ABSTRACT
Background: Objectives of the study was to study the effect of Azilsartan 40mg once daily versus Telmisartan 40mg once daily in patients with Grade I-II essential hypertension.Methods: A prospective study was conducted at MGM Medical college and Hospital which included 80 patients in each group with Grade I–II essential hypertension. The sex, age, presenting illness, and family history of the patients were recorded. Investigations such as blood sugar, urine analysis, kidney function test, lipid profile, and ECG were performed before starting the treatment. Any adverse effects during the treatment were noted. Blood pressure was recorded at baseline and during follow-up. One group received Azilsartan 40mg once daily and another group Telmisartan 40mg once daily. Patients were followed-up every week for 5 weeks.Results: Patients receiving Azilsartan 40mg and Telmisartan 40mg showed a significant fall (P <0.05) in systolic (SBP) at the end of fifth week, when compared to baseline and diastolic blood pressure (DBP) significant fall at fourth and fifth week. The difference in fall in SBP and DBP was insignificant between the groups, after first, second and third week (P >0.05). Adverse effects such as Nasopharyngitis, Upper respiratory tract inflammation, Gastroenteritis, headache, dizziness, and fatigue were reported with both drugs.Conclusions: Reduction of blood pressure with Azilsartan and Telmisartan was similar, but fall in blood pressure from baseline was highly significant in both groups.
ABSTRACT
OBJECTIVE To provide reference for the industry, introduce the experimental design of animal efficacy studies and human dosage extrapolating strategy about drugs and biological products (including vaccines) approved by FDA under animal rule. METHODS This article provides an overview catalogued by the indications of drugs (including vaccines), on experimental grouping, dosage regimen, critical efficacy endpoints and other elements in the adequate and well-controlled animal efficacy studies, and further analyses the strategy of extrapolating animals efficacy data. RESULTS The regulations commonly known as the animal rule allow for the licensure of drugs and biological products developed to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances, when human efficacy studies are not ethical and field trials to study the effectiveness of drugs or biological products are not feasible. CONCLUSION Under the animal rule, drug efficacy can be established based on adequate and well-controlled studies in animal models and the human dosing regimens can be extrapolated based on the animal data.
ABSTRACT
The need for an efficacious HIV/AIDS vaccine remains the highest priority of the world HIV/AIDS agenda. The generation of an efficacious HIV/AIDS vaccine proves an enormous scientific challenge. This article reviews the neutralizing antibody problem, elusive immune protection, immunogen design, pre-existing anti-vector immunity and design of phase 3 vaccine trials and the challenges and opportunities in development of HIV/AIDS vaccine are discussed.