The FDA has approved pregabalin (Lyrica) for treating fibromyalgia.
The drug is the first treatment for the condition; it was approved in 2004 for use in diabetic peripheral neuropathy and postherpetic neuralgia. The expanded approval was based on two double-blind controlled trials involving about 1800 patients. Lyrica "reduces pain and improves daily functions for some patients," according to the FDA. The agency says that the drug's mechanism is unknown.
The manufacturer, Pfizer, has agreed to study use of the drug in children and breast-feeding women, according to the FDA.
The most common side effects are mild-to-moderate dizziness and sleepiness.
Sunday, June 24, 2007
Lab Screening in Children with Suspected Inflammatory Bowel Disease
When clinical suspicion is high, normal screening lab values have limited value.
Primary care clinicians often perform screening laboratory tests when they suspect that a child might have inflammatory bowel disease (IBD). Investigators evaluated the screening utility of hemoglobin values, platelet counts, erythrocyte sedimentation rate (ESR), and albumin levels using prospectively collected data from a multisite registry of 526 children (mean age, 11.6 years) who were newly diagnosed with IBD (392 with Crohn disease; 134 with ulcerative colitis).
All four tests were normal in 30% of children with mild disease (21% of patients with Crohn disease and 54% of those with ulcerative colitis), compared with only 4% of children with moderate or severe IBD. Of the four tests, ESR was the least likely to be normal (defined as <20 mm/hour), regardless of disease severity. For example, among children with moderate or severe IBD, 18% had normal ESRs, 24% had normal hemoglobin levels, 43% had normal platelet counts, and 50% had normal albumin levels. Hematochezia was the most common presenting feature in children with mild IBD.
Comment: These results indicate that the four IBD screening tests assessed have limited value. I wish the authors had performed more sophisticated analyses, such as calculating sensitivity for different combinations of laboratory values, because early identification of children with IBD is important. The authors note that new laboratory markers, such as antibodies against neutrophils or microbial antigens, and antiglycan antibodies, might hold greater promise.
— Howard Bauchner, MD
Published in Journal Watch Pediatrics and Adolescent Medicine June 13, 2007
Citation(s):
Mack DR et al. Laboratory values for children with newly diagnosed inflammatory bowel disease. Pediatrics 2007 Jun; 119:1113-9.
Primary care clinicians often perform screening laboratory tests when they suspect that a child might have inflammatory bowel disease (IBD). Investigators evaluated the screening utility of hemoglobin values, platelet counts, erythrocyte sedimentation rate (ESR), and albumin levels using prospectively collected data from a multisite registry of 526 children (mean age, 11.6 years) who were newly diagnosed with IBD (392 with Crohn disease; 134 with ulcerative colitis).
All four tests were normal in 30% of children with mild disease (21% of patients with Crohn disease and 54% of those with ulcerative colitis), compared with only 4% of children with moderate or severe IBD. Of the four tests, ESR was the least likely to be normal (defined as <20 mm/hour), regardless of disease severity. For example, among children with moderate or severe IBD, 18% had normal ESRs, 24% had normal hemoglobin levels, 43% had normal platelet counts, and 50% had normal albumin levels. Hematochezia was the most common presenting feature in children with mild IBD.
Comment: These results indicate that the four IBD screening tests assessed have limited value. I wish the authors had performed more sophisticated analyses, such as calculating sensitivity for different combinations of laboratory values, because early identification of children with IBD is important. The authors note that new laboratory markers, such as antibodies against neutrophils or microbial antigens, and antiglycan antibodies, might hold greater promise.
— Howard Bauchner, MD
Published in Journal Watch Pediatrics and Adolescent Medicine June 13, 2007
Citation(s):
Mack DR et al. Laboratory values for children with newly diagnosed inflammatory bowel disease. Pediatrics 2007 Jun; 119:1113-9.
Effect of Soy Intake on Blood Pressure and Lipids
In hypertensive women who added soy to their diets, blood pressure decreased.
Dietary soy is one of several factors that might explain the lower incidence of coronary heart disease in Asian countries than in Western countries. In a randomized, crossover trial, 60 healthy postmenopausal women followed the National Cholesterol Education Program (NCEP) diet or the NCEP diet with 25 g of soy protein supplied as one half cup of unsalted soy nuts (i.e., roasted soy beans) daily while maintaining an equivalent total protein content. Each phase was continued for 8 weeks, and researchers assessed the effect of the diets upon lipids and blood pressure (BP). Patients with systolic BP 165 mm Hg or diastolic BP of 100 mm Hg were excluded from the trial.
Mean BP was lower with soy than without, both among hypertensive women (137/82 vs. 152/88 mm Hg) and normotensive women (110/67 vs. 116/69 mm Hg). The soy diet was significantly lower in total and saturated fat than the control diet. Nonetheless, among normotensive women, total, LDL, and HDL cholesterol levels did not differ across diets. Among hypertensive women, LDL decreased by 11%; total and HDL cholesterol levels did not differ significantly.
Comment: In this small randomized crossover trial, adding soy protein to a diet showed impressive reductions in blood pressure; the magnitude of this effect was surprising and certainly requires confirmation. In contrast, the effect upon lipids was limited.
— Jamaluddin Moloo, MD, MPH
Published in Journal Watch General Medicine June 14, 2007
Citation(s):
Welty FK et al. Effect of soy nuts on blood pressure and lipid levels in hypertensive, prehypertensive, and normotensive postmenopausal women. Arch Intern Med 2007 May 28; 167:1060-7.
Dietary soy is one of several factors that might explain the lower incidence of coronary heart disease in Asian countries than in Western countries. In a randomized, crossover trial, 60 healthy postmenopausal women followed the National Cholesterol Education Program (NCEP) diet or the NCEP diet with 25 g of soy protein supplied as one half cup of unsalted soy nuts (i.e., roasted soy beans) daily while maintaining an equivalent total protein content. Each phase was continued for 8 weeks, and researchers assessed the effect of the diets upon lipids and blood pressure (BP). Patients with systolic BP 165 mm Hg or diastolic BP of 100 mm Hg were excluded from the trial.
Mean BP was lower with soy than without, both among hypertensive women (137/82 vs. 152/88 mm Hg) and normotensive women (110/67 vs. 116/69 mm Hg). The soy diet was significantly lower in total and saturated fat than the control diet. Nonetheless, among normotensive women, total, LDL, and HDL cholesterol levels did not differ across diets. Among hypertensive women, LDL decreased by 11%; total and HDL cholesterol levels did not differ significantly.
Comment: In this small randomized crossover trial, adding soy protein to a diet showed impressive reductions in blood pressure; the magnitude of this effect was surprising and certainly requires confirmation. In contrast, the effect upon lipids was limited.
— Jamaluddin Moloo, MD, MPH
Published in Journal Watch General Medicine June 14, 2007
Citation(s):
Welty FK et al. Effect of soy nuts on blood pressure and lipid levels in hypertensive, prehypertensive, and normotensive postmenopausal women. Arch Intern Med 2007 May 28; 167:1060-7.
Friday, June 15, 2007
Calcium and Vitamin D Intake and Risk for Breast Cancer
Higher calcium and vitamin D intake showed modest benefit in premenopausal women.
Animal experiments and observational human studies suggest that calcium and vitamin D may decrease risk for breast cancer. Researchers prospectively assessed this relation among 10,000 premenopausal and 20,000 postmenopausal women enrolled in the Women’s Health Study. Calcium and vitamin D intake was determined from self-reported questionnaires about food and vitamin supplement intake.
During a mean follow-up of 10 years, the overall incidence of invasive breast cancer was 2.6% among premenopausal women and 3.6% among postmenopausal women. The hazard ratio for developing invasive breast cancer was 0.61 for premenopausal women at the highest versus lowest quintiles of calcium intake and 0.65 for vitamin D intake. No relation was found between calcium and vitamin D intake and risk for invasive breast cancer among postmenopausal women.
Comment: In this large, prospective study, a higher intake of calcium and vitamin D was associated with a lower risk for invasive breast cancer among premenopausal but not postmenopausal women. Although the hazard ratios appear relatively large, the absolute risk reduction was modest. Limitations of this study include ascertainment of calcium and vitamin D intake only once at baseline and the possibility that unmeasured confounding variables explain the findings in this nonrandomized assessment of diet.
— Jamaluddin Moloo, MD, MPH
Published in Journal Watch General Medicine June 14, 2007
Citation(s):
Lin J et al. Intakes of calcium and vitamin D and breast cancer risk in women. Arch Intern Med 2007 May 28; 167:1050-9
Animal experiments and observational human studies suggest that calcium and vitamin D may decrease risk for breast cancer. Researchers prospectively assessed this relation among 10,000 premenopausal and 20,000 postmenopausal women enrolled in the Women’s Health Study. Calcium and vitamin D intake was determined from self-reported questionnaires about food and vitamin supplement intake.
During a mean follow-up of 10 years, the overall incidence of invasive breast cancer was 2.6% among premenopausal women and 3.6% among postmenopausal women. The hazard ratio for developing invasive breast cancer was 0.61 for premenopausal women at the highest versus lowest quintiles of calcium intake and 0.65 for vitamin D intake. No relation was found between calcium and vitamin D intake and risk for invasive breast cancer among postmenopausal women.
Comment: In this large, prospective study, a higher intake of calcium and vitamin D was associated with a lower risk for invasive breast cancer among premenopausal but not postmenopausal women. Although the hazard ratios appear relatively large, the absolute risk reduction was modest. Limitations of this study include ascertainment of calcium and vitamin D intake only once at baseline and the possibility that unmeasured confounding variables explain the findings in this nonrandomized assessment of diet.
— Jamaluddin Moloo, MD, MPH
Published in Journal Watch General Medicine June 14, 2007
Citation(s):
Lin J et al. Intakes of calcium and vitamin D and breast cancer risk in women. Arch Intern Med 2007 May 28; 167:1050-9
Monday, June 11, 2007
FDA Approves Extended-Release Zyflo
The FDA has approved an extended-release formulation of the asthma drug, Zyflo (zileuton), the manufacturer announced.
The leukotriene synthesis inhibitor is approved for the prevention and chronic treatment of asthma in patients ages 12 and older and will be marketed as Zyflo CR, beginning in the fall. The recommended dosage is two 600-mg tablets twice a day.
Zyflo CR is contraindicated in patients with active liver disease or elevated liver enzymes. The manufacturer reminds physicians to measure patients' liver enzyme levels before beginning treatment and at regular intervals thereafter.
JW June 2007
The leukotriene synthesis inhibitor is approved for the prevention and chronic treatment of asthma in patients ages 12 and older and will be marketed as Zyflo CR, beginning in the fall. The recommended dosage is two 600-mg tablets twice a day.
Zyflo CR is contraindicated in patients with active liver disease or elevated liver enzymes. The manufacturer reminds physicians to measure patients' liver enzyme levels before beginning treatment and at regular intervals thereafter.
JW June 2007
Reducing the Intensity of Treatment in Mild Asthma
Two randomized trials demonstrate the feasibility of step-down therapy in patients whose asthma is well controlled.
Many patients with mild asthma take standard daily doses of inhaled corticosteroids indefinitely. Two new industry-supported, placebo-controlled, randomized trials — each with about 500 participants whose mild asthma was controlled with twice-daily inhaled steroids — show that "step-down" therapy may be reasonable for such patients.
One study compared twice-daily inhaled steroid therapy with once-daily oral or inhaled alternatives. Patients received one of three treatments: inhaled fluticasone (Flovent Diskus, 100 µg), twice daily; combined fluticasone/salmeterol (Advair Diskus, 100/50 µg), once daily in the evening; or oral montelukast (Singulair), once daily. At 16 weeks, treatment failure (an endpoint that included several clinical and spirometric outcomes) had occurred in 20% of patients in each inhaled-therapy group and in 30% of montelukast patients, a significant difference. This difference reflected primarily spirometric outcomes, and not differences in need for systemic steroids or urgent asthma care.
The second study examined the relatively novel idea that as-needed inhaled steroids might be as effective as daily maintenance therapy. Patients received one of four treatments: twice-daily inhaled beclomethasone (250 µg) with as-needed albuterol; twice-daily combined beclomethasone/albuterol, with as-needed albuterol; the same beclomethasone/albuterol combination, but only as needed; and as-needed albuterol only. At 6 months, the primary outcome — morning peak expiratory flow rate — was similar in the twice-daily beclomethasone and the as-needed beclomethasone/albuterol groups, and was significantly higher in both groups than in the as-needed albuterol group. Both twice-daily beclomethasone and as-needed beclomethasone/albuterol were associated with fewer exacerbations than as-needed albuterol.
Comment: These important trials demonstrate the feasibility of step-down therapy in patients whose mild persistent asthma is well controlled with standard twice-daily inhaled corticosteroids. An objective of this research is to minimize cumulative lifetime exposure to inhaled steroids, which may have systemic effects after years of use. The first trial shows that once-daily montelukast or a once-daily combination of an inhaled steroid plus salmeterol are both reasonable alternatives (although treatment failures occurred somewhat more frequently with montelukast). In the second trial, symptom-driven inhaled corticosteroids worked as well as daily therapy in patients with mild asthma.
— Allan S. Brett, MD
Published in Journal Watch General Medicine May 16, 2007
http://content.nejm.org/cgi/content/full/356/20/2040
Many patients with mild asthma take standard daily doses of inhaled corticosteroids indefinitely. Two new industry-supported, placebo-controlled, randomized trials — each with about 500 participants whose mild asthma was controlled with twice-daily inhaled steroids — show that "step-down" therapy may be reasonable for such patients.
One study compared twice-daily inhaled steroid therapy with once-daily oral or inhaled alternatives. Patients received one of three treatments: inhaled fluticasone (Flovent Diskus, 100 µg), twice daily; combined fluticasone/salmeterol (Advair Diskus, 100/50 µg), once daily in the evening; or oral montelukast (Singulair), once daily. At 16 weeks, treatment failure (an endpoint that included several clinical and spirometric outcomes) had occurred in 20% of patients in each inhaled-therapy group and in 30% of montelukast patients, a significant difference. This difference reflected primarily spirometric outcomes, and not differences in need for systemic steroids or urgent asthma care.
The second study examined the relatively novel idea that as-needed inhaled steroids might be as effective as daily maintenance therapy. Patients received one of four treatments: twice-daily inhaled beclomethasone (250 µg) with as-needed albuterol; twice-daily combined beclomethasone/albuterol, with as-needed albuterol; the same beclomethasone/albuterol combination, but only as needed; and as-needed albuterol only. At 6 months, the primary outcome — morning peak expiratory flow rate — was similar in the twice-daily beclomethasone and the as-needed beclomethasone/albuterol groups, and was significantly higher in both groups than in the as-needed albuterol group. Both twice-daily beclomethasone and as-needed beclomethasone/albuterol were associated with fewer exacerbations than as-needed albuterol.
Comment: These important trials demonstrate the feasibility of step-down therapy in patients whose mild persistent asthma is well controlled with standard twice-daily inhaled corticosteroids. An objective of this research is to minimize cumulative lifetime exposure to inhaled steroids, which may have systemic effects after years of use. The first trial shows that once-daily montelukast or a once-daily combination of an inhaled steroid plus salmeterol are both reasonable alternatives (although treatment failures occurred somewhat more frequently with montelukast). In the second trial, symptom-driven inhaled corticosteroids worked as well as daily therapy in patients with mild asthma.
— Allan S. Brett, MD
Published in Journal Watch General Medicine May 16, 2007
http://content.nejm.org/cgi/content/full/356/20/2040
FDA Approves 7-Day Glucose Monitoring System
The FDA has approved a new continuous glucose monitoring system that doubles the time between sensor replacements, making the system more convenient for patients with diabetes.
The agency says that the percutaneous STS-7 system was found to be "safe and effective for detecting trends and tracking patterns of glucose levels in adults" in tests conducted in 72 patients at five clinical sites. The probe measures glucose levels every 5 minutes and has an alarm that can be set to warn of hypo- or hyperglycemia. Patients must replace the sensor weekly; an earlier, 3-day version received FDA approval in March of last year.
FDA Announcement: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01647.html
The agency says that the percutaneous STS-7 system was found to be "safe and effective for detecting trends and tracking patterns of glucose levels in adults" in tests conducted in 72 patients at five clinical sites. The probe measures glucose levels every 5 minutes and has an alarm that can be set to warn of hypo- or hyperglycemia. Patients must replace the sensor weekly; an earlier, 3-day version received FDA approval in March of last year.
FDA Announcement: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01647.html
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