ABSTRACT
Abstract: Objective: To evaluate efficacy and safety of 60 mg and 120 mg Fimasartan (FMS) alone or combined with 12.5 mg hydrochlorothiazide (HCTZ) in a Mexican population. Methods: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60 mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90 mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90 mmHg were randomised to either 120 mg FMS or 60 mg FMS + 12.5 mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90 mmHg received 120 mg FMS + 12.5 mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. Results: FMS 60 mg (n = 272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3 ± 8.9 (p<.0001) and 16.0 ± 14.1 (p<.0001) mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120 mg, FMS 60 mg + HCTZ 12.5 mg, or FMS 120 mg + HCTZ 12.5 mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP < 90 mmHg and an SBP<140 mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). Conclusion: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.
Resumen: Objetivo: Evaluar la eficacia y la seguridad de 60 y 120 mg de fimasartán (FMS) solo o combinado con 12.5 mg de hidroclorotiazida (HCTZ) en población mexicana. Métodos: Estudio abierto, de 24 semanas, con tratamiento escalado hasta el objetivo terapéutico en sujetos hipertensos grados 1-2. Tratamiento inicial: FMS 60 mg una vez al día; en la semana 8, los sujetos con presión arterial diastólica (PAD) <90 mmHg mantuvieron su tratamiento inicial durante el estudio, mientras que los sujetos con PAD ≥90 mmHg fueron aleatorizados a 120 mg de FMS o a 60 mg de FMS + 12.5 mg de HCTZ. En la semana 12, los sujetos aleatorizados con PAD ≥90 mmHg recibieron 120 mg de FMS + 12.5 mg de HCTZ; quienes alcanzaron el objetivo terapéutico mantuvieron su tratamiento asignado hasta finalizar el estudio. Resultados: FMS 60 mg (n = 272) disminuyó la PAD y la presión arterial sistólica (PAS) en 11.3 ± 8.9 (p < 0.0001) y 16.0 ± 14.1 (p < 0.0001) mmHg, respectivamente, con logro del objetivo de tratamiento en el 75.4% de los sujetos. Los sujetos asignados a 120 mg de FMS, a 60 mg de FMS + 12.5 mg de HCTZ 12.5 y a 120 mg de FMS + 12.5 mg de HCTZ mostraron reducciones significativas de PAD y PAS; al final del estudio, 237/272 sujetos (87.1%) lograron PAD <90 y PAS <140 mmHg. Las reacciones adversas más frecuentemente reportadas fueron: cefalea (3.7%), boca seca (1.1%), incremento de enzimas hepáticas (1.1%) y mareo (0.7%). Conclusión: FMS es seguro y eficaz en sujetos mexicanos con hipertensión esencial de grados 1-2.
Subject(s)
Humans , Male , Female , Middle Aged , Pyrimidines/administration & dosage , Tetrazoles/administration & dosage , Biphenyl Compounds/administration & dosage , Essential Hypertension/drug therapy , Hydrochlorothiazide/administration & dosage , Antihypertensive Agents/administration & dosage , Pyrimidines/adverse effects , Tetrazoles/adverse effects , Biphenyl Compounds/adverse effects , Severity of Illness Index , Prospective Studies , Treatment Outcome , Drug Therapy, Combination , Mexico , Antihypertensive Agents/adverse effectsSubject(s)
Humans , Male , Female , Middle Aged , Hypertension/drug therapy , Anti-Inflammatory Agents/administration & dosage , Antihypertensive Agents/administration & dosage , Atenolol/administration & dosage , Tetrazoles/administration & dosage , Tetrazoles/adverse effects , Biphenyl Compounds/administration & dosage , Biphenyl Compounds/adverse effects , Blood Pressure/drug effects , Review Literature as Topic , Randomized Controlled Trials as Topic , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Double-Blind Method , Administration, Oral , Multicenter Studies as Topic , Treatment Outcome , Amlodipine/administration & dosage , Amlodipine/adverse effects , Cross-Over Studies , Drug Combinations , Medication Adherence , Irbesartan , Hydrochlorothiazide/administration & dosage , Hydrochlorothiazide/adverse effects , Anti-Inflammatory Agents/adverse effects , Antihypertensive Agents/adverse effectsABSTRACT
No presente trabalho foi realizada uma revisäo bibliográfica a respeito de bifenilas policloradas onde se procurou enfocar os aspectos relacionados as suas características, os riscos potenciais de contaminaçäo do meio ambiente e homem, as experiências realizadas com animais e seus achados, os acidentes e as medidas adequadas ao seu manuseio e destino final