EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study.

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.

Acute hepatitis associated with Barakol.

Barakol is a natural anxiolytic extracted from Cassia siamea, known as "Khi-lek" in Thailand. The authors studied the adverse effects of Barakol in 12 healthy Thai patients, aged 29-81 years (mean 52.5) who took Barakol 3-180 days (mean 76.9). Eight of them were admitted with the first episode of anorexia and jaundice for 4-60 days (mean 14.3) after taking 20-40 mg/day (2-4 tablets) of Barakol. There was no relationship between degree of symptom and dosage/duration of Barakol intake. Three asymptomatic cases were detected with increased aminotransferase from a routine check-up, including an 81 year old female who took half of the dosage for 120 days. The last one was a male patient who presented with low-grade fever and nausea and vomiting. All patients had neither a history of chronic liver disease nor known hepatotoxic substance ingestion. On admission, the mean total bilirubin was 5.7 mg/dl and liver function test (LFT) revealed moderate to severe hepatitis (Aspartate amino transferase (AST) range 111-1,473 U/L: mean = 692). None of them had detected viral markers. Liver biopsy was done in 3 cases and the histopathological findings were compatible with interface hepatitis. Two non-biopsy cases developed recurrent transaminitis after one-week re-challenging without informing the physician. Their symptoms and LFT completely improved within 2-20 weeks (mean 5.9) after Barakol abstinence.