Ajanta Pharma Launches World's 1st FDC Met XL AMT for Patients with Uncontrolled Hypertension and Cardiovascular Co-morbidity in India

Ajanta Pharma, one of the leaders in the cardiology segment has announced the launch of Met XL AMT, a novel triple drug combination for the management of hypertensive patients in India.

Consisting of the unique DCGI-approved combination of Telmisartan, Amlodipine, and Metoprolol, the combination has been introduced for the first time in India to help millions of patients suffering from uncontrolled hypertension and cardiovascular comorbidities.

Met XL AMT has been approved by DCGI for the management of uncontrolled hypertension with stable coronary artery disease. It is the world’s 1st Fixed Dose Combination (FDC) of Metoprolol Succinate (extended-release) 50mg, Amlodipine 5mg, and Telmisartan 40mg.

This triple antihypertensive FDC is used for the treatment of uncontrolled hypertension with cardiovascular comorbidities who have not achieved adequate BP control with dual drug therapy or are intolerant to diuretic-based combinations.

The most recent European Society of Hypertension (ESH) 2023 Guidelines recommend the consideration for the use of a triple combination of blood pressure lowering therapies including angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and Beta Blockers (BB) in uncontrolled hypertension on dual therapy. The guidelines also reaffirm the use of single-pill combination at any step of treatment to improve treatment adherence & patient compliance¹.

Metoprolol is a cardioselective beta-1-adrenergic receptor blocker that decreases cardiac output by negative inotropic & chronotropic effects. Amlodipine in addition to BP-lowering effects, also possesses the ability to enhance the synthesis of nitric oxide (NO), a critical vasodilator that supports endothelial function. Telmisartan is a unique ARB by virtue of having a terminal elimination half-life of 24 hours & high lipophilicity; leading to a sustained 24-hour BP-lowering effect².

Hypertension is the most important risk factor for CVD in India.³ Studies have reported that Indian patients with hypertension are 11 times more likely to be affected by Coronary Artery Disease (CAD) as compared to non-hypertensive adult population.⁴ Hypertension is attributed as the top risk factor for stroke in India.³ Among young Indian hypertensive patients aged 18-45 years, >70% reported suffering from multiple other cardiovascular risk factors.⁵ Such multiple cardiovascular risk factors & co-morbidities also contribute to uncontrolled hypertension, as indicated in Indian studies⁶

Commenting on the launch, Mr. Pourus Vakil, President – India Business Ajanta Pharma stated “We recognize the role of effective combination treatment medications for the management of hypertension. Met XL AMT is the world’s 1st FDC of 3 best-in-class antihypertensive agents to offer aggressive BP control and better cardiovascular protection. The launch of Met XL AMT is a step towards our commitment to addressing unmet medical needs to improve patient care outcomes in Hypertension.”

Mr. Chanchal Kumar Gop, Sr General Manager, Ajanta Pharma further added “Uncontrolled hypertension doubles the risk of cardiovascular events and stroke. As per a scientific survey, 75% of Indian HCPs opined they would consider triple drug combinations for patients uncontrolled with dual therapy⁷. Our initiative will further strengthen the India Hypertension Control Initiative (IHCI) and mark a significant milestone in the fight against hypertension”.

Ajanta Pharma is an Indian multinational pharmaceutical engaged in the development manufacturing and marketing of diverse pharmaceutical formulations; and many of the first to market formulations, providing access to premium quality medicines across 30+ countries around the world.

References:

1. 2023 ESH Guidelines for the management of arterial hypertension
2. Gosse P. A review of telmisartan in the treatment of hypertension: blood pressure control in the early morning hours. Vasc Health Risk Manag. 2006;2(3):195-201. doi: 10.2147/vhrm.2006.2.3.195. PMID: 17326326; PMCID: PMC1993985.
3. Gupta R, Xavier D. Hypertension: The most important noncommunicable disease risk factor in India. Indian Heart J. 2018;70(4):565-572. doi:10.1016/j.ihj.2018.02.003
4. Biswas A, Singh SK, Singh RK. Linkages between Hypertension and Coronary Heart Disease in India: Evidence from India Human Development Survey-2 (2011-2012). Indian J Community Med. 2017 Oct-Dec;42(4):200-203. doi 10.4103/ijcm.IJCM_168_16. PMID: 29184318; PMCID: PMC5682717.
5. Desai, N., et.al (2021). Risk Factors and Comorbidities in Young Indian Patients with Hypertension: REAL YOUNG (Hypertension) Study. Integrated blood pressure control, 14, 31–41. https://doi.org/10.2147/IBPC.S272548
6. Kapoor M, Dhar M, Mirza A, Saxena V, Pathania M. Factors responsible for Uncontrolled Hypertension in the Adults over 50 years of age: A pilot study from Northern India. Indian Heart J. 2021 Sep-Oct;73(5):644-646. doi: 10.1016/j.ihj.2021.07.003. Epub 2021 Jul 17. PMID: 34627585; PMCID: PMC8514408.
7. Abhyankar M, et. Al Triple drug therapy to manage uncontrolled BP in hypertensive patients during Covid-19 lockdown: perspectives from India. Eur J Cardiovasc Nurs. 2021;20(Suppl 1):zvab060.030. Published 2021 Jul 29. doi:10.1093/eurjcn/zvab060.030