Dr Reddy’s Laboratories has received approval for Optidoz – a drug for the treatment of essential hypertension and will be available in the Indian market. Optidoz is a single pill combination of three anti-hypertensive drugs (Amlodipine 2.5mg, Telmisartan 20mg and Hydrochlorothiazide 6.25mg) with optimal (half of standard) dose of individual drugs.
Efficacy and safety of Optidoz has been established through the CONTROL-Hypertension clinical study, approved by Drug Controller General of India (DCGI). The study (512 patients with mild to moderate Hypertension at 18 centers for a treatment period of eight weeks), was conducted between Nov. 2010 and June 2011, per the Good Clinical Practices (GCP) in accordance with the Helsinki Declaration. The study, demonstrated that Optidoz controls hypertension faster and more effectively with much lesser incidence of adverse events as compared to standard dose double drug combination. Optidoz will also simplify the traditional, complicated step-care treatment approach for hypertension management. The prolonged blood pressure control with minimal adverse effects is expected to improve efficacy response in normalising the blood pressure due to good tolerability with Optidoz and enhanced compliance in patients.
While over 125 anti-hypertensive drugs are available in the Indian market, 76 per cent cases of blood pressure still remain uncontrolled. Such a paradox is attributed to ineffective drug doses and non-adherence to therapy, which may lead to disease progression of co-morbid conditions like heart disease, heart failure, stroke and kidney diseases. Optidoz is an attempt from Dr Reddy’s to address these concerns and alleviate hypertension related disease burden in India.
EP News Bureau – Mumbai