An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension

Kamayani Gupta; Poonam Patel; Krishna Kaushal Bhardwaj; Prem Nyati; Suraj Tripathi

doi:10.5455/njppp.2022.12.09320202109092021

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Original Research
Online Published: 30 Sep 2021

Natl J Physiol Pharm Pharmacol. 2022; 12(3): 343-349

doi: 10.5455/njppp.2022.12.09320202109092021

An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension

Kamayani Gupta, Poonam Patel, Krishna Kaushal Bhardwaj, Prem Nyati, Suraj Tripathi.

Abstract
Background: Hypertension is a chronic disease and is a major risk factor for chronic heart disease, stroke, coronary heart disease, and its complications include heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage, and visual impairment. Antihypertensive drugs are important to avoid such complications but compliance of patient is needed which may depend on the cost of therapy.

Aim and Objective: This study aimed to assess the efficacy and safety of a branded generic with an economical generic.

Materials and Methods: Out of 110 patients, 105 patients (53 patients in group A and 52 patients in group B) completed the study with follow-up over a period of 6 months. Group A patients received generic Telmisartan 40 mg in the beginning (0th day) which was continued for 12 weeks, cross-over was done with branded generic Telmisartan (Telma 40) which was given for further 3 months. Group B patients received the branded generic followed by generic Telmisartan in that sequence for 3 months each. Blood pressure (BP) was recorded at the baseline visit and at the end of 4, 8, 12, 16, 20, and 24 weeks. The adverse events were assessed throughout the study period.

Results: Intra-group comparison show significant reduction in systolic (SBP) and diastolic BP (DBP) in each groups (P < 0.001) but when we compare the reduction of SBP and DBP in between the two groups the difference was not significant. Common adverse events were headache, dizziness, light-headedness, and vertigo.

Conclusion: There was a huge difference between the prices of branded generic and unbranded generic. This study showed that both branded generic and unbranded generic are comparable in terms of efficacy, safety except the cost of therapy. Thus substitution of a Pharmacological generic (unbranded generic) drug could save lot of expenses.

Key words: Branded Generic; Unbranded Generic; Telmisartan; Hypertension

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How to Cite this Article

Pubmed Style

Gupta K, Patel P, Bhardwaj KK, Nyati P, Tripathi S. An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. Natl J Physiol Pharm Pharmacol. 2022; 12(3): 343-349. doi:10.5455/njppp.2022.12.09320202109092021

Web Style

Gupta K, Patel P, Bhardwaj KK, Nyati P, Tripathi S. An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. https://www.njppp.com/?mno=118723 [Access: November 01, 2024]. doi:10.5455/njppp.2022.12.09320202109092021

AMA (American Medical Association) Style

Gupta K, Patel P, Bhardwaj KK, Nyati P, Tripathi S. An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. Natl J Physiol Pharm Pharmacol. 2022; 12(3): 343-349. doi:10.5455/njppp.2022.12.09320202109092021

Vancouver/ICMJE Style

Gupta K, Patel P, Bhardwaj KK, Nyati P, Tripathi S. An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. Natl J Physiol Pharm Pharmacol. (2022), [cited November 01, 2024]; 12(3): 343-349. doi:10.5455/njppp.2022.12.09320202109092021

Harvard Style

Gupta, K., Patel, . P., Bhardwaj, . K. K., Nyati, . P. & Tripathi, . S. (2022) An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. Natl J Physiol Pharm Pharmacol, 12 (3), 343-349. doi:10.5455/njppp.2022.12.09320202109092021

Turabian Style

Gupta, Kamayani, Poonam Patel, Krishna Kaushal Bhardwaj, Prem Nyati, and Suraj Tripathi. 2022. An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. National Journal of Physiology, Pharmacy and Pharmacology, 12 (3), 343-349. doi:10.5455/njppp.2022.12.09320202109092021

Chicago Style

Gupta, Kamayani, Poonam Patel, Krishna Kaushal Bhardwaj, Prem Nyati, and Suraj Tripathi. "An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension." National Journal of Physiology, Pharmacy and Pharmacology 12 (2022), 343-349. doi:10.5455/njppp.2022.12.09320202109092021

MLA (The Modern Language Association) Style

Gupta, Kamayani, Poonam Patel, Krishna Kaushal Bhardwaj, Prem Nyati, and Suraj Tripathi. "An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension." National Journal of Physiology, Pharmacy and Pharmacology 12.3 (2022), 343-349. Print. doi:10.5455/njppp.2022.12.09320202109092021

APA (American Psychological Association) Style

Gupta, K., Patel, . P., Bhardwaj, . K. K., Nyati, . P. & Tripathi, . S. (2022) An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension. National Journal of Physiology, Pharmacy and Pharmacology, 12 (3), 343-349. doi:10.5455/njppp.2022.12.09320202109092021

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