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Hard-to-Treat HT Responded to Simple Regimen
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglycerides, or low HDL. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
The study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel added.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglycerides, or low HDL. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
The study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel added.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglycerides, or low HDL. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
The study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel added.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
Physicians Turn to HPV Testing In Women With AGUS Pap Results
VANCOUVER, CANADA — When Kaiser Permanente instituted testing for human papillomavirus in 2001, physicians were instructed not to test for the virus as a way to triage patients with Pap results showing atypical glandular cells of undetermined significance.
Clinicians “paid no attention whatsoever” to this guideline, however, resulting in data on 877 women with atypical glandular cells of undetermined significance (AGUS) smears who underwent testing for the human papillomavirus (HPV) and biopsies, Walter Kinney, M.D., said at the 22nd International Papillomavirus Conference.
National guidelines recommend HPV testing in two situations: to help manage women with Pap smears showing atypical squamous cells of undetermined significance (ASCUS), or as cotesting with Pap smears for cervical screening in women older than 30 years.
HPV tests were positive in 33% of the women with AGUS. Of these, 33% had cervical intraepithelial neoplasia grades 2/3 or higher (CIN 2/3+). Among HPV-negative women, 3% had CIN 2/3+, said Dr. Kinney of the Permanente Medical Group, Sacramento.
Of more interest to investigators were the women whose initial colposcopies produced negative biopsy results. Their HPV status at the time of AGUS diagnosis was more predictive than biopsy results of the likelihood of developing cervical abnormalities during a 12-month follow-up, he said at the conference, sponsored by the University of California, San Francisco.
Among 95 women who were initially HPV positive but had negative biopsies, 24 (25%) developed CIN 2/3+ during follow-up. None of 260 women who were HPV negative with benign biopsies at their initial evaluation developed CIN 2/3+.
The lead investigator in this study was Barbara Fetterman, Ph.D., of the Permanente Medical Group, Oakland, Calif. In a poster presentation at the meeting, she said the “current American Society for Colposcopy and Cervical Pathology recommendations for rescreening [at 4–6 month intervals for four times] in women with atypical glandular cell cytology, and a negative initial evaluation could be replaced with a single rescreen in 12 months if a woman is also HPV negative.”
Kaiser clinicians also crossed the HPV guidelines to test for HPV in 161 women with Pap results showing “atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions” (ASC-H).
Results showed that HPV positivity fell significantly after age 30, from a rate of 90% in women younger than 30, to 69% of women aged 30–39 years, 45% of women aged 40–49 years, and 30% of women aged 50 and older, Dr. Fetterman reported in a separate poster.
Among 125 of the women with ASC-H who also had biopsies, 38% had CIN2/3+, including one adenocarcinoma in situ. All women with CIN2/3+ were HPV positive. As time goes on, there probably will be an HPV-negative woman with ASC-H who has CIN2–3+, Dr. Kinney acknowledged, but the correlation between a negative HPV test and low risk for CIN 2/3+ in women with ASC-H is useful.
Dr. Fetterman described how the high negative predictive value of the HPV test for CIN 2/3+ and the falling HPV positivity rate with age make it useful to triage women with ASC-H. HPV triage of women with ASC-H would send 64% of women of all ages and 48% of women aged 30 and over to colposcopy. These rates are similar to the 56% of women with ASC US sent to colposcopy in the National Cancer Institute's ALTS study (ASCUS/Low-Grade Squamous Intraepithelial Lesions Triage Study), suggesting that “HPV triage of ASC-H may be useful in clinical practice, particularly in women age 30 and over,” she said.
VANCOUVER, CANADA — When Kaiser Permanente instituted testing for human papillomavirus in 2001, physicians were instructed not to test for the virus as a way to triage patients with Pap results showing atypical glandular cells of undetermined significance.
Clinicians “paid no attention whatsoever” to this guideline, however, resulting in data on 877 women with atypical glandular cells of undetermined significance (AGUS) smears who underwent testing for the human papillomavirus (HPV) and biopsies, Walter Kinney, M.D., said at the 22nd International Papillomavirus Conference.
National guidelines recommend HPV testing in two situations: to help manage women with Pap smears showing atypical squamous cells of undetermined significance (ASCUS), or as cotesting with Pap smears for cervical screening in women older than 30 years.
HPV tests were positive in 33% of the women with AGUS. Of these, 33% had cervical intraepithelial neoplasia grades 2/3 or higher (CIN 2/3+). Among HPV-negative women, 3% had CIN 2/3+, said Dr. Kinney of the Permanente Medical Group, Sacramento.
Of more interest to investigators were the women whose initial colposcopies produced negative biopsy results. Their HPV status at the time of AGUS diagnosis was more predictive than biopsy results of the likelihood of developing cervical abnormalities during a 12-month follow-up, he said at the conference, sponsored by the University of California, San Francisco.
Among 95 women who were initially HPV positive but had negative biopsies, 24 (25%) developed CIN 2/3+ during follow-up. None of 260 women who were HPV negative with benign biopsies at their initial evaluation developed CIN 2/3+.
The lead investigator in this study was Barbara Fetterman, Ph.D., of the Permanente Medical Group, Oakland, Calif. In a poster presentation at the meeting, she said the “current American Society for Colposcopy and Cervical Pathology recommendations for rescreening [at 4–6 month intervals for four times] in women with atypical glandular cell cytology, and a negative initial evaluation could be replaced with a single rescreen in 12 months if a woman is also HPV negative.”
Kaiser clinicians also crossed the HPV guidelines to test for HPV in 161 women with Pap results showing “atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions” (ASC-H).
Results showed that HPV positivity fell significantly after age 30, from a rate of 90% in women younger than 30, to 69% of women aged 30–39 years, 45% of women aged 40–49 years, and 30% of women aged 50 and older, Dr. Fetterman reported in a separate poster.
Among 125 of the women with ASC-H who also had biopsies, 38% had CIN2/3+, including one adenocarcinoma in situ. All women with CIN2/3+ were HPV positive. As time goes on, there probably will be an HPV-negative woman with ASC-H who has CIN2–3+, Dr. Kinney acknowledged, but the correlation between a negative HPV test and low risk for CIN 2/3+ in women with ASC-H is useful.
Dr. Fetterman described how the high negative predictive value of the HPV test for CIN 2/3+ and the falling HPV positivity rate with age make it useful to triage women with ASC-H. HPV triage of women with ASC-H would send 64% of women of all ages and 48% of women aged 30 and over to colposcopy. These rates are similar to the 56% of women with ASC US sent to colposcopy in the National Cancer Institute's ALTS study (ASCUS/Low-Grade Squamous Intraepithelial Lesions Triage Study), suggesting that “HPV triage of ASC-H may be useful in clinical practice, particularly in women age 30 and over,” she said.
VANCOUVER, CANADA — When Kaiser Permanente instituted testing for human papillomavirus in 2001, physicians were instructed not to test for the virus as a way to triage patients with Pap results showing atypical glandular cells of undetermined significance.
Clinicians “paid no attention whatsoever” to this guideline, however, resulting in data on 877 women with atypical glandular cells of undetermined significance (AGUS) smears who underwent testing for the human papillomavirus (HPV) and biopsies, Walter Kinney, M.D., said at the 22nd International Papillomavirus Conference.
National guidelines recommend HPV testing in two situations: to help manage women with Pap smears showing atypical squamous cells of undetermined significance (ASCUS), or as cotesting with Pap smears for cervical screening in women older than 30 years.
HPV tests were positive in 33% of the women with AGUS. Of these, 33% had cervical intraepithelial neoplasia grades 2/3 or higher (CIN 2/3+). Among HPV-negative women, 3% had CIN 2/3+, said Dr. Kinney of the Permanente Medical Group, Sacramento.
Of more interest to investigators were the women whose initial colposcopies produced negative biopsy results. Their HPV status at the time of AGUS diagnosis was more predictive than biopsy results of the likelihood of developing cervical abnormalities during a 12-month follow-up, he said at the conference, sponsored by the University of California, San Francisco.
Among 95 women who were initially HPV positive but had negative biopsies, 24 (25%) developed CIN 2/3+ during follow-up. None of 260 women who were HPV negative with benign biopsies at their initial evaluation developed CIN 2/3+.
The lead investigator in this study was Barbara Fetterman, Ph.D., of the Permanente Medical Group, Oakland, Calif. In a poster presentation at the meeting, she said the “current American Society for Colposcopy and Cervical Pathology recommendations for rescreening [at 4–6 month intervals for four times] in women with atypical glandular cell cytology, and a negative initial evaluation could be replaced with a single rescreen in 12 months if a woman is also HPV negative.”
Kaiser clinicians also crossed the HPV guidelines to test for HPV in 161 women with Pap results showing “atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions” (ASC-H).
Results showed that HPV positivity fell significantly after age 30, from a rate of 90% in women younger than 30, to 69% of women aged 30–39 years, 45% of women aged 40–49 years, and 30% of women aged 50 and older, Dr. Fetterman reported in a separate poster.
Among 125 of the women with ASC-H who also had biopsies, 38% had CIN2/3+, including one adenocarcinoma in situ. All women with CIN2/3+ were HPV positive. As time goes on, there probably will be an HPV-negative woman with ASC-H who has CIN2–3+, Dr. Kinney acknowledged, but the correlation between a negative HPV test and low risk for CIN 2/3+ in women with ASC-H is useful.
Dr. Fetterman described how the high negative predictive value of the HPV test for CIN 2/3+ and the falling HPV positivity rate with age make it useful to triage women with ASC-H. HPV triage of women with ASC-H would send 64% of women of all ages and 48% of women aged 30 and over to colposcopy. These rates are similar to the 56% of women with ASC US sent to colposcopy in the National Cancer Institute's ALTS study (ASCUS/Low-Grade Squamous Intraepithelial Lesions Triage Study), suggesting that “HPV triage of ASC-H may be useful in clinical practice, particularly in women age 30 and over,” she said.
Trachelectomy Indications, Complications Studied
RANCHO MIRAGE, CALIF. — Renewed interest in performing supracervical rather than total hysterectomies in the past 2 decades means some of these women will need trachelectomy or cervical stump removal at some point in the future.
To better understand the indications for trachelectomy and its potential complications, Wesley Hilger, M.D., and his associates at the Mayo Clinic, Scottsdale (Ariz.) reviewed 310 trachelectomies performed at the clinic from 1974 to 2003.
Prolapse was the predominant reason for trachelectomy, particularly in the 202 patients who underwent vaginal trachelectomy. A pelvic mass was the most common reason for abdominal trachelectomy, he said at the annual meeting of the Society of Gynecologic Surgeons.
The study found low rates of complications, especially in the vaginal trachelectomy. “When only trachelectomy was performed,” without concomitant procedures, “complications were almost nonexistent,” he said.
Half of the trachelectomies in the series were performed in the first of the 3 decades studied. Historically, 95% of hysterectomies performed before the 1950s were supracervical procedures, due to a lack of antibiotics and anesthetics, Dr. Hilger noted. Starting in the 1950s, surgeons shifted to total hysterectomies, which the new drugs made safer to perform. By the late 1970s and 1980s, however, some began to question whether retaining the cervix might help maintain sexual and bladder function, prevent prolapse, and reduce surgical morbidity. The rate of supracervical hysterectomies increased from 0.7% to 2% of U.S. hysterectomies between 1990 and 1997.
“Whether one approach is superior to another is still debated. What we know is that if someone undergoes a supracervical hysterectomy, the cervix may need to be removed in the future. If the supracervical hysterectomy rates continue to rise, we may see an increase in the number of trachelectomies in the future,” he said.
The 108 patients who underwent abdominal trachelectomy were younger than the vaginal trachelectomy group (58 vs. 67 years), lost more blood during surgery (606 cc vs. 193 cc), and were hospitalized longer (8 days vs. 6 days). The time between hysterectomy and trachelectomy was significantly shorter in the abdominal trachelectomy group—19 years, compared with 30 years after vaginal trachelectomy.
The third most common indication (after prolapse or pelvic mass) was cervical dysplasia or cancer. The interval between hysterectomy and trachelectomy for dysplasia or cancer averaged 21 years, compared with a 31-year interval for trachelectomies performed due to prolapse.
Because so much time passes between the surgeries, physicians who perform supracervical hysterectomies are unlikely to be the ones performing trachelectomies in the same patients, Dr. Hilger noted.
Bleeding was the indication for trachelectomy in 9% of patients. “Patients who are contemplating a supracervical hysterectomy should be counseled that cyclic or even noncyclic bleeding may persist and may necessitate another procedure,” said Dr. Stephen B. Young, who discussed the study following Dr. Hilger's presentation.
Patients also should be counseled about a risk for developing cancer in the cervical stump after supracervical hysterectomy, added Dr. Young of the University of Massachusetts, Worcester.
Histologic analysis of the cervical stumps removed in the study found that 5% had cervical cancer, 6% had dysplasia, 1% had adenocarcinoma, 1% had fibroids, 32% were normal, 53% had cervicitis that was not considered clinically significant, and 2% had other findings.
No postoperative complications were seen in 80% of vaginal trachelectomies and 57% of abdominal procedures. Infections developed in 7% of the vaginal group and 13% of the abdominal group, and urinary retention in 6% and 8% of vaginal and abdominal trachelectomies, respectively.
RANCHO MIRAGE, CALIF. — Renewed interest in performing supracervical rather than total hysterectomies in the past 2 decades means some of these women will need trachelectomy or cervical stump removal at some point in the future.
To better understand the indications for trachelectomy and its potential complications, Wesley Hilger, M.D., and his associates at the Mayo Clinic, Scottsdale (Ariz.) reviewed 310 trachelectomies performed at the clinic from 1974 to 2003.
Prolapse was the predominant reason for trachelectomy, particularly in the 202 patients who underwent vaginal trachelectomy. A pelvic mass was the most common reason for abdominal trachelectomy, he said at the annual meeting of the Society of Gynecologic Surgeons.
The study found low rates of complications, especially in the vaginal trachelectomy. “When only trachelectomy was performed,” without concomitant procedures, “complications were almost nonexistent,” he said.
Half of the trachelectomies in the series were performed in the first of the 3 decades studied. Historically, 95% of hysterectomies performed before the 1950s were supracervical procedures, due to a lack of antibiotics and anesthetics, Dr. Hilger noted. Starting in the 1950s, surgeons shifted to total hysterectomies, which the new drugs made safer to perform. By the late 1970s and 1980s, however, some began to question whether retaining the cervix might help maintain sexual and bladder function, prevent prolapse, and reduce surgical morbidity. The rate of supracervical hysterectomies increased from 0.7% to 2% of U.S. hysterectomies between 1990 and 1997.
“Whether one approach is superior to another is still debated. What we know is that if someone undergoes a supracervical hysterectomy, the cervix may need to be removed in the future. If the supracervical hysterectomy rates continue to rise, we may see an increase in the number of trachelectomies in the future,” he said.
The 108 patients who underwent abdominal trachelectomy were younger than the vaginal trachelectomy group (58 vs. 67 years), lost more blood during surgery (606 cc vs. 193 cc), and were hospitalized longer (8 days vs. 6 days). The time between hysterectomy and trachelectomy was significantly shorter in the abdominal trachelectomy group—19 years, compared with 30 years after vaginal trachelectomy.
The third most common indication (after prolapse or pelvic mass) was cervical dysplasia or cancer. The interval between hysterectomy and trachelectomy for dysplasia or cancer averaged 21 years, compared with a 31-year interval for trachelectomies performed due to prolapse.
Because so much time passes between the surgeries, physicians who perform supracervical hysterectomies are unlikely to be the ones performing trachelectomies in the same patients, Dr. Hilger noted.
Bleeding was the indication for trachelectomy in 9% of patients. “Patients who are contemplating a supracervical hysterectomy should be counseled that cyclic or even noncyclic bleeding may persist and may necessitate another procedure,” said Dr. Stephen B. Young, who discussed the study following Dr. Hilger's presentation.
Patients also should be counseled about a risk for developing cancer in the cervical stump after supracervical hysterectomy, added Dr. Young of the University of Massachusetts, Worcester.
Histologic analysis of the cervical stumps removed in the study found that 5% had cervical cancer, 6% had dysplasia, 1% had adenocarcinoma, 1% had fibroids, 32% were normal, 53% had cervicitis that was not considered clinically significant, and 2% had other findings.
No postoperative complications were seen in 80% of vaginal trachelectomies and 57% of abdominal procedures. Infections developed in 7% of the vaginal group and 13% of the abdominal group, and urinary retention in 6% and 8% of vaginal and abdominal trachelectomies, respectively.
RANCHO MIRAGE, CALIF. — Renewed interest in performing supracervical rather than total hysterectomies in the past 2 decades means some of these women will need trachelectomy or cervical stump removal at some point in the future.
To better understand the indications for trachelectomy and its potential complications, Wesley Hilger, M.D., and his associates at the Mayo Clinic, Scottsdale (Ariz.) reviewed 310 trachelectomies performed at the clinic from 1974 to 2003.
Prolapse was the predominant reason for trachelectomy, particularly in the 202 patients who underwent vaginal trachelectomy. A pelvic mass was the most common reason for abdominal trachelectomy, he said at the annual meeting of the Society of Gynecologic Surgeons.
The study found low rates of complications, especially in the vaginal trachelectomy. “When only trachelectomy was performed,” without concomitant procedures, “complications were almost nonexistent,” he said.
Half of the trachelectomies in the series were performed in the first of the 3 decades studied. Historically, 95% of hysterectomies performed before the 1950s were supracervical procedures, due to a lack of antibiotics and anesthetics, Dr. Hilger noted. Starting in the 1950s, surgeons shifted to total hysterectomies, which the new drugs made safer to perform. By the late 1970s and 1980s, however, some began to question whether retaining the cervix might help maintain sexual and bladder function, prevent prolapse, and reduce surgical morbidity. The rate of supracervical hysterectomies increased from 0.7% to 2% of U.S. hysterectomies between 1990 and 1997.
“Whether one approach is superior to another is still debated. What we know is that if someone undergoes a supracervical hysterectomy, the cervix may need to be removed in the future. If the supracervical hysterectomy rates continue to rise, we may see an increase in the number of trachelectomies in the future,” he said.
The 108 patients who underwent abdominal trachelectomy were younger than the vaginal trachelectomy group (58 vs. 67 years), lost more blood during surgery (606 cc vs. 193 cc), and were hospitalized longer (8 days vs. 6 days). The time between hysterectomy and trachelectomy was significantly shorter in the abdominal trachelectomy group—19 years, compared with 30 years after vaginal trachelectomy.
The third most common indication (after prolapse or pelvic mass) was cervical dysplasia or cancer. The interval between hysterectomy and trachelectomy for dysplasia or cancer averaged 21 years, compared with a 31-year interval for trachelectomies performed due to prolapse.
Because so much time passes between the surgeries, physicians who perform supracervical hysterectomies are unlikely to be the ones performing trachelectomies in the same patients, Dr. Hilger noted.
Bleeding was the indication for trachelectomy in 9% of patients. “Patients who are contemplating a supracervical hysterectomy should be counseled that cyclic or even noncyclic bleeding may persist and may necessitate another procedure,” said Dr. Stephen B. Young, who discussed the study following Dr. Hilger's presentation.
Patients also should be counseled about a risk for developing cancer in the cervical stump after supracervical hysterectomy, added Dr. Young of the University of Massachusetts, Worcester.
Histologic analysis of the cervical stumps removed in the study found that 5% had cervical cancer, 6% had dysplasia, 1% had adenocarcinoma, 1% had fibroids, 32% were normal, 53% had cervicitis that was not considered clinically significant, and 2% had other findings.
No postoperative complications were seen in 80% of vaginal trachelectomies and 57% of abdominal procedures. Infections developed in 7% of the vaginal group and 13% of the abdominal group, and urinary retention in 6% and 8% of vaginal and abdominal trachelectomies, respectively.
Study Identifies Risk Factor for Mesh Erosion
RANCHO MIRAGE, CALIF. — Performing an abdominal sacral suspension using polypropylene mesh concurrent with a total abdominal hysterectomy increases the risk of mesh erosion, Giti Bensinger, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
A retrospective analysis of charts on 121 women who underwent abdominal sacral suspension for pelvic organ prolapse at North Shore University Hospital in Manhasset, N.Y., found four mesh erosions over a mean 1-year follow-up. Polypropylene mesh had been used in all of the surgeries.
The four mesh erosions occurred among 49 women who had concurrent total abdominal hysterectomy, resulting in a mesh erosion rate of 8% in that group.
There were no erosions in 37 women who underwent concurrent supracervical hysterectomy or in 35 women who had a previous total abdominal hysterectomy and then underwent sacral suspension alone, said Dr. Bensinger of Albert Einstein College of Medicine, New York. The differences in erosion rates between groups were statistically significant.
The low rate of mesh erosion overall suggests polypropylene mesh is safe to use, and a low rate of complications supports reports in medical literature that sacral colpopexy is a safe treatment for vaginal vault prolapse, added Dr. Bensinger, formerly of North Shore University Hospital.
In formal comments after Dr. Bensinger's presentation, Kimberly Kenton, M.D., said the findings echo a report at the Society's 2002 meeting of a 27% mesh erosion rate in women undergoing both colpopexy and hysterectomy, compared with a 1% erosion rate in women who did not undergo hysterectomy at the time of abdominal sacral colpopexy.
“The demand for supracervical hysterectomy is increasing. As a result, many pelvic reconstructive surgeons are beginning to perform supracervical hysterectomy at the time of colpopexy, hypothesizing that this may decrease the rate of mesh erosion” by leaving the vaginal apex intact, said Dr. Kenton of Loyola University, Maywood, Ill. The current study's results support that strategy.
The small number of patients and short follow-up on some of the women limit the weight of the findings, she added. The shortest follow-up was less than 1 month. To evaluate reconstructive surgery results, follow-up should be for 1–5 years, she said.
The median follow-up in all three groups of patients was 5 months, Dr. Bensinger replied. A separate analysis that excluded patients with less than 6 months of follow-up found a similar trend in results that approached statistical significance.
Three previous studies of mesh erosions in women with an intact or missing vaginal apex produced conflicting results. Two found increased mesh erosion rates when a total hysterectomy was performed at the time of abdominal sacral colpopexy, and the third found no difference in erosions with or without an intact vaginal apex.
Reports of mesh erosions after sacral colpopexy suggest that 3%–16% will erode, usually 4–24 months after surgery, she said.
About 10% of women aged 80 years or older will have some type of pelvic reconstructive surgery in their lifetime, Dr. Bensinger noted. From 4% to 33% of surgeries for pelvic organ prolapse fail. Roughly 30% of pelvic reconstructive surgeries are done for prolapse recurrences.
She and her associates focused on abdominal rather than vaginal sacral colpopexy, because the abdominal approach has the advantage of restoring the normal midline axis of the vagina. Also, the abdominal approach seems to provide the best long-term results, with no recurrences in 84%–99% of patients, she added.
A trend toward increasing use of permanent mesh for sacral colpopexy, combined with concerns about synthetic mesh erosions, led them to focus on sacral suspensions that used polypropylene mesh.
RANCHO MIRAGE, CALIF. — Performing an abdominal sacral suspension using polypropylene mesh concurrent with a total abdominal hysterectomy increases the risk of mesh erosion, Giti Bensinger, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
A retrospective analysis of charts on 121 women who underwent abdominal sacral suspension for pelvic organ prolapse at North Shore University Hospital in Manhasset, N.Y., found four mesh erosions over a mean 1-year follow-up. Polypropylene mesh had been used in all of the surgeries.
The four mesh erosions occurred among 49 women who had concurrent total abdominal hysterectomy, resulting in a mesh erosion rate of 8% in that group.
There were no erosions in 37 women who underwent concurrent supracervical hysterectomy or in 35 women who had a previous total abdominal hysterectomy and then underwent sacral suspension alone, said Dr. Bensinger of Albert Einstein College of Medicine, New York. The differences in erosion rates between groups were statistically significant.
The low rate of mesh erosion overall suggests polypropylene mesh is safe to use, and a low rate of complications supports reports in medical literature that sacral colpopexy is a safe treatment for vaginal vault prolapse, added Dr. Bensinger, formerly of North Shore University Hospital.
In formal comments after Dr. Bensinger's presentation, Kimberly Kenton, M.D., said the findings echo a report at the Society's 2002 meeting of a 27% mesh erosion rate in women undergoing both colpopexy and hysterectomy, compared with a 1% erosion rate in women who did not undergo hysterectomy at the time of abdominal sacral colpopexy.
“The demand for supracervical hysterectomy is increasing. As a result, many pelvic reconstructive surgeons are beginning to perform supracervical hysterectomy at the time of colpopexy, hypothesizing that this may decrease the rate of mesh erosion” by leaving the vaginal apex intact, said Dr. Kenton of Loyola University, Maywood, Ill. The current study's results support that strategy.
The small number of patients and short follow-up on some of the women limit the weight of the findings, she added. The shortest follow-up was less than 1 month. To evaluate reconstructive surgery results, follow-up should be for 1–5 years, she said.
The median follow-up in all three groups of patients was 5 months, Dr. Bensinger replied. A separate analysis that excluded patients with less than 6 months of follow-up found a similar trend in results that approached statistical significance.
Three previous studies of mesh erosions in women with an intact or missing vaginal apex produced conflicting results. Two found increased mesh erosion rates when a total hysterectomy was performed at the time of abdominal sacral colpopexy, and the third found no difference in erosions with or without an intact vaginal apex.
Reports of mesh erosions after sacral colpopexy suggest that 3%–16% will erode, usually 4–24 months after surgery, she said.
About 10% of women aged 80 years or older will have some type of pelvic reconstructive surgery in their lifetime, Dr. Bensinger noted. From 4% to 33% of surgeries for pelvic organ prolapse fail. Roughly 30% of pelvic reconstructive surgeries are done for prolapse recurrences.
She and her associates focused on abdominal rather than vaginal sacral colpopexy, because the abdominal approach has the advantage of restoring the normal midline axis of the vagina. Also, the abdominal approach seems to provide the best long-term results, with no recurrences in 84%–99% of patients, she added.
A trend toward increasing use of permanent mesh for sacral colpopexy, combined with concerns about synthetic mesh erosions, led them to focus on sacral suspensions that used polypropylene mesh.
RANCHO MIRAGE, CALIF. — Performing an abdominal sacral suspension using polypropylene mesh concurrent with a total abdominal hysterectomy increases the risk of mesh erosion, Giti Bensinger, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
A retrospective analysis of charts on 121 women who underwent abdominal sacral suspension for pelvic organ prolapse at North Shore University Hospital in Manhasset, N.Y., found four mesh erosions over a mean 1-year follow-up. Polypropylene mesh had been used in all of the surgeries.
The four mesh erosions occurred among 49 women who had concurrent total abdominal hysterectomy, resulting in a mesh erosion rate of 8% in that group.
There were no erosions in 37 women who underwent concurrent supracervical hysterectomy or in 35 women who had a previous total abdominal hysterectomy and then underwent sacral suspension alone, said Dr. Bensinger of Albert Einstein College of Medicine, New York. The differences in erosion rates between groups were statistically significant.
The low rate of mesh erosion overall suggests polypropylene mesh is safe to use, and a low rate of complications supports reports in medical literature that sacral colpopexy is a safe treatment for vaginal vault prolapse, added Dr. Bensinger, formerly of North Shore University Hospital.
In formal comments after Dr. Bensinger's presentation, Kimberly Kenton, M.D., said the findings echo a report at the Society's 2002 meeting of a 27% mesh erosion rate in women undergoing both colpopexy and hysterectomy, compared with a 1% erosion rate in women who did not undergo hysterectomy at the time of abdominal sacral colpopexy.
“The demand for supracervical hysterectomy is increasing. As a result, many pelvic reconstructive surgeons are beginning to perform supracervical hysterectomy at the time of colpopexy, hypothesizing that this may decrease the rate of mesh erosion” by leaving the vaginal apex intact, said Dr. Kenton of Loyola University, Maywood, Ill. The current study's results support that strategy.
The small number of patients and short follow-up on some of the women limit the weight of the findings, she added. The shortest follow-up was less than 1 month. To evaluate reconstructive surgery results, follow-up should be for 1–5 years, she said.
The median follow-up in all three groups of patients was 5 months, Dr. Bensinger replied. A separate analysis that excluded patients with less than 6 months of follow-up found a similar trend in results that approached statistical significance.
Three previous studies of mesh erosions in women with an intact or missing vaginal apex produced conflicting results. Two found increased mesh erosion rates when a total hysterectomy was performed at the time of abdominal sacral colpopexy, and the third found no difference in erosions with or without an intact vaginal apex.
Reports of mesh erosions after sacral colpopexy suggest that 3%–16% will erode, usually 4–24 months after surgery, she said.
About 10% of women aged 80 years or older will have some type of pelvic reconstructive surgery in their lifetime, Dr. Bensinger noted. From 4% to 33% of surgeries for pelvic organ prolapse fail. Roughly 30% of pelvic reconstructive surgeries are done for prolapse recurrences.
She and her associates focused on abdominal rather than vaginal sacral colpopexy, because the abdominal approach has the advantage of restoring the normal midline axis of the vagina. Also, the abdominal approach seems to provide the best long-term results, with no recurrences in 84%–99% of patients, she added.
A trend toward increasing use of permanent mesh for sacral colpopexy, combined with concerns about synthetic mesh erosions, led them to focus on sacral suspensions that used polypropylene mesh.
Formal Surgery Curriculum Sharpens Ob.Gyn. Skills
RANCHO MIRAGE, CALIF. — A formal curriculum for teaching surgery significantly improved the skills of ob.gyn. residents in performing specific surgical tasks, a 6-year study found.
The University of Washington instituted an ob.gyn. surgery curriculum for residents starting in 1997 and compared results of testing in two groups: residents whose 4 years of training included the curriculum in each year and residents who trained earlier and encountered the curriculum only during their last 1 or 2 years of training. Residents in the second group were considered controls.
The curriculum included baseline testing at the start of each academic year, prelaboratory instruction, and twice-yearly surgical skills training sessions for 24 ob.gyn. residents; training involved both inanimate lifelike models and animal laboratories.
At the end of each year, residents were tested on individual bench skills and underwent objective structured assessment of technical skills (OSATS), which served as a means to test their abilities on procedures rather than on single tasks, Gretchen M. Lentz, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
Residents who had 4 years of exposure to the curriculum showed significantly better bench skills on both laparoscopic and open surgical tasks, compared with the control group, according to Dr. Lentz of the university and her associates.
OSATS scores also were higher in the intervention group than the control group, but the difference was not statistically significant, perhaps due to the small numbers of procedures that could be evaluated. “We have to change the tasks that they do every year, so that they don't know what we're going to test them on, and it limits our numbers overall,” she explained.
A previous survey of 206 ob.gyn. residency programs by Dr. Lentz and associates found only 29% had a formal training program in surgical skills. The optimal format for teaching residents surgical skills, giving them feedback, and evaluating their performance has not been defined.
“Yet our educators in this field have core competencies identified for residents that we should be teaching,” she said.
Many educators are calling for new standardized methods for teaching surgical skills, Dr. Lentz added. Some of this is in response to the 80-hour limits on residents' workweeks or in reaction to declining surgical volumes at some institutions. Concerns about medical errors also have increased attention on the training that residents get in operating rooms.
In the University of Washington curriculum, the intensive twice-yearly training sessions lasted 6 hours each, with two residents and one faculty member per animal. “Expert feedback is known to improve training, so we wanted this to be part of our formal program,” Dr. Lentz said.
Additional sessions were scheduled throughout the year to work on hysteroscopy, laparoscopy, and cystoscopy and to familiarize residents with new procedures, techniques, or instruments before encountering them in the operating room.
In formal commentary after Dr. Lentz's presentation, Roger P. Smith, M.D., called for more studies in this area. “There can be little doubt of the wisdom of both critically addressing how we teach and learn the craft of surgery and in moving from the apprenticeship model under which we all trained,” he said.
He noted, however, that the survey showing that only 26% of ob.gyn. programs had formal surgery curricula also found that 54% of programs provided some surgical experience in animal laboratories. “There may not be as wide a curriculum gap as there appears on first blush,” said Dr. Smith of the University of Missouri, Kansas City. Those animal laboratory experiences often consist of a single session, Dr. Lentz said.
RANCHO MIRAGE, CALIF. — A formal curriculum for teaching surgery significantly improved the skills of ob.gyn. residents in performing specific surgical tasks, a 6-year study found.
The University of Washington instituted an ob.gyn. surgery curriculum for residents starting in 1997 and compared results of testing in two groups: residents whose 4 years of training included the curriculum in each year and residents who trained earlier and encountered the curriculum only during their last 1 or 2 years of training. Residents in the second group were considered controls.
The curriculum included baseline testing at the start of each academic year, prelaboratory instruction, and twice-yearly surgical skills training sessions for 24 ob.gyn. residents; training involved both inanimate lifelike models and animal laboratories.
At the end of each year, residents were tested on individual bench skills and underwent objective structured assessment of technical skills (OSATS), which served as a means to test their abilities on procedures rather than on single tasks, Gretchen M. Lentz, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
Residents who had 4 years of exposure to the curriculum showed significantly better bench skills on both laparoscopic and open surgical tasks, compared with the control group, according to Dr. Lentz of the university and her associates.
OSATS scores also were higher in the intervention group than the control group, but the difference was not statistically significant, perhaps due to the small numbers of procedures that could be evaluated. “We have to change the tasks that they do every year, so that they don't know what we're going to test them on, and it limits our numbers overall,” she explained.
A previous survey of 206 ob.gyn. residency programs by Dr. Lentz and associates found only 29% had a formal training program in surgical skills. The optimal format for teaching residents surgical skills, giving them feedback, and evaluating their performance has not been defined.
“Yet our educators in this field have core competencies identified for residents that we should be teaching,” she said.
Many educators are calling for new standardized methods for teaching surgical skills, Dr. Lentz added. Some of this is in response to the 80-hour limits on residents' workweeks or in reaction to declining surgical volumes at some institutions. Concerns about medical errors also have increased attention on the training that residents get in operating rooms.
In the University of Washington curriculum, the intensive twice-yearly training sessions lasted 6 hours each, with two residents and one faculty member per animal. “Expert feedback is known to improve training, so we wanted this to be part of our formal program,” Dr. Lentz said.
Additional sessions were scheduled throughout the year to work on hysteroscopy, laparoscopy, and cystoscopy and to familiarize residents with new procedures, techniques, or instruments before encountering them in the operating room.
In formal commentary after Dr. Lentz's presentation, Roger P. Smith, M.D., called for more studies in this area. “There can be little doubt of the wisdom of both critically addressing how we teach and learn the craft of surgery and in moving from the apprenticeship model under which we all trained,” he said.
He noted, however, that the survey showing that only 26% of ob.gyn. programs had formal surgery curricula also found that 54% of programs provided some surgical experience in animal laboratories. “There may not be as wide a curriculum gap as there appears on first blush,” said Dr. Smith of the University of Missouri, Kansas City. Those animal laboratory experiences often consist of a single session, Dr. Lentz said.
RANCHO MIRAGE, CALIF. — A formal curriculum for teaching surgery significantly improved the skills of ob.gyn. residents in performing specific surgical tasks, a 6-year study found.
The University of Washington instituted an ob.gyn. surgery curriculum for residents starting in 1997 and compared results of testing in two groups: residents whose 4 years of training included the curriculum in each year and residents who trained earlier and encountered the curriculum only during their last 1 or 2 years of training. Residents in the second group were considered controls.
The curriculum included baseline testing at the start of each academic year, prelaboratory instruction, and twice-yearly surgical skills training sessions for 24 ob.gyn. residents; training involved both inanimate lifelike models and animal laboratories.
At the end of each year, residents were tested on individual bench skills and underwent objective structured assessment of technical skills (OSATS), which served as a means to test their abilities on procedures rather than on single tasks, Gretchen M. Lentz, M.D., said at the annual meeting of the Society of Gynecologic Surgeons.
Residents who had 4 years of exposure to the curriculum showed significantly better bench skills on both laparoscopic and open surgical tasks, compared with the control group, according to Dr. Lentz of the university and her associates.
OSATS scores also were higher in the intervention group than the control group, but the difference was not statistically significant, perhaps due to the small numbers of procedures that could be evaluated. “We have to change the tasks that they do every year, so that they don't know what we're going to test them on, and it limits our numbers overall,” she explained.
A previous survey of 206 ob.gyn. residency programs by Dr. Lentz and associates found only 29% had a formal training program in surgical skills. The optimal format for teaching residents surgical skills, giving them feedback, and evaluating their performance has not been defined.
“Yet our educators in this field have core competencies identified for residents that we should be teaching,” she said.
Many educators are calling for new standardized methods for teaching surgical skills, Dr. Lentz added. Some of this is in response to the 80-hour limits on residents' workweeks or in reaction to declining surgical volumes at some institutions. Concerns about medical errors also have increased attention on the training that residents get in operating rooms.
In the University of Washington curriculum, the intensive twice-yearly training sessions lasted 6 hours each, with two residents and one faculty member per animal. “Expert feedback is known to improve training, so we wanted this to be part of our formal program,” Dr. Lentz said.
Additional sessions were scheduled throughout the year to work on hysteroscopy, laparoscopy, and cystoscopy and to familiarize residents with new procedures, techniques, or instruments before encountering them in the operating room.
In formal commentary after Dr. Lentz's presentation, Roger P. Smith, M.D., called for more studies in this area. “There can be little doubt of the wisdom of both critically addressing how we teach and learn the craft of surgery and in moving from the apprenticeship model under which we all trained,” he said.
He noted, however, that the survey showing that only 26% of ob.gyn. programs had formal surgery curricula also found that 54% of programs provided some surgical experience in animal laboratories. “There may not be as wide a curriculum gap as there appears on first blush,” said Dr. Smith of the University of Missouri, Kansas City. Those animal laboratory experiences often consist of a single session, Dr. Lentz said.
Tips for Assessing Malpractice Lawyers : Poor communication, neglect, and unclear billing policies top the list of complaints.
KOHALA COAST, HAWAII — You're a physician, not a lawyer. How do you know that the lawyer defending you in a malpractice suit is doing a good job?
When a physician gets sued, the malpractice insurer assigns the case to a legal defense firm. According to Annette Friend, M.D., a psychiatrist, physicians should expect five basic things from a competent lawyer: a plan of action, clear communication, ongoing communications, management of your expectations, and clear explanations of billing policies.
A review of past disciplinary actions against lawyers suggests more than half stemmed from clients' complaints that the lawyers were neglectful, failed to communicate, or failed to represent clients diligently or competently. Another complaint—that failure to communicate billing policies led to fee disputes—is an increasing cause of disciplinary dockets, Dr. Friend, who also is a lawyer, said at a conference on clinical dermatology sponsored by the Center for Bio-Medical Communications Inc.
“We want to satisfy you, but you have to insist on being satisfied,” Dennis J. Sinclitico, J.D., a defense lawyer, said in a separate presentation at a conference in Cabo San Lucas, Mexico, on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
Get a copy of the malpractice insurance company's guidelines on expectations of lawyers to know what the insurer expects for your case, said Mr. Sinclitico of Long Beach, Calif.
To get your lawyer to do the best job for you, Dr. Friend and Mr. Sinclitico advised, think about these factors:
Plan. The physician and lawyer jointly plan a course of action. The lawyer should explain what is involved in the case, what needs to be done, what may happen next, and various means of resolving the case. The client makes the final decision about how to resolve the legal matter, said Dr. Friend of Fort Lauderdale, Fla.
She suggested asking whether the lawyer has ever handled this type of case before, and if there is some other way to settle the matter other than going to trial. Your bill for an inexperienced lawyer may be higher as more hours are needed to learn the matter.
Communicate. Expect plain speaking, clear writing, and good listening skills from your lawyer. When a complex legal issue can be explained in a way that one's grandmother might understand, that's clear speaking, she said. If you don't understand something your lawyer wrote, chances are the judge and others won't understand it, either. The lawyer should be able to listen to the client and think about the case without being distracted by calls, e-mails, or an overload of other cases.
If your lawyer isn't communicating well and regularly or you don't get along, demand a new lawyer from the firm's associates or from the insurer's panel of lawyers, Mr. Sinclitico said. Communication is a two-way street, he added. If you see an article in the medical literature that's pertinent to your case, send it to the lawyer. Insist on participating in selecting the medical experts whom your attorney will rely on.
Communicate some more. The legal process can drag on for years, so expect ongoing communication from your legal team, preferably from your lawyer personally, Dr. Friend said.
Request regular, periodic status reports from the lawyer, Mr. Sinclitico advised. If the flow of paper stops, or if you call three or four times without a response from the lawyer, that's a red flag that something's wrong.
Manage expectations. As the lawyer continually analyzes and updates you on the pros and cons of the legal proceedings, options should be articulated in a commonsense way without exaggerating the probable success of the case and without painting an overly bleak outcome.
Explain billing. Demand an up-front, detailed accounting of billing policies. Firms may bill for face time with the client, phone calls, conversations between firm members, time reviewing documents, legal research, preparation of forms or documents, revisions, document reviews, travel time and expenses, and many other services. If the lawyer in charge of the case changes while the case is in progress, the client should not have to pay for the firm to bring a new lawyer up to speed, Dr. Friend said. Ask whether legal interns will bill at the same rate as senior lawyers, and be sure that you'll get access to all legal work done on your behalf, she said.
KOHALA COAST, HAWAII — You're a physician, not a lawyer. How do you know that the lawyer defending you in a malpractice suit is doing a good job?
When a physician gets sued, the malpractice insurer assigns the case to a legal defense firm. According to Annette Friend, M.D., a psychiatrist, physicians should expect five basic things from a competent lawyer: a plan of action, clear communication, ongoing communications, management of your expectations, and clear explanations of billing policies.
A review of past disciplinary actions against lawyers suggests more than half stemmed from clients' complaints that the lawyers were neglectful, failed to communicate, or failed to represent clients diligently or competently. Another complaint—that failure to communicate billing policies led to fee disputes—is an increasing cause of disciplinary dockets, Dr. Friend, who also is a lawyer, said at a conference on clinical dermatology sponsored by the Center for Bio-Medical Communications Inc.
“We want to satisfy you, but you have to insist on being satisfied,” Dennis J. Sinclitico, J.D., a defense lawyer, said in a separate presentation at a conference in Cabo San Lucas, Mexico, on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
Get a copy of the malpractice insurance company's guidelines on expectations of lawyers to know what the insurer expects for your case, said Mr. Sinclitico of Long Beach, Calif.
To get your lawyer to do the best job for you, Dr. Friend and Mr. Sinclitico advised, think about these factors:
Plan. The physician and lawyer jointly plan a course of action. The lawyer should explain what is involved in the case, what needs to be done, what may happen next, and various means of resolving the case. The client makes the final decision about how to resolve the legal matter, said Dr. Friend of Fort Lauderdale, Fla.
She suggested asking whether the lawyer has ever handled this type of case before, and if there is some other way to settle the matter other than going to trial. Your bill for an inexperienced lawyer may be higher as more hours are needed to learn the matter.
Communicate. Expect plain speaking, clear writing, and good listening skills from your lawyer. When a complex legal issue can be explained in a way that one's grandmother might understand, that's clear speaking, she said. If you don't understand something your lawyer wrote, chances are the judge and others won't understand it, either. The lawyer should be able to listen to the client and think about the case without being distracted by calls, e-mails, or an overload of other cases.
If your lawyer isn't communicating well and regularly or you don't get along, demand a new lawyer from the firm's associates or from the insurer's panel of lawyers, Mr. Sinclitico said. Communication is a two-way street, he added. If you see an article in the medical literature that's pertinent to your case, send it to the lawyer. Insist on participating in selecting the medical experts whom your attorney will rely on.
Communicate some more. The legal process can drag on for years, so expect ongoing communication from your legal team, preferably from your lawyer personally, Dr. Friend said.
Request regular, periodic status reports from the lawyer, Mr. Sinclitico advised. If the flow of paper stops, or if you call three or four times without a response from the lawyer, that's a red flag that something's wrong.
Manage expectations. As the lawyer continually analyzes and updates you on the pros and cons of the legal proceedings, options should be articulated in a commonsense way without exaggerating the probable success of the case and without painting an overly bleak outcome.
Explain billing. Demand an up-front, detailed accounting of billing policies. Firms may bill for face time with the client, phone calls, conversations between firm members, time reviewing documents, legal research, preparation of forms or documents, revisions, document reviews, travel time and expenses, and many other services. If the lawyer in charge of the case changes while the case is in progress, the client should not have to pay for the firm to bring a new lawyer up to speed, Dr. Friend said. Ask whether legal interns will bill at the same rate as senior lawyers, and be sure that you'll get access to all legal work done on your behalf, she said.
KOHALA COAST, HAWAII — You're a physician, not a lawyer. How do you know that the lawyer defending you in a malpractice suit is doing a good job?
When a physician gets sued, the malpractice insurer assigns the case to a legal defense firm. According to Annette Friend, M.D., a psychiatrist, physicians should expect five basic things from a competent lawyer: a plan of action, clear communication, ongoing communications, management of your expectations, and clear explanations of billing policies.
A review of past disciplinary actions against lawyers suggests more than half stemmed from clients' complaints that the lawyers were neglectful, failed to communicate, or failed to represent clients diligently or competently. Another complaint—that failure to communicate billing policies led to fee disputes—is an increasing cause of disciplinary dockets, Dr. Friend, who also is a lawyer, said at a conference on clinical dermatology sponsored by the Center for Bio-Medical Communications Inc.
“We want to satisfy you, but you have to insist on being satisfied,” Dennis J. Sinclitico, J.D., a defense lawyer, said in a separate presentation at a conference in Cabo San Lucas, Mexico, on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
Get a copy of the malpractice insurance company's guidelines on expectations of lawyers to know what the insurer expects for your case, said Mr. Sinclitico of Long Beach, Calif.
To get your lawyer to do the best job for you, Dr. Friend and Mr. Sinclitico advised, think about these factors:
Plan. The physician and lawyer jointly plan a course of action. The lawyer should explain what is involved in the case, what needs to be done, what may happen next, and various means of resolving the case. The client makes the final decision about how to resolve the legal matter, said Dr. Friend of Fort Lauderdale, Fla.
She suggested asking whether the lawyer has ever handled this type of case before, and if there is some other way to settle the matter other than going to trial. Your bill for an inexperienced lawyer may be higher as more hours are needed to learn the matter.
Communicate. Expect plain speaking, clear writing, and good listening skills from your lawyer. When a complex legal issue can be explained in a way that one's grandmother might understand, that's clear speaking, she said. If you don't understand something your lawyer wrote, chances are the judge and others won't understand it, either. The lawyer should be able to listen to the client and think about the case without being distracted by calls, e-mails, or an overload of other cases.
If your lawyer isn't communicating well and regularly or you don't get along, demand a new lawyer from the firm's associates or from the insurer's panel of lawyers, Mr. Sinclitico said. Communication is a two-way street, he added. If you see an article in the medical literature that's pertinent to your case, send it to the lawyer. Insist on participating in selecting the medical experts whom your attorney will rely on.
Communicate some more. The legal process can drag on for years, so expect ongoing communication from your legal team, preferably from your lawyer personally, Dr. Friend said.
Request regular, periodic status reports from the lawyer, Mr. Sinclitico advised. If the flow of paper stops, or if you call three or four times without a response from the lawyer, that's a red flag that something's wrong.
Manage expectations. As the lawyer continually analyzes and updates you on the pros and cons of the legal proceedings, options should be articulated in a commonsense way without exaggerating the probable success of the case and without painting an overly bleak outcome.
Explain billing. Demand an up-front, detailed accounting of billing policies. Firms may bill for face time with the client, phone calls, conversations between firm members, time reviewing documents, legal research, preparation of forms or documents, revisions, document reviews, travel time and expenses, and many other services. If the lawyer in charge of the case changes while the case is in progress, the client should not have to pay for the firm to bring a new lawyer up to speed, Dr. Friend said. Ask whether legal interns will bill at the same rate as senior lawyers, and be sure that you'll get access to all legal work done on your behalf, she said.
In-Office Detection of White Coat Hypertension Is Possible
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid BP readings matched ambulatory BP measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office BPs were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory BP measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes. The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory BP.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory BPs. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office BP measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as BPs above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid BP readings matched ambulatory BP measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office BPs were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory BP measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes. The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory BP.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory BPs. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office BP measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as BPs above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid BP readings matched ambulatory BP measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office BPs were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory BP measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes. The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory BP.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory BPs. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office BP measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as BPs above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
Simple Regimen Reins In Resistant Hypertension : Adding angiotensin II receptor blocker to diuretic brought hard-to-treat hypertensives below target BP.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., reported.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., reported.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., reported.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions In Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week study, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg.
Improvements in blood pressure were similar between the subgroups studied, with systolic pressures dropping 15–23 mm Hg on average. The subgroup of diabetic patients had the lowest rates of control, with systolic pressure controlled in 56% and diastolic pressure controlled in 63% of patients. In the other subgroups, 72%–82% achieved systolic pressure control and 77%–96% achieved diastolic pressure control.
In-Office Detection of White Coat Hypertension Possible
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid blood pressure readings matched ambulatory blood pressure measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office blood pressures were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory blood pressure measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes.
The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory blood pressure.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory blood pressures. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office blood pressure measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as blood pressures above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients (white coat hypertension) and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
The study shows that white coat hypertension also occurs when nurses take the measurements, he noted.
Average systolic blood pressure readings in the 41 patients with white coat hypertension were 137 mm Hg by doctors' measurements, 133 mm Hg by nurses, 123 mm Hg by the automated device, and 121 mm Hg on ambulatory daytime monitoring. Ambulatory monitoring took place between 7 a.m. and 5 p.m.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid blood pressure readings matched ambulatory blood pressure measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office blood pressures were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory blood pressure measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes.
The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory blood pressure.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory blood pressures. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office blood pressure measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as blood pressures above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients (white coat hypertension) and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
The study shows that white coat hypertension also occurs when nurses take the measurements, he noted.
Average systolic blood pressure readings in the 41 patients with white coat hypertension were 137 mm Hg by doctors' measurements, 133 mm Hg by nurses, 123 mm Hg by the automated device, and 121 mm Hg on ambulatory daytime monitoring. Ambulatory monitoring took place between 7 a.m. and 5 p.m.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
SAN FRANCISCO — You may not need to send patients with suspected “white coat hypertension” home with an ambulatory blood pressure monitor. Automated repeat measurements in the office work just as well for ruling out this type of hypertension, Giuseppe Crippa, M.D., said at the annual meeting of the American Society of Hypertension.
In a study of 122 patients, measurements from an automated, in-office oscillometric device that obtained 10 valid blood pressure readings matched ambulatory blood pressure measurements closely enough that the in-office readings identified 40 out of 41 patients with white coat hypertension, said Dr. Crippa of Guglielmo da Saliceto Hospital, Piacenza, Italy.
The study included consecutive patients referred to the hospital's hypertension unit to confirm or rule out suspected hypertension. All patients had clinic readings above 140/90 mm Hg, but reported measurements at home that were consistently below 140/90 mm Hg.
For each patient, in-office blood pressures were taken by a physician, a nurse, and the automated device (in random order) and compared with ambulatory blood pressure measurements. The doctor and nurse each took three readings after the patient had rested for 20 minutes.
The automated repeat measurements were taken at 2.5-minute intervals with the patient sitting alone in a clinic room. Investigators compared the average of the last two measurements taken by the doctor and nurse with the average of the last five measurements by the automated device and the mean daytime ambulatory blood pressure.
Blood pressures taken by doctors and nurses were significantly higher than daytime ambulatory measurements. The automated and ambulatory measurements closely overlapped, however, with no significant differences between them, he said.
Doctor's measurements averaged 15/11 mm Hg higher, and nurses' measurements averaged 11/9 mm Hg higher, than daytime ambulatory blood pressures. Only 1 of 41 patients who were normotensive on daytime ambulatory monitoring had hypertension on automated in-office testing.
Automated repeat office blood pressure measurements “could be a substitute for home blood pressure monitoring,” he said.
Hypertension was defined as blood pressures above 132/85 mm Hg. Conventional measurements by physicians in the office can be inaccurate because of variable reactions by the patients (white coat hypertension) and errors in technique. This can lead to an overestimate of hypertension, incorrect diagnoses, and inappropriate treatment, Dr. Crippa said.
The study shows that white coat hypertension also occurs when nurses take the measurements, he noted.
Average systolic blood pressure readings in the 41 patients with white coat hypertension were 137 mm Hg by doctors' measurements, 133 mm Hg by nurses, 123 mm Hg by the automated device, and 121 mm Hg on ambulatory daytime monitoring. Ambulatory monitoring took place between 7 a.m. and 5 p.m.
Average diastolic blood pressure readings in patients with white coat hypertension were 86 mm Hg when taken by doctors, 83 mm Hg by nurses, 75 mm Hg by the automated device, and 73 mm Hg by ambulatory monitoring.
Hard-to-Treat Hypertensives Responded to Simple Regimen
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week trial, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week trial, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.
SAN FRANCISCO — A simple, aggressive hypertension treatment regimen controlled systolic hypertension in 77% of 1,005 hard-to-treat patients after 18 weeks, Elijah Saunders, M.D., said.
The initial treatment consisted of a diuretic alone. If blood pressure control was not achieved, patients were switched to a combination pill containing the same diuretic and an angiotensin II receptor blocker.
The study included at least 100 patients from each of several populations in which high blood pressure often is difficult to control: patients aged 65 years or older, African Americans and Hispanic patients, patients with type 2 diabetes, and patients with metabolic syndrome.
The study, known as the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial, is the first large-scale hypertension study to include such a broad range of patient groups, Dr. Saunders said at the annual meeting of the American Society of Hypertension. Women comprised 52% of the cohort.
Some of the study participants had risk factors for cardiovascular disease including obesity, abnormal glucose tolerance, high triglyceride levels, or low HDL cholesterol. A large proportion of hypertensive people have these risk factors, and they often need two or more medications to control hypertension.
Patients entered the trial with high blood pressure that was not controlled adequately with one medication. After a 4-week washout period in which patients received placebo, treatment began with the diuretic hydrochlorothiazide at 12.5 mg/day. After 2 weeks, blood pressures were under control in 27% of patients.
The remaining patients were switched to combination treatment with 12.5 mg of hydrochlorothiazide and 150 mg of the angiotensin II receptor blocker irbesartan in a single daily pill (Avalide) for 8 weeks. During this second phase of treatment, a majority of patients reached blood pressure control: Systolic pressure was under control in 56% of patients, and diastolic was controlled in 72%.
Patients who still had high blood pressures 12 weeks into the study were switched to a double dose of Avalide: 25 mg of hydrochlorothiazide with 300 mg of irbesartan per day.
At the end of the 18-week trial, the study regimen had controlled 77% of systolic blood pressures and 83% of diastolic pressures, said Dr. Saunders, professor of medicine at the University of Maryland, Baltimore. The other principal investigator in the study was Joel Neutel, M.D., of the Orange County Research Center, Tustin, Calif., and the University of California, Irvine.
No particular efforts were made by the study patients to alter diet or exercise habits, suggesting that the benefits could be attributed to the medications.
Study patients were seen in 119 clinics, showing that high rates of blood pressure control can be achieved in general clinic settings, Dr. Neutel said.
The study was funded by the two companies that distribute Avalide in partnership, Bristol-Myers Squibb Co. and Sanofi-Synthelabo. Dr. Saunders is a consultant to both companies. Dr. Neutel is a speaker for Bristol-Myers Squibb.
The treatment was well tolerated. Dizziness was the most common side effect, occurring in 3% of patients. The incidence of hypokalemia did not increase with the higher thiazide dose.
In the United States, 53% of patients treated for hypertension reach recommended blood pressure goals of less than 140/90 mm Hg for the general population or 130/80 mm Hg for people with diabetes or chronic kidney disease, a 2000 study found. The magnitude of success in the current study surprised investigators, Dr. Saunders said.
Systolic blood pressures in the study dropped an average of 21 mm Hg, from 154 to 133 mm Hg. Diastolic pressures fell 10 mm Hg, from 91 to 81 mm Hg on average.