Diabetes mellitus has reached epidemic proportions and continues to be a major burden on society globally. The International Diabetes Federation (IDF) estimated the global burden of diabetes to be 366 million in 2011 and predicted that by 2030 this will have risen to 552 million. In spite of newer and effective treatment options, newer delivery and diagnostic devices, stricter glycaemic targets, better treatment guidelines and increased awareness of the disease, baseline glycosylated hemoglobin remains relatively high in subjects diagnosed and treated with type 2 diabetes. The search continues for an ideal anti diabetic drug that will not only normalize blood glucose but also provide beta cell rest and possibly restoration of beta cell function. The development of anti diabetic drugs is riddled with fundamental challenges. The concept of beta cell rest and restoration is yet to be completely understood and proven on a long term. The ideal therapeutic approach to treating type 2 diabetes is not yet determined. Our understanding of drug safety in early clinical development is primarily limited to “Type A” reactions. Until marketing authorization most drugs are approved based on the principle of confirming non-inferiority with an existing gold standard or determining superiority to a placebo. The need to obtain robust pharmaco-economic data prior to marketing authorization in order to determine appropriate pricing of a new drug remains a major challenge. The present review outlines some of the challenges in drug development of anti-diabetic drugs citing examples of pulmonary insulin, insulin analogues, thiazolidinediones and the GLP1 analogues.
Background:This open-labeled, post-marketing study was conducted to assess the efficacy and tolerability of fixed dose combination of amlodipine and metoprolol extended release capsules in mild to moderate hypertension in adult Indian patients.Materials and Methods:Of 101 enrolled patients, 64 drug naïve patients were treated with regimen A (amlodipine 5 mg + metoprolol 25 mg) and those with prior history of hypertension (n = 37) were treated with regimen B (amlodipine 5 mg + metoprolol 50 mg) for 8 weeks. Treatment response was assessed at week 4 and 8. Dose up titration to regimen B was carried out for those who failed to achieve the target blood pressure (BP) at week 4 in regimen A and additional antihypertensives were added to those in regimen B. Safety laboratory tests were performed at baseline and end of study.Results:Mean age (±SD) of patients was 53.36 (±11.26) years and body weight (±SD) 63.40 (10.03) kg. Ninety five patients (94.06%) were only hypertensive and 6 (5.94%) had hypertension with history of coronary artery disease; mean duration (±SD) of hypertension was 42.50 (48.07) months. At baseline, patients had a mean (±SD) systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 154.98 (±7.76) mmHg and 95.55 (±5.70) mmHg respectively. There was a statistically significant (P < 0.001) reduction of 12.16% and 14.69% in SBP, 11.49% and 14.65% in DBP at week 4 and week 8 respectively, compared to baseline. Normalization of overall BP was achieved in 49.49% and 70.71% patients at week 4 and 8, respectively. Peripheral edema was reported in 2.97% (3/101) patients.Conclusion:This combination was safe, efficacious, and well-tolerated in study population.
e 31Conclusion: Telephone and network remote health education to middle-aged and elderly hypertension can control hypertension effectively, decrease the incidence of cardio-cerebrovascular complication.Background: Drugs with complementary mechanisms, even at low-doses, may produce synergistic action resulting in equivalent/superior efficacy with better therapeutic outcome & clinical response.Objective: To determine the safety and efficacy of two strengths of fixed dose combination (TAH)Telmisartan 20/40 mg+Amlodipine 2.5/5 mg+ Hydrochlorothiazide(HCTZ)6.25/12.5 mg administered o.d in patients with essential hypertension compared to TH-Telmisartan40/80mg+HCTZ12.5 mg to achieve normalization of blood pressure (NBP). Method:In this Phase 3, Double-Blind, Double-Dummy, 8weekstudy, subjects were randomized into four groups based on their BP stratification. Therapy was initiated with low dose of medicationsfor four weeks. If N-BP was achieved at week4, same was continued till week8; if not, dose was up-titrated.Result: Enrolled subjects (n = 512) with uncontrolled hypertension and on medications(s), had a mean duration of disease of 47.7 months. Dose up-titration required in was less with TAH(27.34%, 70/256) compared to TH(35.16%, 90/256). NBP was seen in 346 subjects(TAH-183&TH-163) in Intent to treat(ITT) population at week8. There was a statistically significant improvement in NBP in the Modified ITT(mITT, p = 0.041) and Per Protocol (PP, p = 0.041) populations. Among nondiabetics, significantly better NBP was seen in ITT (p = 0.025), mitt (p = 0.015), PP population (p = 0.016). Early therapeutic response was seen among diabetic subjects in ITT(p = 0.043), mITT(p = 0.036), PP population (p = 0.041) at week4 and overall in ITT (p = 0.22), mITT (p = 0.015) populations. There were significant diastolic BP responders in TAH (PP population, p = 0.046) arm. There were 77(50 subjects)non-serious adverse events (AE) and six serious AEs.Conclusion: TAH,with constituents half the strength of comparatordemonstratedequi-efficacyas that of TH(attributed to possible complimentary action and physiological synergy), good safety profileand better tolerability.Background: Hypertension is the silent killer. Approximately 85% to 90% of hypertension cases have unknown cause (primary hypertension). Previous studies revealed that prooxidant effect of uric acid causes an increase in blood pressure. However, other studies revealed that uric acid was not an independent risk factor of hypertension. The difference in these results lead the author interested in conducting this research.
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