ABSTRACT
Background: High blood pressure (BP) is the most prevalent chronic disease in India and its prevalence is rapidly increasing among urban and rural populations. This study was conducted to assess the efficacy and safety of triple drug fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorothiazide 12.5mg. Methods: 30 hypertensive patients having systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg who were uncontrolled on dual drug therapy with Telmisartan-Amlodipine or Telmisartan-Hydrochlorothiazide combinations were enrolled in this study. The treatment period was of 120 days and patients were administered once daily fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg. Patients were evaluated on 30th, 60th and 120th days of treatment. Results: There was statistically significant (p<0.0001) decrease in systolic blood pressure from baseline to 30th, 60th and 120th day of treatment mean±SD (157.0±8.68 mmHg vs 148.7±8.19, 137.3±7.84, and 127.0±7.02 mmHg) respectively. Similarly the diastolic blood pressure (DBP) was significantly (p<0.0001) reduced from the baseline to the 30th, 60th and 120th day of treatment (100.0±6.43 mmHg vs. 96.0±6.21, 86.6±6.06 and 80.6±2.53 mmHg respectively). Conclusion: Thus triple drug fixed dose combination of Telmisartan, Amlodipine and hydrochlorothiazide was found to be effective and safe option for the optimal management of hypertension.
ABSTRACT
Background: Hypertension is a major health problem in India. Being a multifactorial condition often requires the administration of multiple drugs. Despite improvements in the management of hypertension and the availability of effective antihypertensive agents, only 50% of these individuals achieve BP control. The present study was undertaken to evaluate the efficacy and safety of, fixed dose combination of olmesartan 40 mg + chlorthalidone 12.5 mg, in the management of hypertension uncontrolled with olmesartan monotherapy. Methods: 110 patients were enrolled in this Post-Marketing Surveillance (PMS) study. Patients were prescribed to take fixed dose combination for 60 days. Results: There was significant decrease (P <0.0001) in Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP) from the baseline to 15th, 30th and 60th days of the treatment. At the end of the study period of 60 days 95.4% & 90.9% patients of age group >60 years and <60 years achieved the Joint National Committee (JNC VIII) recommended goal respectively. (<150/90 for elder patients aged above 60 year and 140/90 for those aged less than 60 years). Conclusion: Thus fixed dose combination therapy of olmesartan & chlorthalidone has been shown to be excellent in efficacy and tolerability & gives another option for the optimal management of hypertension.
ABSTRACT
The objective of EVOLVE [nebivolol (nevol) evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73 +/- 14.16 mm Hg which dropped to 135.13 +/- 11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p < 0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21 +/- 8.25 mm Hg that dropped to 83.69 +/- 6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p < 0.001). The heart rate in this study showed a significant decrease from 86.13 +/- 9.35 at basal to 75.09 +/- 7.42 at the end of the study (p < 0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n = 22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by JNC VII. EVOLVE PMS study confirms the safety and efficacy of nebivolol hydrochloride in Indian population.