EFFICACY AND SAFETY OF THE DIPEPTIDYL PEPTIDASE-4 INHIBITOR, SITAGLIPTIN,

COMPARED WITH THE SULFONYLUREA, GLIPIZIDE IN PATIENTS WITH TYPE 2

DIABETES INADEQUATELY CONTROLLED ON METFORMIN ALONE: A RANDOMIZED,
DOUBLE-BLIND, NON-INFERIORITY TRIAL
A. Are the results of the trial valid
1. Did the trial address a clearly focused issue? YA
- The population studied: laki-laki dan perempuan umur 17-78 tahun yang
didiagnosa DMT2 dan menerima monoterapi OAD, terapi kombinasi
metformin
- The intervention given: pasien diberikan sitagliptin 100 mg sekali sehari
- The comparator given: kelompok sitagliptin dibandingkan dengan pemberain
glipizid
- The outcomes considered: disebutkan pada bagian study evolution
2. Was the assignment of patients to treatments randomised? YA
Disebutkan pada bagian study design bahwa penelitian ini bersifat
randomisasi
3. Were patients, health workers, and study personal blinded? YA
- Health workers could be clinicians, nurses, etc
- Study personal-especially outcome assessors
Disebutkan bahwa penelitian ini bersifat double-blind
4. Were the groups similiar at the start of the trial? YA
- Other factors that might affect the outcome such as age, sex, social class,
these may be called baseline characteristics
5. Aside from the experimental intervention, were the groups treated eqully? YA.
Pasien kemudian diambil sampel darah untuk diperiksa kadar HbA1c dan FPG
6. Were all the patients who entered the trial properly accounted for at its
conclusion? Tidak.
Was the trial stopped early? Ya. Sebanyak 202 orang berhenti untuk tidak
melanjutkan penelitian pada kelompok sitagliptin, dan 172 orang pada
kelompok glipizid
- Were patients analysed in the groups to which they were randomised?
B. What are the results?
7. How large was the treatment effect?
- What outcomes wre measured? Perubahan kadar HbA1c dan FPG
- Is the primary outcome clearly specified? Sebanyak 63% dari kelompok
sitagliptin yang mencapai kadar HbA1c, sedangkan pada kelompok glipizid
sebanyak 59%. Perubahan nilai FPG pada kelompok sitagliptin berkurang 10
mg/dl, sedangkan pada kelompok glipizide 7,5 mg/dl
- What results were found for each outcome?
- Is there evidence of selective reporting of outcomes?
8. How precise was the estimate of the treatment office?
- What are the confidence limits? P<0,001
- Were they statistically significant? Ya.
C. Will the results help locally?
9. Can the results be applied in your context? (or to the local population?) Ya. Hasil
dapat disesuaikan pada pasien dewasa dengan umur 18-78 tahun
10. Were all clinically important outcomes considered? Ya.
11. Are the benefits worth the harms and costs? Ya. Penambahan sitagliptin pada
monoterapi metformin efektif untuk mengatur kadar gula darah dengan resiko
rendah hipoglikemi dan dapat menurunkan berat badan. Namu harga cukup
mahal, Rp 453.260.

SAFETY AND EFFICACY OF LINAGLIPTIN AS ADD ON THERAPY TO METFORMIN IN

PATIENTS WITH TYPE 2 DIABETES: A RANDOMIZED, DOUBLE-BLIND, PLACEBOOCONTROLLED STUDY
A. Are the results of the trial valid
1. Did the trial address a clearly focused issue? Ya
- The population studied: laki-laki dan perempuan 18-80 tahun yang didiagnosa
DMT2 dengan BMI 40 kg/m2
- The intervention given: pemberian linagliptin 5 mg sekali sehari selama 24
minggu
- The comparator given: pemberian plasebo
- The outcomes considered: primer dan sekunder outcome disebutkan dalam
jurnal pada bagian study outcome
2. Was the assignment of patients to treatments randomised? Ya, disebutkan pada
bagian study design
3. Were patients, health workers, and study personal blinded? Ya. Penelitian
dilakukan secara double-blind
4. Were the groups similiar at the start of the trial? Ya.
5. Aside from the experimental intervention, were the groups treated eqully? Ya.
Pasien yang telah dipastikan dapat mengikuti percobaan, dipilih secara acak
untuk mengkonsumsi plasebo atau linagliptin selama 24 minggu. Semua
kelompok kemudian mengkonsumsi dosis umum metformin.
6. Were all the patients who entered the trial properly accounted for at its
conclusion? Tidak.
- Was the trial stopped early? Ya.
- Were patients analysed in the groups to which they were randomised? Pada
kelompok kontrol sebanyak 39 pasien yang berhenti dari penelitian, dan 14
pasien berhenti pada kelompok plasebo.
B. What are the results?
7. How large was the treatment effect?
- What outcomes wre measured? Primer outcome: perubahan HbA1c,
secondary outcome: perubahan nilai FPG dan 2hPPG
- Is the primary outcome clearly specified? Ya.
- What results were found for each outcome? Perubahan HbA1c sebesar
0,49%, nilai FPG 0,59%, dan 2hPPG 2,7%
8. How precise was the estimate of the treatment office?
- What are the confidence limits? P=0,0001%
- Were they statistically significant? Ya.
C. Will the results help locally?
9. Can the results be applied in your context? (or to the local population?) Ya.
Hasil dapat disesuaikan pada pasien dewasa yang berumur 18-80 tahun.
10. Were all clinically important outcomes considered? Ya.
11. Are the benefits worth the harms and costs? Ya.
Penambahan 5 mg linagliptin sekali sehari dapat membantu dalam mengontrol
kadar gula darah tanpa adanya resiko meningkatnya berat badan dan resiko
hipoglikemi. Harga linagliptin tergolong murah yaiotu Rp 16.000

A RANDOMIZED CONTROLLED TRIAL OF THE EFFICACY AND SAFETY OR TWICEDAILY SAXAGLIPTIN PLUS METFORMIN COMBINATION THERAPY IN PATIENTS WITH
TYPE 2 DIABETES AND INADEQUATE GLYCEMIC CONTROL ON METFORMIN
MONOTHERAPY
A. Are the results of the trial valid
1. Did the trial address a clearly focused issue? Ya.
- The population studied: laki-laki dan perempuan yang tidak dalam masa
hamil atau menyusui berumur 18-78 tahun.
- The intervention given: pasien diberikan saxagliptin 2,5 mg dua kali sehari
- The comparator given: pasien diberikan plasebo
- The outcomes considered: primer outcome menentukan nilai perubahan
HbA1c dan secondary outcome menentukan nilai perubahan FPG
2. Was the assignment of patients to treatments randomised? Ya.
3. Were patients, health workers, and study personal blinded? Ya. Percobaan ini
menggunakan metode double-blind
4. Were the groups similiar at the start of the trial? Ya.
5. Aside from the experimental intervention, were the groups treated eqully? Ya.
Kelompok plasebo dan kelompok kontrol setelah diberikan masing-masing
plasebo dan saxagliptin diperiksa kadar perubahan FPG dan HbA1c.
6. Were all the patients who entered the trial properly accounted for at its
conclusion? Tidak.
- Was the trial stopped early? Ya.
- Were patients analysed in the groups to which they were randomised?
Sebanyak 8 orang dari kelompok kontrol berhenti dari 8 orang dari kelompok
plasebo berhenti dari penelitian.
B. What are the results?
7. How large was the treatment effect?
- What outcomes wre measured? Perubahan nilai HbA1c dan FPG.
- Is the primary outcome clearly specified? Ya.
- What results were found for each outcome? Perubahan nilai HbA1c 0,56%.
Penurunan nilai FPG sebesar 9,5 mg/dl
8. How precise was the estimate of the treatment office?
- What are the confidence limits? P=0,006
- Were they statistically significant? Ya.
C. Will the results help locally?
9. Can the results be applied in your context? (or to the local population?) Ya.
Hasil dapat diaplikasikan pada pasien dewasa 18-78 tahun
10. Were all clinically important outcomes considered? Ya.
11.Are the benefits worth the harms and costs? Ya. Tidak terjadi hal-hal yang
membahayakan keselamatan. Namun harga terbilang mahal yaitu Rp 370.779
dengan efek samping yang tidak membahayakan.