PHILADELPHIA -- Milnacipran (Savella) improved pain and mental functioning in patients suffering from fibromyalgia, researchers said here.
"Significant improvements in pain were seen by the second week of the dose escalation period and were sustained throughout the three-month treatment period," said Lesley M. Arnold, MD, a psychiatrist at the University of Cincinnati College of Medicine.
"An important benefit of milnacipran therapy may be the demonstrated ability to improve mental functioning in addition to pain," she told attendees at the American College of Rheumatology meeting.
Arnold said patients with fibromyalgia suffer a "constellation of symptoms that affect all parts of the body." The symptoms often interfere with sleep, and in turn cause difficulty concentrating.
Milnacipran is a selective, dual serotonin-norepinephrine reuptake inhibitor that was approved by the FDA earlier this year for the management of fibromyalgia.
Arnold reported that 27.7% of patients on milnacipran experienced at least a 50% decrease in 24-hour recall pain scores from baseline to endpoint compared with 18.1% of patients taking placebo (P<0.001).
In addition, after three months of therapy, a greater proportion of patients treated with milnacipran experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment.
"Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week one of treatment with a stable dose of milnacipran that persisted throughout the study," Arnold told MedPageToday.
Patients also showed significant improvements with the drug relative to placebo on the Mental Component Summary of the Short Form-36 (SF-36) assessment and the Fibromyalgia Impact Questionnaire (FIQ), which evaluates patients' overall ability to function.
Whereas placebo patients had a 0.5-point decrease in SF-36 mental scores from baseline, those on milnacipran had an increase of 1.54 points (P<0.001).
There was also a 5-point improvement in FIQ scores with milnacipran relative to placebo (P<0.001), Arnold reported.
She said the results are consistent with previous trials that have demonstrated the safety and efficacy of milnacipran at doses of 100 mg/day and 200 mg/day.
This phase III, double-blind, placebo-controlled trial of 1,025 fibromyalgia patients was designed to further evaluate the efficacy and tolerability of milnacipran 100 mg/day.
Arnold and her colleagues randomly assigned 516 patients to milnacipran 100 mg/day. Another 509 patients were assigned placebo. The patients underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.
"Fibromyalgia is a huge problem for a great many people," said Daniel Lewis, MD, of the Deakin University Integrative Health Research Unit in Melbourne, Australia. "This study shows that milnacipran appears to be helpful in reducing pain, but its impact in other areas is worth noting."
Lewis said the sleep disturbances and mental confusion are major problems for patients with fibromyalgia.
Arnold reported that the most common adverse event in both treatment groups was nausea, which, like other adverse events, tended to be mild to moderate in severity, with approximately 70% of the incidences in both groups resolved within three weeks after onset.
Discontinuations due to adverse events were 13.9% in the placebo group and 17.8% in the milnacipran group. About eight serious adverse events were experienced by milnacipran patients, six occurred among placebo patients.
"For most patients, milnacipran was well tolerated during the three-month treatment period," Arnold said.
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Monday, October 26, 2009
New treatment for Osteoarthritis. Reported By Dr. Humeira Badsha Rheumatologist Dubai, United Arab Emirates
PHILADELPHIA -- Patients who were treated with tanezumab, an investigational monoclonal antibody against nerve growth factor, had relief of osteoarthritis knee pain over the course of a year, researchers said here.
At a dosage of 50 mcg/kg, mean pain scores declined 26 points (SD 30) from a baseline mean of 67 after 16 weeks in the initial randomized, placebo-controlled study, according to Thomas Schnitzer, MD, PhD, of Northwestern University, who presented the findings at a poster session at the American College of Rheumatology's annual meeting.
After another 32 weeks of treatment at that dosage, mean scores declined an additional 9 points, settling at 35 (SD 27) at the end of the extension phase.
Pain scores in patients on higher and lower doses of the drug during the randomized portion appeared to converge toward the mid-30s when they were switched to the 50-mcg/kg dose during the extension.
"Repeated dosing with this compound gives sustained pain relief," Schnitzer said.
Tanezumab's target, nerve growth factor, plays an important role in the development of chronic pain states, such that the pain often takes on a life of its own, Schnitzer said.
Injured and inflamed tissues often show elevated levels of nerve growth factor, which in turns seems to mediate heightened perceptions of pain.
In addition to being studied for osteoarthritis knee pain, tanezumab has also been investigated as a treatment for pain associated with endometriosis, prostatitis, and bone metastases in cancer.
The current osteoarthritis study was an extension of a dose-ranging, placebo-controlled trial that found tanezumab significantly better than placebo in improving patients' walking pain and overall global assessment of response to treatment. That study tested five doses of tanezumab.
In the extension trial, patients on placebo, 10 mcg/kg of tanezumab or 25 mcg/kg of tanezumab said they achieved greater pain relief when switched to the 50 mcg/kg dose of tanezumab.
Schnitzer said patients who had been taking 100 mcg/kg and 200 mcg/kg said they experienced slightly decreased efficacy.
However, the mean pain scores by the end of the study were similar across all the treatment groups, he reported.
"Administration of repeat doses of tanezumab 50 mcg/kg in patients with moderate to severe osteoarthritis knee pain was safe and well tolerated for up to one year," Schnitzer said.
He said 281 patients entered the extension phase of the study. About 40% of the patients were men. The mean age of the group was 59, and 90% were white.
Most adverse events were rated as mild and transient, and none of the serious adverse events experienced in the study were considered drug-related. None of the participants died.
About 11% of the patients discontinued the study for lack of efficacy.
Asked whether a biologic drug could ever be cost-effective as a pain reliever in osteoarthritis -- having no impact on the underlying joint erosion -- Schnitzer said it was not out of the question.
He said it was conceivable that a year's treatment cost with the drug could be in the vicinity of $1,000, which would be competitive with more conventional brand-name drugs.
For example, the COX-2 inhibitor celecoxib (Celebrex) retails for about $1,500 per year at the most common dosage.
Joanne Jordan, MD, MPH, director of the arthritis center at the University of North Carolina in Chapel Hill, N.C., said that an alternative to opioid drugs would be welcome for patients whose pain is not controlled with nonsteroidal anti-inflammatory drugs.
"Patients don't like [opioids]," she said. "They're afraid of them, they worry about dependence."
Jordan agreed that pain in osteoarthritis cases "often doesn't match up with their structural abnormalities," suggesting a neurogenic component that may need to be targeted specifically in therapy.
Poster session discussant Timothy McAlindon, MD, of Tufts Medical Center in Boston, said there was increasing recognition that chronic pain from osteoarthritis may require treatments that go beyond the affected joints.
"We're beginning to recognize that chronic pain [from somatic conditions] has a neurological component," he said.
Treatments targeting pain regulators in the central nervous system are likely to attract more attention from rheumatologists in the future, McAlindon predicted
At a dosage of 50 mcg/kg, mean pain scores declined 26 points (SD 30) from a baseline mean of 67 after 16 weeks in the initial randomized, placebo-controlled study, according to Thomas Schnitzer, MD, PhD, of Northwestern University, who presented the findings at a poster session at the American College of Rheumatology's annual meeting.
After another 32 weeks of treatment at that dosage, mean scores declined an additional 9 points, settling at 35 (SD 27) at the end of the extension phase.
Pain scores in patients on higher and lower doses of the drug during the randomized portion appeared to converge toward the mid-30s when they were switched to the 50-mcg/kg dose during the extension.
"Repeated dosing with this compound gives sustained pain relief," Schnitzer said.
Tanezumab's target, nerve growth factor, plays an important role in the development of chronic pain states, such that the pain often takes on a life of its own, Schnitzer said.
Injured and inflamed tissues often show elevated levels of nerve growth factor, which in turns seems to mediate heightened perceptions of pain.
In addition to being studied for osteoarthritis knee pain, tanezumab has also been investigated as a treatment for pain associated with endometriosis, prostatitis, and bone metastases in cancer.
The current osteoarthritis study was an extension of a dose-ranging, placebo-controlled trial that found tanezumab significantly better than placebo in improving patients' walking pain and overall global assessment of response to treatment. That study tested five doses of tanezumab.
In the extension trial, patients on placebo, 10 mcg/kg of tanezumab or 25 mcg/kg of tanezumab said they achieved greater pain relief when switched to the 50 mcg/kg dose of tanezumab.
Schnitzer said patients who had been taking 100 mcg/kg and 200 mcg/kg said they experienced slightly decreased efficacy.
However, the mean pain scores by the end of the study were similar across all the treatment groups, he reported.
"Administration of repeat doses of tanezumab 50 mcg/kg in patients with moderate to severe osteoarthritis knee pain was safe and well tolerated for up to one year," Schnitzer said.
He said 281 patients entered the extension phase of the study. About 40% of the patients were men. The mean age of the group was 59, and 90% were white.
Most adverse events were rated as mild and transient, and none of the serious adverse events experienced in the study were considered drug-related. None of the participants died.
About 11% of the patients discontinued the study for lack of efficacy.
Asked whether a biologic drug could ever be cost-effective as a pain reliever in osteoarthritis -- having no impact on the underlying joint erosion -- Schnitzer said it was not out of the question.
He said it was conceivable that a year's treatment cost with the drug could be in the vicinity of $1,000, which would be competitive with more conventional brand-name drugs.
For example, the COX-2 inhibitor celecoxib (Celebrex) retails for about $1,500 per year at the most common dosage.
Joanne Jordan, MD, MPH, director of the arthritis center at the University of North Carolina in Chapel Hill, N.C., said that an alternative to opioid drugs would be welcome for patients whose pain is not controlled with nonsteroidal anti-inflammatory drugs.
"Patients don't like [opioids]," she said. "They're afraid of them, they worry about dependence."
Jordan agreed that pain in osteoarthritis cases "often doesn't match up with their structural abnormalities," suggesting a neurogenic component that may need to be targeted specifically in therapy.
Poster session discussant Timothy McAlindon, MD, of Tufts Medical Center in Boston, said there was increasing recognition that chronic pain from osteoarthritis may require treatments that go beyond the affected joints.
"We're beginning to recognize that chronic pain [from somatic conditions] has a neurological component," he said.
Treatments targeting pain regulators in the central nervous system are likely to attract more attention from rheumatologists in the future, McAlindon predicted
Vitamin D deficiency in kids
The AP (10/26, Tanner) reports that, according to a study published in Pediatrics, "at least one in five US children aged one to 11 don't get enough vitamin D and could be at risk for a variety of health problems, including weak bones." Harvard University researchers analyzed "data from a 2001-06 government health survey of nearly 3,000 children" who had undergone "blood tests measuring vitamin D levels." The investigators found that "about 20 percent of kids" under 12 had "blood levels that are too low." In addition, "applying a less strict, higher cutoff," the study authors found that "two-thirds of children that age, including 90 percent of black kids and 80 percent of Hispanics, are deficient in vitamin D."
Free Yoga Classes in Dubai UAE (And yoga specifically for arthritis)
Elevate your well-being with yoga!
Every Monday in the month of November At the Helipad Area, Festival Marina, Dubai Festival City with Dr. Vishwas Chhabra.
2nd November : 7.30am
9th November : 5.30pm
16th November : 7.30am
23rd November : 5.30pm
30th November : 7.30am
Duration of each class : 30mins to 45 mins.
All participants must remember to bring their own mats and drinking water.
Classes are free but we accept donations that go towards funding medical care for arthritis sufferers in the UAE. Donations are encouraged but not an obligation.
About Emirates Arthritis Foundation.
Emirates Arthritis Foundation is a non-profit organization that strives to breathe life into leading ideas of health, hope and happiness and to raise awareness about the rigours of arthritis. We launch a number of initiatives across the country to encourage education and understanding of arthritis; what it is, who it affects and how it affects them.
To learn more about the Emirates Arthritis Foundation and how you can help, please visit our website www.arthritis.ae.
Every Monday in the month of November At the Helipad Area, Festival Marina, Dubai Festival City with Dr. Vishwas Chhabra.
2nd November : 7.30am
9th November : 5.30pm
16th November : 7.30am
23rd November : 5.30pm
30th November : 7.30am
Duration of each class : 30mins to 45 mins.
All participants must remember to bring their own mats and drinking water.
Classes are free but we accept donations that go towards funding medical care for arthritis sufferers in the UAE. Donations are encouraged but not an obligation.
About Emirates Arthritis Foundation.
Emirates Arthritis Foundation is a non-profit organization that strives to breathe life into leading ideas of health, hope and happiness and to raise awareness about the rigours of arthritis. We launch a number of initiatives across the country to encourage education and understanding of arthritis; what it is, who it affects and how it affects them.
To learn more about the Emirates Arthritis Foundation and how you can help, please visit our website www.arthritis.ae.
Gout Treatment. Posted by Dr. Badsha, Rheumatologist, Dubai, United Arab Emirates
PHILADELPHIA -- Going beyond the recommended dosing of allopurinol (Zyloprim) to treat patients with gout may help prevent recurrence safely, researchers contended here.
"While allopurinol is the mainstay of treatment, physicians have concerns about increasing the dose above recommended guidelines particularly in patients with impaired kidney function, "said Lisa Stamp, MD, PhD, of the University of Otago in Christchurch, New Zealand.
"This has led to poor control of gout which causes significant pain, impacts on quality of life, and can lead to permanent joint damage," she said at the annual meeting of the American College of Rheumatology.
Stamp argued instead for a "treat-to-target" approach for urate lowering therapy.
She said using sufficient allopurinol to keep serum urate to less than 6 mg/dL may be a better strategy than persisting with doses perceived to be safe but which are inadequate to achieve the goals of treatment.
She explained that recommendations for allopurinol use are tied partly to kidney function. But these conservative doses may fail to achieve adequate serum uric acid reduction, she said.
Stamp and colleagues recruited 90 people with gout who were on a stable dose of allopurinol for at least one month. The average age of the participants was 58.3; 87.8% were male. At the initial visit, 52 participants had serum uric acid levels greater than 6 mg/dL, the critical level above which gout is more likely to occur.
For 45 participants their dose of allopurinol was increased anywhere from 50 to 400 milligrams above the recommended range. Of these, three developed rashes and discontinued the drug or went back to a lower dose, and six failed to attend follow-up appointments or developed intervening medical problems unrelated to gout.
Of the 36 patients who completed the 12-month study, 86% saw a drop in serum urate levels to 6 mg/dL or less.
"There was no increase in toxicity with higher doses of allopurinol in this cohort, including those with renal impairment," Stamp said. Three patients on high-dose allopurinol had rashes.
Baseline doses of allopurinol were about 35% higher in patients co-treated with furosemide (248 mg/day versus 180 mg/day in patients not given furosemide), Stamp reported.
But similar proportions of patients achieved the 6-mg/dL urate target whether they were on furosemide of not (72% versus 89%, P=0.24).
Increasing the dose of allopurinol above the recommended levels could help reduce gout attacks, agreed Eric Matteson, MD, of the Mayo Clinic in Rochester, Minn.
"The key message in this study is that in those patients who can tolerate the 300 mg dose of allopurinol, the dose can be safely pushed higher," Matteson said. "We may be far too conservative in treating these patients to prevent gout."
He noted, though, that 10% to 20% of people who are prescribed allopurinol cannot tolerate the drug because of adverse side effects.
"While allopurinol is the mainstay of treatment, physicians have concerns about increasing the dose above recommended guidelines particularly in patients with impaired kidney function, "said Lisa Stamp, MD, PhD, of the University of Otago in Christchurch, New Zealand.
"This has led to poor control of gout which causes significant pain, impacts on quality of life, and can lead to permanent joint damage," she said at the annual meeting of the American College of Rheumatology.
Stamp argued instead for a "treat-to-target" approach for urate lowering therapy.
She said using sufficient allopurinol to keep serum urate to less than 6 mg/dL may be a better strategy than persisting with doses perceived to be safe but which are inadequate to achieve the goals of treatment.
She explained that recommendations for allopurinol use are tied partly to kidney function. But these conservative doses may fail to achieve adequate serum uric acid reduction, she said.
Stamp and colleagues recruited 90 people with gout who were on a stable dose of allopurinol for at least one month. The average age of the participants was 58.3; 87.8% were male. At the initial visit, 52 participants had serum uric acid levels greater than 6 mg/dL, the critical level above which gout is more likely to occur.
For 45 participants their dose of allopurinol was increased anywhere from 50 to 400 milligrams above the recommended range. Of these, three developed rashes and discontinued the drug or went back to a lower dose, and six failed to attend follow-up appointments or developed intervening medical problems unrelated to gout.
Of the 36 patients who completed the 12-month study, 86% saw a drop in serum urate levels to 6 mg/dL or less.
"There was no increase in toxicity with higher doses of allopurinol in this cohort, including those with renal impairment," Stamp said. Three patients on high-dose allopurinol had rashes.
Baseline doses of allopurinol were about 35% higher in patients co-treated with furosemide (248 mg/day versus 180 mg/day in patients not given furosemide), Stamp reported.
But similar proportions of patients achieved the 6-mg/dL urate target whether they were on furosemide of not (72% versus 89%, P=0.24).
Increasing the dose of allopurinol above the recommended levels could help reduce gout attacks, agreed Eric Matteson, MD, of the Mayo Clinic in Rochester, Minn.
"The key message in this study is that in those patients who can tolerate the 300 mg dose of allopurinol, the dose can be safely pushed higher," Matteson said. "We may be far too conservative in treating these patients to prevent gout."
He noted, though, that 10% to 20% of people who are prescribed allopurinol cannot tolerate the drug because of adverse side effects.
Thursday, October 8, 2009
New Medicine for osteoarthritis, by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE
NicOx SA has filed a New Drug Application (NDA) for the first in a new class of anti-inflammatory agents, the CINODs (cyclooxygenase-inhibiting nitric oxide donators). The new drug, naproxcinod, is intended for the relief of the signs and symptoms of osteoarthritis (OA).
NicOx also expected to seek European approval for Naproxcinod
The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.
Michele Garufi, Chairman and CEO of NicOx, declared, "The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx's planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx's future commercial operations in the US."
No untoward blood pressure effects seen with naproxcinod
The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.
Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, said, "To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."
NicOx also expected to seek European approval for Naproxcinod
The NDA request is based on data from three large pivotal phase 3 studies in more than 2700 patients with knee or hip OA. All 3 studies met their co-primary efficacy endpoints (the WOMAC pain subscale, the WOMAC function subscale and subject's overall rating of the disease status). The company plans also to seek European Medicines Agency (EMEA) approval in Q4 2009.
Michele Garufi, Chairman and CEO of NicOx, declared, "The submission of a New Drug Application is a tremendous achievement for any company and represents a particularly important milestone for NicOx. This accomplishment represents another major step in NicOx's planned transformation into a self-sustainable pharmaceutical company, able to make significant contributions to the successful commercialization of naproxcinod. To achieve this key corporate goal, we continue to focus on building NicOx's future commercial operations in the US."
No untoward blood pressure effects seen with naproxcinod
The phase 3 assessments of naproxcinod's blood pressure profile, as well as 3 randomized, controlled clinical pharmacology studies in a total of 548 subjects, all found that the drug was well tolerated.
Pascal Pfister, Chief Scientific Officer and Head of Research & Development at NicOx, said, "To our knowledge, naproxcinod is the first New Chemical Entity anti-inflammatory to be submitted to the FDA for OA since the withdrawal of the COX-2 inhibitors rofecoxib and valdecoxib and we believe it could become an important treatment option for patients with OA. We would like to congratulate our whole Research & Development department on the submission of this high quality NDA, which includes extensive data on naproxcinod's efficacy, safety and tolerability, collected in more than 4,000 patients. We look forward to submitting a Marketing Authorization Application to the European authorities within the end of the year."
30 % of Back pain patients recover within a year. Article posted by Dr. Humeira Badsha, Rheumatologist, Dubai, UAE
A third of patients may completely recover from chronic lower back pain by 9 months, according to a BMJ study.
Researchers enrolled some 400 patients who presented to general practitioners, physiotherapists, or chiropractors soon after experiencing low back pain and who had persistent pain at 3 months. The patients were followed for 1 year. By 9 months, some 35% had fully recovered (i.e., they were pain-free, had no back-related disability, and had fully returned to work), and by 12 months, 41% had.
The following groups were at increased risk for delayed recovery: those with previous sick leave related to low back pain, high disability levels at enrollment, lower education levels, and a higher perceived risk for persistent pain.
Link(s):
BMJ article (Free) http://click.jwatch.org/cts/click?q=227%3B67291090%3BTwT0Ho0B0jeunokFTBFf4qznfZCd4J%2F1IKrXW7GcEu8%3D
Researchers enrolled some 400 patients who presented to general practitioners, physiotherapists, or chiropractors soon after experiencing low back pain and who had persistent pain at 3 months. The patients were followed for 1 year. By 9 months, some 35% had fully recovered (i.e., they were pain-free, had no back-related disability, and had fully returned to work), and by 12 months, 41% had.
The following groups were at increased risk for delayed recovery: those with previous sick leave related to low back pain, high disability levels at enrollment, lower education levels, and a higher perceived risk for persistent pain.
Link(s):
BMJ article (Free) http://click.jwatch.org/cts/click?q=227%3B67291090%3BTwT0Ho0B0jeunokFTBFf4qznfZCd4J%2F1IKrXW7GcEu8%3D
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