Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study.
Aged
Amlodipine
/ adverse effects
Antihypertensive Agents
/ administration & dosage
Calcium Channel Blockers
/ adverse effects
Cardiovascular Diseases
/ epidemiology
China
Comparative Effectiveness Research
Cost-Benefit Analysis
Double-Blind Method
Female
Humans
Hypertension
/ drug therapy
Male
Middle Aged
Niacin
/ adverse effects
Prospective Studies
Amlodipine besylate
Cardiovascular events
Comparative effectiveness research
Hypertension
Levoamlodipine maleate
Pragmatic clinical trial
Journal
Cardiovascular drugs and therapy
ISSN: 1573-7241
Titre abrégé: Cardiovasc Drugs Ther
Pays: United States
ID NLM: 8712220
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
accepted:
07
08
2020
pubmed:
12
9
2020
medline:
15
12
2021
entrez:
11
9
2020
Statut:
ppublish
Résumé
Antihypertensive treatment is the most important method to reduce the risk of cardiovascular events in hypertensive patients. However, there is scant evidence of the benefits of levoamlodipine maleate for antihypertensive treatment using a head-to-head comparison in the real-world. This study aims to examine the effectiveness of levoamlodipine maleate used to treat outpatients with primary hypertension compared with amlodipine besylate in a real-world setting. This was a pragmatic comparative effectiveness study carried out at 110 centers across China in outpatients with primary hypertension treated with levoamlodipine maleate or amlodipine besylate, with 24 months of follow-up. The primary outcomes used for evaluating the effectiveness were composite major cardiovascular and cerebrovascular events (MACCE), adverse reactions, and cost-effectiveness. Among the included 10,031 patients, there were 482 MACCE, 223 (4.4%) in the levoamlodipine maleate group (n = 5018) and 259 (5.2%) in the amlodipine besylate group (n = 5013) (adjusted hazard ratio = 0.90, 95%CI: 0.75-1.08, P = 0.252). The levoamlodipine maleate group had lower overall incidences of any adverse reactions (6.0% vs. 8.4%, P < 0.001), lower extremity edema (1.1% vs. 3.0%, P < 0.001) and headache (0.7% vs. 1.1%, P = 0.045). There was a nearly 100% chance of the levoamlodipine maleate being cost-effective at a willingness to pay threshold of 150,000 Yuan per quality-adjusted life years (QALYs) gained, resulting in more QALYs (incremental QALYs: 0.00392) and cost savings (saving 2725 Yuan or 28.8% reduction in overall costs) per patient. In conclusion, levoamlodipine maleate could reduce cost by 29% with a similar MACCE incidence rate and lower occurrence of adverse reactions (especially edema and headache) compared with amlodipine besylate. Clinicaltrials.gov NCT01844570 registered at May 1, 2013.
Identifiants
pubmed: 32915349
doi: 10.1007/s10557-020-07054-1
pii: 10.1007/s10557-020-07054-1
doi:
Substances chimiques
Antihypertensive Agents
0
Calcium Channel Blockers
0
levamlodipine
0P6NLP6806
Amlodipine
1J444QC288
Niacin
2679MF687A
Banques de données
ClinicalTrials.gov
['NCT01844570']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
41-50Références
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