Professional Documents
Culture Documents
www.guidelines.gov/
How is LoE implemented in
Recommendation Guidelines? (2)
• Strength of Recommendation:
– Class I: Conditions for which there is evidence/general agreement
that a given procedure/therapy is useful and effective.
– Class II: Condition for which there is conflicting evidence or
divergence of opinion about the usefulness /efficacy of performing the
procedure /therapy.
» Class IIa: in favor of usefulness
» Class IIb: usefulness is less well established
– Class III:Condition for which there is evidence/general agreement
that a procedure/therapy is not useful/effective and may be harmful.
www.guidelines.gov/
How is LoE implemented in
Recommendation Guidelines? (3)
• “The strength of evidence does not necessarily
reflect the strength of recommendation. A
treatment may be considered controversial
although it has been evaluated in CTs;
conversely, a strong recommendation may be
based on years of clinical experience and be
supported only by historical data or by no data
at all”.
• Disini conflict of interest dari penilai dijaga ketat!!
www.guidelines.gov/
Drug Safety in increased focus
around the world
• Increasing number of drug withdrawals
because of harmful effects (recently: Prepulsid,
Posicor, Hismanal, Rezulin, Lipobay, etc).
• Scientific report on epidemic proportions of
serious ADRs in hospitalized patients.
(Lazarou, JAMA 1998)
• Medical mistakes (45.000 deaths/annually)
and medication errors (28%) are reported,
including under-utilization of proven drug
therapies. (US Institute of Medicine, 2001)
Inhaled Steroids Can Cause Bone Loss in Young Asthmatic Women
by Elliot Israel, M.D., Taruna R., Banerjee, M.P.H., Garrett M. Fitzmaurice, Sc.D., Tania V.
Kotlov, M.S., Karen LaHive, M.D., and Meryl S. LeBoff, M.D.;
The New England Journal of Medicine, September 27, 2001.
Background
Here is the important background information that the authors give us:
-consensus reports recommend increased use of inhaled corticosteroids
(also referred to as glucocorticoids) for patients with asthma,
-it is known that oral corticosteroids accelerate bone loss, and that
fractures occur in 30 to 50% of patients on oral corticoids,
-it is not clear, however, whether inhaled corticosteroids accelerate bone
loss.
ES obat kronis dapat
diperkirakan dari parameter
Chronicity Index
CHRONICITY INDEX is
a measure of chronic toxicity:
LD50 7
Endrin : = = CI = 7
LD50 1
(90 hari)
120
Deksametason : = 1714
0.07
EBM sebenarnya merupakan cara yg
biasa dilakukan dalam proses penilaian
suatu obat baru yg akan dipasarkan.
Disini malah diperlukan juga penilaian
animal dan in-vitro studies.
Perbedaannya:
* Penilaian obat pra-pemasaran
mempertimbangkan seluruh masyarakat,
Correction
of errors
Much of it is correct
• Atypical pneumonia
• Viral peumonia
• Acute bacterial pneumonia
• Aspiration pneumonia
• Ventilator-associated pneumonia
• Pneumonia in an immuno-compromised
and/or neutropenic host.
Community acquired pneumonia (2):
(FDA “Points to Consider” doc.)
•Dokter bahwa
•Spesialis “evidence”
•Herbalis berbeda-beda
•Naturo- menurut
setiap orang
patis atau profesi.
•Awam
dsb.
Number Needed to Treat (NNT)
sebagai petunjuk statistik & klinis EBM
• RCT, karena keterbatasannya sendiri, kadang-kadang
tidak memberi petunjuk jelas akan manfaat suatu
pengobatan untk penderita yg akan diobati (EBM).
• NNT mungkin dapat memberi pegangan yg lebih mudah
diartikan dalam keputusan memberi (obat) atau tidak.
• NNT= “the number of patients who must be treated for a
given period to prevent a clinical outcome (e.g. stroke)”.
• NNT= 100/absolute risk reduction.
• Absolute risk reduction (stroke) =
Stroke Pla (20%) - Stroke Aktif (12%) = 0.20 - 0.12 = 0.08.
NNT untuk mengobati hipertensi
mencegah stroke
Stroke in 5 yrs
RRR Absolute RR NNT
Hypertension Control Active
group group (PC - PA)/PC P C - PA 1/(PC - PA)
Data ini ialah untuk unstable angina. In practice: dipakai untuk kasus lain
dengan indikasi yg berbeda. Apakah ini evidence -based atau ‘extended
evidence’?
EBM menjembatani
Ilmu Kedokteran dan Hukum ?
• EBM mulai dibutuhkan juga oleh seorang
hakim menentukan apakah suatu
pengobatan tertentu sudah benar dalam
persidangan. Diperlukan “ilmu” (evidence)
di belakang pertimbangan suatu testimoni
seorang saksi ahli. (JAMA Vol. 283 No.21, June 2000)
• Juga, EBM menentukan harga saham
pabrik obat, yang disebarkan mass media
ekonomi.
• Namun, masih akan dijumpai
berbagai kendala, karena ilmu
pengobatan dan EBM sendiri
tidak sesederhana itu.
New Pediatric Studies
will change current State of the Art
• Pediatric studies are rare, although FDA
had recommended since 1962.
• There will be more pediatric clinical trials in
the future to support claim.
• FDA Modernization Act (FDAMA 1993) and
the Pediatric Exclusivity Right Act (1998)
will make the above an incentive for the
industry to do pediatric clinical trials.
FDA’s Approved Drugs under
Pediatric Exclusivity Rights Act (1998)
(36/37 active moieties)
Abacavir Glaxo Ketorolac Allergan
Ammon. lactate Westwod-Squibb Lamivudine Glaxo
Azelastine Asta Medica Loratadine Schering Corp.
Bisoprolol Wyeth Ayerst Lovastatin Merck
Buspirone BMS Metformin BMS
Calcitriol Abbott Midazolam Roche
Cromolyn Pharmacia-Upjohn Nabumetone SmithKline
Didanosine BMS Omeprazole Astra Zeneca
Enalapril Merck Oxaprozin Glaxo
Etodolac Wyeth-Ayerst Pemiroplast Santen
Famotidine Merck Propofol Zeneca
Felodipine Astra Zeneca Ranitidine Glaxo
Fluoxetine Lilly Remifentanil Abbott
Flufoxamine Solvay Ribavirin/Intron A Schering Corp.
Gabapentin Parke-Davis Sevoflurane Abbott
Ibuprofen 2 companies Sotalol Berlex
Insulin glargine Aventis Stavudine BMS
isotretinoin Roche Tramadol Johnson