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Clinical effectiveness and safety of low cost versus innovator brand amlodipine in hypertension: A single-blinded, randomized, crossover, noninferiority trial

OBJECTIVES: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension. MATERIALS AND METHODS: The primary end-point was change of systolic blood pr...

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Detalles Bibliográficos
Autores principales: Das, Alak Kumar, Chatterjee, Suparna, Pal, Jyotirmoy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5155474/
https://www.ncbi.nlm.nih.gov/pubmed/28066111
http://dx.doi.org/10.4103/0253-7613.194844
Descripción
Sumario:OBJECTIVES: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension. MATERIALS AND METHODS: The primary end-point was change of systolic blood pressure (BP) from baseline to study end. Adult patients with Stage 1 hypertension or isolated systolic hypertension were randomized to receive 5 mg amlodipine LCB or IB once daily for 6 weeks in each period in a 2 × 2 crossover manner with three follow-up visits in each sequence. In 28 evaluable patients, the reduction of systolic BP (SBP), diastolic BP, and safety profile between two brands was comparable. RESULTS: The lower bound of the 95% confidence interval of the difference in reduction of SBP (−5.04 mmHg) was within the noninferiority margin of 10 mmHg. CONCLUSION: LCB amlodipine is noninferior to IB in terms of BP reduction and is a cost-effective alternative as it is less expensive than IB.