Mary Ann Moon

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

Patients with treatment-naive chronic hepatitis C virus infection who carry the rs12979860 C/C or rs8099917 T/T polymorphisms in the region of the IL28B gene are more likely than are noncarriers to show an early virologic response, as well as a sustained virologic response, to interferon-based therapy, Dr. Albert Stättermayer and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Currently, the IL28B status of patients is obtained routinely and is used to predict the likelihood of their response to combined peginterferon/ribavirin therapy. If further prospective, controlled research confirms the findings of this study, determining patients’ status regarding these polymorphisms will also become useful in treatment planning, the researchers said (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.07.019]).

Previous genome-wide association studies in patients with chronic HCV infection found strong associations between treatment response and the single-nucleotide polymorphisms (SNPs) rs12979860 and rs8099917. Dr. Stättermayer of the Medical University of Vienna and his associates examined these associations in 682 treatment-naive patients with chronic HCV.

The study subjects were patients who completed a full course of peginterferon-alpha plus ribavirin treatment in 2001-2009 at several medical centers across Austria. All had tested positive for HCV RNA for at least 6 months before beginning the therapy.

HCV RNA levels were assessed at baseline, after 4 weeks of treatment, and after 12 weeks of treatment. Treatment duration ranged from 24 to 72 weeks. Patients’ SNP status was determined from whole blood samples using real-time PCR.

A total of 36% of patients showed a rapid virologic response to peginterferon-based therapy. These patients also had a high rate of sustained virologic response (92%), compared with patients who had not shown a rapid response (46%). A rapid virologic response was the single strongest predictor of achieving a sustained virologic response, with an odds ratio of 17.

Overall, 63% of patients showed a sustained virologic response to peginterferon-based therapy. Patients with either the rs12979860 SNP or the 8099917 SNP were the most likely to achieve a sustained virologic response, with rates of over 80%. Baseline viral load, patient age, and fibrosis stage all were independent predictors of a sustained virologic response, but SNP status remained the most strongly predictive factor.

"Our study confirms the previously reported findings in various populations around the world," Dr. Stättermayer and his colleagues said. "The precise role of this polymorphism remains unknown. Based on our data, the SNP in the IL28B region appears to be associated with the early phases of viral clearance.

"Differences in viral load reduction between genotypes were detectable as early as week 2, which was the earliest time point evaluated." In addition, the divergence in treatment response peaked at week 4.

"The main focus of our study was the clinical applicability of genetic testing. The positive predictive value of rs12979860 C/C (the favorable genotype) for a sustained virologic response was high, but specificity and sensitivity were low," the researchers noted.

Their results indicate that "a patient with a low baseline viral load and 2 C alleles may benefit from standard of care, with a possible reduction of treatment duration to 24 weeks. On the other hand, T-allele carriers with advanced fibrosis and a high baseline viral load could possibly benefit from novel therapeutic strategies such as polymerase or protease inhibitors added to peginterferon and ribavirin, to maximize viral response," the investigators said.

Dr. Stättermayer had no disclosures, but several coauthors, including Dr. Peter Ferenci, the principal investigator, reported financial relationships with Roche. Dr. Ferenci receives an unrestricted research grant from Roche Austria.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

GoLytely is superior to MiraLAX as a bowel preparation for screening colonoscopy, Dr. Michael Hjelkrem and his colleagues reported in the April issue of Clinical Gastroenterology and Hepatology.

Although both agents showed adequate bowel cleansing in a prospective, randomized, blinded clinical trial, GoLytely achieved better cleansing of the overall bowel and three individual segments of the colon, as measured by the Ottawa Bowel Preparation Scale (OBPS) score, said Dr. Hjelkrem and his associates at Brooke Army Medical Center in San Antonio (Clin. Gastroenterol. Hepatol. 2011 April [doi:10.1016/j.cgh.2010.11.007]).

GoLytely is one of the safest and most frequently used bowel preparation regimens available, but the large volume (4 L) that patients must drink in a relatively short time, as well as the unpleasant taste attributed to the electrolytes it contains, can make it difficult to tolerate, the authors wrote. Clinicians often use MiraLAX as an alternative because it lacks electrolytes and therefore tastes better, and the volume is more tolerable at 2 L; the MiraLAX was combined with 64 oz of Gatorade. However, MiraLAX is not Food and Drug Administration approved for bowel cleansing before screening colonoscopy.

Until now, no controlled clinical trial has compared the efficacy, safety, and tolerability of the two agents. Both agents were given as split-dose regimens in the study.

The issue is more than just a matter of personal preference, because the regimen’s effectiveness can affect the number of polyps detected, the length of the procedure, and the rate of incomplete procedures. Moreover, improved tolerability may promote better patient compliance and remove a major barrier to undergoing the procedure.

These factors "can translate into health care dollars saved and impact the number of patients who embrace colonoscopy as a valuable screening exam for colon cancer," the researchers said.

Dr. Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1-year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment. In all, 403 patients completed the colonoscopy.

The average patient age was 54 years (range, 29-80 years) and the average BMI was 30 kg/m2 (range, 19-53). Slightly more than half of patients were men.

GoLytely was more effective for overall bowel cleansing and for cleansing of the ascending, transverse, and descending colon, as measured by the OBPS score. GoLytely yielded an "excellent" score in 49% of patients, compared with only 15% of patients who took MiraLAX alone, 20% of those who took MiraLAX plus bisacodyl, and 19% of those who took MiraLAX plus lubiprostone.

However, all of the bowel prep regimens produced adequate bowel cleansing. And there were no differences in effectiveness among the four treatments across several patient subgroups based on diabetes status, BMI, presence or absence of constipation, or morning vs. afternoon procedure times.

In addition, patients who received GoLytely had a shorter procedure time, but the difference was not statistically significant. There also were no significant differences among the study groups in the number of polyps detected.

Patients rated all three MiraLAX regimens as superior to the GoLytely regimen and reported significantly greater satisfaction with them, even though there were no differences among the regimens with regard to nausea, abdominal bloating, or abdominal cramping. This preference can be attributed to the lower volume of solution they were required to drink "and/or improved taste likely due to the absence of electrolytes," the investigators said.

"We conclude that although MiraLAX is more highly tolerated, it is inferior to GoLytely as a bowel preparation prior to screening colonoscopy.

"For those who value efficacy as the most important variable in bowel preparation, MiraLAX should not be used as first-line therapy. However, for those who value palatability as a major factor in bowel preparation and are willing to forgo some efficacy, MiraLAX may be considered an adequate option," they noted.

Safety concerns have been raised regarding MiraLAX’s absence of electrolytes, because the diarrhea-induced volume depletion during bowel prep might predispose to hyponatremia. "Although we did not check serum chemistry panels on our patients after the preparation, there were no deaths and no side effects resulting in hospitalization. If hyponatremia did occur, it was clinically insignificant in our study subjects," they added.

No conflicts of interest or funding for the study were reported.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

Injectable long-acting risperidone was no better than was a psychiatrist’s choice of oral antipsychotic agents in forestalling hospitalization of patients with unstable schizophrenia and schizoaffective disorder, according to a report in the March 3 issue of the New England Journal of Medicine.

In a multicenter clinical trial comparing the two treatment approaches, the time to psychiatric hospitalization was no different between patients receiving risperidone injections approximately every 2 weeks and those receiving daily oral therapy. Results were the same on several standard measures of psychiatric symptoms and quality of life, and the use of other medical services also was the same.

"Taken together, these findings are consistent with [those of] 3 efficacy trials that also showed no superiority of long-acting injectable risperidone over oral regimens in patients with stable schizophrenia," wrote Dr. Robert A. Rosenheck of the Veterans Affairs New England Mental Illness, Research Education, and Clinical Center, West Haven, Conn., and his associates.

It was hoped that long-acting injectable delivery would improve treatment adherence by ensuring sustained blood levels of the drug, which would in turn improve symptom control and reduce the rate of hospitalization for relapse. Dr. Rosenheck and his colleagues tested that hypothesis in what they described as the first long-term randomized clinical trial of this formulation involving patients with unstable disease.

The study included patients with unstable schizophrenia or schizoaffective disorder who were considered at risk for rehospitalization because they were currently hospitalized (40%), had been hospitalized during the preceding 2 years (55%), or had recently increased their use of psychiatric services (5%). Most had demonstrated difficulty with medication adherence.

The study population comprised 369 older, predominantly male veterans treated at 14 sites and followed for up to 2 years.

During a mean follow-up of approximately 11 months, 81 (45%) of the 182 patients who had been randomly assigned to receive oral medication required psychiatric hospitalization, compared with 72 (39%) of 187 patients randomly assigned to receive long-acting risperidone. This difference was not significant, the investigators said (N. Engl. J. Med. 2011;364:842-51).

The time interval until hospitalization and the hospital length of stay also were not significantly different between the two study groups. Changes since baseline in patients’ total scores and subscale scores on the Positive and Negative Syndrome Scale (PANSS) also were no different. Similarly, scores on three measures of quality of life, the Clinical Global Impressions scale, and the Addiction Severity Index were similar between the two study groups.

Long-acting injectable risperidone was associated with more "general disorders and administration site conditions" such as pain or induration at the injection site, as well as with more "nervous system disorders" such as headache and extrapyramidal signs and symptoms. This suggests that patients who take oral agents "may flexibly adjust their medication use to avoid such adverse effects," Dr. Rosenheck and his associates said.

This study was supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs, which also provided the injectable risperidone.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.

In patients with acute decompensated heart failure, outcomes are essentially the same regardless of whether diuretic therapy is administered in continuous infusions or boluses, and at high or low doses, according to a report in the March 3 New England Journal of Medicine.

In a prospective, double-blind, randomized trial, both patients’ own global assessments of their symptoms and objective changes in several measures of renal and cardiac function were similar, regardless of diuretic treatment approach, said Dr. G. Michael Felker of Duke University Heart Center, Durham, N.C., and his associates in the Diuretic Optimization Strategies Evaluation (DOSE) study.

The National Heart, Lung, and Blood Institute funded the DOSE trial because even though intravenous loop diuretics are "an essential component of current treatment and are administered to approximately 90% of patients hospitalized with heart failure," there is still widespread uncertainty about the best type of dosing and mode of administration. "Despite decades of clinical experience with these agents, prospective data to guide the use of loop diuretics are sparse, and current guidelines are based primarily on expert opinion. As a result, clinical practice varies widely," the investigators said.

The 308 patients were hospitalized at 26 clinical sites in the United States and Canada for acute decompensated heart failure. The mean patient age was 66 years; 27% were women, and 25% were black. Approximately three-quarters of the subjects had been hospitalized for heart failure during the preceding year. Most had moderate renal dysfunction, elevated levels of natriuretic peptide, and a decreased ejection fraction.

The subjects were randomly assigned to either a low-dose strategy in which the total daily IV furosemide dose was equivalent to their total daily oral diuretic dose, or a high-dose strategy in which the total daily IV furosemide dose was equivalent to 2.5 times their total daily diuretic dose. They also were randomly assigned to receive furosemide by either an IV bolus every 12 hours or by a continuous IV infusion.

Patients were assessed at baseline, 72 hours, and 60 days. The primary efficacy end point was the patient’s global assessment of symptoms from baseline through 72 hours, and the primary safety end point was the change in serum creatinine level from baseline to 72 hours.

There were no significant differences among the four study groups in either of these end points. There also were no significant differences across a variety of secondary end points, including dyspnea, change in body weight, net fluid loss, percentage of patients affected by congestion, worsening renal function, worsening heart failure, or changes in several biomarkers, Dr. Felker and his colleagues said (N. Engl. J. Med. 2011;364:797-805).

There was a trend toward greater improvement of patient-reported global symptoms with the high-dose strategy, but this did not reach statistical significance. Moreover, this potential benefit was offset by a higher incidence of transient worsening renal function that also did not reach statistical significance.

The median length of stay was 5 days in all four groups. A total of 130 patients (42%) died, required rehospitalization, or required a visit to the emergency department within 60 days, but there were no significant differences among the treatment groups in this composite end point. The total number of patients who were alive and not hospitalized at 60 days also did not differ significantly among the four groups.

The DOSE study was funded by the National Heart, Lung, and Blood Institute. Dr. Felker and his associates reported numerous ties to drug and device companies, including those that manufacture diuretics.