Wilson W et al. Prevention of infective endocarditis: Guidelines from the American Heart Association. A Guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007 Apr 19;
original article
Monday, July 23, 2007
Managing Sepsis — Early Goal-Directed Therapy Saves Lives, Again
Implementation of a bundle of five quality indicators for early management of severe sepsis was associated with reduced mortality.
Although there are outcome data supporting the Surviving Sepsis Campaign guideline components, little is known about the feasibility of implementing a comprehensive treatment protocol for sepsis ("severe sepsis bundle") in an emergency department. In a prospective observational study, researchers examined compliance and outcomes at a single ED that implemented a severe sepsis bundle with physician feedback.
The bundle consisted of five quality indicators:
Initiation of central venous pressure and central venous oxygen saturation monitoring within 2 hours
Administration of broad-spectrum antibiotics within 4 hours
Completion of early goal-directed therapy (EGDT) within 6 hours
Administration of corticosteroid therapy for patients receiving vasopressors or with suspected adrenal insufficiency
Monitoring of lactate clearance
The 2-year project was divided into a pre-implementation phase in which education and infrastructure were established, an observational phase in which physicians were given the tools to implement the program, and a quality initiative phase in which department feedback was provided.
During the 2-year study period, 330 patients (mean age, 63.8) presented with severe sepsis or septic shock. The mean ED length of stay (LOS) was 8.5 hours, mean hospital LOS was 11.3 days, and in-hospital mortality was 35.2%. Bundle compliance increased progressively from 0% to 51.2%. In-hospital mortality was significantly lower in patients who had all bundle components completed than in those who did not (20.8% vs. 39.5%). After the authors adjusted for oxygen debt, bundle completion still was associated with increased survival. In multivariate logistic regression analysis, EGDT was the sole quality indicator associated with lower mortality (odds ratio, 0.36). Administration of fluids, vasopressors, transfusions, and inotropes was similar in the groups with and without bundle completion.
Comment: This observational study of a well-designed quality improvement program demonstrates that bundle completion resulted in an absolute reduction in mortality of nearly 19%. EGDT is the most important of the measures, and other studies have shown that it can be successfully implemented in an ED. Every ED should implement EGDT for patients with severe sepsis or septic shock. EGDT can be initiated by a shock team or an intensive care unit team or by ED personnel.
— Tiffany M. Osborn, MD
Published in Journal Watch Emergency Medicine July 20, 2007
Citation(s):
Nguyen HB et al. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med 2007 Apr; 35:1105-12.
Although there are outcome data supporting the Surviving Sepsis Campaign guideline components, little is known about the feasibility of implementing a comprehensive treatment protocol for sepsis ("severe sepsis bundle") in an emergency department. In a prospective observational study, researchers examined compliance and outcomes at a single ED that implemented a severe sepsis bundle with physician feedback.
The bundle consisted of five quality indicators:
Initiation of central venous pressure and central venous oxygen saturation monitoring within 2 hours
Administration of broad-spectrum antibiotics within 4 hours
Completion of early goal-directed therapy (EGDT) within 6 hours
Administration of corticosteroid therapy for patients receiving vasopressors or with suspected adrenal insufficiency
Monitoring of lactate clearance
The 2-year project was divided into a pre-implementation phase in which education and infrastructure were established, an observational phase in which physicians were given the tools to implement the program, and a quality initiative phase in which department feedback was provided.
During the 2-year study period, 330 patients (mean age, 63.8) presented with severe sepsis or septic shock. The mean ED length of stay (LOS) was 8.5 hours, mean hospital LOS was 11.3 days, and in-hospital mortality was 35.2%. Bundle compliance increased progressively from 0% to 51.2%. In-hospital mortality was significantly lower in patients who had all bundle components completed than in those who did not (20.8% vs. 39.5%). After the authors adjusted for oxygen debt, bundle completion still was associated with increased survival. In multivariate logistic regression analysis, EGDT was the sole quality indicator associated with lower mortality (odds ratio, 0.36). Administration of fluids, vasopressors, transfusions, and inotropes was similar in the groups with and without bundle completion.
Comment: This observational study of a well-designed quality improvement program demonstrates that bundle completion resulted in an absolute reduction in mortality of nearly 19%. EGDT is the most important of the measures, and other studies have shown that it can be successfully implemented in an ED. Every ED should implement EGDT for patients with severe sepsis or septic shock. EGDT can be initiated by a shock team or an intensive care unit team or by ED personnel.
— Tiffany M. Osborn, MD
Published in Journal Watch Emergency Medicine July 20, 2007
Citation(s):
Nguyen HB et al. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med 2007 Apr; 35:1105-12.
Friday, July 20, 2007
Estrogen Therapy and Coronary Calcification
More evidence that estrogen therapy early in menopause may confer more benefit than risk
Findings from the Women’s Health Initiative (WHI) trial showed that taking conjugated equine estrogens did not reduce the risk for coronary events in postmenopausal women who had undergone hysterectomies. A subgroup analysis, however, suggested an age interaction, in which estrogen conferred a cardiovascular benefit on the younger subjects. To pursue this issue further, the WHI Coronary-Artery Calcium Study was designed to determine whether the younger women treated with estrogens had lower coronary-artery calcium scores than those treated with placebo. This substudy was restricted to women who were 50 to 59 years old at the time of randomization; follow-up scans were obtained an average of 8.7 years later.
Coronary-artery calcium scores were available for 1064 eligible participants. The mean scores were 83 in the estrogen group and 123 in the placebo group (P=0.02). The 50th percentile value of the scores was 0 in both groups, and the 75th percentile values were 43 in the estrogen group and 84 in the placebo group. The overall distribution of scores was significantly lower in the estrogen group than in the placebo group.
Comment: This WHI follow-up study provides additional evidence that estrogens may be beneficial for younger postmenopausal women. These results, however, should not be considered independent confirmation of the original subgroup analysis, because they were found in the same group of patients. Also, although coronary-artery calcium scores are predictive of outcomes, these findings do not translate directly to better outcomes with estrogen treatment, nor do they overturn current recommendations that hormone therapy be limited to the treatment of moderate-to-severe menopausal symptoms, using the lowest effective dose for the shortest duration necessary.
— Harlan M. Krumholz, MD, SM
Published in Journal Watch Cardiology July 18, 2007
Citation(s):
Manson JE et al. for the WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007 Jun 21; 356:2591-602.
Findings from the Women’s Health Initiative (WHI) trial showed that taking conjugated equine estrogens did not reduce the risk for coronary events in postmenopausal women who had undergone hysterectomies. A subgroup analysis, however, suggested an age interaction, in which estrogen conferred a cardiovascular benefit on the younger subjects. To pursue this issue further, the WHI Coronary-Artery Calcium Study was designed to determine whether the younger women treated with estrogens had lower coronary-artery calcium scores than those treated with placebo. This substudy was restricted to women who were 50 to 59 years old at the time of randomization; follow-up scans were obtained an average of 8.7 years later.
Coronary-artery calcium scores were available for 1064 eligible participants. The mean scores were 83 in the estrogen group and 123 in the placebo group (P=0.02). The 50th percentile value of the scores was 0 in both groups, and the 75th percentile values were 43 in the estrogen group and 84 in the placebo group. The overall distribution of scores was significantly lower in the estrogen group than in the placebo group.
Comment: This WHI follow-up study provides additional evidence that estrogens may be beneficial for younger postmenopausal women. These results, however, should not be considered independent confirmation of the original subgroup analysis, because they were found in the same group of patients. Also, although coronary-artery calcium scores are predictive of outcomes, these findings do not translate directly to better outcomes with estrogen treatment, nor do they overturn current recommendations that hormone therapy be limited to the treatment of moderate-to-severe menopausal symptoms, using the lowest effective dose for the shortest duration necessary.
— Harlan M. Krumholz, MD, SM
Published in Journal Watch Cardiology July 18, 2007
Citation(s):
Manson JE et al. for the WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007 Jun 21; 356:2591-602.
Antibiotic Use Early in Life Increases Risk for Asthma
This population-based study confirms previous studies that found an association between antibiotic use and development of childhood asthma.
Results from previous studies have been equivocal regarding the association between antibiotic use early in life and the development of asthma during childhood. To examine risk factors for asthma at age 7, Canadian investigators conducted a longitudinal cohort study using healthcare and prescription databases in Manitoba, Canada.
Among 13,116 children born in 1995, 65% received oral antibiotics during the first year (mostly broad spectrum). To control for reverse causation, children who were diagnosed with asthma during the first year were excluded. After controlling for gender, maternal history of asthma, number of siblings, urban or rural location, and number of healthcare visits, antibiotic use during the first year of life compared with no use was associated with significantly increased risk for developing asthma (odds ratios, 1.27 for 1–2 doses; 1.41 for 3–4 doses; and 1.74 for >4 doses). The association between asthma and antibiotic use was increased among children who lived in rural areas, children whose mothers did not have asthma, and children who did not live with a dog at home during the first year, especially among those who had received multiple doses. The association between asthma and broad-spectrum antibiotic use was statistically significant; the association with narrow-spectrum antibiotics was not. Children who received antibiotics for nonrespiratory infections were about twice as likely to have asthma at age 7 as children who had not used antibiotics.
Comment: The results of this population-based study confirm those of previous studies that found an association between multiple doses of antibiotics and development of childhood asthma and provide yet another reason to avoid unnecessary use of antibiotics, particularly broad-spectrum agents.
— F. Bruder Stapleton, MD
Published in Journal Watch Pediatrics and Adolescent Medicine July 18, 2007
Citation(s):
Kozyrskyj AL et al. Increased risk of childhood asthma from antibiotic use in early life. Chest 2007 Jun; 131:1753-9.
Results from previous studies have been equivocal regarding the association between antibiotic use early in life and the development of asthma during childhood. To examine risk factors for asthma at age 7, Canadian investigators conducted a longitudinal cohort study using healthcare and prescription databases in Manitoba, Canada.
Among 13,116 children born in 1995, 65% received oral antibiotics during the first year (mostly broad spectrum). To control for reverse causation, children who were diagnosed with asthma during the first year were excluded. After controlling for gender, maternal history of asthma, number of siblings, urban or rural location, and number of healthcare visits, antibiotic use during the first year of life compared with no use was associated with significantly increased risk for developing asthma (odds ratios, 1.27 for 1–2 doses; 1.41 for 3–4 doses; and 1.74 for >4 doses). The association between asthma and antibiotic use was increased among children who lived in rural areas, children whose mothers did not have asthma, and children who did not live with a dog at home during the first year, especially among those who had received multiple doses. The association between asthma and broad-spectrum antibiotic use was statistically significant; the association with narrow-spectrum antibiotics was not. Children who received antibiotics for nonrespiratory infections were about twice as likely to have asthma at age 7 as children who had not used antibiotics.
Comment: The results of this population-based study confirm those of previous studies that found an association between multiple doses of antibiotics and development of childhood asthma and provide yet another reason to avoid unnecessary use of antibiotics, particularly broad-spectrum agents.
— F. Bruder Stapleton, MD
Published in Journal Watch Pediatrics and Adolescent Medicine July 18, 2007
Citation(s):
Kozyrskyj AL et al. Increased risk of childhood asthma from antibiotic use in early life. Chest 2007 Jun; 131:1753-9.
FDA Approves Artificial Disc for Degenerative Cervical Spine Disease
The FDA has approved the Prestige Cervical Disc, a first-of-its-kind device used for the treatment of degenerative disc disease, a common source of neck and arm pain.
The device consists of two pieces of hinged stainless steel that, after removal of the damaged disc, are attached to adjacent vertebrae with bone screws.
Its approval was based in part on a clinical trial of about 540 patients that found surgery to replace the damaged disc with the artificial one was as safe and effective as cervical fusion.
The device consists of two pieces of hinged stainless steel that, after removal of the damaged disc, are attached to adjacent vertebrae with bone screws.
Its approval was based in part on a clinical trial of about 540 patients that found surgery to replace the damaged disc with the artificial one was as safe and effective as cervical fusion.
Tuesday, July 17, 2007
CDC Yellow Book
The CDC has released its biennial revision of "the yellow book," a health guide for international travel.
The book describes travel-related infections and diseases endemic to each region. Changes in the latest edition include updates on recommended immunizations, developments in malaria treatment and prevention, advice for avoiding deep vein thrombosis while flying, and a section on avian influenza.
The yellow-covered book, officially titled "CDC Health Information for International Travel 2008," is available free online (and can also be purchased in bookstores).
http://wwwn.cdc.gov/travel/ybToc.aspx
The book describes travel-related infections and diseases endemic to each region. Changes in the latest edition include updates on recommended immunizations, developments in malaria treatment and prevention, advice for avoiding deep vein thrombosis while flying, and a section on avian influenza.
The yellow-covered book, officially titled "CDC Health Information for International Travel 2008," is available free online (and can also be purchased in bookstores).
http://wwwn.cdc.gov/travel/ybToc.aspx
Wednesday, July 11, 2007
Prophylaxis Not Associated with Lower Recurrence of UTIs in Children
The use of antimicrobial prophylaxis after a first childhood urinary tract infection is not associated with lower rates of recurrence — and in fact is associated with an increased risk for resistant infections, according to a JAMA study.
Researchers followed some 600 children under age 6 with first episodes of UTI for over a year to examine the characteristics that would predict recurrent infections. They found that white race, age 3 to 5 years, and grade 4 to 5 vesicoureteral reflux were all factors associated with increased risk for recurrence. Antimicrobial prophylaxis had no effect on recurrence risk, but among children in whom infection recurred, prophylaxis was associated with an increased risk for resistant infections.
The authors suggest that clinicians "discuss the risks and unclear benefits of prophylaxis with families ... after a first UTI."
Full text:
http://jama.ama-assn.org/cgi/content/full/298/2/179
Researchers followed some 600 children under age 6 with first episodes of UTI for over a year to examine the characteristics that would predict recurrent infections. They found that white race, age 3 to 5 years, and grade 4 to 5 vesicoureteral reflux were all factors associated with increased risk for recurrence. Antimicrobial prophylaxis had no effect on recurrence risk, but among children in whom infection recurred, prophylaxis was associated with an increased risk for resistant infections.
The authors suggest that clinicians "discuss the risks and unclear benefits of prophylaxis with families ... after a first UTI."
Full text:
http://jama.ama-assn.org/cgi/content/full/298/2/179
Functional Ovarian Cysts: Do OCs Hasten Resolution?
Review: the current evidence does not suggest that oral contraceptives hasten resolution of functional ovarian cysts
Grimes DA, Jones LB, Lopez LM, et al. Oral contraceptives for functional ovarian cysts. Cochrane Database Syst Rev 2006;(4):CD006134. [Medline® abstract]
Evidence-Based Medicine 2007;12:76; doi:10.1136/ebm.12.3.76 [Free full-text EBM article pdf] [Medline® abstract]
Commentary
Kathleen Hoeger, MD
University of Rochester,
Rochester, New York, USA
Functional ovarian cysts are one of the most common gynaecological problems diagnosed in reproductive aged women. Grimes et al reviewed RCTs that examined the role of OCs for treatment after a cyst is diagnosed. It is important to be aware that many women have ovarian cysts with few or no symptoms; thus, the studies included in this report represent either symptomatic cysts or cysts identified during routine assessment for fertility treatment. At least 2 RCTs in the review included many women who may not have had symptoms at the time of the ultrasound diagnosis of the cyst, as ultrasonography was done routinely during clomiphene or gonadotropin treatment cycles.
Because functional ovarian cysts often result from dysfunction at the level of the hypothalamic pituitary ovarian (HPO) axis, they occur more frequently in women with irregular menses or in the perimenopausal period.1 Additionally, there is evidence that use of OCs, which suppress the HPO axis, may reduce the development of ovarian cysts,2 making the suppression of the HPO axis a logical choice for treatment of an existing cyst. Despite the benign nature of the majority of functional appearing ovarian cysts, when they are discovered at the time of ultrasonography, patients experience increased anxiety and often request treatment.
The review by Grimes et al revealed that, in most cases, cysts will resolve without treatment and those that persist are often not functional in nature. Although there were too few large RCTs to allow for meta-analysis, the use of OCs neither increased the probability of cyst resolution nor decreased the time to resolution. However, the review did not address the issue of recurrent cyst formation, for which evidence does suggest a role for HPO axis suppression.
In summary, Grimes et al showed that no strong evidence exists for use of OCs in the treatment of ovarian cysts. Reassurance alone is appropriate, with follow up to detect cysts that do not resolve, as persistent cysts are likely to represent pathological conditions.
REFERENCES
1. Parazzini F, Moroni S, Negri E, et al. Risk factors for functional ovarian cysts. Epidemiology 1996;7:547–9. [Medline® abstract]
2. Chiaffarino F, Parazzini F, La Vecchia C, et al. Oral contraceptive use and benign gynecologic conditions. A review. Contraception 1998;57:11–8. [Medline® abstract]
Grimes DA, Jones LB, Lopez LM, et al. Oral contraceptives for functional ovarian cysts. Cochrane Database Syst Rev 2006;(4):CD006134. [Medline® abstract]
Evidence-Based Medicine 2007;12:76; doi:10.1136/ebm.12.3.76 [Free full-text EBM article pdf] [Medline® abstract]
Commentary
Kathleen Hoeger, MD
University of Rochester,
Rochester, New York, USA
Functional ovarian cysts are one of the most common gynaecological problems diagnosed in reproductive aged women. Grimes et al reviewed RCTs that examined the role of OCs for treatment after a cyst is diagnosed. It is important to be aware that many women have ovarian cysts with few or no symptoms; thus, the studies included in this report represent either symptomatic cysts or cysts identified during routine assessment for fertility treatment. At least 2 RCTs in the review included many women who may not have had symptoms at the time of the ultrasound diagnosis of the cyst, as ultrasonography was done routinely during clomiphene or gonadotropin treatment cycles.
Because functional ovarian cysts often result from dysfunction at the level of the hypothalamic pituitary ovarian (HPO) axis, they occur more frequently in women with irregular menses or in the perimenopausal period.1 Additionally, there is evidence that use of OCs, which suppress the HPO axis, may reduce the development of ovarian cysts,2 making the suppression of the HPO axis a logical choice for treatment of an existing cyst. Despite the benign nature of the majority of functional appearing ovarian cysts, when they are discovered at the time of ultrasonography, patients experience increased anxiety and often request treatment.
The review by Grimes et al revealed that, in most cases, cysts will resolve without treatment and those that persist are often not functional in nature. Although there were too few large RCTs to allow for meta-analysis, the use of OCs neither increased the probability of cyst resolution nor decreased the time to resolution. However, the review did not address the issue of recurrent cyst formation, for which evidence does suggest a role for HPO axis suppression.
In summary, Grimes et al showed that no strong evidence exists for use of OCs in the treatment of ovarian cysts. Reassurance alone is appropriate, with follow up to detect cysts that do not resolve, as persistent cysts are likely to represent pathological conditions.
REFERENCES
1. Parazzini F, Moroni S, Negri E, et al. Risk factors for functional ovarian cysts. Epidemiology 1996;7:547–9. [Medline® abstract]
2. Chiaffarino F, Parazzini F, La Vecchia C, et al. Oral contraceptive use and benign gynecologic conditions. A review. Contraception 1998;57:11–8. [Medline® abstract]
ADA/EASD consensus guidelines and algorithm
**also see memo on palm under "endo"
The ADA/EASD consensus guidelines and algorithm emphasize:1
Achievement and maintenance of normal glycemic goals
Initial therapy with lifestyle intervention and (usually) metformin
Rapid addition of medications, and/or transition to new interventions/regimens as rapidly as possible — when target glycemic goals are not achieved or sustained
Early addition of insulin therapy in patients who do not meet target goals using other medications, or promptly in patients with greater hyperglycemia
Selecting antihyperglycemic interventions
As seen in algorithm below, the ADA/EASD consensus is that metformin therapy should be initiated concurrently with lifestyle intervention at diagnosis in all but the mildest patients with T2 DM (without contraindications). However, given the progressive nature of T2 DM, more than one medication will be necessary for the majority of patients over time.1 The goal is “to achieve and maintain glycemic levels as close to the nondiabetic range as possible and to change interventions at as rapid a pace as titration of medication allows.” 1
Note that the ADA/EASD algorithm above does not include the incretin mimetics, synthetic amylin, or DPP-4 inhibitors, as limited clinical data were available on these relatively new classes of medication at the time of the guideline publication. However, these drugs may be appropriate choices in selected patients.
Per the guidelines, a number of factors influence the selection of antihyperglycemic medications: their effectiveness in lowering glucose, their extraglycemic effects that may reduce long-term complications, safety profiles, tolerability, and cost.1
When adding a second and potentially third antihyperglycemic medication, the physician should consider potential synergy and other interactions of particular combinations. Generally, agents with different mechanisms of action have greater synergy. For example, insulin plus metformin or insulin plus a thiazolidinedione (TZD) are particularly effective in lowering glycemia.1
Initiation and intensification of basal insulin in patients who fail on oral agents1
The ADA/EASD recommends basal insulin either as second-line therapy if metformin fails, or as third-line therapy if metformin plus a second oral agent fails to meet A1C targets. As stated in the guidelines: “Although 3 oral agents can be used in patients who fail to reach target A1C, the initiation and intensification of insulin therapy is preferred based on effectiveness and expense.”1
For patients with T2 DM, initial insulin therapy is aimed at lowering fasting blood glucose, typically with long- or intermediate-acting insulins. Some patients may also require preprandial rapid- or short-acting insulin therapy.1
Current options in basal insulin therapy
Among the currently available basal insulin therapies to choose from are the insulin analogs and NPH insulin:
Insulin analogs: The newer long-acting insulin analogs, such as Lantus® (insulin glargine [rDNA origin]), and Levemir® (insulin detemir [rDNA origin]) are preferred by many physicians and patients due to their lack of pronounced peak and approximate 24-hour duration of action. Both agents were created by recombinant DNA modification of human insulin, and have the advantage of providing a steady, consistent level of basal insulin coverage.2,3 The physio/chemical structure of LANTUS enables slow release of drug, allowing it to be dosed once-daily.2 Levemir can be dosed once- or twice-daily.3 Treatment with a single-dose of long-acting insulin analog can minimize the complexity of insulin therapy, and decrease the risk of hypoglycemia and weight gain seen with NPH insulin.4 It also compares favorably to adding a third oral agent (a TZD) for impact on health-related quality of life.5
NPH insulin: Neutral protamine Hagedorn, or NPH, insulin has an intermediate duration of action and typically requires twice-daily injection to achieve required basal insulin levels over 24 hours. NPH insulin is lower in cost than the analogs.1,6 So, in patients for whom cost is a consideration, physicians may want to prescribe NPH beginning at bedtime (not dinner) to lower fasting blood glucose (FBG). Target FBG levels in T2 DM are generally 100 mg/dL or slightly less.
Both long-acting analogs and bedtime NPH as basal insulin can be added to oral or other diabetes medications. They can also be started as initial antihyperglycemic therapy when patients have greater hyperglycemia (eg, FBG >300 mg/dL and/or A1C >10%; these patients almost always require insulin treatment to control their glucose intolerance).
BD Ultra-Fine™ Insulin Syringes and Pen Needles: Quality, Comfort and Convenience
MYTH: Taking injections of insulin and other diabetes medications will be painful.
REALITY: Many patients have no idea just how small and thin an insulin needle actually is, and are pleasantly surprised when they finally see and use one for the first time. Also, many are benefiting from the increasing range and availability of insulin pens, since they find it easier and more convenient to dial and administer their dose with this delivery device. Both the insulin analogs and NPH insulin are available in pens.
BD Ultra-Fine Insulin Syringes and Pen Needles are an excellent choice for patients on, or transitioning to, insulin therapy:
No insulin syringe needle is shorter or thinner than BD Ultra-Fine
BD pen needles are universally compatible with all makes of diabetes pens and dosers in the US
BD pen needles come in a variety of lengths, including the shortest pen needle available (5mm) to meet the needs of all patients
BD Getting Started™ Take Home Kits are available to help your patients effectively transition to injection therapy
For more information on BD Ultra-Fine injection products and how to access complimentary BD Getting Started™ kits for your medical practice, visit www.bddiabetes.com/us/
REFERENCES
1. Nathan DM, Buse JB, Davidson MB, et al. Management of Hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29:1963-1972.
2. Lantus [prescribing information]. February 2006. Bridgewater, NJ, sanofi-aventis, U.S., LLC.
3. Levemir [prescribing information]. 2005. Princeton, NJ, NovoNordisk, Inc.
4. Bethel MA, Feinglos MN. Basal insulin therapy in type 2 diabetes. J Am Board Fam Med. 2005;18:199-204.
5. Vinik AI, Zhang Q: Adding Insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007;30(4):795-800.
6. Goldman-Levine JD. Insulin detemir (Levemir) for diabetes mellitus. STEPS: New drug reviews. Am Fam Physician. 2006;74(2). Available at: http://www.aafp.org/afp/20060715/steps.html.
The ADA/EASD consensus guidelines and algorithm emphasize:1
Achievement and maintenance of normal glycemic goals
Initial therapy with lifestyle intervention and (usually) metformin
Rapid addition of medications, and/or transition to new interventions/regimens as rapidly as possible — when target glycemic goals are not achieved or sustained
Early addition of insulin therapy in patients who do not meet target goals using other medications, or promptly in patients with greater hyperglycemia
Selecting antihyperglycemic interventions
As seen in algorithm below, the ADA/EASD consensus is that metformin therapy should be initiated concurrently with lifestyle intervention at diagnosis in all but the mildest patients with T2 DM (without contraindications). However, given the progressive nature of T2 DM, more than one medication will be necessary for the majority of patients over time.1 The goal is “to achieve and maintain glycemic levels as close to the nondiabetic range as possible and to change interventions at as rapid a pace as titration of medication allows.” 1
Note that the ADA/EASD algorithm above does not include the incretin mimetics, synthetic amylin, or DPP-4 inhibitors, as limited clinical data were available on these relatively new classes of medication at the time of the guideline publication. However, these drugs may be appropriate choices in selected patients.
Per the guidelines, a number of factors influence the selection of antihyperglycemic medications: their effectiveness in lowering glucose, their extraglycemic effects that may reduce long-term complications, safety profiles, tolerability, and cost.1
When adding a second and potentially third antihyperglycemic medication, the physician should consider potential synergy and other interactions of particular combinations. Generally, agents with different mechanisms of action have greater synergy. For example, insulin plus metformin or insulin plus a thiazolidinedione (TZD) are particularly effective in lowering glycemia.1
Initiation and intensification of basal insulin in patients who fail on oral agents1
The ADA/EASD recommends basal insulin either as second-line therapy if metformin fails, or as third-line therapy if metformin plus a second oral agent fails to meet A1C targets. As stated in the guidelines: “Although 3 oral agents can be used in patients who fail to reach target A1C, the initiation and intensification of insulin therapy is preferred based on effectiveness and expense.”1
For patients with T2 DM, initial insulin therapy is aimed at lowering fasting blood glucose, typically with long- or intermediate-acting insulins. Some patients may also require preprandial rapid- or short-acting insulin therapy.1
Current options in basal insulin therapy
Among the currently available basal insulin therapies to choose from are the insulin analogs and NPH insulin:
Insulin analogs: The newer long-acting insulin analogs, such as Lantus® (insulin glargine [rDNA origin]), and Levemir® (insulin detemir [rDNA origin]) are preferred by many physicians and patients due to their lack of pronounced peak and approximate 24-hour duration of action. Both agents were created by recombinant DNA modification of human insulin, and have the advantage of providing a steady, consistent level of basal insulin coverage.2,3 The physio/chemical structure of LANTUS enables slow release of drug, allowing it to be dosed once-daily.2 Levemir can be dosed once- or twice-daily.3 Treatment with a single-dose of long-acting insulin analog can minimize the complexity of insulin therapy, and decrease the risk of hypoglycemia and weight gain seen with NPH insulin.4 It also compares favorably to adding a third oral agent (a TZD) for impact on health-related quality of life.5
NPH insulin: Neutral protamine Hagedorn, or NPH, insulin has an intermediate duration of action and typically requires twice-daily injection to achieve required basal insulin levels over 24 hours. NPH insulin is lower in cost than the analogs.1,6 So, in patients for whom cost is a consideration, physicians may want to prescribe NPH beginning at bedtime (not dinner) to lower fasting blood glucose (FBG). Target FBG levels in T2 DM are generally 100 mg/dL or slightly less.
Both long-acting analogs and bedtime NPH as basal insulin can be added to oral or other diabetes medications. They can also be started as initial antihyperglycemic therapy when patients have greater hyperglycemia (eg, FBG >300 mg/dL and/or A1C >10%; these patients almost always require insulin treatment to control their glucose intolerance).
BD Ultra-Fine™ Insulin Syringes and Pen Needles: Quality, Comfort and Convenience
MYTH: Taking injections of insulin and other diabetes medications will be painful.
REALITY: Many patients have no idea just how small and thin an insulin needle actually is, and are pleasantly surprised when they finally see and use one for the first time. Also, many are benefiting from the increasing range and availability of insulin pens, since they find it easier and more convenient to dial and administer their dose with this delivery device. Both the insulin analogs and NPH insulin are available in pens.
BD Ultra-Fine Insulin Syringes and Pen Needles are an excellent choice for patients on, or transitioning to, insulin therapy:
No insulin syringe needle is shorter or thinner than BD Ultra-Fine
BD pen needles are universally compatible with all makes of diabetes pens and dosers in the US
BD pen needles come in a variety of lengths, including the shortest pen needle available (5mm) to meet the needs of all patients
BD Getting Started™ Take Home Kits are available to help your patients effectively transition to injection therapy
For more information on BD Ultra-Fine injection products and how to access complimentary BD Getting Started™ kits for your medical practice, visit www.bddiabetes.com/us/
REFERENCES
1. Nathan DM, Buse JB, Davidson MB, et al. Management of Hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29:1963-1972.
2. Lantus [prescribing information]. February 2006. Bridgewater, NJ, sanofi-aventis, U.S., LLC.
3. Levemir [prescribing information]. 2005. Princeton, NJ, NovoNordisk, Inc.
4. Bethel MA, Feinglos MN. Basal insulin therapy in type 2 diabetes. J Am Board Fam Med. 2005;18:199-204.
5. Vinik AI, Zhang Q: Adding Insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007;30(4):795-800.
6. Goldman-Levine JD. Insulin detemir (Levemir) for diabetes mellitus. STEPS: New drug reviews. Am Fam Physician. 2006;74(2). Available at: http://www.aafp.org/afp/20060715/steps.html.
Strep throat guidelines
Primary care clinicians often fail to follow guidelines when treating patients with sore throats
When doctors see patients with sore throats (pharyngitis), a chief concern is to diagnose or rule out strep throat (caused by the bacterium group A B-hemolytic streptococci). Yet in two-thirds of sore throat visits, primary care clinicians do not follow any available clinical guideline. During these visits, doctors frequently give a strep test to or prescribe antibiotics for patients who are at low risk of strep throat, or for whom tests and antibiotics are not recommended, note researchers at Brigham and Women's Hospital in Boston.
To measure the rate of physician adherence to 3 guidelines, the researchers retrospectively analyzed visits to Boston area primary care clinics by 2,097 adults diagnosed with pharyngitis. The three guidelines included the American College of Physicians (ACP) empirical strategy, the ACP test strategy, and the Infectious Diseases Society of America (IDSA) strategy. Primary care clinicians followed the ACP empirical strategy in 12 percent of visits, the ACP test strategy in 30 percent of visits, and the IDSA strategy in 30 percent of visits. Physicians followed none of these strategies in 66 percent of visits.
The ACP recommends evaluation of adults with pharyngitis using the four-point Centor criteria: fever, absence of cough, tender and swollen anterior lymph nodes, and exudate (pus) on the tonsils. The ACP recommends two potential treatment strategies: empirical antibiotic treatment of patients who meet three of the four Centor criteria (ACP empirical strategy), or testing patients with two or three criteria using a rapid strep test and prescribing antibiotics to patients with a positive test or with four criteria (ACP test strategy). The IDSA guideline agrees with the ACP guideline that adults with zero or one Centor criteria, who are at low risk for strep throat, should neither be tested nor treated with antibiotics. However, the IDSA recommends microbiologic confirmation for all adults with pharyngitis prior to antibiotic prescribing. The study was supported in part by the Agency for Healthcare Research and Quality (HS14420 and HS14563).
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More details are in "Evaluation and treatment of pharyngitis in primary care practice," Jeffrey A. Linder, M.D., M.P.H., Joseph C. Chan, B.S., and David W. Bates, M.D., M.Sc., in the July 10, 2006, Archives of Internal Medicine 166, pp. 1374-1379. [Medline® abstract]
Research Activities Newsletter. April 2007, No. 320. AHRQ Publication No. 07-0027. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/apr07/
The above message comes from "AHRQ", who is solely responsible for its conten
When doctors see patients with sore throats (pharyngitis), a chief concern is to diagnose or rule out strep throat (caused by the bacterium group A B-hemolytic streptococci). Yet in two-thirds of sore throat visits, primary care clinicians do not follow any available clinical guideline. During these visits, doctors frequently give a strep test to or prescribe antibiotics for patients who are at low risk of strep throat, or for whom tests and antibiotics are not recommended, note researchers at Brigham and Women's Hospital in Boston.
To measure the rate of physician adherence to 3 guidelines, the researchers retrospectively analyzed visits to Boston area primary care clinics by 2,097 adults diagnosed with pharyngitis. The three guidelines included the American College of Physicians (ACP) empirical strategy, the ACP test strategy, and the Infectious Diseases Society of America (IDSA) strategy. Primary care clinicians followed the ACP empirical strategy in 12 percent of visits, the ACP test strategy in 30 percent of visits, and the IDSA strategy in 30 percent of visits. Physicians followed none of these strategies in 66 percent of visits.
The ACP recommends evaluation of adults with pharyngitis using the four-point Centor criteria: fever, absence of cough, tender and swollen anterior lymph nodes, and exudate (pus) on the tonsils. The ACP recommends two potential treatment strategies: empirical antibiotic treatment of patients who meet three of the four Centor criteria (ACP empirical strategy), or testing patients with two or three criteria using a rapid strep test and prescribing antibiotics to patients with a positive test or with four criteria (ACP test strategy). The IDSA guideline agrees with the ACP guideline that adults with zero or one Centor criteria, who are at low risk for strep throat, should neither be tested nor treated with antibiotics. However, the IDSA recommends microbiologic confirmation for all adults with pharyngitis prior to antibiotic prescribing. The study was supported in part by the Agency for Healthcare Research and Quality (HS14420 and HS14563).
______________________________________________
More details are in "Evaluation and treatment of pharyngitis in primary care practice," Jeffrey A. Linder, M.D., M.P.H., Joseph C. Chan, B.S., and David W. Bates, M.D., M.Sc., in the July 10, 2006, Archives of Internal Medicine 166, pp. 1374-1379. [Medline® abstract]
Research Activities Newsletter. April 2007, No. 320. AHRQ Publication No. 07-0027. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/apr07/
The above message comes from "AHRQ", who is solely responsible for its conten
Guideline: Mammography optional in women 40-49
Clinical Question: Should screening mammography be used in women between the ages of 40 years and 49 years?
Bottom Line: In a break from other authorities, this evidence-based guideline from the American College of Physicians (ACP) makes no absolute recommendation for or against the screening of women between the ages of 40 years and 49 years. Instead, it recommends routine, periodic risk assessment, as well as discussions with individuals regarding the benefits and harms of screening mammography.(LOE = 1a)
Reference: Armstrong K, Moye E, Williams S, Berlin JA, Reynolds EE. Screening mammography in women 40 to 49 years of age: a systematic review for the American College of Physicians. Ann Intern Med 2007;146:516-526. [Free full-text Annals article online] [Medline® abstract]
Study Design: Practice guideline
Funding: Foundation
Setting: Various (guideline)
Synopsis
Here's an underappreciated fact: More women between the ages of 40 and 49 years die from heart disease (6800) than from breast cancer (5000) each year. To develop this guideline, the ACP researchers analyzed the latest meta-analyses on this topic and considered an additional study that was subsequently published. The main findings: There are 7% to 23% fewer deaths due to breast cancer over an average of 14 years with screening starting at age 40; an overall mortality reduction hasn't been shown; screening increases rates of mastectomy; rates of ductal carcinoma in situ diagnosis skyrocket 7-fold with increased screening, representing 25% of the diagnoses of "cancer" in this age group; and, 20% to 56% of women will have a false-positive diagnosis when tested yearly for 10 years. In addition to recommending more research, the authors made 3 recommendations:
(1) The decision of whether to order a screening mammography should be made on an individual basis, taking into account the benefits, harms, risk profile, and patient preferences.
(2) Clinicians should update a woman's risk profile every 1 to 2 years. Risk factors for all women include a family history of breast cancer, earlier menarche, later age at time of first birth, and a history of breast biopsy. In addition, women aged 40 to 49 years with certain risk factors are at higher risk than the average 50-year-old woman, including 2 first-degree relatives with breast cancer and 2 previous breast biopsies. The Gail Risk Model Calculator (available in InfoRetriever) can be used to determine an individual woman's risk.
(3) Clinicians should discuss the potential benefits and harm of screening mammography with their patients. The most recent meta-analysis found a reduction in breast cancer-related mortality by 15%, although the confidence interval was wide (as little as 1% risk reduction and as much as 27% risk reduction). A more recent randomized trial, which was not included in the meta-analysis, found no statistically significant reduction in risk of breast cancer mortality. Potential harms include false-positive results, which are as high as 20% to 56% over the course of 10 mammograms, as well as the anxiety associated with the false-positives. Other theoretical risks include discomfort with the procedure. The authors found no evidence of increased radiation-induced cancer or overdiagnosis due to screening.
Written by Cung Pham, MD
Copyright © 2007 by Wiley Subscription Services, Inc. All rights reserved. www.infopoems.com
Bottom Line: In a break from other authorities, this evidence-based guideline from the American College of Physicians (ACP) makes no absolute recommendation for or against the screening of women between the ages of 40 years and 49 years. Instead, it recommends routine, periodic risk assessment, as well as discussions with individuals regarding the benefits and harms of screening mammography.(LOE = 1a)
Reference: Armstrong K, Moye E, Williams S, Berlin JA, Reynolds EE. Screening mammography in women 40 to 49 years of age: a systematic review for the American College of Physicians. Ann Intern Med 2007;146:516-526. [Free full-text Annals article online] [Medline® abstract]
Study Design: Practice guideline
Funding: Foundation
Setting: Various (guideline)
Synopsis
Here's an underappreciated fact: More women between the ages of 40 and 49 years die from heart disease (6800) than from breast cancer (5000) each year. To develop this guideline, the ACP researchers analyzed the latest meta-analyses on this topic and considered an additional study that was subsequently published. The main findings: There are 7% to 23% fewer deaths due to breast cancer over an average of 14 years with screening starting at age 40; an overall mortality reduction hasn't been shown; screening increases rates of mastectomy; rates of ductal carcinoma in situ diagnosis skyrocket 7-fold with increased screening, representing 25% of the diagnoses of "cancer" in this age group; and, 20% to 56% of women will have a false-positive diagnosis when tested yearly for 10 years. In addition to recommending more research, the authors made 3 recommendations:
(1) The decision of whether to order a screening mammography should be made on an individual basis, taking into account the benefits, harms, risk profile, and patient preferences.
(2) Clinicians should update a woman's risk profile every 1 to 2 years. Risk factors for all women include a family history of breast cancer, earlier menarche, later age at time of first birth, and a history of breast biopsy. In addition, women aged 40 to 49 years with certain risk factors are at higher risk than the average 50-year-old woman, including 2 first-degree relatives with breast cancer and 2 previous breast biopsies. The Gail Risk Model Calculator (available in InfoRetriever) can be used to determine an individual woman's risk.
(3) Clinicians should discuss the potential benefits and harm of screening mammography with their patients. The most recent meta-analysis found a reduction in breast cancer-related mortality by 15%, although the confidence interval was wide (as little as 1% risk reduction and as much as 27% risk reduction). A more recent randomized trial, which was not included in the meta-analysis, found no statistically significant reduction in risk of breast cancer mortality. Potential harms include false-positive results, which are as high as 20% to 56% over the course of 10 mammograms, as well as the anxiety associated with the false-positives. Other theoretical risks include discomfort with the procedure. The authors found no evidence of increased radiation-induced cancer or overdiagnosis due to screening.
Written by Cung Pham, MD
Copyright © 2007 by Wiley Subscription Services, Inc. All rights reserved. www.infopoems.com
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