[ABSTRAK
Penggunaan obat golongan statin (penghambat hidroksimetil glutaril-CoA reduktase) sebagai terapi lini pertama pada hiperkolesterolemia dapat menyebabkan terjadinya beberapa reaksi obat yang tidak dikehendaki (ROTD). Tujuan penelitian ini adalah menilai risiko penggunaan obat golongan statin terhadap kejadian ROTD pada pasien hiperkolesterolemia di Instalasi Rawat Jalan RSUD Pasar Rebo, Jakarta. Penelitian dilakukan dengan metode kohort prospektif pada pasien yang menggunakan atorvastatin dan simvastatin. Data primer diperoleh melalui wawancara dengan menggunakan kuesioner, data sekunder diperoleh melalui rekam medis dan resep yang diterima oleh pasien. Data yang diperoleh dianalisis menggunakan chi-square dan regresi logistik. Dari penelitian diketahui bahwa ROTD terjadi pada 38.20% pasien yang menggunakan obat golongan statin, kejadian ROTD terbesar adalah gangguan sistem pencernaan (35.45%) dan gangguan sistem saraf (23.64%). Sedangkan ROTD pada otot dan hati masing-masing sebesar 2.73%. Pasien yang menggunakan simvastatin memiliki risiko relatif mengalami ROTD lebih besar jika dibandingkan dengan pasien yang menggunakan atorvastatin (RR: 6.439; CI: 2.963-13.992). Variabel perancu yang secara signifikan mempengaruhi kejadian ROTD adalah aktivitas fisik. Pasien yang mengalami ROTD memiliki risiko relatif lebih besar mengalami putus obat daripada pasien yang tidak mengalami ROTD (RR: 2.554; CI: 1.724- 3.754).

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ABSTRACT
The use derivate of statin (hydroxymethylglutaryl-CoA reductase inhibitors) for management of hypercholesterolemia can cause advers drug reactions (ADR). The purpose of this study was to assess the risk of the use of statins on the incidence of ADR in hypercholesterolemic patients in the Outpatient Installation in RSUD Pasar Rebo, Jakarta. This study was conducted using a prospective cohort to the patients using atorvastatin and simvastatin, the data obtained by interview with questionnaires, medical records, and patient prescriptions. The data collected analyzed using chi-square and logistic regression. ADR occurred in 38.20% patients who treated with statins, the most often ADR experienced by patient are gastrointestinal disorder (35.45%) and nerve system disorder (23.64%). Muscle and liver disorder experienced by 2.73% patients respectively. The patients using simvastatin have a greater risk of experiencing ADR compared to atorvastatin (RR: 6.439; CI: 2.963-13.992). Physical activity is the confounding variable significantly influence the incidence of ADR. Patients who experience ADR had a greater risk for experiencing drug withdrawal than patients who did not experience ADR (RR: 2.554; CI: 1.724- 3.754).;The use derivate of statin (hydroxymethylglutaryl-CoA reductase inhibitors) for management of hypercholesterolemia can cause advers drug reactions (ADR). The purpose of this study was to assess the risk of the use of statins on the incidence of ADR in hypercholesterolemic patients in the Outpatient Installation in RSUD Pasar Rebo, Jakarta. This study was conducted using a prospective cohort to the patients using atorvastatin and simvastatin, the data obtained by interview with questionnaires, medical records, and patient prescriptions. The data collected analyzed using chi-square and logistic regression. ADR occurred in 38.20% patients who treated with statins, the most often ADR experienced by patient are gastrointestinal disorder (35.45%) and nerve system disorder (23.64%). Muscle and liver disorder experienced by 2.73% patients respectively. The patients using simvastatin have a greater risk of experiencing ADR compared to atorvastatin (RR: 6.439; CI: 2.963-13.992). Physical activity is the confounding variable significantly influence the incidence of ADR. Patients who experience ADR had a greater risk for experiencing drug withdrawal than patients who did not experience ADR (RR: 2.554; CI: 1.724- 3.754)., The use derivate of statin (hydroxymethylglutaryl-CoA reductase inhibitors) for management of hypercholesterolemia can cause advers drug reactions (ADR). The purpose of this study was to assess the risk of the use of statins on the incidence of ADR in hypercholesterolemic patients in the Outpatient Installation in RSUD Pasar Rebo, Jakarta. This study was conducted using a prospective cohort to the patients using atorvastatin and simvastatin, the data obtained by interview with questionnaires, medical records, and patient prescriptions. The data collected analyzed using chi-square and logistic regression. ADR occurred in 38.20% patients who treated with statins, the most often ADR experienced by patient are gastrointestinal disorder (35.45%) and nerve system disorder (23.64%). Muscle and liver disorder experienced by 2.73% patients respectively. The patients using simvastatin have a greater risk of experiencing ADR compared to atorvastatin (RR: 6.439; CI: 2.963-13.992). Physical activity is the confounding variable significantly influence the incidence of ADR. Patients who experience ADR had a greater risk for experiencing drug withdrawal than patients who did not experience ADR (RR: 2.554; CI: 1.724- 3.754).]