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Athaya Marwah Vedita/A3/1102011049

Skenario
Nn. A 15 tahun datang ke RS YARSI dengan keluhan kedua kaki kesemutan terus menerus, kram dan
sakit bila berjalan sejak 5 hari yang lalu. Keluhan disertai mual, kepala pusing dan susah tidur sehingga
sulit konsentrasi belajar. Pasien sering buang air kecil terutama pada malam hari, banyak makan tetapi
badan semakin kurus. Pada riwayat keluarga diketahui ada yang menderita penyakit diabetes mellitus tipe
2. Sekitar 1 tahun yang lalu pasien pernah ke dokter karena keluhan yang sama dan diberikan obat
metformin. Dari keterangan ibu pasien diketahui selain mengkonsumsi metformin, pasien juga mengubah
gaya hidup dengan rutin berolahraga dan mengatur pola makannya.
PF : KU baik, kesadaran: compos mentis, TD 120/80 mmHg, nadi 80x/menit, pernafasan 20x/menit,
suhu:36,5 C, BB: 57 kg, TB: 144 cm. Hasil laboratorium GDS 250 mg/dl dan HbA 1C = 7.5%
Berdasarkan hasil pemeriksaan, dokter mendiagnosis diabetes mellitus tipe 2 dan memberikan obat
kombinasi metformin dan rosiglitazone dikarenakan GDS dan HbA 1C yang masih tinggi padahal sudah
mengkonsumsi monoterapi metformin , lalu ibu pasien bertanya tentang keefektifan pemberian kombinasi
metformin disertai rosiglitazone dengan monoterapi metformin saja dan metformin disertai perubahan
gaya hidup pada anaknya.
Foreground question
Manakah yang lebih efektif antara pemberian obat kombinasi metformin disertai rosiglitazone dengan
monoterapi metformin dan metformin disertai perubahan gaya hidup pada pasien remaja penyakit
diabetes mellitus tipe 2?
P : pasien remaja berumur 15 tahun
I : monoterapi metformin dan metformin disertai perubahan gaya hidup
C : kombinasi metformin dan rosiglitazone
O : efektifitas terapi
Kata kunci
Diabetes type 2 AND metformin AND rosiglitazone
Pemilihan situs
www.nejm.org
Hasil pencarian
Sebanyak 15 artikel
Limitation
Last 5 year, full article
Artikel yang dipilih
A clinical trial to maintain glycemic control in youth with type 2 diabetes

REVIEW JURNAL
Background
Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We
compared the efficacy of three treatment regimens to achieve durable glycemic control in children and
adolescents with recent-onset type 2 diabetes
Methods
Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to
attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment
with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyleintervention program focusing on weight loss through eating and activity behaviors. The primary outcome
was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or
sustained metabolic decompensation requiring insulin.
Results
Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319
(45.6%) reached the primary outcome over an average followup of 3.86 years. Rates of failure were
51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone,
metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus
rosiglitazone was superior to metformin alone (P = 0.006); metformin plus lifestyle intervention was
intermediate but not significantly different from metformin alone or metformin plus rosiglitazone.
Prespecified analyses according to sex and race or ethnic group showed differences in sustained
effectiveness, with metformin alone least effective in nonHispanic black participants and metformin plus
rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants.
Conclusion
Monotherapy with metformin was associated with durable glycemic control in approximately half of
children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle
intervention, was superior to metformin alone.

I.

VALIDITAS

1.A Was the assignment of patient to treatment randomized?


Ya, penelitian dilakukan dengan cara randomized

1.B Were the group similar at the start of the trial ?


Ya, sesuai dengan baseline condition dalam table

2.A Aside from the allocated treatment, were the group treated equally?
Ya follow up dilakukan dengan cara yang sama

2.B Were all patients who entered the trial accounted for ? and were they analyzed in the groups to
which they were randomized?
Ya dilakukan analisis

3. Were measured objective or were the patients and clinicians kept blind to which treatment
was being received ?
Ya, pasien dan peneliti tidak tahu obat mana yang diberikan

II.
1. How large was the treatment effect?

RESULT

a. Perbandingan efektifitas pemberian obat kombinasi metformin dan rosiglitazone dengan


monoterapi metformin
RR
: 0,386 / 0,517 = 0,75
ARR : 0,517 0,386 = 0,131
RRR : 1 0,75 = 0,25
NNT : 1 / 0,131 = 7,63
b. Perbandingan efektifitas pemberian obat kombinasi metformin dan rosiglitazone dengan
metformin disertai perubahan gaya hidup
RR
: 0,386 / 0,466 = 0,83
ARR : 0,466 0,386 = 0,08
RRR : 1 0,83 = 0,17
NTT : 1 / 0,08 = 12,5
2. How precise was the estimate of the treatment effect?

Will The Result Helps Me In Caring For My Patient?


1. Dari segi umur sesuai karena penelitian ini dilakukan pada anak usia 10-17 tahun sedangkan
pasien saya berumur 15 tahun
2. Bisa karena obat metformin dan rosiglitazone ada di Indonesia
3. Ya karena berdasarkan penelitian pemberian obat kombinasi metformin dan rosiglitazone paling
merupakn terapi yang paling efektif untuk diabetes tipe 2 pada usia remaja