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

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.