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Título

Therapeutic Efficacy and Safety of Aprocicentan in Resistant Hypertension: A Meta-Analysis of Randomized Clinical Trials.

Resumo

Introduction: Systemic arterial hypertension (SAH) is a condition with increasing prevalence globally. Despite the diversity of pharmacological options available, there is a growing incidence of resistance to blood pressure control. In this context, aprocicentan, an endothelin receptor antagonist, emerges as a promising alternative in pharmacology, especially for patients whose blood pressure is not adequately controlled with available conventional treatments. Objectives: To conduct a systematic review with meta-analysis to evaluate the therapeutic efficacy, safety, and associated side effects of Aprocicentan use in patients with SAH. Methods: Randomized clinical trials (RCTs) were searched in the PubMed Central, Lilacs, ScienceDirect, and Cochrane Library databases. Meta-analysis was conducted using Review Manager Web. RCTs conducted in the last 5 years in English were included; the standardized mean difference (SMD) with 95% confidence intervals (CI) was used for continuous outcomes with statistically significant P values (P < 0.00001). Results: After analysis, 7 RCTs were included. Regarding dose efficacy, two double-blind RCTs assessed the response with 5, 12.5, 25, and 50 mg versus placebo twice daily in the morning. Maximum efficacy in reducing blood pressure (BP) was observed in the aprocicentan 25 mg group [-7.31 (95% CI: -9.45 to -5.16), p < 0.00001] with effects persisting up to 24 hours. Regarding safety of adverse effects (AEs), three double-blind RCTs were conducted in healthy patients. After analysis the safety was confirmed, demonstrating tolerability of doses up to 100 mg once daily at night, as well as the absence of severe adverse events in the outcomes of Aprocicentan RCTs at different doses. In the second study, use was discontinued in two patients due to respiratory tract infection and throat irritation, both treated without complications. Dose analysis revealed that the number of AEs, such as lower limb edema, increased with increasing offered dose. Conclusion: In summary, it is evident that the aprocitentan can offer a new therapeutic option by reducing BP levels in patients refractory to conventional therapies without major systemic effects that may lead to life-threatening risks. New research reveals safety in medication administration of the drug, which has recently been approved by the Food and Drug Administration (FDA), underscoring the continued importance of investing in pharmacological research to combat SAH.

Palavras Chave

Hypertension; Endothelin Receptor Antagonists; Pharmacology Clinical.

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