JOURNAL READING

Departemen Kesehatam Masyarakat FK USU

Efficacy of Landiolol Hydrochloride for Preventive of Atrial Fibrillation After Heart Valve Surgery
Oleh :

Endah Rahmadani Lider Olmen Panggabean Astrawinata G

Pembimbing :

dr. Yuki Yunanda

(Papers in Journal of Medicine / Health Sciences)

Evidence-Based Medicine

VIA
Valid Methodology of study Important Result of study

Applicability Discussion

Treatment / Therapeutic intervention

Answerable Clinical Question (ACQ)

P I C O

: Patient, Problem, Population : Intervention : Comparison : Outcome

Efficacy of Landiolol Hydrochloride for Preventive of Atrial Fibrillation After Heart Valve Surgery
Patient

60 pasien yang menjalani pembedahan katup jantung dengan anestesi umum Intervention Landiolol Hydrochloride intravena Comparison Plasebo Outcome Kejadian atrial fibrillation pada fase akut postoperative katup jantung nerkurang secara signifikan. Landiolol Hydrochloride adalah obat yang berguna untuk mencegah atrial fibrillation setelah pembedahan katup jantung.

 Objective

Tujuan dari studi prospectif ini adalah untuk melihat efek dari ladiolol hydrochloride terhadap pencegahan atrial fibrillationdan hemodinamik pada fase akut post operative katup jantung. Methods 60 pasien yang menjalani operasi katup jantung dari april 2008 sampai Juli 2010 diacak dan dibagi dalam 2 kelompok : group ladiolol hydrochloride (30 pasien), group control (30 pasien). Landilol hydrochloride diberikan secara intravena saat setela operasi pada dosis 10 g/ KgBB/ menit. Kejadian AF dicatat selama 72 jam setelah operasi dan dibandingkan dengan kelompok kontrol.

 Result

AF terjadi pada 6 pasien di group landiolol hydrochloride (20%) dan 16 pasien pada group kontrol (53,3%). Detak jantung berkurang pada signifikan dengan landilolol hydrochloride akan tetapi perubahan hemodinamik tidak terlalu tampak. Conclusion Hasil studi ini menunjukkan landiolol hydrochloride adalah obat yang bermanfaat untuk pencegahan AF setelah operasi katup jantung

Validity

Are the results of this single preventive or therapeutic trial valid? Primary Guides:
1. 1. Was the assignment of patients to treatments randomized? YES

1.2. Was the randomization list concealed? Cant tell

1.3. Was follow-up of patients sufficiently long and complete? YES

1.4. Were patients analyzed in the groups to which they were randomized? Yes

Secondary Guides :
1.5. Were patients, health workers, and study personnel "blind" to treatment? YES

1.6. were the groups treated equally, apart from the experimental treatment?

1.7. Were the groups similar at the start of the trial apart from the experimental therapy ? YES sinus rythme and no history of AF preoperative

Important

Are the valid result of this randomized trial important?

2.1 Was is the magnitude of the treatment effect ? NNT, ARR, RRR, CER, EER 2.2. How precise is the estimate of the treatment effect? P < 0,05 3.3. What are our patients potential benefits and harms from the therapy? keuntungannya dapat menumpulkan respon hemodinamik pada intubasi trakheal. Potensi resiko dari terapi yaitu hipotensi dan bradikardi.

Eksperiment (Landilol

Yes (No AF) 24

No (AF) 6

Total 30

Hydrochloride)
Control (Placebo)

14

16

30

Relative Risk Reduction (RRR)

Control Event Rate (CER): 16/30 = 53,3% Experimental Event Rate (EER): 6/30 = 20% RRR = (CER-EER)/CER = (53,3% - 20%) / 53,3% = 33.3% / 53,3% = 62,47%

Absolute Risk Reduction (ARR) & Number Needed to Treat (NNT)

ARR = CER-EER = 53,3% - 20% = 33.3% NNT = 1/ARR = 1/33.3% =3

 ARR : CER-EER

: 40% - 6.7% : 33.3%

NNT : 1/ARR

: 1/33.3% :3

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SAMPLE CALCULATIONS
Occurrence of diabetic neuropathy at 5 years among insulin-dependent diabetics in the DCCT trial Usual insulin Regimen control event rate (CER) 53,3 % Intensive insulin regimen experimental event rate (EER) 20 % Relative risk reduction (RRR)
CER EER CER

Absolute risk reduction (ARR)

CER EER

Number needed to treat (NNT)

1/ARR 1/33,3%

53,3% 20% 53,3%

53,3% 20% =3 patients 33.3 22,8%

62,47%
95% CI a

a 95% confidence interval (CI) on an NNT =1/(limits on the CI of its ARR)

10,5% to 56,1%

2-9

ARR= 33.3% 27.7% = 5.6%-61% NNT= 2-18

Applicability

Can you apply this valid, important evidence about therapy in caring for your patient?
3.1. Is our patient so different from those in the study that its results cannot apply? NO 3.2. Is the treatment feasible in our setting? YES 3.3. What are our patients potential benefits and harms from the therapy? the benefits is to prevent hemodynamic unstability and prevent embolus due to the Af

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What are our patients potential benefits and harms from the therapy?

Method I : f

Risk of the outcome in our patient, relative to patients in the trial. Expressed as a decimal: NNT/ f =3/1= 3 (NNT for patients like ours)

Are our patients values and preferences satisfied by the regimen and its consequences?

3.4. Do we and our patient have a clear assessment of their values and preferences? YES, to prevent the event of Af during postoperative phase 3.5. Are they met by this regimen and its consequences?
YES

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Do these results apply to our patient?

Is our patient so different from those in the study that its results cannot apply? Is the treatment feasible in our setting? Yes No

Yes

TERIMA KASIH