[The pharmacovigilance system in Portugal (its establishment and development)]. / O sistema de farmacovigilância em Portugal (sua criação e desenvolvimento).

The safety profile of a drug is not a static concept. It progresses and can change on the basis of scientific data gathered before and after it is marketed. Therefore, it is now considered fundamental that all countries have the capacity to continuously monitor the safety of medicines authorized for sale. Based on the resulting and appropriate data, this allows them to alter the previously authorized conditions for use of a given drug as a public health safeguard. This paper describes how a pharmacovigilance system is being developed in Portugal in the 1990s. The system is being implemented based on our national characteristics and positions within the European Union. The article includes some results from the initial implementation of these methods. Many similarities allow one to extrapolate some of the procedures from one country to another. When we began we borrowed and adapted extensively from experiences already tested by others.

Isradipine in the treatment of mild-to-moderate hypertension in geriatric patients.

A number of studies have shown the benefit of hypertensive treatment even though the most common forms of the disease are mild-to-moderate in severity. Considering the overall aging of the world's population, it is of particular interest to study hypertension and its treatment in geriatric patients. A short-term study of isradipine was conducted to assess its effectiveness and tolerability in patients with mild-to-moderate hypertension. The study was carried out by general practitioners and involved 3343 patients, aged > or = 18 years, with diastolic blood pressures (DBPs) ranging from 95 to 114 mm Hg. A 4-week wash-out and placebo run-in phase was followed by a 12-week active treatment period with isradipine at 1.25 or 2.5 mg/day, depending on the blood pressure response. Posttreatment results in a subgroup of 1092 patients (444 men and 648 women), aged > or = 60 years, showed decreases in systolic blood pressure (SBP) from 173.1 to 149.2 mm Hg (mean decrease, 20.9 mm Hg) and, in DBP, from 102.0 to 85.0 mm Hg (mean decrease, 16.9 mm Hg). The majority (84.6%) of these patients showed DBP reductions of > 10 mm Hg, and 82.3% achieved normalization (DBP < 90 mm Hg) at the end of treatment. The mean dosage was 1.74 +/- 0.69 mg twice daily, and 37% of patients doubled their initial 1.25 mg twice daily dosages. There were no significant changes in either heart rate or major metabolic parameters. Adverse events were reported by 3.1% of the patients, and 90% of both patients and physicians expressed satisfaction with the therapy. There were no differences between men and women with regard to adverse events or efficacy, nor were the results in patients > or = 60 years different from those in younger patients. Thus, isradipine was effective and well tolerated in these geriatric patients.

[Hypertension and well-being: a study with indapamide]. / Hipertensão e bem-estar: estudo com indapamida.

STUDY OBJECTIVE: Evaluate the clinical efficacy and quality of life of indapamide in patients with mild and moderate arterial systemic hypertension under indapamide. DESIGN: Open prospective design. SETTING: Outpatient clinics of the Instituto Nacional de Cardiologia Preventiva in Lisbon. PATIENTS: Thirty-two patients whose supine diastolic blood pressure was between 95 ans 115 mmHg without known secondary hypertension, unstable diabetes, cardiac, renal or hepatic failure, hypokalemia, coronary artery disease or stroke in the previous year. INTERVENTION: After a two week wash-out and four week placebo periods, indapamide has been given in a single daily dose of 2.5 mg at breakfast during 12 weeks. MEASUREMENTS AND MAIN RESULTS: The mean systolic/diastolic blood pressures was reduced from 155.7/103.7 to 138.6/86.1 mmHg (p < 0.0001). The mean standing systolic/diastolic blood pressure lowered from 160.2/103.7 to 141.6/85.9 mmHg (p < 0.0001). The questionnaires on quality of life and the analogic visual scale showed a progressive and significant improvement in general well-being. In the patient questionnaire the percentage of improvement was 80% (16/20 items) namely asthenia, headache, attention, dizziness, tinnitus and visual disturbance. In the physician questionnaire all the items improved. Biochemical acceptability was characterized by the stability of sodium, chlorine, glucose, creatinine, urea, cholesterol, triglycerides, uric acid and slight decrease in potassium from 4.38 to 4.14 mmol/l (p < 0.01) ranging in normal values. CONCLUSIONS: These results confirm the clinical efficacy of indapamide and its beneficial effects on quality of life in patients with mild and moderate hypertension when administered in monotherapy.

Isradipine in the treatment of mild-to-moderate hypertension in Portugal.

A short-term trial of isradipine was conducted to assess its effectiveness and tolerability in the treatment of mild-to-moderate hypertension. The study was carried out by general practitioners and involved 2,702 patients, aged 18-70 years, who had diastolic blood pressures (DBP) of 95-114 mm Hg. Patients completed a pretreatment phase of up to 4 weeks for antihypertensive drug washout and placebo run-in, before entering a 12-week active-treatment phase with 1.25 mg of isradipine twice daily, which was increased after 4 weeks to 2.5 mg twice daily, depending on the blood pressure response. At the end of 12 weeks, the mean systolic blood pressure (SBP) and DBP were 148.1 and 86.7 mm Hg compared with 169.0 and 103.0 mm Hg after placebo, respectively. The majority of patients (89.6%) had a DBP reduction greater than 10 mm Hg, and 86.2% had normalized DBP (less than or equal to 90 mm Hg) at the end of treatment. Adverse events were reported by 2.8% of patients, and 90% of patients and general practitioners reported satisfaction with the treatment. Thus, our results indicate that isradipine is effective and well tolerated, and may deserve a place as first-line treatment in mild-to-moderate hypertension.