Abstract
The majority of patients with hypertension require combination therapy to acheive their BP goals. Fixed-dose combination therapy (FDCT) may improve BP lowering and response rates without an increase in side effects. The purpose of this study was to compare the BP lowering effects, response rates, and side effects of FDCT with monotherapy. A MEDLINE search was conducted to identify randomized controlled trials with the FDCT trandolapril/verapamil. Studies with adequate design and sample size were pooled using standard meta-analytic techniques. Systolic BP (sBP), diastolic BP (dBP), response rates (RR), all side effects (SE ALL) and side effects resulting in drug discontinuation (SE DC) were compared between FDCT trandolapril/verapamil (T/V) and verapamil monotherapy (V) and trandolapril monotherapy (T). Outcomes were compared statistically using a ‘t’ test corrected for mutiple comparisons. A total of 20 randomised controlled trials were included in the analysis. There were 11 cohorts with V, 9 with T, and 20 with T/V. A total of 696 patients were included in the V cohorts, 493 in the T cohorts, and 1365 in the T/V cohorts. When V and T were compared, there were no signficant differences between the groups with regard to sBP, dBP, or RR. T had significantly lower rates of SE ALL and SE DC than V (p < 0.05). T/V produced significantly greater sBP and dBP reductions with a greater RR than both V and T (p < 0.05). The incidence of SE ALL and SE DC were not different between T and T/V. However, the incidence of SE AL and SE DC were significantly higher with V and T/V (p < 0.05). FDCT with V/T was significantly more effective than V and T with regard to BP lowering and RR. SE ALL and SE DC were not different between T/V and T. SE ALL and SE DC were significantly greater with V compared to T and T/V. T/V should be considered a safe and effective FDCT product. (See Table)BP, Response and Side Effects with V, T, and T/V Drug Number sBP (mmHg) dBP (mmHg) Response (%) SE ALL (%) SE DC (%) Verapamil 696 9.2 7.2 45 47 17 Trandolapril 493 12.6 9.5 57 24 3 T/V 1365 19.3 13.8 74 28 3