Insulin, hypoglecemia and hospital admissions
Feb 7, 2014 14:54:37 GMT -5
liane, BD, and 2 more like this
Post by jpg on Feb 7, 2014 14:54:37 GMT -5
I was attending grand rounds on oral anticoagulants this am and one the slides shown by the speaker stood out. It dealt with hospital admission by drug class and shows the significant burden diabetic medications side effects put on our patients and on our health care system. I did a bit of digging (see below) after the conference. Interesting (to me anyway) stuff. Maybe someone should send this to MNKD and the FDA...
Check out table 4 from the below link. It ranks insulin as the #2 cause of hospital admission because of adverse drug events. That is a lot of $$$...
www.nejm.org/doi/full/10.1056/NEJMsa1103053#t=articleResults
Emergency Hospitalizations for Adverse Drug Events in Older Americans
Daniel S. Budnitz, M.D., M.P.H., Maribeth C. Lovegrove, M.P.H., Nadine Shehab, Pharm.D., M.P.H., and Chesley L. Richards, M.D., M.P.H.
N Engl J Med 2011; 365:2002-2012November 24, 2011DOI: 10.1056/NEJMsa1103053
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From the Results section:
Thirteen medications and medication classes were implicated, alone or in combination, in at least 1% of estimated hospitalizations for adverse drug events (Table 4Table 4National Estimates of Medications Commonly Implicated in Emergency Hospitalizations for Adverse Drug Events in Older U.S. Adults, 2007–2009.). The four most commonly implicated — warfarin (33.3%), insulins (13.9%), oral antiplatelet agents (13.3%), and oral hypoglycemic agents (10.7%) — accounted for an estimated two thirds of hospitalizations (67.0%; 95% CI, 60.0 to 74.1), and these remained the most commonly implicated drugs when stratified according to age (65 to 74 years, 75 to 84 years, and ≥85 years) and sex. Nearly all hospitalizations involving warfarin (95.1%; 95% CI, 91.7 to 98.4), insulins (99.4%; 95% CI, 98.7 to 100.0), or oral hypoglycemic agents (99.1%; 95% CI, 98.1 to 100.0) resulted from unintentional overdoses. Of hospitalizations attributed to warfarin, another medication was implicated in 12.5% of visits (95% CI, 6.7 to 18.3), most often an oral antiplatelet agent (6.7%; 95% CI, 3.2 to 10.2). Of hospitalizations attributed to insulins, another medication was implicated in 15.4% of visits (95% CI, 7.9 to 22.9), most often an oral hypoglycemic agent (10.1%; 95% CI, 6.3 to 14.0).
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From the Discussions section:
The high numbers of hospitalizations for hypoglycemia from antidiabetic agents is consistent with mounting evidence of adverse outcomes from hypoglycemia and suggestions that current guideline and performance measures may not reflect optimal diabetes management for all patients.33
The reference #33 is particularly interesting. Hopefully someone will email this to MNKD (or the FDA) before they meet...
jama.jamanetwork.com/article.aspx?articleid=185923
JAMA; May 26, 2010, Vol 303, No. 20 >
Commentary | May 26, 2010
Balancing Hypoglycemia and Glycemic ControlA Public Health Approach for Insulin Safety
Leonard Pogach, MD, MBA; David Aron, MD, MS
From the JAMA article:
Nonetheless, recent industry-sponsored and professional society–sponsored public service campaigns have framed the discussion in terms of achieving “optimal” control, rather than as carefully reasoned shared decision making based on the individual's absolute risks and benefits.9 A proactive public health effort is necessary to restore a more balanced approach in addressing hypoglycemia in guidelines, policy, measures, and practice.
The Centers for Disease Control and Prevention, the Food and Drug Administration, other federal agencies, and state departments of health should collaborate to improve reporting and surveillance of serious hypoglycemic events.
Comparative effectiveness research should evaluate the magnitude of the hypoglycemic problem and its risk factors in nontrial populations in clinical practice. Studies should simultaneously address process (eg, “insulin initiation”), intermediate outcomes (change in hemoglobin A1c levels), and adverse outcomes (episodes of hypoglycemia, hospitalization, morbidity, and mortality). Such studies would complement future publications from the VADT1 and ACCORD2 studies.
In conclusion, rapidly evolving evidence from clinical trials and observational studies indicates that serious hypoglycemia is frequent, incurs morbidity and increased health care utilization, and may be life-threatening. Despite the significant health burden of hypoglycemia, its risk seems to be understated by guideline and performance measurement groups. It is time for a multipronged public health approach to insulin safety that has as its cornerstones both improved surveillance and informed, patient-shared decision making for glycemic control based on the best available data of benefits and risk applicable to each individual.
Check out table 4 from the below link. It ranks insulin as the #2 cause of hospital admission because of adverse drug events. That is a lot of $$$...
www.nejm.org/doi/full/10.1056/NEJMsa1103053#t=articleResults
Emergency Hospitalizations for Adverse Drug Events in Older Americans
Daniel S. Budnitz, M.D., M.P.H., Maribeth C. Lovegrove, M.P.H., Nadine Shehab, Pharm.D., M.P.H., and Chesley L. Richards, M.D., M.P.H.
N Engl J Med 2011; 365:2002-2012November 24, 2011DOI: 10.1056/NEJMsa1103053
-------------------------------------------------------------------------------------------------
From the Results section:
Thirteen medications and medication classes were implicated, alone or in combination, in at least 1% of estimated hospitalizations for adverse drug events (Table 4Table 4National Estimates of Medications Commonly Implicated in Emergency Hospitalizations for Adverse Drug Events in Older U.S. Adults, 2007–2009.). The four most commonly implicated — warfarin (33.3%), insulins (13.9%), oral antiplatelet agents (13.3%), and oral hypoglycemic agents (10.7%) — accounted for an estimated two thirds of hospitalizations (67.0%; 95% CI, 60.0 to 74.1), and these remained the most commonly implicated drugs when stratified according to age (65 to 74 years, 75 to 84 years, and ≥85 years) and sex. Nearly all hospitalizations involving warfarin (95.1%; 95% CI, 91.7 to 98.4), insulins (99.4%; 95% CI, 98.7 to 100.0), or oral hypoglycemic agents (99.1%; 95% CI, 98.1 to 100.0) resulted from unintentional overdoses. Of hospitalizations attributed to warfarin, another medication was implicated in 12.5% of visits (95% CI, 6.7 to 18.3), most often an oral antiplatelet agent (6.7%; 95% CI, 3.2 to 10.2). Of hospitalizations attributed to insulins, another medication was implicated in 15.4% of visits (95% CI, 7.9 to 22.9), most often an oral hypoglycemic agent (10.1%; 95% CI, 6.3 to 14.0).
-------------------------------------------------------------------------------------------------
From the Discussions section:
The high numbers of hospitalizations for hypoglycemia from antidiabetic agents is consistent with mounting evidence of adverse outcomes from hypoglycemia and suggestions that current guideline and performance measures may not reflect optimal diabetes management for all patients.33
The reference #33 is particularly interesting. Hopefully someone will email this to MNKD (or the FDA) before they meet...
jama.jamanetwork.com/article.aspx?articleid=185923
JAMA; May 26, 2010, Vol 303, No. 20 >
Commentary | May 26, 2010
Balancing Hypoglycemia and Glycemic ControlA Public Health Approach for Insulin Safety
Leonard Pogach, MD, MBA; David Aron, MD, MS
From the JAMA article:
Nonetheless, recent industry-sponsored and professional society–sponsored public service campaigns have framed the discussion in terms of achieving “optimal” control, rather than as carefully reasoned shared decision making based on the individual's absolute risks and benefits.9 A proactive public health effort is necessary to restore a more balanced approach in addressing hypoglycemia in guidelines, policy, measures, and practice.
The Centers for Disease Control and Prevention, the Food and Drug Administration, other federal agencies, and state departments of health should collaborate to improve reporting and surveillance of serious hypoglycemic events.
Comparative effectiveness research should evaluate the magnitude of the hypoglycemic problem and its risk factors in nontrial populations in clinical practice. Studies should simultaneously address process (eg, “insulin initiation”), intermediate outcomes (change in hemoglobin A1c levels), and adverse outcomes (episodes of hypoglycemia, hospitalization, morbidity, and mortality). Such studies would complement future publications from the VADT1 and ACCORD2 studies.
In conclusion, rapidly evolving evidence from clinical trials and observational studies indicates that serious hypoglycemia is frequent, incurs morbidity and increased health care utilization, and may be life-threatening. Despite the significant health burden of hypoglycemia, its risk seems to be understated by guideline and performance measurement groups. It is time for a multipronged public health approach to insulin safety that has as its cornerstones both improved surveillance and informed, patient-shared decision making for glycemic control based on the best available data of benefits and risk applicable to each individual.
