ABSTRACT
Objective: 1) To compare the efficacy of two drugs, Amlodipine and hydrochlorothiazide (HCTZ), in elderly Thai patients with isolated systolic hypertension (ISH) in terms of regression of left ventricular hypertrophy (LVH) and blood pressure control. 2) To detect the short (six months) and medium (18 months) terms of clinical outcomes of major cardiovascular events, i.e., congestive heart failure (CHF), myocardial infarction (MI), cerebrovascular disorders (CVD), death and minor clinical outcomes or adverse drug effects. This is a prospective randomized control study. Methods: From October 1997 to March 2000, 200 elderly patients with ISH, mean age of 69.3 years, were randomized into two groups, to receive either Amlodipine or HCTZ as a primary drug. Their baseline clinical data, blood chemistry, ECG, and echocardiography (ECHO) were evaluated. Regression of LVH was re-examined at six months; BP measurement was measured every 3 months for 18 months; and, clinical outcomes were followed at the end of study. Clinical end points were defined as death, myocardial infarction, and congestive heart failure. Results: Sixty-six percent of all patients had LVH by the ECHO criteria. After six months of monotherapy, there was regression of LVH in both groups (p < 0.01), but no difference in the reduction of LVMI between the two groups (p = 0.33). There was a significant reduction in BPsys in both treatment groups (p < 0.01). Those who received Amlodipine had more frequent side effects and were withdrawn from the study (p =0.02). The major adverse drug effect was leg edema (Amlodipine). However, more patients in the HCTZ group required additional drugs (Prazosin) in order to control BP to the desired level (39.2% vs 14.5%, p < 0.001). There was no statistical difference in clinical end points during follow-up. Difference of total drugs costs for one year of treatment was 8,084 Baht/patient in favor of the HCTZ regimen. Conclusion: It is suggested that a low dose of the HCTZ regimen is more cost effective when compared with Amlodipine and should be considered as the first antihypertensive agent of choice for ISH in the Thai elderly.
ABSTRACT
Percutaneous Old Balloon Angioplasty (POBA) is accepted worldwide for the treatment of obstructive coronary artery disease because this technique is safe, and quick and the patient may return to work earlier than with bypass surgery (particularly elderly patients). But the major problem with POBA is restenosis which occurs between 20-40 per cent. Stent placement has been reported to reduce the restenosis rate to 10-20 per cent. OBJECTIVE: The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in elderly Thai patients with obstructive coronary artery disease. METHOD: The study was a randomized controlled trial. The sample size was 45 lesions in 42 patients who were assigned into 2 groups; 23 in the balloon angioplasty group and 22 in the stent placement group (Crown Stent). Clinical information and coronary angiography were recorded and performed at the time of the index procedure and six months later. RESULTS: There was 100 per cent procedural success in 22 lesions treated in the stent group and 82.6 per cent in the 23 lesions treated in the balloon angioplasty group. Patients in the stent group had a lesser degree of stenosis immediately after the procedure (8.78 +/- 8.63 vs 30.92 +/- 9.01%, p < 0.001) and a greater minimal luminal diameter (MLD) (3.04 +/- 0.44 vs 2.15 +/- 0.33 mm, p < 0.001). There were no major complications in either group during the procedure or during their hospital stay. These were not maintained at the six months follow-up. (26.88 +/- 16.23 vs 33.82 +/- 14.63 mm, p = 0.19, 2.28 +/- 0.67 vs 2.01 +/- 0.51 mm, p = 0.17) for the degree of stenosis and the MLD respectively. The restenosis rate, which was the primary endpoint of the study, was 4.5 per cent in the stent group and 21 per cent in the balloon angioplasty group (p = 0.10). CONCLUSIONS: Stenting in Thai elderly ischemic patients has a higher procedural success rate when compared with balloon angioplasty. The restenosis rate of stenting is also lower than that of balloon angioplasty but did not reach statistical significance. However, both techniques had no major complications either during the procedure or in-hospital.