end points separately, efficacy of the investigational vaccine against cervical precancers caused by the HPV types 16 18, 6, and 11 was 100 percent."
Adverse events related to the injection site were higher among those who received Gardasil compared with placebo recipients. The most common injection site and systemic adverse events were pain and headache, respectively. None of the subjects who received the investigational vaccine discontinued the study due to an adverse experience.
Phase-III clinical trials to evaluate Gardasil are currently under way with over 25,000 participants enrolled worldwide. Phase-II data are expected to be available later this year.
Purchase of Recormon now reimbursed by PhilHealth
Patients using EPOetin beta (Recormon), a commonly prescribed erythropoiesis-stimulating agent (ESA), may now reimburse their expenses for the drug from the Philippine Health Insurance Corporation (PhilHealth).
With this, more patients can now benefit from this medication's efficacy, favorable safety and tolerability, added convenience, and greater cost-effectiveness.
Recently included in the Philippine National Drug Formulary (PNDF), sixth edition, listed under "Essential Drug," Recormon is used to treat anemia in renal failure and chronic kidney disease (CKD), where the organs' ability to produce erythropoietin (EPO) is affected.
EPO is a hormone that makes sure the body is adequately supplied with oxygen. In response to low oxygen levels, peritubular interstitial cells in the kidney release it into the bloodstream to stimulate the production of red blood cells in the bone marrow (erythropoiesis), raising the oxygen-carrying capacity of the blood.
PhilHealth compensates only for medications that are included in the PNDF, which is a method for rationalizing the procurement, distribution, and use of medicines by medical institutions and medical professionals.
Only drugs that have met the criteria for scientific evidence of the Department of Health's National Formulary Committee are included in the PNDF.
Advantages of Recormon
Studies have shown that treatment with Recormon is less expensive and more convenient than other ESAs.
Recormon can be given via subcutaneous (SC) and intravenous (IV) routes. But the revised European Best Practice Guidelines (EBPG) for the Management of Anemia in Patients with Chronic Renal Failure recommend the SC route for dialysis and CKD patients because it is more economical and practical than the IV route.1, 2
Patients on hemodialysis may prefer the IV route for comfort and convenience but the SC route can substantially reduce the dose requirements of ESA, which makes it preferable for economic reasons.1
Also, the SC route may be preferable to CKD patients not on dialysis and transplant patients for economic and practical reasons.
Initially, the EBPG points out that ESAs should be given to all patients with CKD with hemoglobin (HB) levels consistently (measured twice at least two weeks apart) below 11g/dL (hematocrit of <33 percent), where all other causes of anemia have been excluded.
This applies equally to patients with CKD developing anemia, patients with CKD treated with either hemodialysis (HD) or peritoneal dialysis (PD), and patients with chronic renal insufficiency and anemia.
It has to be pointed out that, because of the risk of pure-red-cell aplasia (PRCA), another ESA, EPOetin alfa (Eprex), is not licensed for SC administration in all CKD patients in many European countries (including all member states of the European Union).1
PRCA is a severe, nonregenerative form of anemia caused by a shutdown of the red-cell production in the bone marrow. It is a rare disease but curable.
Studies have found that the SC administration is more efficient than the IV route, which substantially reduces dose requirements for maintaining target hemoglobin or hematocrit levels.1, 5, 6
The half-life for SC administration is 12 to 28 hours versus the four to 12 hours of IV administration. Not only is frequency of dosing reduced, the amount of drug needed is also reduced by as much as 31 percent.2,4
According to the EBPG, in HD patients receiving epoetin alfa or epoetin beta, the drug should be given three times weekly during both correction and maintenance phases.
But with the SC route, the dosing frequency of Recormon can be reduced to once or twice weekly when administered SC in some HD patients.3
In CKD, PD, and transplant patients, Recormon can be given subcutaneously three times per week during the correction phase and once per week during the maintenance phase of treatment.
The storage and handling of Recormon is also more convenient than that of other ESAs. Other ESAs need to be kept at a temperature of two to eight degrees Celsius at all times.
Recormon, on the other hand, can be removed from refrigeration and kept at room temperature (25 degrees Celsius) for a single period of three days. It can also tolerate shaking.4
Recormon's convenient storage and handling plus the advantage of SC administration all add up to improved patient-compliance in treatment. Patients are encouraged to self-administer, which would cut down on their nursing cost.
M. Ciriacruz
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