Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study

Neutel, Joel M.; Giles, Thomas D.; Punzi, Henry; Weiss, Robert; Li, Huiling; Finck, Amy

doi:10.1016/j.jash.2014.09.017

Cited by 12 publications

(10 citation statements)

References 23 publications

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“…Although the Neutel et al 28 trial has notable limitations, the overall tolerability of the combination of nebivolol/valsartan for HTN was consistent with that of Giles et al 24,28 Clinically relevant AEs from treatment included peripheral edema, bradycardia, fatigue, cough, dizziness, and headache. The occurrence of these effects was 2.2% to 5.7%, respectively.…”

Section: Adverse Effectssupporting

confidence: 56%

“…Neutel et al 28 evaluated long-term efficacy in a 52-week phase III, nonrandomized, open-label, single-arm US study. Participants with stage I or II HTN (per JNC7) started nebivolol and valsartan as a free-tablet combination of 5/160 mg titrated to 10/320 mg at week 2 and then to 20/320 mg if not at goal (SBP/DBP ⩽140/90 or, with diabetes, ⩽130/80).…”

Section: Clinical Trials: Efficacymentioning

confidence: 99%

“…Additionally, the study design and 39.6% drop-out rate may have affected results. 28 A reason for the high drop-out rate is not provided by the authors. Details of the above clinical trials are summarized in Table 4.…”

Section: Clinical Trials: Efficacymentioning

confidence: 99%

“…However, the results reflected real-life practice by following participants for 52 weeks, confirming that most patients required multiple agents, and even on dual and triple therapy, approximately 35% of patients did not reach BP targets. 28…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

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Nebivolol/Valsartan: A Novel Antihypertensive Fixed-Dose Combination Tablet

2018

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Data Sources: A PubMed (1966 to October 2018) search was conducted using the following keywords: nebivolol, valsartan, and hypertension (HTN). Additional sources were identified by references. Study Selection and Data Extraction: Articles written in English were included if they evaluated the pharmacology, pharmacokinetics, efficacy, safety, or place in therapy of nebivolol/valsartan in human subjects. Data Synthesis: Most patients with HTN require combination therapy; however, β-adrenergic antagonists and AII type 1 receptor blockers have been considered less effective because of overlapping mechanisms of action. A phase III, randomized trial demonstrated that nebivolol/valsartan produced statistically significant blood pressure (BP) lowering as compared with monotherapy with the individual components or placebo. Substudy analyses confirmed this among subgroups and demonstrated that nebivolol/valsartan decreased plasma renin and aldosterone levels. One trial reported continued BP lowering at 52 weeks. Another study showed that nebivolol/valsartan had similar additivity scores as compared with other antihypertensive combinations. Relevance to Patient Care and Clinical Practice: This review discusses drug information, efficacy, and safety of nebivolol/valsartan and discusses its clinical relevance as a novel combination product in managing patients with HTN. Conclusion: Nebivolol/valsartan combination may offer a benefit to patients with an indication for both classes who desire to decrease pill burden. Although BP lowering was statistically significant in comparison to the individual components as monotherapy, the combination does not offer clinically significant benefits that would elevate its place in HTN management.

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Section: Adverse Effectssupporting

confidence: 56%

Section: Clinical Trials: Efficacymentioning

confidence: 99%

Section: Clinical Trials: Efficacymentioning

confidence: 99%

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

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Nebivolol/Valsartan: A Novel Antihypertensive Fixed-Dose Combination Tablet

2018

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“…However, even when blood pressure is under control, organ damage and abnormal metabolism may not be completely resolved, which suggests that other mechanisms may be involved in, or contribute to, the complex pathological processes of hypertension and may not be eliminated by current drug strategies. Antihypertensive therapy requires the establishment of blood pressure control ( 2 ). Therefore, it is of clinical and practical significance to investigate the mechanism of hypertension.…”

Section: Introductionmentioning

confidence: 99%

Mechanisms in hypertension and target organ damage: Is the role of the thymus key? (Review)

Dai

Chen

et al. 2018

Int J Mol Med

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A variety of cells and cytokines have been shown to be involved in the whole process of hypertension. Data from experimental and clinical studies on hypertension have confirmed the key roles of immune cells and inflammation in the process. Dysfunction of the thymus, which modulates the development and maturation of lymphocytes, has been shown to be associated with the severity of hypertension. Furthermore, gradual atrophy, functional decline or loss of the thymus has been revealed to be associated with aging. The restoration or enhancement of thymus function via upregulation in the expression of thymus transcription factors forkhead box N1 or thymus transplantation may provide an option to halt or reverse the pathological process of hypertension. Therefore, the thymus may be key in hypertension and associated target organ damage, and may provide a novel treatment strategy for the clinical management of patients with hypertension in addition to different commercial drugs. The purpose of this review is to summarize and discuss the advances in our understanding of the impact of thymus function on hypertension from data from animal and human studies, and the potential mechanisms.

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Deep learning for predicting synergistic drug combinations: State‐of‐the‐arts and future directions

Wang,

Liu

2024

Clinical and Translational Dis

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Combination therapy has emerged as an efficacy strategy for treating complex diseases. Its potential to overcome drug resistance and minimize toxicity makes it highly desirable. However, the vast number of potential drug pairs presents a significant challenge, rendering exhaustive clinical testing impractical. In recent years, deep learning‐based methods have emerged as promising tools for predicting synergistic drug combinations. This review aims to provide a comprehensive overview of applying diverse deep‐learning architectures for drug combination prediction. This review commences by elucidating the quantitative measures employed to assess drug combination synergy. Subsequently, we delve into the various deep‐learning methods currently employed for drug combination prediction. Finally, the review concludes by outlining the key challenges facing deep learning approaches and proposes potential challenges for future research.

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Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study

Cited by 12 publications

References 23 publications

Nebivolol/Valsartan: A Novel Antihypertensive Fixed-Dose Combination Tablet

Nebivolol/Valsartan: A Novel Antihypertensive Fixed-Dose Combination Tablet

Mechanisms in hypertension and target organ damage: Is the role of the thymus key? (Review)

Deep learning for predicting synergistic drug combinations: State‐of‐the‐arts and future directions

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