Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE)

Abstract

Background: Observational studies can provide important information on the efficacy and safety of antihypertensive agents in the real-life clinical setting. AdADOSE was a large observational study to assess the effectiveness of nifedipine GITS in combination with other antihypertensive agent(s). The study was also the first to examine the role of combination therapy with nifedipine GITS in the Middle East, Pakistan and Russia, regions that are associated with particularly high cardiovascular risk.

Methods: AdADOSE was a 12-week, international, multicenter, prospective, observational study. Patients with hypertension (ie, blood pressure [BP] >140/90 mm Hg, or >130/80 mm Hg in patients at high or very high cardiovascular risk) received once-daily nifedipine GITS (30, 60 or 90 mg) in combination with another antihypertensive or as add-on to existing therapy. The primary study endpoint was the proportion of patients who achieved the target BP of <140/90 mm Hg (or <130/80 mm Hg for those at high or very high cardiovascular risk). Study outcomes are reported by descriptive statistics.

Results: The study enrolled 4497 patients (n = 4477, safety population; n = 3430, efficacy population). Baseline mean systolic/diastolic BP (SBP/DBP) was 166.4/99.7 mm Hg; 85.2 % of patients had received prior antihypertensive treatment, and 90.6 % had ≥ 1 concomitant diseases. Following combination treatment with nifedipine GITS, target BP was achieved by 64.8% of patients without concomitant diseases, and by 56.5%, 32.3% and 22.6% with 1, 2-3 and >3 concomitant diseases, respectively. The proportion of patients achieving target BP was 51.5% in previously untreated and 33.7% in previously treated patients. Nifedipine GITS combination treatment provided mean SBP/DBP changes of -36.1/-18.8 mm Hg in all patients, -40.2/-21.5 mm Hg in previously untreated patients, and -35.6/-18.4 mm Hg in previously treated patients, with similar BP reductions irrespective of the number of concomitant diseases. Drug-related adverse events (AEs) were reported in 2.6% patients. There were no serious AEs and only 0.8% of patients discontinued due to drug-related AEs.

Conclusions: Combination therapy with nifedipine GITS in a real-life observational setting was highly effective in reducing SBP/DBP in a range of hypertensive patients, with low rates of treatment-related AEs.

Trial registration: at ClinicalTrials.gov registration number NCT01118286 .

Fig. 1

Study design. Disposition of patients treated with nifedipine GITS once daily as part of combination antihypertensive treatment regimens. GITS = gastrointestinal therapeutic system; NIF = nifedipine GITS. Note: * Information on exclusions overlaps

Fig. 2

Change in SBP and DBP. Mean absolute difference in SBP and DBP in patients who had or had not previously received antihypertensive medication and according to number of concomitant diseases (initial to last visit) following 12 weeks’ treatment with nifedipine GITS once daily as part of combination antihypertensive regimens. DBP = diastolic blood pressure; GITS = gastrointestinal therapeutic system; SBP = systolic blood pressure

Fig. 3

Change in SBP and DBP. Mean absolute difference in SBP (a) and DBP (b) according to baseline SBP and DBP following 12 weeks’ treatment (initial to last visit) with nifedipine GITS once daily as part of combination antihypertensive regimens. DBP = diastolic blood pressure; GITS = gastrointestinal therapeutic system; SBP = systolic blood pressure