User login
Jeff Evans has been editor of Rheumatology News/MDedge Rheumatology and the EULAR Congress News since 2013. He started at Frontline Medical Communications in 2001 and was a reporter for 8 years before serving as editor of Clinical Neurology News and World Neurology, and briefly as editor of GI & Hepatology News. He graduated cum laude from Cornell University (New York) with a BA in biological sciences, concentrating in neurobiology and behavior.
Clinical Capsules
H. Pylori Infection, Esophageal Ca
Infection with Helicobacter pylori in individuals younger than 50 years is associated with a fivefold lower likelihood of developing esophageal adenocarcinoma than in those without the infection, according to a nested case-control study.
In addition to H. pylori negativity, overweight (body mass index of 25 kg/m2 or higher) and a history of ever smoking were found to be independent risk factors for development of the cancer in the study of 51 individuals who had esophageal adenocarcinoma and 149 control patients (J. Infect. Dis. 2005;191:761-7).
Catherine de Martel, M.D., of Stanford (Calif.) University, and her associates selected the participants from a cohort of more than 128,000 patients in the Kaiser Permanente Health Care Program in northern California.
The inverse association between H. pylori positivity and esophageal adenocarcinoma—which was not significant in patients older than 50 years—remained significant after adjustment for body mass index, cigarette smoking, and education level.
Thalidomide Limits Cancer Cachexia
Thalidomide therapy significantly reduced further loss of body weight and lean muscle mass in advanced pancreatic cancer patients with cachexia, reported John N. Gordon, M.B.B.S., and his colleagues at the Southampton General Hospital (England).
In a randomized double-blind trial, patients received either 200 mg thalidomide daily or placebo. After 4 weeks, weight had changed significantly less for 17 thalidomide patients than for 16 placebo patients (mean gain of 0.37 kg vs. mean loss of 2.21 kg). This difference was still significant after 8 weeks between the 12 remaining thalidomide patients (mean loss of 0.06 kg) and 8 remaining placebo patients (mean loss of 3.62 kg) (Gut 2005;54:540-5).
Compared with placebo patients, those who took thalidomide had lost significantly less bone-free arm muscle area at week 4 (average gain of 1 cm3 vs. average loss of 4.6 cm3) and week 8 (loss of 0.5 cm3 vs. loss of 8.4 cm3). Global health scores and physical functioning did not differ significantly between the two groups. No significant difference in survival occurred.
Colonic Biopsies in Chronic Diarrhea
About 80% of chronic diarrhea patients with no abnormalities on colonoscopy undergo colonic biopsy, according to the largest study to examine the biopsy rate in such patients.
Of 5,565 patients with no colonoscopic abnormality, 4,410 had colonoscopic biopsy during 2000-2003; they were treated by 580 GI specialists in 24 states, reported Gavin C. Harewood, M.D., of the Mayo Clinic, Rochester, Minn., and his associates (Gastrointest. Endosc. 2005;61:371-5).
Expert consensus says that all chronic diarrhea patients with normal endoscopic findings should have the colon biopsied to look for microscopic colitis. Sigmoidoscopy may be most appropriate for young patients with chronic watery diarrhea without blood or pus in the stool who do not have irritable bowel syndrome by clinical criteria, suggested Lawrence R. Schiller, M.D., of Baylor University, Dallas, Tex., in an editorial (Gastrointest. Endosc. 2005;61:376-7).
Colonoscopy with biopsy of the left and right colon would be appropriate for older patients (because they have a higher risk of colonic or ileal pathology) or any patient with alarming findings, Dr. Schiller added.
Cetuximab in Metastatic Colorectal Ca
Cetuximab appears to yield the same response rate in metastatic colorectal tumors that test negative for epidermal growth factor receptors as it does in its original target population— patients who test positive for the receptor.
The review of 16 EGFR-negative patients with metastatic colorectal cancer was conducted by Ki Young Chung, M.D., and colleagues at Memorial Sloan-Kettering Cancer Center, New York. Cetuximab (Erbitux) was used alone in 2 patients and in combination with irinotecan in 14 patients.
The findings suggest that “as currently used, immunohistochemistry testing for EGFR expression is a poor screening method for identifying patients with colorectal cancer who will not respond to cetuximab therapy,” wrote Neal J. Meropol, M.D., of Fox Chase Cancer Center, Philadelphia, in an editorial (J. Clin. Oncol. 2005;23:1791-3). Four patients experienced a partial response of greater than 50% reduction in the size of measurable lesions, whereas two patients had minor responses, with 32% and 39% reductions.
Some of the investigators reported financial interests in the form of research funding or consultant or advisory roles with ImClone Systems, which markets cetuximab.
H. Pylori Infection, Esophageal Ca
Infection with Helicobacter pylori in individuals younger than 50 years is associated with a fivefold lower likelihood of developing esophageal adenocarcinoma than in those without the infection, according to a nested case-control study.
In addition to H. pylori negativity, overweight (body mass index of 25 kg/m2 or higher) and a history of ever smoking were found to be independent risk factors for development of the cancer in the study of 51 individuals who had esophageal adenocarcinoma and 149 control patients (J. Infect. Dis. 2005;191:761-7).
Catherine de Martel, M.D., of Stanford (Calif.) University, and her associates selected the participants from a cohort of more than 128,000 patients in the Kaiser Permanente Health Care Program in northern California.
The inverse association between H. pylori positivity and esophageal adenocarcinoma—which was not significant in patients older than 50 years—remained significant after adjustment for body mass index, cigarette smoking, and education level.
Thalidomide Limits Cancer Cachexia
Thalidomide therapy significantly reduced further loss of body weight and lean muscle mass in advanced pancreatic cancer patients with cachexia, reported John N. Gordon, M.B.B.S., and his colleagues at the Southampton General Hospital (England).
In a randomized double-blind trial, patients received either 200 mg thalidomide daily or placebo. After 4 weeks, weight had changed significantly less for 17 thalidomide patients than for 16 placebo patients (mean gain of 0.37 kg vs. mean loss of 2.21 kg). This difference was still significant after 8 weeks between the 12 remaining thalidomide patients (mean loss of 0.06 kg) and 8 remaining placebo patients (mean loss of 3.62 kg) (Gut 2005;54:540-5).
Compared with placebo patients, those who took thalidomide had lost significantly less bone-free arm muscle area at week 4 (average gain of 1 cm3 vs. average loss of 4.6 cm3) and week 8 (loss of 0.5 cm3 vs. loss of 8.4 cm3). Global health scores and physical functioning did not differ significantly between the two groups. No significant difference in survival occurred.
Colonic Biopsies in Chronic Diarrhea
About 80% of chronic diarrhea patients with no abnormalities on colonoscopy undergo colonic biopsy, according to the largest study to examine the biopsy rate in such patients.
Of 5,565 patients with no colonoscopic abnormality, 4,410 had colonoscopic biopsy during 2000-2003; they were treated by 580 GI specialists in 24 states, reported Gavin C. Harewood, M.D., of the Mayo Clinic, Rochester, Minn., and his associates (Gastrointest. Endosc. 2005;61:371-5).
Expert consensus says that all chronic diarrhea patients with normal endoscopic findings should have the colon biopsied to look for microscopic colitis. Sigmoidoscopy may be most appropriate for young patients with chronic watery diarrhea without blood or pus in the stool who do not have irritable bowel syndrome by clinical criteria, suggested Lawrence R. Schiller, M.D., of Baylor University, Dallas, Tex., in an editorial (Gastrointest. Endosc. 2005;61:376-7).
Colonoscopy with biopsy of the left and right colon would be appropriate for older patients (because they have a higher risk of colonic or ileal pathology) or any patient with alarming findings, Dr. Schiller added.
Cetuximab in Metastatic Colorectal Ca
Cetuximab appears to yield the same response rate in metastatic colorectal tumors that test negative for epidermal growth factor receptors as it does in its original target population— patients who test positive for the receptor.
The review of 16 EGFR-negative patients with metastatic colorectal cancer was conducted by Ki Young Chung, M.D., and colleagues at Memorial Sloan-Kettering Cancer Center, New York. Cetuximab (Erbitux) was used alone in 2 patients and in combination with irinotecan in 14 patients.
The findings suggest that “as currently used, immunohistochemistry testing for EGFR expression is a poor screening method for identifying patients with colorectal cancer who will not respond to cetuximab therapy,” wrote Neal J. Meropol, M.D., of Fox Chase Cancer Center, Philadelphia, in an editorial (J. Clin. Oncol. 2005;23:1791-3). Four patients experienced a partial response of greater than 50% reduction in the size of measurable lesions, whereas two patients had minor responses, with 32% and 39% reductions.
Some of the investigators reported financial interests in the form of research funding or consultant or advisory roles with ImClone Systems, which markets cetuximab.
H. Pylori Infection, Esophageal Ca
Infection with Helicobacter pylori in individuals younger than 50 years is associated with a fivefold lower likelihood of developing esophageal adenocarcinoma than in those without the infection, according to a nested case-control study.
In addition to H. pylori negativity, overweight (body mass index of 25 kg/m2 or higher) and a history of ever smoking were found to be independent risk factors for development of the cancer in the study of 51 individuals who had esophageal adenocarcinoma and 149 control patients (J. Infect. Dis. 2005;191:761-7).
Catherine de Martel, M.D., of Stanford (Calif.) University, and her associates selected the participants from a cohort of more than 128,000 patients in the Kaiser Permanente Health Care Program in northern California.
The inverse association between H. pylori positivity and esophageal adenocarcinoma—which was not significant in patients older than 50 years—remained significant after adjustment for body mass index, cigarette smoking, and education level.
Thalidomide Limits Cancer Cachexia
Thalidomide therapy significantly reduced further loss of body weight and lean muscle mass in advanced pancreatic cancer patients with cachexia, reported John N. Gordon, M.B.B.S., and his colleagues at the Southampton General Hospital (England).
In a randomized double-blind trial, patients received either 200 mg thalidomide daily or placebo. After 4 weeks, weight had changed significantly less for 17 thalidomide patients than for 16 placebo patients (mean gain of 0.37 kg vs. mean loss of 2.21 kg). This difference was still significant after 8 weeks between the 12 remaining thalidomide patients (mean loss of 0.06 kg) and 8 remaining placebo patients (mean loss of 3.62 kg) (Gut 2005;54:540-5).
Compared with placebo patients, those who took thalidomide had lost significantly less bone-free arm muscle area at week 4 (average gain of 1 cm3 vs. average loss of 4.6 cm3) and week 8 (loss of 0.5 cm3 vs. loss of 8.4 cm3). Global health scores and physical functioning did not differ significantly between the two groups. No significant difference in survival occurred.
Colonic Biopsies in Chronic Diarrhea
About 80% of chronic diarrhea patients with no abnormalities on colonoscopy undergo colonic biopsy, according to the largest study to examine the biopsy rate in such patients.
Of 5,565 patients with no colonoscopic abnormality, 4,410 had colonoscopic biopsy during 2000-2003; they were treated by 580 GI specialists in 24 states, reported Gavin C. Harewood, M.D., of the Mayo Clinic, Rochester, Minn., and his associates (Gastrointest. Endosc. 2005;61:371-5).
Expert consensus says that all chronic diarrhea patients with normal endoscopic findings should have the colon biopsied to look for microscopic colitis. Sigmoidoscopy may be most appropriate for young patients with chronic watery diarrhea without blood or pus in the stool who do not have irritable bowel syndrome by clinical criteria, suggested Lawrence R. Schiller, M.D., of Baylor University, Dallas, Tex., in an editorial (Gastrointest. Endosc. 2005;61:376-7).
Colonoscopy with biopsy of the left and right colon would be appropriate for older patients (because they have a higher risk of colonic or ileal pathology) or any patient with alarming findings, Dr. Schiller added.
Cetuximab in Metastatic Colorectal Ca
Cetuximab appears to yield the same response rate in metastatic colorectal tumors that test negative for epidermal growth factor receptors as it does in its original target population— patients who test positive for the receptor.
The review of 16 EGFR-negative patients with metastatic colorectal cancer was conducted by Ki Young Chung, M.D., and colleagues at Memorial Sloan-Kettering Cancer Center, New York. Cetuximab (Erbitux) was used alone in 2 patients and in combination with irinotecan in 14 patients.
The findings suggest that “as currently used, immunohistochemistry testing for EGFR expression is a poor screening method for identifying patients with colorectal cancer who will not respond to cetuximab therapy,” wrote Neal J. Meropol, M.D., of Fox Chase Cancer Center, Philadelphia, in an editorial (J. Clin. Oncol. 2005;23:1791-3). Four patients experienced a partial response of greater than 50% reduction in the size of measurable lesions, whereas two patients had minor responses, with 32% and 39% reductions.
Some of the investigators reported financial interests in the form of research funding or consultant or advisory roles with ImClone Systems, which markets cetuximab.
Study Compares Hemorrhoidectomy Devices
Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, according to Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.
Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).
The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.), the investigators said.
No between-group differences in complications or other parameters (length of hospital stay, amount of pethidine required, time to first bowel movement, and patient satisfaction) were identified in the study.
Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, according to Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.
Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).
The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.), the investigators said.
No between-group differences in complications or other parameters (length of hospital stay, amount of pethidine required, time to first bowel movement, and patient satisfaction) were identified in the study.
Hemorrhoidectomy performed with a Ligasure hemostatic device causes less postoperative pain and takes less time to do than hemorrhoidectomy with the Harmonic Scalpel, according to Shek Yuen Kwok, M.D., and colleagues at the Pamela Youde Nethersole Eastern Hospital, Hong Kong.
Seven days after patients with a total of three grade 3 or 4 hemorrhoids underwent a hemorrhoidectomy in a single-blind, randomized trial, the median postoperative pain score (assessed pain with a visual analog score) for the 24 patients in the Ligasure group was significantly lower than that for 23 patients in the Harmonic Scalpel group (2.6 vs. 4.8) (Dis. Colon Rectum [online] Dec. 21, 2004).
The Ligasure operation took significantly less time to perform than did the procedure using the Harmonic Scalpel (11 min. vs. 18 min.), the investigators said.
No between-group differences in complications or other parameters (length of hospital stay, amount of pethidine required, time to first bowel movement, and patient satisfaction) were identified in the study.
COX-2 Inhibitor Spares Kidneys In Liver Cirrhosis
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
The analysis excluded seven patients who had hepatorenal syndrome at baseline and three patients who did not have measurements available to calculate glomerular filtration rate or renal plasma flow. A total of 20 patients who were initially randomized did not receive a study drug because their plasma renin activity was less than 4 ng/mL/per hour.
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
The analysis excluded seven patients who had hepatorenal syndrome at baseline and three patients who did not have measurements available to calculate glomerular filtration rate or renal plasma flow. A total of 20 patients who were initially randomized did not receive a study drug because their plasma renin activity was less than 4 ng/mL/per hour.
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
The analysis excluded seven patients who had hepatorenal syndrome at baseline and three patients who did not have measurements available to calculate glomerular filtration rate or renal plasma flow. A total of 20 patients who were initially randomized did not receive a study drug because their plasma renin activity was less than 4 ng/mL/per hour.
Rivastigmine May Delay Dementia in Parkinson's
The cholinesterase inhibitor rivastigmine transiently halted cognitive deterioration associated with Parkinson's disease but fell short of actually modifying the course of either Parkinsonism or related dementia, according to the results of a randomized clinical trial reported by Murat Emre, M.D., of Istanbul (Turkey) University and his colleagues.
In the double-blind study of patients with mild to moderately severe dementia associated with Parkinson's disease, scores on the cognitive subscale of the Alzheimer's Disease Assessment Scale were significantly improved in the 329 patients given 24 weeks of treatment with rivastigmine compared with 160 patients who received placebo (N. Engl. J. Med. 2004;351:2509-18).
Patients also showed significant, though moderate, improvement with rivastigmine, compared with placebo, according to scores on the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change. About 80% of the patients who received rivastigmine did not have clinically meaningful improvement on that scale.
Rivastigmine patients received an average 8.6 mg of the drug per day. During the study, 95% of patients took levodopa and 46% took dopamine agonists.
Significantly more rivastigmine patients reported Parkinsonian symptoms than did placebo patients (27% vs. 16%), but this was not reflected in overall motor function scores on the Unified Parkinson's Disease Rating Scale, the researchers said.
Dr. Emre and many of the other investigators in the study reported being paid for work performed for Novartis, which funded the study and markets rivastigmine as Exelon.
Daniel Z. Press, M.D., of Harvard Medical School, Boston, said in an editorial that clinicians' ability to treat the motor symptoms of Parkinson's disease far outstrips their ability to treat cognitive symptoms (N. Engl. J. Med. 2004;351:2547-9). Yet the optimal approach to the management of motor symptoms remains controversial.
Another randomized study showed that levodopa improved motor symptoms at sufficiently high doses but did not alter the course of Parkinson's disease for better or worse.
Stanley Fahn, M.D., of Columbia University, New York, and his colleagues conducted a double-blind trial of levodopa in patients who were considered not likely to require therapy for the symptoms of Parkinson's disease during the 9 months that followed enrollment.
Clinical deterioration of the symptoms of Parkinson's disease did not occur in 81 patients who received carbidopa and levodopa at 600 mg/day after 42 weeks, according to scores on the Unified Parkinson's Disease Rating Scale. Patients who took lower daily doses of carbidopa and levodopa (150 mg and 300 mg) experienced some deterioration, but significantly less than the 70 placebo patients (N. Engl. J. Med. 2004;351:2498-508).
In a separate substudy using single photon emission CT (SPECT), striatal dopamine transporter density in the 106 patients who received levodopa was similar to that of 29 patients on placebo after 40 weeks of treatment. But when they excluded 19 patients with normal dopaminergic activity, the patients who took levodopa had a significantly greater decrease in the density of striatal dopamine transporters than did patients on placebo.
Counter to the neuroprotective effects of levodopa seen in the clinical part of the study, the result of the SPECT study “suggests the possibility of a levodopa-induced toxic effect on dopamine neurons,” according to the investigators.
All of the patients took levodopa during the SPECT study. Levodopa could have had a pharmacologic effect on the dopamine transporter by interfering with and reducing the binding of the radioligand used to detect the density of dopamine transporters.
But the small number of patients in the study and the relatively short period of treatment make it impossible to “exclude the possibility that levodopa may simply downregulate the dopamine transporter,” said Dr. Fahn, who has served as an unpaid consultant to Teva Pharmaceuticals, which supplied the drugs used in the study.
Only levodopa at doses of 600 mg/day was associated with a significantly higher adverse event (dyskinesia, headache, hypertonia, infection) rate than placebo.
The cholinesterase inhibitor rivastigmine transiently halted cognitive deterioration associated with Parkinson's disease but fell short of actually modifying the course of either Parkinsonism or related dementia, according to the results of a randomized clinical trial reported by Murat Emre, M.D., of Istanbul (Turkey) University and his colleagues.
In the double-blind study of patients with mild to moderately severe dementia associated with Parkinson's disease, scores on the cognitive subscale of the Alzheimer's Disease Assessment Scale were significantly improved in the 329 patients given 24 weeks of treatment with rivastigmine compared with 160 patients who received placebo (N. Engl. J. Med. 2004;351:2509-18).
Patients also showed significant, though moderate, improvement with rivastigmine, compared with placebo, according to scores on the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change. About 80% of the patients who received rivastigmine did not have clinically meaningful improvement on that scale.
Rivastigmine patients received an average 8.6 mg of the drug per day. During the study, 95% of patients took levodopa and 46% took dopamine agonists.
Significantly more rivastigmine patients reported Parkinsonian symptoms than did placebo patients (27% vs. 16%), but this was not reflected in overall motor function scores on the Unified Parkinson's Disease Rating Scale, the researchers said.
Dr. Emre and many of the other investigators in the study reported being paid for work performed for Novartis, which funded the study and markets rivastigmine as Exelon.
Daniel Z. Press, M.D., of Harvard Medical School, Boston, said in an editorial that clinicians' ability to treat the motor symptoms of Parkinson's disease far outstrips their ability to treat cognitive symptoms (N. Engl. J. Med. 2004;351:2547-9). Yet the optimal approach to the management of motor symptoms remains controversial.
Another randomized study showed that levodopa improved motor symptoms at sufficiently high doses but did not alter the course of Parkinson's disease for better or worse.
Stanley Fahn, M.D., of Columbia University, New York, and his colleagues conducted a double-blind trial of levodopa in patients who were considered not likely to require therapy for the symptoms of Parkinson's disease during the 9 months that followed enrollment.
Clinical deterioration of the symptoms of Parkinson's disease did not occur in 81 patients who received carbidopa and levodopa at 600 mg/day after 42 weeks, according to scores on the Unified Parkinson's Disease Rating Scale. Patients who took lower daily doses of carbidopa and levodopa (150 mg and 300 mg) experienced some deterioration, but significantly less than the 70 placebo patients (N. Engl. J. Med. 2004;351:2498-508).
In a separate substudy using single photon emission CT (SPECT), striatal dopamine transporter density in the 106 patients who received levodopa was similar to that of 29 patients on placebo after 40 weeks of treatment. But when they excluded 19 patients with normal dopaminergic activity, the patients who took levodopa had a significantly greater decrease in the density of striatal dopamine transporters than did patients on placebo.
Counter to the neuroprotective effects of levodopa seen in the clinical part of the study, the result of the SPECT study “suggests the possibility of a levodopa-induced toxic effect on dopamine neurons,” according to the investigators.
All of the patients took levodopa during the SPECT study. Levodopa could have had a pharmacologic effect on the dopamine transporter by interfering with and reducing the binding of the radioligand used to detect the density of dopamine transporters.
But the small number of patients in the study and the relatively short period of treatment make it impossible to “exclude the possibility that levodopa may simply downregulate the dopamine transporter,” said Dr. Fahn, who has served as an unpaid consultant to Teva Pharmaceuticals, which supplied the drugs used in the study.
Only levodopa at doses of 600 mg/day was associated with a significantly higher adverse event (dyskinesia, headache, hypertonia, infection) rate than placebo.
The cholinesterase inhibitor rivastigmine transiently halted cognitive deterioration associated with Parkinson's disease but fell short of actually modifying the course of either Parkinsonism or related dementia, according to the results of a randomized clinical trial reported by Murat Emre, M.D., of Istanbul (Turkey) University and his colleagues.
In the double-blind study of patients with mild to moderately severe dementia associated with Parkinson's disease, scores on the cognitive subscale of the Alzheimer's Disease Assessment Scale were significantly improved in the 329 patients given 24 weeks of treatment with rivastigmine compared with 160 patients who received placebo (N. Engl. J. Med. 2004;351:2509-18).
Patients also showed significant, though moderate, improvement with rivastigmine, compared with placebo, according to scores on the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change. About 80% of the patients who received rivastigmine did not have clinically meaningful improvement on that scale.
Rivastigmine patients received an average 8.6 mg of the drug per day. During the study, 95% of patients took levodopa and 46% took dopamine agonists.
Significantly more rivastigmine patients reported Parkinsonian symptoms than did placebo patients (27% vs. 16%), but this was not reflected in overall motor function scores on the Unified Parkinson's Disease Rating Scale, the researchers said.
Dr. Emre and many of the other investigators in the study reported being paid for work performed for Novartis, which funded the study and markets rivastigmine as Exelon.
Daniel Z. Press, M.D., of Harvard Medical School, Boston, said in an editorial that clinicians' ability to treat the motor symptoms of Parkinson's disease far outstrips their ability to treat cognitive symptoms (N. Engl. J. Med. 2004;351:2547-9). Yet the optimal approach to the management of motor symptoms remains controversial.
Another randomized study showed that levodopa improved motor symptoms at sufficiently high doses but did not alter the course of Parkinson's disease for better or worse.
Stanley Fahn, M.D., of Columbia University, New York, and his colleagues conducted a double-blind trial of levodopa in patients who were considered not likely to require therapy for the symptoms of Parkinson's disease during the 9 months that followed enrollment.
Clinical deterioration of the symptoms of Parkinson's disease did not occur in 81 patients who received carbidopa and levodopa at 600 mg/day after 42 weeks, according to scores on the Unified Parkinson's Disease Rating Scale. Patients who took lower daily doses of carbidopa and levodopa (150 mg and 300 mg) experienced some deterioration, but significantly less than the 70 placebo patients (N. Engl. J. Med. 2004;351:2498-508).
In a separate substudy using single photon emission CT (SPECT), striatal dopamine transporter density in the 106 patients who received levodopa was similar to that of 29 patients on placebo after 40 weeks of treatment. But when they excluded 19 patients with normal dopaminergic activity, the patients who took levodopa had a significantly greater decrease in the density of striatal dopamine transporters than did patients on placebo.
Counter to the neuroprotective effects of levodopa seen in the clinical part of the study, the result of the SPECT study “suggests the possibility of a levodopa-induced toxic effect on dopamine neurons,” according to the investigators.
All of the patients took levodopa during the SPECT study. Levodopa could have had a pharmacologic effect on the dopamine transporter by interfering with and reducing the binding of the radioligand used to detect the density of dopamine transporters.
But the small number of patients in the study and the relatively short period of treatment make it impossible to “exclude the possibility that levodopa may simply downregulate the dopamine transporter,” said Dr. Fahn, who has served as an unpaid consultant to Teva Pharmaceuticals, which supplied the drugs used in the study.
Only levodopa at doses of 600 mg/day was associated with a significantly higher adverse event (dyskinesia, headache, hypertonia, infection) rate than placebo.
Clinical Capsules
Renal Effect of NSAIDs in Cirrhosis
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo during the same time interval (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
Ablating Colorectal Ca Liver Metastases
Small size of colorectal cancer liver metastases may indicate a good prognosis after radiofrequency thermal ablation, reported Eren Berber, M.D., and colleagues at the Cleveland Clinic Foundation, Cleveland.
In their prospective study, the presence of a liver tumor larger than 5 cm decreased the likelihood of overall survival by a factor of 2.5 in a multivariate analysis of 135 patients with colorectal cancer liver metastases. Factors that were significant in cutting overall survival in univariate, but not multivariate, analyses included more than three liver lesions, a size of 3-5 cm for the largest liver lesion, and a serum carcinoembryonic antigen level of more than 200 ng/mL. Although 30% of the patients had minor extrahepatic metastases, this was not a prognostic factor for survival (J. Clin. Oncol. 2005;23:1358-64).
Before enrollment in 1997-2002, 80% of patients had intrahepatic tumor progression despite prior chemotherapy with fluorouracil and leucovorin or irinotecan and/or oxaliplatin; 14% had had liver resection before radiofrequency thermal ablation (RFA). Median survival was 29 months after RFA, similar to survival reported after chemotherapy alone.
Detecting Colorectal Ca Mutations
Conversion analysis detects many of the mismatch repair mutations and clinically important information that genomic DNA sequencing misses in colorectal cancer patients, reported Graham Casey, Ph.D., of the Cleveland Clinic Lerner College of Medicine, Cleveland, and his associates.
In 89 patients with colorectal cancer, conversion analysis (which separates alleles in hybrids prior to mutation screening) detected all 28 likely mutations detected with conventional genomic DNA sequence analysis, plus 14 additional likely pathogenic mutations in the mismatch repair genes MLH1, MSH2, or MSH6. Conversion analysis detected a likely pathogenic role for an additional 21 mutations that could not be interpreted with genomic DNA sequencing alone. All patients were suspected to have mutations in the mismatch repair genes MLH1, MSH2, or MSH6 based on tumor microsatellite instability status and loss of MLH1 or MSH2 staining (JAMA 2005;293:799-809).
Conversion analysis increased the diagnostic yield of clinically relevant mutations by 56% (35 of 63), compared with genomic DNA sequencing. The researchers detected likely deleterious mutations in 49 of 64 patients with hereditary nonpolyposis colorectal cancer (HNPCC), 7 of 8 patients with HNPCC-like colorectal cancer, and 7 of 17 patients with colorectal cancer diagnosed before age 50 years.
Nonhepatic Ca in Hepatitis C Patients
Patients with chronic hepatitis C infection have an increased risk of developing non-Hodgkin's lymphoma and multiple myeloma, based on findings from a study of all notifications of chronic hepatitis C cases sent to the Swedish Institute for Infectious Disease Control during 1990-2000.
Patients with chronic hepatitis C virus (HCV) for more than 15 years were 1.89 times as likely to have non-Hodgkin's lymphoma and 2.54 times as likely to have multiple myeloma, compared with age-, sex-, and calendar year-specific incidence rates. The significant increase in risk for non-Hodgkin's lymphoma disappeared when four patients with HIV infection and non-Hodgkin's lymphoma were dropped from the analysis, said Ann-Sofi Duberg, M.D., of Örebro (Sweden) University Hospital, and her associates (Hepatology 2005;41:652-9).
The study included 26,686 persons with an observation time of 122,272 person-years, not including patients with a cancer diagnosis before or within 3 months of notification of HCV infection.
Renal Effect of NSAIDs in Cirrhosis
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo during the same time interval (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
Ablating Colorectal Ca Liver Metastases
Small size of colorectal cancer liver metastases may indicate a good prognosis after radiofrequency thermal ablation, reported Eren Berber, M.D., and colleagues at the Cleveland Clinic Foundation, Cleveland.
In their prospective study, the presence of a liver tumor larger than 5 cm decreased the likelihood of overall survival by a factor of 2.5 in a multivariate analysis of 135 patients with colorectal cancer liver metastases. Factors that were significant in cutting overall survival in univariate, but not multivariate, analyses included more than three liver lesions, a size of 3-5 cm for the largest liver lesion, and a serum carcinoembryonic antigen level of more than 200 ng/mL. Although 30% of the patients had minor extrahepatic metastases, this was not a prognostic factor for survival (J. Clin. Oncol. 2005;23:1358-64).
Before enrollment in 1997-2002, 80% of patients had intrahepatic tumor progression despite prior chemotherapy with fluorouracil and leucovorin or irinotecan and/or oxaliplatin; 14% had had liver resection before radiofrequency thermal ablation (RFA). Median survival was 29 months after RFA, similar to survival reported after chemotherapy alone.
Detecting Colorectal Ca Mutations
Conversion analysis detects many of the mismatch repair mutations and clinically important information that genomic DNA sequencing misses in colorectal cancer patients, reported Graham Casey, Ph.D., of the Cleveland Clinic Lerner College of Medicine, Cleveland, and his associates.
In 89 patients with colorectal cancer, conversion analysis (which separates alleles in hybrids prior to mutation screening) detected all 28 likely mutations detected with conventional genomic DNA sequence analysis, plus 14 additional likely pathogenic mutations in the mismatch repair genes MLH1, MSH2, or MSH6. Conversion analysis detected a likely pathogenic role for an additional 21 mutations that could not be interpreted with genomic DNA sequencing alone. All patients were suspected to have mutations in the mismatch repair genes MLH1, MSH2, or MSH6 based on tumor microsatellite instability status and loss of MLH1 or MSH2 staining (JAMA 2005;293:799-809).
Conversion analysis increased the diagnostic yield of clinically relevant mutations by 56% (35 of 63), compared with genomic DNA sequencing. The researchers detected likely deleterious mutations in 49 of 64 patients with hereditary nonpolyposis colorectal cancer (HNPCC), 7 of 8 patients with HNPCC-like colorectal cancer, and 7 of 17 patients with colorectal cancer diagnosed before age 50 years.
Nonhepatic Ca in Hepatitis C Patients
Patients with chronic hepatitis C infection have an increased risk of developing non-Hodgkin's lymphoma and multiple myeloma, based on findings from a study of all notifications of chronic hepatitis C cases sent to the Swedish Institute for Infectious Disease Control during 1990-2000.
Patients with chronic hepatitis C virus (HCV) for more than 15 years were 1.89 times as likely to have non-Hodgkin's lymphoma and 2.54 times as likely to have multiple myeloma, compared with age-, sex-, and calendar year-specific incidence rates. The significant increase in risk for non-Hodgkin's lymphoma disappeared when four patients with HIV infection and non-Hodgkin's lymphoma were dropped from the analysis, said Ann-Sofi Duberg, M.D., of Örebro (Sweden) University Hospital, and her associates (Hepatology 2005;41:652-9).
The study included 26,686 persons with an observation time of 122,272 person-years, not including patients with a cancer diagnosis before or within 3 months of notification of HCV infection.
Renal Effect of NSAIDs in Cirrhosis
Short-term use of celecoxib did not affect renal function in patients with decompensated liver cirrhosis and ascites who participated in a small randomized trial.
In the double-blind study of 28 patients conducted by Joan Clària, Ph.D., of the University of Barcelona (Spain) and his colleagues, the glomerular filtration rate, renal plasma flow, and serum creatine levels worsened significantly in patients who received five therapeutic doses of naproxen during a 3-day period, compared with baseline values. None of these changes occurred in patients who received five therapeutic doses of celecoxib (Celebrex) or placebo during the same time interval (Hepatology 2005;41:579-87).
Naproxen significantly inhibited platelet aggregation and ex vivo thromboxane B2 synthesis and decreased urinary excretion of prostaglandin E2. Naproxen patients had significantly reduced diuretic and natriuretic responses to furosemide, which normally increases urine volume and urinary sodium excretion. Short-term celecoxib therapy does not reduce platelet or renal function, or response to diuretic drugs, in patients with decompensated cirrhosis, the authors concluded.
Ablating Colorectal Ca Liver Metastases
Small size of colorectal cancer liver metastases may indicate a good prognosis after radiofrequency thermal ablation, reported Eren Berber, M.D., and colleagues at the Cleveland Clinic Foundation, Cleveland.
In their prospective study, the presence of a liver tumor larger than 5 cm decreased the likelihood of overall survival by a factor of 2.5 in a multivariate analysis of 135 patients with colorectal cancer liver metastases. Factors that were significant in cutting overall survival in univariate, but not multivariate, analyses included more than three liver lesions, a size of 3-5 cm for the largest liver lesion, and a serum carcinoembryonic antigen level of more than 200 ng/mL. Although 30% of the patients had minor extrahepatic metastases, this was not a prognostic factor for survival (J. Clin. Oncol. 2005;23:1358-64).
Before enrollment in 1997-2002, 80% of patients had intrahepatic tumor progression despite prior chemotherapy with fluorouracil and leucovorin or irinotecan and/or oxaliplatin; 14% had had liver resection before radiofrequency thermal ablation (RFA). Median survival was 29 months after RFA, similar to survival reported after chemotherapy alone.
Detecting Colorectal Ca Mutations
Conversion analysis detects many of the mismatch repair mutations and clinically important information that genomic DNA sequencing misses in colorectal cancer patients, reported Graham Casey, Ph.D., of the Cleveland Clinic Lerner College of Medicine, Cleveland, and his associates.
In 89 patients with colorectal cancer, conversion analysis (which separates alleles in hybrids prior to mutation screening) detected all 28 likely mutations detected with conventional genomic DNA sequence analysis, plus 14 additional likely pathogenic mutations in the mismatch repair genes MLH1, MSH2, or MSH6. Conversion analysis detected a likely pathogenic role for an additional 21 mutations that could not be interpreted with genomic DNA sequencing alone. All patients were suspected to have mutations in the mismatch repair genes MLH1, MSH2, or MSH6 based on tumor microsatellite instability status and loss of MLH1 or MSH2 staining (JAMA 2005;293:799-809).
Conversion analysis increased the diagnostic yield of clinically relevant mutations by 56% (35 of 63), compared with genomic DNA sequencing. The researchers detected likely deleterious mutations in 49 of 64 patients with hereditary nonpolyposis colorectal cancer (HNPCC), 7 of 8 patients with HNPCC-like colorectal cancer, and 7 of 17 patients with colorectal cancer diagnosed before age 50 years.
Nonhepatic Ca in Hepatitis C Patients
Patients with chronic hepatitis C infection have an increased risk of developing non-Hodgkin's lymphoma and multiple myeloma, based on findings from a study of all notifications of chronic hepatitis C cases sent to the Swedish Institute for Infectious Disease Control during 1990-2000.
Patients with chronic hepatitis C virus (HCV) for more than 15 years were 1.89 times as likely to have non-Hodgkin's lymphoma and 2.54 times as likely to have multiple myeloma, compared with age-, sex-, and calendar year-specific incidence rates. The significant increase in risk for non-Hodgkin's lymphoma disappeared when four patients with HIV infection and non-Hodgkin's lymphoma were dropped from the analysis, said Ann-Sofi Duberg, M.D., of Örebro (Sweden) University Hospital, and her associates (Hepatology 2005;41:652-9).
The study included 26,686 persons with an observation time of 122,272 person-years, not including patients with a cancer diagnosis before or within 3 months of notification of HCV infection.
Probiotic Drink Cut Cases of Antibiotic-Associated Diarrhea in Hospital
ORLANDO, FLA. — Daily intake of a lactobacilli-fermented milk may help prevent antibiotic-associated diarrhea in hospitalized patients, Natalie A. Fortier reported at the annual meeting of the American College of Gastroenterology.
Few of the published studies on the use of probiotics to prevent antibiotic-associated diarrhea have had a strong randomized, placebo-controlled design, said Ms. Fortier of the University of Montreal.
The daily drink, which contained 50 billion colony-forming units of live Lactobacillus acidophilus and L. casei, was associated with significantly fewer cases of antibiotic-associated diarrhea (7 of 41 patients) than was a placebo drink composed of lactoserum that was devoid of any microorganisms (16 of 43 patients).
Ms. Fortier and her colleagues at the university defined antibiotic-associated diarrhea as three or more liquid stools in a 24-hour period in the randomized, double-blind trial.
The researchers provided the active treatment or placebo daily to adult patients with an average age of 70 years on the 7-10 days that they were taking antibiotics.
The researchers then obtained follow-up from the patients for 21 days after they stopped taking antibiotics.
The patients began prophylactic treatment in the first 48 hours after starting antibiotics, which were primarily for upper respiratory tract infections.
Those with active diarrhea, GI bleeding, inflammatory bowel disease, Clostridium difficile infection in the last 3 months, a high risk of an immunocompromised state, lactose intolerance, or a regular intake of probiotics were excluded from the trial.
Diarrhea associated with C. difficile occurred less often in patients who received the active treatment (1 of 41) than in placebo patients (7 of 43), although the difference did not reach statistical significance.
Actively treated patients had a significantly shorter median length of stay in the hospital, compared with patients who received placebo (8 days vs. 10 days).
Ms. Fortier and her associates obtained their results from a multivariate analysis after controlling for risk factors for antibiotic-associated diarrhea and C. difficile-associated diarrhea as well for the fact that significantly more placebo patients received β-lactam antibiotics (67%) than did actively treated patients (41%).
Side effects—mostly of a GI nature—occurred in nearly half of patients in each group, she said.
The active and placebo preparations were provided by Bio−K+ International Inc., Laval, Que., which manufactures and markets the active treatment.
ORLANDO, FLA. — Daily intake of a lactobacilli-fermented milk may help prevent antibiotic-associated diarrhea in hospitalized patients, Natalie A. Fortier reported at the annual meeting of the American College of Gastroenterology.
Few of the published studies on the use of probiotics to prevent antibiotic-associated diarrhea have had a strong randomized, placebo-controlled design, said Ms. Fortier of the University of Montreal.
The daily drink, which contained 50 billion colony-forming units of live Lactobacillus acidophilus and L. casei, was associated with significantly fewer cases of antibiotic-associated diarrhea (7 of 41 patients) than was a placebo drink composed of lactoserum that was devoid of any microorganisms (16 of 43 patients).
Ms. Fortier and her colleagues at the university defined antibiotic-associated diarrhea as three or more liquid stools in a 24-hour period in the randomized, double-blind trial.
The researchers provided the active treatment or placebo daily to adult patients with an average age of 70 years on the 7-10 days that they were taking antibiotics.
The researchers then obtained follow-up from the patients for 21 days after they stopped taking antibiotics.
The patients began prophylactic treatment in the first 48 hours after starting antibiotics, which were primarily for upper respiratory tract infections.
Those with active diarrhea, GI bleeding, inflammatory bowel disease, Clostridium difficile infection in the last 3 months, a high risk of an immunocompromised state, lactose intolerance, or a regular intake of probiotics were excluded from the trial.
Diarrhea associated with C. difficile occurred less often in patients who received the active treatment (1 of 41) than in placebo patients (7 of 43), although the difference did not reach statistical significance.
Actively treated patients had a significantly shorter median length of stay in the hospital, compared with patients who received placebo (8 days vs. 10 days).
Ms. Fortier and her associates obtained their results from a multivariate analysis after controlling for risk factors for antibiotic-associated diarrhea and C. difficile-associated diarrhea as well for the fact that significantly more placebo patients received β-lactam antibiotics (67%) than did actively treated patients (41%).
Side effects—mostly of a GI nature—occurred in nearly half of patients in each group, she said.
The active and placebo preparations were provided by Bio−K+ International Inc., Laval, Que., which manufactures and markets the active treatment.
ORLANDO, FLA. — Daily intake of a lactobacilli-fermented milk may help prevent antibiotic-associated diarrhea in hospitalized patients, Natalie A. Fortier reported at the annual meeting of the American College of Gastroenterology.
Few of the published studies on the use of probiotics to prevent antibiotic-associated diarrhea have had a strong randomized, placebo-controlled design, said Ms. Fortier of the University of Montreal.
The daily drink, which contained 50 billion colony-forming units of live Lactobacillus acidophilus and L. casei, was associated with significantly fewer cases of antibiotic-associated diarrhea (7 of 41 patients) than was a placebo drink composed of lactoserum that was devoid of any microorganisms (16 of 43 patients).
Ms. Fortier and her colleagues at the university defined antibiotic-associated diarrhea as three or more liquid stools in a 24-hour period in the randomized, double-blind trial.
The researchers provided the active treatment or placebo daily to adult patients with an average age of 70 years on the 7-10 days that they were taking antibiotics.
The researchers then obtained follow-up from the patients for 21 days after they stopped taking antibiotics.
The patients began prophylactic treatment in the first 48 hours after starting antibiotics, which were primarily for upper respiratory tract infections.
Those with active diarrhea, GI bleeding, inflammatory bowel disease, Clostridium difficile infection in the last 3 months, a high risk of an immunocompromised state, lactose intolerance, or a regular intake of probiotics were excluded from the trial.
Diarrhea associated with C. difficile occurred less often in patients who received the active treatment (1 of 41) than in placebo patients (7 of 43), although the difference did not reach statistical significance.
Actively treated patients had a significantly shorter median length of stay in the hospital, compared with patients who received placebo (8 days vs. 10 days).
Ms. Fortier and her associates obtained their results from a multivariate analysis after controlling for risk factors for antibiotic-associated diarrhea and C. difficile-associated diarrhea as well for the fact that significantly more placebo patients received β-lactam antibiotics (67%) than did actively treated patients (41%).
Side effects—mostly of a GI nature—occurred in nearly half of patients in each group, she said.
The active and placebo preparations were provided by Bio−K+ International Inc., Laval, Que., which manufactures and markets the active treatment.
Gene Variants May Predict Upper Gastrointestinal Disease in Crohn's
ORLANDO, FLA. — Crohn's disease patients with two allelic variants of the NOD2/CARD15 gene have an increased risk of upper GI disease involvement, Houssam E. Mardini, M.D., reported at the annual meeting of the American College of Gastroenterology.
Genetic testing of patients in an inflammatory bowel disease database revealed that six of nine patients with Crohn's disease in the upper GI tract had two allelic variants of the NOD2/CARD15 gene. In comparison, a significantly lower percentage of patients without upper GI disease had two allelic variants of the gene (4% of 169).
“Our data suggest that patients with two NOD2/CARD15 allelic variants should be carefully evaluated for upper GI involvement,” Dr. Mardini and his associates said in a poster presentation.
NOD2/CARD15 is so far the only gene that is highly associated with Crohn's disease.
Four of the patients with upper GI disease had homozygous allelic variants, whereas none of the patients without upper GI disease were homozygous for an allelic variant.
Wild type alleles of NOD2/CARD15 occurred in 68% of the patients without upper GI disease; another 28% of those without upper GI disease had one allelic variant.
Compared with patients who did not have upper GI disease, significantly more of the patients with upper GI involvement had a family history of inflammatory bowel disease (19% vs. 44%), were male (41% vs. 78%), and were younger at diagnosis (25 years vs. 17 years).
Osteopenia or osteoporosis developed significantly more often in patients with upper GI disease than in those without (33% vs. 9%).
ORLANDO, FLA. — Crohn's disease patients with two allelic variants of the NOD2/CARD15 gene have an increased risk of upper GI disease involvement, Houssam E. Mardini, M.D., reported at the annual meeting of the American College of Gastroenterology.
Genetic testing of patients in an inflammatory bowel disease database revealed that six of nine patients with Crohn's disease in the upper GI tract had two allelic variants of the NOD2/CARD15 gene. In comparison, a significantly lower percentage of patients without upper GI disease had two allelic variants of the gene (4% of 169).
“Our data suggest that patients with two NOD2/CARD15 allelic variants should be carefully evaluated for upper GI involvement,” Dr. Mardini and his associates said in a poster presentation.
NOD2/CARD15 is so far the only gene that is highly associated with Crohn's disease.
Four of the patients with upper GI disease had homozygous allelic variants, whereas none of the patients without upper GI disease were homozygous for an allelic variant.
Wild type alleles of NOD2/CARD15 occurred in 68% of the patients without upper GI disease; another 28% of those without upper GI disease had one allelic variant.
Compared with patients who did not have upper GI disease, significantly more of the patients with upper GI involvement had a family history of inflammatory bowel disease (19% vs. 44%), were male (41% vs. 78%), and were younger at diagnosis (25 years vs. 17 years).
Osteopenia or osteoporosis developed significantly more often in patients with upper GI disease than in those without (33% vs. 9%).
ORLANDO, FLA. — Crohn's disease patients with two allelic variants of the NOD2/CARD15 gene have an increased risk of upper GI disease involvement, Houssam E. Mardini, M.D., reported at the annual meeting of the American College of Gastroenterology.
Genetic testing of patients in an inflammatory bowel disease database revealed that six of nine patients with Crohn's disease in the upper GI tract had two allelic variants of the NOD2/CARD15 gene. In comparison, a significantly lower percentage of patients without upper GI disease had two allelic variants of the gene (4% of 169).
“Our data suggest that patients with two NOD2/CARD15 allelic variants should be carefully evaluated for upper GI involvement,” Dr. Mardini and his associates said in a poster presentation.
NOD2/CARD15 is so far the only gene that is highly associated with Crohn's disease.
Four of the patients with upper GI disease had homozygous allelic variants, whereas none of the patients without upper GI disease were homozygous for an allelic variant.
Wild type alleles of NOD2/CARD15 occurred in 68% of the patients without upper GI disease; another 28% of those without upper GI disease had one allelic variant.
Compared with patients who did not have upper GI disease, significantly more of the patients with upper GI involvement had a family history of inflammatory bowel disease (19% vs. 44%), were male (41% vs. 78%), and were younger at diagnosis (25 years vs. 17 years).
Osteopenia or osteoporosis developed significantly more often in patients with upper GI disease than in those without (33% vs. 9%).
Non-BMI Assessments Miss Many Overweight Children
Assessments of overweight that use methods not based on body mass index may grossly underdiagnose that condition in children, according to findings from a retrospective study.
During well-child visits, only 29% of overweight children were diagnosed as overweight and 1% of children at risk for overweight were classified as such using clinical impression as well as weight-for-age and weight-for-height percentiles.
Howard Taras, M.D., a member of the American Academy of Pediatrics Task Force on Obesity, said body mass index for age is recommended for determining overweight and risk for overweight in children, but most practices probably do not use it.
In most practices, a nurse or a nurse's aide records the height and weight at well-child visits into the patient's chart and may then plot them on a graph. Calculating the BMI for age just adds another step beyond that, he said in an interview.
In a 2-week period, 93 (20%) of 473 patients aged 2–18 years were categorized as overweight, and another 82 (17%) patients were categorized as at risk for overweight, reported Miriam V. Louthan, M.D., and her colleagues at the University of Louisville (Ky.).
They defined “at risk to be overweight” as BMI for age between the 85th and 95th percentile and overweight as BMI for age at the 95th percentile or greater (Clin. Pediatr. [Phila.] 2005;44:57–61).
“Severely overweight children are unlikely to be missed by any method of detection of overweight,” the investigators wrote, but “children who are younger and mildly overweight and who have more potential to have their disease process successfully interrupted are the ones who were typically missed by the non-BMI-based methods of identification.”
Most of the children who were overweight were younger than 12 years (68 patients), yet the physicians diagnosed significantly fewer of them than children older than 12 years (22% vs. 48%).
“I think we have to make sure that doctors feel that this is worthwhile, that it's going to change their management or change the instructions they give,” because it may take more money and staffing to direct additional clinical time to obesity, said Dr. Taras, professor of community pediatrics at the University of California, San Diego.
Physicians will have a better chance of reversing obesity in childhood and adolescence if they can refer patients to resources in the community on nutrition and physical activity that insurance will pay for, he added.
The physicians in the study gave 85% of the children diagnosed as overweight some sort of treatment plan, most of which consisted of recommendations for increased exercise, improved nutrition, and changes in eating patterns.
BMI-for-age percentiles for ages 2–20 years can be found at www.cdc.gov/nchs/about/major/nhanes/growthcharts/clinical_charts.htm
Assessments of overweight that use methods not based on body mass index may grossly underdiagnose that condition in children, according to findings from a retrospective study.
During well-child visits, only 29% of overweight children were diagnosed as overweight and 1% of children at risk for overweight were classified as such using clinical impression as well as weight-for-age and weight-for-height percentiles.
Howard Taras, M.D., a member of the American Academy of Pediatrics Task Force on Obesity, said body mass index for age is recommended for determining overweight and risk for overweight in children, but most practices probably do not use it.
In most practices, a nurse or a nurse's aide records the height and weight at well-child visits into the patient's chart and may then plot them on a graph. Calculating the BMI for age just adds another step beyond that, he said in an interview.
In a 2-week period, 93 (20%) of 473 patients aged 2–18 years were categorized as overweight, and another 82 (17%) patients were categorized as at risk for overweight, reported Miriam V. Louthan, M.D., and her colleagues at the University of Louisville (Ky.).
They defined “at risk to be overweight” as BMI for age between the 85th and 95th percentile and overweight as BMI for age at the 95th percentile or greater (Clin. Pediatr. [Phila.] 2005;44:57–61).
“Severely overweight children are unlikely to be missed by any method of detection of overweight,” the investigators wrote, but “children who are younger and mildly overweight and who have more potential to have their disease process successfully interrupted are the ones who were typically missed by the non-BMI-based methods of identification.”
Most of the children who were overweight were younger than 12 years (68 patients), yet the physicians diagnosed significantly fewer of them than children older than 12 years (22% vs. 48%).
“I think we have to make sure that doctors feel that this is worthwhile, that it's going to change their management or change the instructions they give,” because it may take more money and staffing to direct additional clinical time to obesity, said Dr. Taras, professor of community pediatrics at the University of California, San Diego.
Physicians will have a better chance of reversing obesity in childhood and adolescence if they can refer patients to resources in the community on nutrition and physical activity that insurance will pay for, he added.
The physicians in the study gave 85% of the children diagnosed as overweight some sort of treatment plan, most of which consisted of recommendations for increased exercise, improved nutrition, and changes in eating patterns.
BMI-for-age percentiles for ages 2–20 years can be found at www.cdc.gov/nchs/about/major/nhanes/growthcharts/clinical_charts.htm
Assessments of overweight that use methods not based on body mass index may grossly underdiagnose that condition in children, according to findings from a retrospective study.
During well-child visits, only 29% of overweight children were diagnosed as overweight and 1% of children at risk for overweight were classified as such using clinical impression as well as weight-for-age and weight-for-height percentiles.
Howard Taras, M.D., a member of the American Academy of Pediatrics Task Force on Obesity, said body mass index for age is recommended for determining overweight and risk for overweight in children, but most practices probably do not use it.
In most practices, a nurse or a nurse's aide records the height and weight at well-child visits into the patient's chart and may then plot them on a graph. Calculating the BMI for age just adds another step beyond that, he said in an interview.
In a 2-week period, 93 (20%) of 473 patients aged 2–18 years were categorized as overweight, and another 82 (17%) patients were categorized as at risk for overweight, reported Miriam V. Louthan, M.D., and her colleagues at the University of Louisville (Ky.).
They defined “at risk to be overweight” as BMI for age between the 85th and 95th percentile and overweight as BMI for age at the 95th percentile or greater (Clin. Pediatr. [Phila.] 2005;44:57–61).
“Severely overweight children are unlikely to be missed by any method of detection of overweight,” the investigators wrote, but “children who are younger and mildly overweight and who have more potential to have their disease process successfully interrupted are the ones who were typically missed by the non-BMI-based methods of identification.”
Most of the children who were overweight were younger than 12 years (68 patients), yet the physicians diagnosed significantly fewer of them than children older than 12 years (22% vs. 48%).
“I think we have to make sure that doctors feel that this is worthwhile, that it's going to change their management or change the instructions they give,” because it may take more money and staffing to direct additional clinical time to obesity, said Dr. Taras, professor of community pediatrics at the University of California, San Diego.
Physicians will have a better chance of reversing obesity in childhood and adolescence if they can refer patients to resources in the community on nutrition and physical activity that insurance will pay for, he added.
The physicians in the study gave 85% of the children diagnosed as overweight some sort of treatment plan, most of which consisted of recommendations for increased exercise, improved nutrition, and changes in eating patterns.
BMI-for-age percentiles for ages 2–20 years can be found at www.cdc.gov/nchs/about/major/nhanes/growthcharts/clinical_charts.htm
Avoiding Drug Interactions in Endocrine Patients
WASHINGTON — Simply placing a list of common drug interactions on patient charts will make it easier to identify such interactions in patients with endocrine disorders, John B. Tourtelot, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.
“This is such a simple thing to do, but no one does it anymore or very few people do,” he said.
Not only will it be helpful to have a drug interaction list available, but the information can help patients and consultant physicians know why a particular medication is prescribed, said Dr. Tourtelot, an endocrinologist at the Morton Plant Hospital, Clearwater, Fla.
Drug interactions in diabetes and endocrine disorders are a “significant problem,” he said, adding that much of the data on adverse drug reactions come from hospitalized patients.
A metaanalysis of 39 prospective studies from U.S. hospitals estimated that approximately 2.2 million serious adverse drug reactions and 106,000 fatal reactions were recorded in 1994. This made adverse drug reactions the sixth leading cause of death in the United States (JAMA 1998;279:1200–5).
“The stuff you don't hear about comes from the emergency room, it comes from ambulatory care, and a lot of it just isn't reported,” Dr. Tourtelot said. Adverse drug reactions are a “far greater issue than what we're seeing statistically.”
In one study of elderly patients in an ambulatory care setting, 28% of 1,523 adverse drug events were considered preventable. The preventable events included several medication categories commonly used in elderly patients with endocrine disorders, such as cardiovascular and hypoglycemic agents (JAMA 2003;289:1107–16).
Three factors should be considered when evaluating the potential significance of a drug interaction:
▸ The magnitude of the interaction. This depends on the extent to which the drug in question is affected by another drug or environmental factor.
A good rule of thumb is that if a drug interaction affects the efficacy of a drug by 30% or less, then most interactions at that level will not be significant, Dr. Tourtelot said.
▸ The documentation of interaction in human studies. Much of the data on drug interactions are first obtained in animal studies and these studies may show changes in pharmacokinetics that are not related to how the drugs interact in humans.
Absorption can be altered by a variety of factors, including pH and the presence of cations and foods. These factors can delay the onset of therapy and increase or decrease its effectiveness. For example, calcium and other cations can prevent the absorption of levothyroxine.
Changes in the metabolism of a drug could delay or speed up the excretion of that drug.
Diabetic patients with chronic renal insufficiency and many other patients with endocrine disorders will have abnormalities in excretion. “It may not be a significant interaction in a nondiabetic, but it becomes significant when they have a change in their ability to excrete a drug,” he said.
▸ The therapeutic index of a drug. At high doses, many medications reach the end of their therapeutic value and approach their threshold for toxicity.
Some drugs have a wide therapeutic index and only reach toxic levels at doses higher than those that have any kind of therapeutic value, while other drugs may have a very narrow therapeutic index or a therapeutic index where toxicity occurs simultaneously with therapy, as in the case of agents used in chemotherapy regimens.
The conference was cosponsored by the American College of Endocrinology and the American Association of Clinical Endocrinologists.
WASHINGTON — Simply placing a list of common drug interactions on patient charts will make it easier to identify such interactions in patients with endocrine disorders, John B. Tourtelot, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.
“This is such a simple thing to do, but no one does it anymore or very few people do,” he said.
Not only will it be helpful to have a drug interaction list available, but the information can help patients and consultant physicians know why a particular medication is prescribed, said Dr. Tourtelot, an endocrinologist at the Morton Plant Hospital, Clearwater, Fla.
Drug interactions in diabetes and endocrine disorders are a “significant problem,” he said, adding that much of the data on adverse drug reactions come from hospitalized patients.
A metaanalysis of 39 prospective studies from U.S. hospitals estimated that approximately 2.2 million serious adverse drug reactions and 106,000 fatal reactions were recorded in 1994. This made adverse drug reactions the sixth leading cause of death in the United States (JAMA 1998;279:1200–5).
“The stuff you don't hear about comes from the emergency room, it comes from ambulatory care, and a lot of it just isn't reported,” Dr. Tourtelot said. Adverse drug reactions are a “far greater issue than what we're seeing statistically.”
In one study of elderly patients in an ambulatory care setting, 28% of 1,523 adverse drug events were considered preventable. The preventable events included several medication categories commonly used in elderly patients with endocrine disorders, such as cardiovascular and hypoglycemic agents (JAMA 2003;289:1107–16).
Three factors should be considered when evaluating the potential significance of a drug interaction:
▸ The magnitude of the interaction. This depends on the extent to which the drug in question is affected by another drug or environmental factor.
A good rule of thumb is that if a drug interaction affects the efficacy of a drug by 30% or less, then most interactions at that level will not be significant, Dr. Tourtelot said.
▸ The documentation of interaction in human studies. Much of the data on drug interactions are first obtained in animal studies and these studies may show changes in pharmacokinetics that are not related to how the drugs interact in humans.
Absorption can be altered by a variety of factors, including pH and the presence of cations and foods. These factors can delay the onset of therapy and increase or decrease its effectiveness. For example, calcium and other cations can prevent the absorption of levothyroxine.
Changes in the metabolism of a drug could delay or speed up the excretion of that drug.
Diabetic patients with chronic renal insufficiency and many other patients with endocrine disorders will have abnormalities in excretion. “It may not be a significant interaction in a nondiabetic, but it becomes significant when they have a change in their ability to excrete a drug,” he said.
▸ The therapeutic index of a drug. At high doses, many medications reach the end of their therapeutic value and approach their threshold for toxicity.
Some drugs have a wide therapeutic index and only reach toxic levels at doses higher than those that have any kind of therapeutic value, while other drugs may have a very narrow therapeutic index or a therapeutic index where toxicity occurs simultaneously with therapy, as in the case of agents used in chemotherapy regimens.
The conference was cosponsored by the American College of Endocrinology and the American Association of Clinical Endocrinologists.
WASHINGTON — Simply placing a list of common drug interactions on patient charts will make it easier to identify such interactions in patients with endocrine disorders, John B. Tourtelot, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.
“This is such a simple thing to do, but no one does it anymore or very few people do,” he said.
Not only will it be helpful to have a drug interaction list available, but the information can help patients and consultant physicians know why a particular medication is prescribed, said Dr. Tourtelot, an endocrinologist at the Morton Plant Hospital, Clearwater, Fla.
Drug interactions in diabetes and endocrine disorders are a “significant problem,” he said, adding that much of the data on adverse drug reactions come from hospitalized patients.
A metaanalysis of 39 prospective studies from U.S. hospitals estimated that approximately 2.2 million serious adverse drug reactions and 106,000 fatal reactions were recorded in 1994. This made adverse drug reactions the sixth leading cause of death in the United States (JAMA 1998;279:1200–5).
“The stuff you don't hear about comes from the emergency room, it comes from ambulatory care, and a lot of it just isn't reported,” Dr. Tourtelot said. Adverse drug reactions are a “far greater issue than what we're seeing statistically.”
In one study of elderly patients in an ambulatory care setting, 28% of 1,523 adverse drug events were considered preventable. The preventable events included several medication categories commonly used in elderly patients with endocrine disorders, such as cardiovascular and hypoglycemic agents (JAMA 2003;289:1107–16).
Three factors should be considered when evaluating the potential significance of a drug interaction:
▸ The magnitude of the interaction. This depends on the extent to which the drug in question is affected by another drug or environmental factor.
A good rule of thumb is that if a drug interaction affects the efficacy of a drug by 30% or less, then most interactions at that level will not be significant, Dr. Tourtelot said.
▸ The documentation of interaction in human studies. Much of the data on drug interactions are first obtained in animal studies and these studies may show changes in pharmacokinetics that are not related to how the drugs interact in humans.
Absorption can be altered by a variety of factors, including pH and the presence of cations and foods. These factors can delay the onset of therapy and increase or decrease its effectiveness. For example, calcium and other cations can prevent the absorption of levothyroxine.
Changes in the metabolism of a drug could delay or speed up the excretion of that drug.
Diabetic patients with chronic renal insufficiency and many other patients with endocrine disorders will have abnormalities in excretion. “It may not be a significant interaction in a nondiabetic, but it becomes significant when they have a change in their ability to excrete a drug,” he said.
▸ The therapeutic index of a drug. At high doses, many medications reach the end of their therapeutic value and approach their threshold for toxicity.
Some drugs have a wide therapeutic index and only reach toxic levels at doses higher than those that have any kind of therapeutic value, while other drugs may have a very narrow therapeutic index or a therapeutic index where toxicity occurs simultaneously with therapy, as in the case of agents used in chemotherapy regimens.
The conference was cosponsored by the American College of Endocrinology and the American Association of Clinical Endocrinologists.
Patency Capsule Ascertains Safety of Deploying Video Capsule
ORLANDO, FLA.—A new diagnostic capsule can verify the presence of small bowel strictures seen on radiology and determine when it is safe to use video capsule endoscopy, Cristiano Spada, M.D., reported at the annual meeting of the American College of Gastroenterology.
Small bowel radiology is not always reliable in determining the presence of a stricture and the functional patency of the small bowel, so it is necessary to identify the presence of any stricture before using the Pillcam SB (formerly called the M2A video capsule) to perform capsule endoscopy. Both devices are manufactured by Given Imaging.
The investigational Patency Capsule contains a radiofrequency tag surrounded by a dissolvable lactose and parylene polymer coating. A small window exposes the inside of the capsule to GI fluids to help digest the coating. A timing plug built into the capsule keeps the capsule intact for about 40-100 hours, after which it can pass through the small bowel if it encounters a stricture. At 8 and 24 hours after patients ingested the Patency Capsule, Dr. Spada and his colleagues identified the location of the capsule by using fluoroscopy and a device called the Patency scanner to locate the radiofrequency signal emitted by the capsule.
Overall, 46 of the 91 patients with radiologically confirmed or suspected small bowel stricture who ingested the Patency Capsule excreted the capsule intact. The other 45 patients excreted a partially intact or nonintact (dissolved) capsule. Most of the patients in the study had Crohn's disease, said Dr. Spada of Catholic University, Rome.
Overall, 22 patients reported abdominal pain after ingesting the Patency Capsule. The pain resolved within 24 hours in 17 patients, and 3 went to the hospital with severe pain that passed once the capsule was excreted.
Two patients underwent surgery for pain: One patient's stricture was so large that the intestinal lumen became completely occluded with the capsule while another underwent surgery for an unrelated problem. The Patency scanner failed to detect the capsule in two patients.
The transit time of the Patency Capsule was correlated with dissolving of the capsule. But the researchers could not find a correlation between the anatomical features of the stricture and the capsule's transit time.
“In fact, in some patients with a tight stricture, the capsule was excreted intact after 2 hours,” Dr. Spada said.
These data suggested that the Patency Capsule could be used to confirm the functional patency of small bowel and show that it is safe to use the Pillcam, he said.
In 67 patients with a small bowel stricture who excreted the capsule in 72 hours, 29 had a functionally patent small bowel and received the Pillcam video capsule. The other 38 were not eligible to use the Pillcam. All 29 patients with small bowel strictures who used the Pillcam passed the capsule uneventfully in the same mean transit time that they had passed the Patency Capsule.
ORLANDO, FLA.—A new diagnostic capsule can verify the presence of small bowel strictures seen on radiology and determine when it is safe to use video capsule endoscopy, Cristiano Spada, M.D., reported at the annual meeting of the American College of Gastroenterology.
Small bowel radiology is not always reliable in determining the presence of a stricture and the functional patency of the small bowel, so it is necessary to identify the presence of any stricture before using the Pillcam SB (formerly called the M2A video capsule) to perform capsule endoscopy. Both devices are manufactured by Given Imaging.
The investigational Patency Capsule contains a radiofrequency tag surrounded by a dissolvable lactose and parylene polymer coating. A small window exposes the inside of the capsule to GI fluids to help digest the coating. A timing plug built into the capsule keeps the capsule intact for about 40-100 hours, after which it can pass through the small bowel if it encounters a stricture. At 8 and 24 hours after patients ingested the Patency Capsule, Dr. Spada and his colleagues identified the location of the capsule by using fluoroscopy and a device called the Patency scanner to locate the radiofrequency signal emitted by the capsule.
Overall, 46 of the 91 patients with radiologically confirmed or suspected small bowel stricture who ingested the Patency Capsule excreted the capsule intact. The other 45 patients excreted a partially intact or nonintact (dissolved) capsule. Most of the patients in the study had Crohn's disease, said Dr. Spada of Catholic University, Rome.
Overall, 22 patients reported abdominal pain after ingesting the Patency Capsule. The pain resolved within 24 hours in 17 patients, and 3 went to the hospital with severe pain that passed once the capsule was excreted.
Two patients underwent surgery for pain: One patient's stricture was so large that the intestinal lumen became completely occluded with the capsule while another underwent surgery for an unrelated problem. The Patency scanner failed to detect the capsule in two patients.
The transit time of the Patency Capsule was correlated with dissolving of the capsule. But the researchers could not find a correlation between the anatomical features of the stricture and the capsule's transit time.
“In fact, in some patients with a tight stricture, the capsule was excreted intact after 2 hours,” Dr. Spada said.
These data suggested that the Patency Capsule could be used to confirm the functional patency of small bowel and show that it is safe to use the Pillcam, he said.
In 67 patients with a small bowel stricture who excreted the capsule in 72 hours, 29 had a functionally patent small bowel and received the Pillcam video capsule. The other 38 were not eligible to use the Pillcam. All 29 patients with small bowel strictures who used the Pillcam passed the capsule uneventfully in the same mean transit time that they had passed the Patency Capsule.
ORLANDO, FLA.—A new diagnostic capsule can verify the presence of small bowel strictures seen on radiology and determine when it is safe to use video capsule endoscopy, Cristiano Spada, M.D., reported at the annual meeting of the American College of Gastroenterology.
Small bowel radiology is not always reliable in determining the presence of a stricture and the functional patency of the small bowel, so it is necessary to identify the presence of any stricture before using the Pillcam SB (formerly called the M2A video capsule) to perform capsule endoscopy. Both devices are manufactured by Given Imaging.
The investigational Patency Capsule contains a radiofrequency tag surrounded by a dissolvable lactose and parylene polymer coating. A small window exposes the inside of the capsule to GI fluids to help digest the coating. A timing plug built into the capsule keeps the capsule intact for about 40-100 hours, after which it can pass through the small bowel if it encounters a stricture. At 8 and 24 hours after patients ingested the Patency Capsule, Dr. Spada and his colleagues identified the location of the capsule by using fluoroscopy and a device called the Patency scanner to locate the radiofrequency signal emitted by the capsule.
Overall, 46 of the 91 patients with radiologically confirmed or suspected small bowel stricture who ingested the Patency Capsule excreted the capsule intact. The other 45 patients excreted a partially intact or nonintact (dissolved) capsule. Most of the patients in the study had Crohn's disease, said Dr. Spada of Catholic University, Rome.
Overall, 22 patients reported abdominal pain after ingesting the Patency Capsule. The pain resolved within 24 hours in 17 patients, and 3 went to the hospital with severe pain that passed once the capsule was excreted.
Two patients underwent surgery for pain: One patient's stricture was so large that the intestinal lumen became completely occluded with the capsule while another underwent surgery for an unrelated problem. The Patency scanner failed to detect the capsule in two patients.
The transit time of the Patency Capsule was correlated with dissolving of the capsule. But the researchers could not find a correlation between the anatomical features of the stricture and the capsule's transit time.
“In fact, in some patients with a tight stricture, the capsule was excreted intact after 2 hours,” Dr. Spada said.
These data suggested that the Patency Capsule could be used to confirm the functional patency of small bowel and show that it is safe to use the Pillcam, he said.
In 67 patients with a small bowel stricture who excreted the capsule in 72 hours, 29 had a functionally patent small bowel and received the Pillcam video capsule. The other 38 were not eligible to use the Pillcam. All 29 patients with small bowel strictures who used the Pillcam passed the capsule uneventfully in the same mean transit time that they had passed the Patency Capsule.