Dolcet effective v. postsurgical pain
A recent study demonstrated the comparable efficacies of combination tramadol/paracetamol and combination codeine number 3/paracetamol in managing postsurgical pain, but proved combination tramadol/paracetamol to have fewer side effects.
Published in the American Journal of Surgery, this multicenter, double-blind, placebo-controlled study randomized 305 patients who had recent orthopedic or abdominal surgery into receiving combination tramadol/paracetamol (37.5 mg and 325 mg; marketed in the in the Philippines as Dolcet), codeine/paracetamol, or placebo. The combination of codeine number 3 and paracetamol (Tylenol) is one of the most commonly recommended drugs in the management of postsurgical pain in the United States.
Knee or shoulder arthroscopy comprised the orthopedic procedures, while the abdominal procedures were the repair of an inguinal or ventral hernia. Patients, classified as having moderate or worse pain, were then assessed for pain relief, pain intensity, and adverse events.
Sixty-nine percent of the patients on the tramadol/paracetamol combination reported good to very good pain relief. Meanwhile, 62 percent of the patients on the codeine/paracetamol combination reported the same level of pain relief.
The two combinations differed more obviously in adverse events, with the codeine/paracetamol group showing a rate of constipation that is more than twice as high as that of the tramadol/paracetamol group (10.1 percent v. 4.1 percent). Also, more patients on the codeine/paracetamol combination experienced episodes of vomiting than the tramadol/paracetamol group (14.7 percent v. 9.2 percent). Lastly, rates of discontinuation resulting from adverse events were relatively higher in the codeine/paracetamol group than in the tramadol/paracetamol group (10.1 percent v. 8.2 percent).
Combination tramadol/paracetamol has also been shown in studies on dental pain to have faster onset, longer duration, and greater pain relief than tramadol or paracetamol alone.
Other side effects associated with combination tramadol/paracetamol are somnolence and sweating. Dolcet is marketed in the Philippines by Janssen Pharmaceutica, a Johnson & Johnson company.
Pegasys-Copegus OK for hepa C/HIV
The United States Food and Drug Administration (FDA) has approved the combination of peginterferon alfa-2a 40KD (Pegasys) and ribavirin (Copegus) for the treatment of chronic hepatitis C in patients with hepatitis C and HIV. The first to be approved for such indication, the therapy has been found effective in leading to a sustained virological response (SVR) indicative of a cure, providing a compelling reason to consider treatment in this previously undertreated patient group.
William M. Burns, chief executive officer of Roche's pharmaceutical division, said Pegasys and Copegus bring a much-needed treatment option for patients with both HCV and HIV, a devastating disease combination.
Globally about 30 percent of HIV-infected patients are coinfected with HCV, making coinfection a major public-health concern. Hepatitis C and HIV are the two most prevalent blood-borne infections in the US.
Pegasys has become the most prescribed hepatitis-C medication in the US. The FDA approved it in 2002 for use alone or in combination with Copegus for the treatment of chronic hepatitis C. The new FDA approval follows a similar approval by the European Commission.
The approvals were based on results from the AIDS Pegasys Ribavirin International Coinfection Trial (APRICOTT), the largest study evaluating chronic hepatitis-C treatment in patients with HIV-HCV coinfection and one of six Pegasys studies published in The New England Journal of Medicine.
APRICOTT randomized 868 patients from 19 countries to receive either Pegasys 180 mcg once weekly plus Copegus 800 mg daily; Pegasys 180 mcg monotherapy once weekly (plus placebo), or conventional interferon alfa-2a (Roferon A) 3MIU three TIMEs a week in combination with Copegus 800 mg daily, all for 48 weeks.
The results showed that among patients treated with Pegasys and rivabirin:
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40 percent achieved SVR compared with 20 percent among those treated with Pegasys alone and 12 percent of those treated with conventional interferon/ribavirin,
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those with genotype 1 virus, the most difficult to treat, achieved a four-fold increase in SVR compared with conventional interferon/ribavirin (29 v. seven percent), and
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62 percent of those with genotypes 2/3 achieved SVR vis-ŕ-vis 20 percent of those treated with conventional interferon/ribavirin.
The Pegasys-ribavirin combination was associated with the greatest overall histological improvement, even among patients who did not achieve SVR.
FDA affirms Crestor safety
After reviewing data on Crestor's safety in clinical trials and postmarketing surveillance, the United States Food and Drug Administration (FDA) on March 11 denied a petition by Public Citizen's Health Research Group (HRG) to remove the drug from the market.
The FDA said it found no evidence to support HRG's view that Crestor posed risks of rhabdomyolysis and renal failure. In rejecting the petition, Dr. Stephen Galson, acting director of the FDA center for drug evaluation and research, said: "Our review of all the available evidence…indicates that Crestor does not pose a risk of muscle toxicity greater than that of other approved statins. With respect to renal toxicity, there is no convincing evidence that Crestor poses a risk of serious renal injury."
The FDA also said that AstraZeneca has revised the labeling to address concerns about dose-related risks, proper dosing, and adverse events. Earlier, the FDA said that the potential benefits of Crestor outweigh the potential risks when the drug is taken as directed.
Reacting to the FDA decision, David Brennan, president and chief operating officer of AstraZeneca US said: "Patient safety is our top priority and the FDA's rejection of Public Citizen's petition should reassure the millions of people who have been unnecessarily alarmed by HRG's allegations."
"Crestor is an important treatment option for patients who are unable to achieve their cholesterol goals with diet and exercise alone," said Dr. James Blasetto, AstraZeneca executive director on strategic development for Crestor.
Before the FDA approved Crestor in 2003, its safety had been evaluated in over 12,000 patients, more than any other statin. Now approved in more than 70 countries, Crestor has been prescribed for more than 4.3 million patients.
Crestor is a once-daily adjunct medication for the treatment of lipid disorders including primary hypercholesterolemia, mixed dyslipidemia, and isolated hypertriglyceridemia. It should not be given to patients with active liver disease or unexplained persistent elevations of serum transaminases, women who are pregnant or may become pregnant, and nursing mothers. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Crestor and other statins. It should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, and patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.
Symlin gets go-ahead for diabetes
Pramlintide acetate (Symlin), an injectable medicine that controls blood sugar for adults with type 1 and type 2 diabetes, has been approved by the United States Food and Drug Administration (FDA). It is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugar on intensive insulin therapy alone.
Symlin will be the only therapy for the treatment of type 1 diabetes other than insulin. Oral therapies are also available for patients with type 2 diabetes.
Symlin has been studied in approximately 5,000 patients. Overall Symlin therapy was associated with improvements in the control of blood glucose and with weight loss in patients with both types of diabetes, the FDA said. So-called "tight" control of blood sugar is desirable in all patients with diabetes in order to reduce risks for long-term adverse consequences of the disease.
Symlin, manufactured by Amylin Pharmaceuticals of San Diego, California, is a synthetic analog of human amylin, a hormone naturally produced in the beta cells of the pancreas. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of Symlin contributes to glucose control after meals.
New indication for Temodar
Temozolomide (Temodar) has won US Food and Drug Administration (FDA) approval for a new indication. The drug may now be used concurrently with radiotherapy and as maintenance therapy after radiotherapy to extend the lives of adult patients newly diagnosed with glioblastoma multiforme (GBM), the most common form of malignant brain cancer.
GBM is usually fatal. The annual incidence of GBM is four to five cases per 100,000 persons with 8,000 to 10,000 new cases diagnosed per year in North America.
The approval was based on efficacy and safety data from a large randomized controlled study conducted by the European Organization for Research and Treatment of Cancer to compare radiatherapy alone with radiotherapy plus temozolomide. In the multicenter trial of 573 patients, median survival was improved by two and a half months in the temozolomide group, a significant benefit. The median survival was 14.6 months with radiotherapy plus temozolomide as against 12.1 months with radiotherapy alone.
Manufactured by Schering-Plough Corporation, Temodar was granted accelerated approval in 1999 for the treatment of adult patients with anaplastic astrocytoma in relapse after chemotherapy with nitrosourea and procarbazine.
Based on the clinically important outcome in the GBM study, (GBM and anaplastic astrocytoma are closely related tumors) the anaplastic astrocytoma indication is now approved under traditional procedures, and the accelerated approval requirements no longer apply.
Side effects for Temodar reported include nausea, vomiting, headaches, fatigue, and anorexia. Preventive treatment for Pneumocystis carinii pneumonia is required when Temodar is administered with radiotherapy.
Aspirin better than warfarin
WASHINGTON
Results of a new study in the United States say aspirin is less risky and more efficient for treating arterial blockages in the brain than warfarin, a more expensive anticoagulant.
"This trial is good news," said John Marler, associate director for clinical trials. "A simple low-cost drug works just as well as one that requires complicated and expensive monitoring and dose adjustments."
In the study called the Warfarin Aspirin Symptomatic Intracranial Disease trial, investigators at 59 medical centers across the US compared warfarin to 1300 mg per day of aspirin in a total of 569 patients for an average of 1.8 years. All of the patients had a greater-than-50-percent blockage of a major intracranial artery and had experienced a transitory ischemic accident or nondisabling stroke within 90 days prior to their enrollment in the study.
The investigators found that about 22 percent of the patients had a subsequent ischemic stroke, brain hemorrhage, or death from other blood-vessel-related causes, regardless of whether they received aspirin or warfarin. However, the rates of major hemorrhage and death from all causes were significantly higher in the patients treated with warfarin. Event rates for aspirin compared to warfarin were 3.2 percent v. 8.3 percent for major hemorrhage and 4.3 percent v. 9.7 percent for death.
Since warfarin treatment is a more expensive and complicated therapy than aspirin, not using warfarin and preventing the bleeding complications associated with it would save more than US$20 million per year in the US, estimated lead researcher Dr. Marc Chimowitz of Emory University in Atlanta.
Evra shines in survey
The birth-control patch Evra (ethinyl estradiol), which TIME magazine named one of the "Coolest Inventions of 2002," is a hit with women in the United States.
A survey of more than 8,000 patch users showed that women were quick to embrace the convenience and simplicity of Evra, developed by Johnson & Johnson and launched in the US in May 2002 and last year in the Philippines. It is being marketed by Ortho-McNeil Pharmaceutical in the US and by Janssen Pharmaceutical, a Johnson & Johnson company, in the Philippines.
Based on the results, nine out of 10 patch users prefer Evra to the contraceptive method they used prior to switching and 95 percent were satisfied with Evra as a discreet form of birth control.
Respondents cited the fact that they need only remember about birth control once a week, as Evra is worn on the skin for one full week before they need to replace it, making Evra ideal for the busy lifestyle of women today.
Ortho-McNeil conducted the survey in 2002 on 8,271 Evra users who joined the PatchedIn! program, a free, six-month informational program for new Evra users. More than half of the respondents had been using oral contraceptives for more than a year.
Evra is not just popular with the women, however. Even health professionals are embracing this contraceptive method for their patients. They observe that Evra is able to meet women's need for a simple and easy-to-remember birth-control method.
Women simply apply the thin, smooth, and beige patch on clean, dry, hairless skin on the first day of menstruation on any of the following areas: buttock, abdomen, upper outer arm, or upper torso. The following two weeks, they replace it with a new patch on the same day of the week the first patch was applied.
The fourth week is patch-free and a new cycle begins the day after the patch-free week. And once Evra is applied, it sticks fast for seven days even under conditions of heat, humidity, and exercise. Women can swim, bathe, exercise, and use the sauna while wearing it.
A 2001 survey by the American Women's Association and Ortho-McNeil also looked at women's birth-control practices and obstetricians/gynecologists' views on birth control. Around 600 women and 300 obstetricians/gynecologists responded via telephone interviews. Results showed that 59 percent of women forget to take their birth control, while three in every four women would like a contraceptive method that is more adaptable to their lifestyles. Most of the women and obstetricians/gynecologists said that birth control should not require daily attention (86 percent and 87 percent) or frequent visits to the doctors (67 percent and 76 percent).
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