-
effectivehealthcare.ahrq.gov/sites/default/files/diabetes-update-2015_disposition-comments.pdf
January 01, 2015 - the Methods section of the
Executive Summary that we searched
ClinicalTrials.gov and the Food and Drug … drug 1". … We have
changed the legend for the hypoglycemia figure
to say, "Fewer events with drug 2/drug 1." … What are the specific pros
and cons of the choice of a second drug to add to
metformin when greater … Note glibenclamide and glyburide are the
same drug, right? Needs a table footnote.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/cad-women-treatment_research-protocol.pdf
September 29, 2011 - to this posting, the following changes were included in the key questions:
Adding ―adverse drug … What are the significant safety concerns associated with each treatment strategy (i.e., adverse
drug … What are the significant safety concerns associated with each treatment strategy (i.e., adverse
drug … What are the significant safety concerns associated with each treatment strategy (i.e., adverse
drug … The safety outcomes will be framed to help
identify adverse events, including adverse drug reactions
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/medical-interventions-comparing_methods.pdf
November 01, 2008 - led to a series of Medicare reforms passed by Congress in 2003.
3
These reforms
included a new drug … Accessed November
2007.
3
Medicare Prescription Drug, Improvement,
and Modernization Act of 2008
-
effectivehealthcare.ahrq.gov/sites/default/files/methodsguide_slutsky_comparing_medical_interventions.pdf
November 01, 2008 - led to a series of Medicare reforms passed by Congress in 2003.
3
These reforms
included a new drug … Accessed November
2007.
3
Medicare Prescription Drug, Improvement,
and Modernization Act of 2008
-
effectivehealthcare.ahrq.gov/system/files/docs/headaches-pregnancy-topic-brief.pdf
January 01, 2019 - Drug therapy for treating post-dural puncture
headache. … Nonsteroidal antiinflammatory drug use
among women and the risk of birth defects. … Drug Saf. 2011 Aug 1;34(8):691-703. doi:
10.2165/11590370-000000000-00000. PMID: 21751829.
32. … Pharmacoepidemiol Drug Saf. 2016
May;25(5):493-502. doi: 10.1002/pds.3902. PMID: 26554750. … Drug therapy for treating post-dural puncture
headache.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/type-2-diabetes-medications-update_executive.pdf
March 01, 2011 - Food and Drug
Administration (FDA). … Two-drug combination
therapies with metformin (such as metformin plus
thiazolidinediones, metformin plus … Few studies included insulin
added to oral medications or compared other two-drug
combination therapies … We were unable to
draw any useful conclusions about CHF risk from other
drug comparisons of interest, … their results
by the combination therapy, which includes the
background medication(s) plus the study drug
-
effectivehealthcare.ahrq.gov/sites/default/files/developmental-delays-horizon-scan-high-impact-1306.pdf
June 01, 2013 - similar drugs in the same class are read separately), and then topics in the same class of a
device, drug … Food and Drug Administration
(FDA) has approved intranasal oxytocin for inducing uterine contractions
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND_0583-131115.pdf
March 13, 2013 - Cyclosporine, has a narrow therapeutic window between efficacy and
toxicity, thereby requiring monitoring of drug … mainly as CNI-minimization,
CNI-avoidance, or CNI-withdrawal protocols, seek to reduce the amount of drug
-
effectivehealthcare.ahrq.gov/sites/default/files/crosscutting-horizon-scan-high-impact-1312.pdf
December 01, 2013 - Digital Medicines (Proteus Digital Health Feedback System) for Chronic Conditions
Requiring Long-term Drug … Food and Drug Administration for the monitoring device
in March 2010 and marketing clearance for the … Once activated, the sensor transmits
digital information regarding the drug taken, its dose, and time … Food and Drug Administration (FDA).
510(k) summary for Raisin personal monitor
[K093976]. … Food and Drug Administration (FDA); 2010 Mar
25 [accessed 2010 Dec 27]. [10 p].
-
effectivehealthcare.ahrq.gov/sites/default/files/01_-arthritis_potential_high_impact_june_2012.pdf
January 01, 2012 - similar drugs in the same class are read separately), and then topics in the same class of a device,
drug … lists the seven topics for which (1) preliminary phase III or later phase data were
available for drug … Key Expert Comments: Overall, experts thought that the drug might address the unmet need
for a … Food and Drug Administration (FDA)-compliant manner will be needed in many locations
where there may … tyrosine kinase inhibitor that
is being investigated as a targeted disease-modifying antirheumatic drug
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/stroke-atrial-fibrillation_research-protocol.pdf
January 30, 2012 - Food and Drug Administration (FDA)-approved low-molecular-weight heparins
(e.g., bemiparin, certoparin … Food and Drug Administration; HAS-BLED =
hypertension, abnormal renal/liver function, stroke, bleeding … We will use several approaches to identify relevant gray literature, including requests to drug
and … Food and Drug
Administration (FDA) device registration studies and new drug applications. … Food and Drug Administration
GWTG Get With The Guidelines
HAS-BLED hypertension, abnormal renal/liver
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_disposition-comments.pdf
October 07, 2011 - recommendation for the use of these products in any manner
other than as approved by the Food and Drug … ONTARGET is that
combination therapy had higher adverse event rates but no more
benefit than a single drug … The key questions 1 and 2
specifically examine cardiovascular events and adverse events
between drug … Consideration of drug specific
characteristics such as variations in tissue specificity, side effect … Furthermore, we note that the
report introduces some of the pharmacological differences between
drug
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/crohns-disease-future_research.pdf
July 01, 2016 - first biologic tumor necrosis factor (TNF)-alpha inhibitor,
infliximab, was approved by the Food and Drug … New Drug Application & Biologic License
Application Efficacy Supplements (Approved CY
2008) [Internet … New Drug Application & Biologic License
Application Efficacy Supplements (Approved CY
2008) [Internet … : Cimzia
Drug: Mesalamine
Estimated enrollment: 24
Sponsor OR PI and
Collaborator(s):
Milton S. … : Adalimumab
Drug: 6 Mercaptopurine
Estimated enrollment:
Sponsor OR PI and
Collaborator(s):
-
effectivehealthcare.ahrq.gov/sites/default/files/cer-236-maternal-fetal-child-outcomes-disposition-comments.pdf
April 15, 2021 - • The draft report included references to Food and Drug Administration letter
categories for fetal … lot of studies
did not specify the disorder (they were
based on current vs. past exposure to the
drug … treatment comparison data and the
other comparator data in one table so that readers can
sort by drug … The title of this table should be changed to
“Drug labeling related to pregnancy and nursing”. … Calibration curves were constructed for
each antipsychotic drug assay with free
human plasma by the
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/asthma-pharmacologic-treatment_research-protocol.pdf
December 27, 2016 - of the
pharmacologic interventions include more than one class of medications, in which case
one drug … some of the pharmacologic comparators include more than
one class of medications, in which case one drug … the abstract stage consistent with the process described by the Methods Guide.10
FDA=Food and Drug … Published online September 14, 2016; republished December 27, 2016 10
not on the individual drug … Drug therapies either as individual or combination products of inhaled
corticosteroids, long-acting
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/restless-legs_executive.pdf
November 01, 2012 - Dopamine agonists can result in a treatment complication
called augmentation, which is a drug-induced … Central, the
International Controlled Trials Registry Platform (ICTRP),
Clinicaltrials.gov, Food and Drug … Results
We organized results by Key Question and by class of
drug/therapy. … Four
studies investigated multiple fixed doses of the drug in
separate study arms.25,34,37,39
IRLS … Augmentation,
a drug-induced exacerbation of the disease, can occur with
dopaminergic drugs.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/chronic-pain-opioid-treatment_disposition-comments.pdf
September 29, 2014 - We have previously submitted comments to FDA regarding “Impact of Approved Drug
Labeling on Chronic … Our prescription drug abuse project
works to develop and support policies that will help reduce the … The Pew
Charitable Trusts recognizes prescription drug abuse as a public health crisis in the
United … iii Food and Drug Administration (FDA), “Public Health Advisory: Methadone Use for
Pain Control May … A history of being prescribed controlled substances and risk of drug overdose
death.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/kidney-disease-medicine_surveillance.pdf
October 01, 2012 - would produce prima facie evidence that a conclusion was out of date,
such as the withdrawal of a drug … Is the portion of the CER that is
probably or certainly out of date an issue of safety (a drug withdrawn … from the market, a
black box warning) or the availability of a new drug within class (the latter being … original key questions, the conclusions of the original report, the results of
the literature and drug … screening.tw. or exp drug
evaluation,preclinical/
3. 1 not 2
4.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/high-cholestorol-medicines-update_research-protocol.pdf
December 31, 2013 - The LDL target for moderate-risk patients is less than 130 mg/dL, but the threshold
for starting drug … For moderate-risk
patients with a 10-year CHD risk of 10 to 20 percent, providers should consider drug … above 130 mg/dL; whereas for moderate-risk patients with a 10-year CHD risk
less than 10 percent, drug … Food and Drug Administration; HDL = high-density lipoprotein; IR =
immediate release; LDL = low-density … Food and Drug Administration; HMG-CoA = 3-hydroxy-3-methyl-glutaryl-
coenzyme A reductase; N/A = not
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/hypertension-pulmonary-arterial_disposition-comments.pdf
April 25, 2013 - I liked the clear guidance on BNP testing
and the drug therapy sections. … or continued therapy with that drug plus the addition
of a second drug. … to some “background”
that included another PAH drug. … (i.e. lumping de novo tratment
data with add-on treatment data for a given drug). … If, for example, drug A added to placebo results
in an improvement of X, and when added to drug B (instead