Christine Kilgore

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Two European head-to-head comparisons of the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent have failed to detect any significant clinical differences between the two stents in patients with coronary artery disease, investigators reported at Transcatheter Cardiovascular Therapeutics 2010.

“The sirolimus-eluting stent demonstrated the least amount of late lumen loss among previously released first-generation drug-eluting stents, but its efficacy and safety have not [previously] been compared head-to-head with the second-generation everolimus-eluting stent,” Dr. Lisette Okkels Jensen said in describing the rationale for her team’s SORT OUT IV trial.

Nine-month data from this prospective randomized study, which involved patients in a population-based health care setting and was powered to detect noninferiority, show that the everolimus-eluting Xience V stent (Abbott Vascular) was noninferior to the sirolimus-eluting Cypher Select Plus stent (Cordis) when it came to the primary end point of major adverse cardiac events (MACE) – a composite of cardiac death, myocardial infarction, definite stent thrombosis, and target vessel revascularization.

The rate of MACE was 4.9% in the 1,390 Xience-treated patients and 5.2% in the 1,384 Cypher-treated patients, reported Dr. Jensen of Odense (Denmark) University.

Approximately 55% of the patients in each arm had stable angina, and almost 33% in each arm had NSTEMI/unstable angina. In most of the remaining patients, STEMI drove the need for percutaneous coronary intervention.

The other head-to-head drug-eluting stent comparison was part of the larger randomized, two-center ISAR-TEST 4 trial designed to compare a biodegradable polymer DES with permanent polymer stents. Within the permanent polymer arm of 1,304 subjects, patients were randomized 1:1 to receive either the Xience or Cypher stent.

At 2 years – a longer follow-up period than in SORT OUT I – there were no significant differences in the combined primary end point of cardiac death, target-vessel–related myocardial infarction, and target lesion revascularization (16% in Xience-treated patients and 18.8% in Cypher-treated patients), reported Dr. Robert A. Bryne of Deutsches Herzzentrum in Munich.

The rates of definite or probable stent thrombosis at 2 years – the secondary, safety end point of the study – were also similar (1.4% in those who received the everolimus-eluting stent and 1.9% in patients treated with the sirolimus-eluting stent).

There was a trend toward superior antirestenotic efficacy with the Xience stent, but “specifically powered studies are needed to evaluate the clinical significance of this finding,” said Dr. Byrne, who reported no disclosures. (Target lesion revascularization occurred in 9.9% of Xience-treated patients and 13.5% of the Cypher-treated patients.)

The ISAR-TEST 4 study is powered for noninferiority and included patients with de novo coronary artery stenosis of at least 50% and symptoms or objective evidence of ischemia. Patients with left main stem disease and patients with cardiogenic shock were excluded.

In a press conference announcing the findings, Dr. David Cohen of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., who was not involved in either study, said the studies were the first “reasonably sized comparisons” between a first-generation sirolimus-eluting stent and a second-generation everolimus-eluting stent.

Asked whether physicians should be using the so-called first-generation stents at this point in time, Dr. Cohen said he believes that the question about how the everolimus-eluting stent compares with the paclitaxel-eluting stent “has been pretty well answered through several large studies,” including SPIRIT IV and COMPARE, but that larger studies are still needed to compare the everolimus-eluting stent with the older sirolimus-eluting stent. In the meantime, he added, “more and more data [are] showing that the everolimus-eluting stent is a very safe stent.”

Dr. Jensen disclosed that she has a financial interest/arrangement or affiliation with Cordis, Johnson and Johnson, and Abbott.

The Cypher Select Plus sirolimus-eluting stent that was used in the SORT OUT IV trial is a version of the Cypher stent that is not commercially available in the United States. U.S. physicians who discussed the trial said they have no reason to believe results would be different with other Cypher stent products.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

WASHINGTON – Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial’s lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y12 inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O’Donoghue of Brigham and Women’s Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition ... without a significant increase in bleeding in patients with ACS,” Dr. O’Donoghue reported at the Transcatheter Cardiovascular Therapeutics 2010 meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O’Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O’Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

A platelet function substudy showed there was significant inhibition of platelet aggregation 1-3 hours after the loading dose. Platelet inhibition increased further at 3-6 hours to levels that were maintained until the first maintenance dose. Once maintenance doses began, “there was some evidence of a dose-dependent trend, with greater inhibition of platelet aggregation at the higher doses,” said Dr. O’Donoghue.

Dr. David J. Moliterno, who moderated a discussion of the trial, said that atopaxar is “only the second drug to be studied in this class in a phase II fashion.”

“Should we be concerned by the increase [in the rate of major bleeds], from 0 to 1.8%?” said Dr. Moliterno, chief of cardiology at the University of Kentucky, Lexington. “I don’t think we should be discouraged. ... It was a small trial ... and there was no clear dose effect.”

Similar outcomes of treatment with the new agent were reported this year for the J-LANCELOT trial, which tested atopaxar in patients with ACS and high-risk coronary artery disease in Japan (Eur. Heart J. 2010 [doi:10.1093/eurheartj/ehq320]).

The study was funded by Eisai Inc. Dr. O’Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly & Co. and Daiichi Sankyo.

Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.

Data Source: A population study based on analysis of data from 10 European registries.

Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.

Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.

In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.

Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).

A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).

A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.

Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.

“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.

To see an interview with Dr. Cem Gabay, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical

Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.

Data Source: A population study based on analysis of data from 10 European registries.

Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.

Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.

In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.

Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).

A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).

A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.

Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.

“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.

To see an interview with Dr. Cem Gabay, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical

Major Finding: More patients achieved a EULAR good response at 6 months and 12 months when treated with leflunomide along with rituximab (and also had a lower incidence of retreatment) than did patients who were treated with methotrexate plus rituximab, or rituximab alone.

Data Source: A population study based on analysis of data from 10 European registries.

Disclosures: Dr. Gabay said he has no conflicts of interest relevant to this study. The CERERRA collaboration (of which the European registries are a part) that was mentioned in the story is described by Dr. Gabay as an investigator-led, industry-supported initiative that was formed to evaluate the clinical aspects of rituximab use for RA. This analysis and study abstract were prepared, “without any influence from the supporting medical industry,” Dr. Gabay said.

Leflunomide is an effective concomitant treatment with rituximab in patients with rheumatoid arthritis, according to findings from a population-based study.

In fact, “a combination of leflunomide and rituximab is probably better than a combination of methotrexate and rituximab,” said Dr. Cem Gabay of the University Hospitals of Geneva in an interview with Rheumatology News.

Ten European registries that are participating in the CERERRA collaboration submitted data sets for patients who were treated with rituximab, and more than 1,900 patients were analyzed for their response to treatment with one of three therapeutic approaches: rituximab with either methotrexate (MTX) or leflunomide (LEF), or rituximab alone. Significantly more patients achieved a EULAR good response at 6 months when treated with rituximab and LEF (33%), compared with rituximab and MTX (21%) or with rituximab alone (20%).

A similar trend was observed at 12 months. Fewer patients, moreover, were retreated during the first 12 months when they received LEF (11% in the rituximab plus LEF group vs. 20% in the rituximab plus MTX group and 19% among those on rituximab monotherapy).

A univariate analysis adjusted for age and sex showed that patients who received LEF in combination with rituximab were 2.6 times more likely to have a good EULAR response at 6 months than were patients who received MTX plus rituximab. They were also three times more likely to have a good EULAR response at 6 months than were patients who received rituximab monotherapy. At 12 months, patients who received LEF as a combination therapy were about twice as likely to have a good EULAR response as were patients in the other groups.

Combination therapy with LEF was still predictive of a good EULAR response in a multivariate analysis that took into account factors like disease duration and the number of previous biologic agents used.

“This is a population-based study, so we need to be cautious about the conclusions we draw from the data,” said Dr. Gabay. Among the study's limitations are the lack of randomization and control. The Food and Drug Administration recently required that the leflunomide label contain a Boxed Warning about severe liver injury.

To see an interview with Dr. Cem Gabay, go to

Source Heidi Splete/Elsevier Global Medical Newswww.youtube.com/elsglobalmedical

Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.

Data Source: A descriptive imaging study of 127 patients with hand OA.

Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.

Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.

The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.

In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.

The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.

The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.

Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.

The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.

“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”

And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.

Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.

“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”

The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”

Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.

Source Courtesy Alexander Mathiessen

Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.

Data Source: A descriptive imaging study of 127 patients with hand OA.

Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.

Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.

The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.

In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.

The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.

The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.

Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.

The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.

“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”

And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.

Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.

“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”

The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”

Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.

Source Courtesy Alexander Mathiessen

Major Finding: Osteophytosis was the dominant pathology in more than 3,700 hand joints examined by ultrasound in patients with hand OA.

Data Source: A descriptive imaging study of 127 patients with hand OA.

Disclosures: Dr. Hammer was supported by an unrestricted grant from Abbott Laboratories; this grant was given after the study was completed, however, according to Mr. Mathiessen. Mr. Mathiessen said they have no disclosures or conflicts of interest to report related to this study.

Investigators who are developing an ultrasound “atlas” of hand osteoarthritis hope that their collection of images will aid in the development of a standardized ultrasonographic scoring system for the disease.

The investigators' descriptive study of ultrasonographic findings in 127 patients builds upon the development several years ago of a preliminary ultrasonographic scoring system for the features of hand osteoarthritis.

In the prior effort, reported in 2008 in the Annals of the Rheumatic Diseases, experts led by Dr. Helen Keen of the University of Leeds (England) reached consensus on which ultrasound-detectable abnormalities—synovitis (gray scale and power Doppler) and osteophytes—are important and feasible for inclusion in a scoring system.

The new atlas of characteristic images of osteoarthritis in finger joints takes the effort a step further, “so that we can realize the full potential of ultrasound” as an imaging tool for hand OA, and “move toward validating the preliminary semiquantitative scoring system” for use in epidemiologic and outcome studies, said Alexander Mathiessen, a medical student at the University of Oslo.

The 127 patients who were examined with ultrasound had a mean age of 69 years and symptom duration of approximately 18 years. Two sonographers performed the assessments together and, using a 0-3 scale, achieved consensus in the scoring of osteophytes, gray-scale synovitis, and power Doppler in 30 joints: the first carpometacarpal (CMC), first through fifth metacarpophalangeal (MCP), first through fifth proximal interphalangeal (PIP), second through fifth distal interphalangeal (DIP), dorsal view, from radial to ulnar side bilaterally.

Osteophytosis has been the dominant pathology in the approximately 3,700 joints examined thus far, with a prevalence of 53%. All patients had osteophytes in at least four joints. In joints with osteophyte pathology, the mean scores were 1.8 for CMC, 1.2 for MCP, 1.8 for PIP, and 2.1 for DIP joints.

The imaging study, which Mr. Mathiessen performed with Dr. Hilde B. Hammer at the Diakonhjemmet Hospital in Oslo, revealed a large degree of symmetry between hands—a finding that confirms what other studies have shown, he noted.

“Hand osteoarthritis is remarkably symmetric,” said Mr. Mathiessen. “The odds ratio of having an osteophyte in one joint if you have it in the same opposite joint was 35.1, indicating significant concordance.”

And in another finding that “needs further evaluation,” the investigators found that in 84% of the patients, the sum osteophyte score was similar or greater in the dominant hand than in the nondominant hand. “It [may be] enough to scan only the dominant hand,” he observed.

Gray-scale synovitis and power Doppler activity were found in approximately 16% and 2% of the joints, respectively.

“We found synovitis in one-third of the CMC joints, though, and in about 20% of the small PIP and DIP joints,” Mr. Mathiessen said. “Power Doppler was frequent only in the CMC joint, with a prevalence of 14%.”

The findings might indicate “that the focus should be on osteophytes and synovitis,” he added. “Based on our findings, I'm not sure about the role of power Doppler in a final scoring system…. On the other hand, though, this feature is important for differentiating osteoarthritis against other joint diseases.”

Ultrasound images of hands affected by osteoarthritis, such as the Doppler image above, compose the OMERACT atlas.

Source Courtesy Alexander Mathiessen

Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.

“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC

The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.

In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.

In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.

For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.

The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.

Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.

The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.

Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.

Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.

“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC

The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.

In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.

In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.

For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.

The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.

Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.

The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.

Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.

Prenatal stress is associated with altered patterns of cord blood cytokine production that may raise a child's asthma risk later in life, according to findings of one study.

“Prenatal stress appears to affect immune responses to both innate and adaptive stimuli at the time of birth—effects that may result in enhanced susceptibility to asthma or other atopic disorders,” said Dr. Rosalind J. Wright of Harvard Medical School in Boston and her associates (Am. J. Respir. Crit. Care Med. 2010 March 1 [doi:10.1164/rccm.200904-0637OC

The findings on seemingly stress-induced perinatal immune modulation may offer some new insight into the disproportionately high prevalence of asthma among ethnic minorities and disadvantaged urban communities.

In a prospective birth cohort study of urban, largely minority women, the investigators collected cord blood at birth and examined cord blood mononuclear cell (CBMC) cytokine responses to various innate and adaptive stimuli. Cytokine responses to both types of stimuli were significantly different in babies born to mothers with high levels of reported cumulative stress, compared with babies born to lower-stressed mothers.

In each case, the infants were at high risk for atopic diseases based on family history; either the mother or father had a history of asthma or allergy. Higher prenatal stress was related to increased production of interleukin-8 (IL-8) and tumor necrosis factor–alpha, for example, following microbial (CpG, PIC) stimuli.

For adaptive response, there was evidence that higher stress is tied to lower levels of interferon-gamma production in response to stimulation with PHA (a nonspecific mitogen), which has been linked to an increased risk for later atopic disease. Higher stress was also linked with an increased IL-13 response to dust mite antigen, which has been associated with allergic sensitization in older children.

The investigators studied 560 newborns and their mothers who live in Baltimore, Boston, New York, and St. Louis, and who were participating in the Urban Environment and Childhood Asthma Study. The mothers were primarily minorities (71% black and 19% Hispanic); 69% reported an annual income of less than $15,000.

Families answered detailed questions about various stressors in their lives, including financial hardship, community violence, and neighborhood and housing conditions.

The cohort will continue to be followed, enabling further assessment of the effects of prenatal and postnatal stress on infant immune development, and clinical outcomes, as the infants grow.

Disclosures: The study received funding from the National Institutes of Health. Dr. Wright also received funding from an NIH grant.

Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.

In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).

The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.

Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).

“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.

Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.

Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.

Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.

One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.

Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.

Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.

“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”

Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.

Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.

Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.

And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”

The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.

Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.

Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.

“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.

Disclosures: None was reported.

Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.

In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).

The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.

Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).

“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.

Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.

Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.

Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.

One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.

Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.

Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.

“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”

Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.

Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.

Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.

And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”

The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.

Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.

Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.

“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.

Disclosures: None was reported.

Recently published reports from both sides of the Atlantic on ovarian tissue transplants suggest that the grafts have reasonable longevity and offer support for the development of cryopreservation and transplantation as a method of fertility preservation, U.S. experts told this news organization.

In a report from Denmark published online in Human Reproduction, investigators described the case of a woman who gave birth to her second child almost 3 years after six strips of frozen and thawed ovarian tissue were transplanted back to her ovary (2010 Feb. 25 [doi:10.1093/humrep/deq033]).

The woman became pregnant with her first child after mild ovarian stimulation soon after the transplant, but conceived naturally for her second pregnancy.

Another report published online in the American Society for Reproductive Medicine's journal Fertility and Sterility describes pregnancies and healthy babies in two groups of patients: a series of women who had premature ovarian failure and received a fresh donated ovary from a monozygotic twin and several women who had cryopreserved tissue transplanted (2010 Feb. 19 [doi:10.1016/j. fertnstert.2009.12.073]).

“What all this research suggests is that we're developing a body of evidence that indicates that it's possible to freeze and thaw ovarian strips and transplant them back,” resulting in successful pregnancies, said Dr. William Gibbons, ASRM president and professor and division director for reproductive endocrinology and infertility at Baylor College of Medicine in Houston. “Definitely, researchers have demonstrated proof of concept,” he said.

Comparing outcomes after fresh and frozen transplantation, as was done in the Fertility and Sterility report, is important for understanding the extent to which follicles are lost from cryopreservation, compared with ischemia, he noted.

Among the nine women described in the report who had transplantations of fresh ovarian tissue from their monozygotic twins, 12 pregnancies have occurred without assisted reproductive technology (ART) and eight healthy babies have been born to six of these women thus far, reported Dr. Sherman Silber of the Infertility Center of St. Louis and his associates.

Each of the women returned to regular menses and ovulatory cycles 60-130 days after one-quarter to one-third of the donor ovary was transplanted as a cortical slice, and conception often occurred within the first year after surgery. One woman conceived after 3 years however, and another had her second child more than 4 years ofter her transplant, they reported.

One of the women who had given birth to a healthy child after the transplant of fresh ovarian tissue became menopausal after about 3 years and had a second transplant of some of her twin's tissue that had been frozen. She became pregnant and gave birth to another healthy child. The patient again became menopausal another year-and-a-half later, had a second frozen graft, and was carrying her third child at the time of publication.

Another patient described in the report had a healthy ongoing pregnancy following a frozen transplant of tissue that she had cryopreserved 11 years earlier before treatment for Hodgkin's lymphoma.

Overall, the experience of these patients shows that pregnancy results after frozen transplantation are “as robust” as after fresh transplantation, although the duration of function may be shorter, Dr. Silber said in an interview.

“We used to think that freezing doesn't do any damage, and that the only damage is from ischemia,” he commented. “Now, our thinking has flipped…. Lengthy ischemia does not appear to be a major issue.”

Research has shown, meanwhile, that with standard “slow freezing” cryopreservation techniques, ovarian tissue loses about 50%-60% of its eggs. Dr. Silber said he is finding that vitrification—a “fast-freeze” process, in essence—may be more effective, resulting in percentages of viable oocytes that are “remarkably similar” to those found in fresh tissue grafts.

Reports of ovarian tissue transplants in cancer patients have generated questions about whether pregnancies are indeed achieved from eggs in the transplanted strips rather than eggs in the original ovary.

Dr. Silber said that, in the cases he and his associates looked at, they found no follicles during “intensive examinations” of patients' existing ovaries.

And in the European paper, Dr. Erik Ernst of Aarhus (Denmark) University Hospital and his colleagues reported that a biopsy obtained from the ovary in situ of their patient “revealed no remaining follicles upon histological examination.”

The patient treated in Denmark had previously had her left ovary removed because of a dermoid cyst involving the whole ovary. Approximately one-third of the right ovary (13 strips) was removed prior to chemotherapy for Ewing's sarcoma.

Among Dr. Silber's patients, there have been few miscarriages to date and no birth defects or obstetric complications associated with transplantation.

Questions remain, however, about “what can be done with frozen ovarian tissue of the leukemia survivor if there happen to have been leukemic cells in that tissue,” he and his associates wrote in their report.

“But for patients in whom there is no significant risk of ovarian metastasis, ovary tissue transplantation may now be ready for clinical use,” they said, noting that at least 1 in 250 women of reproductive age is a cancer survivor.

Disclosures: None was reported.

WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.

Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.

“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.

“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.

In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.

The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.

The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.

“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.

About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”

For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”

In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.

One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.

Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”

Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.

Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.

Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.

Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.

WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.

Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.

“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.

“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.

In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.

The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.

The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.

“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.

About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”

For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”

In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.

One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.

Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”

Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.

Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.

Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.

Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.

WASHINGTON — Poor physician adherence to hypertension treatment guidelines is a significant reason why hypertension is undiagnosed and uncontrolled at “alarming rates” in the United States, according to an Institute of Medicine report.

Multiple studies have shown that physicians are not providing treatment consistent with the current Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure guidelines. In particular, physicians are less aggressive about treating older patients, who are most likely to have the condition and who do benefit from therapy. They also are less aggressive in treating isolated systolic hypertension, according to the report.

“We really didn't find any information about why clinicians are not adhering to the most recent guidelines,” commented Dr. Corinne Husten, a member of the Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population, which wrote the report.

“It was quite striking, actually, that physicians do a pretty good job at controlling diastolic blood pressure…. It's systolic blood pressure that they're not aggressively treating, and especially isolated systolic hypertension,” she said at a briefing announcing their findings.

In the report, which was sponsored by the Centers for Disease Control and Prevention, the authors urge the CDC to give high priority to research on guideline adherence, and then to work with accreditation programs, providers, and health care quality organizations to improve providers' adherence to such recommendations.

The IOM committee urged the CDC to move away from a focus on individual and health care–based approaches in favor of taking population- and systems-based approaches that encourage people to lower their sodium intake, increase consumption of potassium, lose weight, and increase physical activity.

The CDC must ensure, they continued, that such population-based efforts—from those involving industry to various state and local projects—are properly targeting those at greatest risk. It also must work with health insurance plans and the Medicare and Medicaid programs to find ways to eliminate or reduce deductibles and co-pays for antihypertensive medications.

“This is where, in a time of limited resources, there's the greatest bang for the buck,” said Dr. David W. Fleming, who chaired the committee.

About three-quarters of Americans already recognize the importance of having their blood pressure checked, leading Dr. Fleming to emphasize that “we're not simply calling for better health education of the public.”

For example, the committee suggested that the CDC consider advocating for “greater use of potassium/sodium chloride combinations.”

In a recent report from the CDC, only about 2% of adults met the current guidelines for dietary potassium intake. Furthermore, more than 8 in 10 Americans consume more salt than is recommended, said Dr. Fleming, director of the department of public health in Seattle and a former deputy director of the CDC.

One in three Americans have hypertension, according to the IOM report, which calls hypertension a “neglected disease.” The disorder accounts for about one in six adult deaths annually, triggering more than one-third of heart attacks and almost half of heart failures.

Hypertension “has dropped off the radar screen,” Dr. Fleming said at the briefing. “It's time to bring it back on.”

Data show that 85% of individuals with uncontrolled hypertension have insurance and visit their physicians, the report noted.

Physicians may not adhere to current recommendations due to a lack of awareness about them or because they don't realize guidelines have been updated. Some physicians may still be waiting for patients to reach the previous 160 mm Hg/95 mm Hg thresholds before treating systolic and diastolic blood pressure, respectively. Current guidelines recommend starting treatment if systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure is greater than 90 mm Hg. Physician may also doubt the benefit of treatment, or may have concerns about drug side effects.

Dr. Husten was executive vice president for program and policy at the Partnership for Prevention in Washington during her work with the committee and has recently been appointed senior medical adviser to the Center for Tobacco Products at the Food and Drug Administration.

Disclosures: All committee members were screened and do not have any conflicts of interest, according to an IOM spokesperson.

Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.

Source of Data: Expert commentary.

Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.

WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.

Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.

Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.

And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.

The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.

EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).

“There is a lot of communication required in the medical home,” he said.

Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”

When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.

Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.

“Your job,” he told the pediatricians, “is to help the systems get better.”

Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr

National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.

“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.

Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.

In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”

The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).

Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.

The advanced medical home requires the use of EMRs that store and offer access to all clinical data.

Source DR. JOHNSON

Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.

Source of Data: Expert commentary.

Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.

WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.

Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.

Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.

And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.

The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.

EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).

“There is a lot of communication required in the medical home,” he said.

Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”

When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.

Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.

“Your job,” he told the pediatricians, “is to help the systems get better.”

Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr

National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.

“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.

Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.

In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”

The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).

Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.

The advanced medical home requires the use of EMRs that store and offer access to all clinical data.

Source DR. JOHNSON

Major Findings: Electronic medical records are essential to make pediatric medical homes a success, but systems for pediatricians fall short.

Source of Data: Expert commentary.

Disclosures: Dr. Johnson reported that he receives royalties from ICA Corp.

WASHINGTON — Pediatricians cannot truly provide an advanced medical home for their patients until they implement fully functional electronic medical record systems.

Although the current systems must still be improved to meet the needs of pediatricians, research is steadily accumulating that demonstrates the benefits of EMR systems for the specialty, Dr. Kevin B. Johnson said at the annual meeting of the American Academy of Pediatrics.

Papers published in the pediatric literature have shown, for instance, that integrated guidelines resulted in better guideline compliance, that physician-patient communication during visits was positively—not negatively—affected by computer-based documentation, and that electronic immunization tracking helps with case finding and improves coverage.

And for meeting the objectives of the medical home, EMR systems just make sense. “The most recent [national] conversation about the advanced medical home definitely thinks about the EMR as a key component of the infrastructure we need,” said Dr. Johnson, a pediatrician who is vice chair of the biomedical informatics department at Vanderbilt University Medical Center in Nashville.

The advanced medical home requires the use of EMRs that store and offer immediate access to all clinical data and test results, for instance, and that provide clinical decision-making support and links to other consultants and health care professionals.

EMRs also should provide the communication and scheduling systems that are needed for ongoing access to care and nonurgent advice, as well as open access scheduling (well-child care appointments in 1–2 days versus weeks, and more than 50% of appointments open each day).

“There is a lot of communication required in the medical home,” he said.

Communication is one area where currently available EMR systems fall short, however, and it's an area that pediatricians must speak up about, Dr. Johnson said. “Most systems don't [meet all our needs] because frankly [the vendors] don't understand what we want.”

When Dr. Johnson queried the AAP's “EMR review” Web site for perspective submitted over the past 2 years, he found other areas for improvement.

Sixteen percent of the 32 pediatricians who submitted information relevant to his query were not happy, for instance, with the immunization data handling/analysis capabilities on their systems. The same number—16%—said that growth parameters were not satisfactory, and 28% were not satisfied with their system's developmental milestone decision support.

“Your job,” he told the pediatricians, “is to help the systems get better.”

Dr. Johnson encouraged pediatricians to post reviews to the AAP's EMR Review Project Web site, which can be found at www.aapcocit.org/emr

National data indicate that about 15% of all practices have a basic EMR system (with patient demographics, problem lists, prescription orders, medication lists, clinical notes, and the ability to view lab results and images), whereas only 6% have a “fully functional” EMR system that allows them to send lab and radiology orders, for instance, and has evidence-based decision-making support.

“From what we know about pediatric primary care, the numbers are about the same,” Dr. Johnson said.

Pediatricians often tell him that they have a computer-based documentation tool but are hesitant to use it during visits because they “fear that it impacts patient-provider communication,” he noted.

In a study published last year, however, Dr. Johnson and his associates at Vanderbilt analyzed pediatric visits that were audiotaped or videotaped and found that any differences in communication dynamics between visits involving paper documentation and visits involving computer-based documentation “were in favor of computer-based documentation.”

The amount of conversation was slightly higher for visits involving computer-based documentation, for instance, as were the number of open-ended questions and “rapport-building statements” (Pediatrics 2008;122;590–8).

Numerous other studies have suggested that the use of computers in the exam room is not associated with worsening satisfaction, and his experience at Vanderbilt suggests that “parents love the technology,” said Dr. Johnson.

The advanced medical home requires the use of EMRs that store and offer access to all clinical data.

Source DR. JOHNSON