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 SHORT COMMUNICATION
Year : 2016  |  Volume : 48  |  Issue : 6  |  Page : 706-709

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


1 Department of Pharmacology, Medical College, Kolkata, West Bengal, India
2 Department of Pharmacology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India
3 Department of Medicine, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India

Correspondence Address:
Alak Kumar Das
Department of Pharmacology, Medical College, Kolkata, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0253-7613.194844

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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.






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