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The study’s methodology involved maintaining all medications within the Summary of Product Characteristics (SPCs) at their standard maximum clinical dosages throughout the period between months two and six. This approach was informed by previous research, such as the work by Ambrosioni and colleagues on low-dose sustained-release indapamide, which demonstrated efficacy and safety in antihypertensive therapy.
A significant strength of this trial lies in the fact that the three individual components of the dual combination therapies examined – amlodipine, perindopril, and indapamide – have previously been utilized in various cardiovascular outcome trials, both as monotherapies and in combination with other agents. These prior studies, including the VALUE trial, the benazepril plus amlodipine or hydrochlorothiazide trial, the ALLHAT trial, and research on ethnic differences in antihypertensive response, have consistently shown considerable benefits across a range of major cardiovascular endpoints and within diverse patient subgroups, such as those with diabetes, a history of stroke, or advanced age. The current study’s findings, in conjunction with the reported blood pressure-lowering efficacy, offer strong support for the submission of these dual combinations in South Asian patients, particularly within the Indian context.The trial’s participant recruitment from 32 diverse locations across India, encompassing a broad age spectrum (30-79 years) and a balanced representation of both genders, along with the inclusion of both previously treated and untreated hypertensive individuals, allows for a reasonable extrapolation of the results to a wide array of Indian patients suffering from hypertension.
this investigation involving South Asian patients in India revealed comparable safety profiles and efficacy in reducing both ambulatory and office blood pressure levels when using dual combinations of amlodipine-perindopril, perindopril-indapamide, and amlodipine-indapamide. The outcomes of this study offer new insights that can guide the selection of dual combination therapies for hypertension management among South Asians residing in India and potentially those in the broader diaspora.
