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Combination therapy with nifedipine GITS 60?mg: subanalysis of a prospective, 12-week observational study (AdADOSE).

ABSTRACT: AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90?mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength.Patients with hypertension who received a daily nifedipine GITS dose of 60?mg, either at constant dose (n?=?686) or up-titrated from 30?mg (n?=?392), were analyzed. Target blood pressure (BP) was <140/90?mmHg (or <130/80?mmHg for those at high/very high cardiovascular risk).Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60?mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30-60?mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were -40.3/-20.7?mmHg and -35.6/-18.5?mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60?mg; 2.0%, 30-60?mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs.Combination therapy with nifedipine GITS 60?mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs.

SUBMITTER: Motaweih AK

PROVIDER: S-EPMC4720040 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE).

Motaweih Ahmed K AK Usova Elena E Hussain Wajid W Dello Ziad Z Petri Thomas T

Clinical and experimental hypertension (New York, N.Y. : 1993) 20150902 1

<h4>Background</h4>AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength.<h4>Methods</h4>Patients with hypertension who rec ...[more]

PMID: 26331311

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Project description:BackgroundObservational 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.MethodsAdADOSE 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.ResultsThe 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.ConclusionsCombination 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 registrationTrial registrationat ClinicalTrials.gov registration number NCT01118286 .

Project description:IntroductionAchieving target blood pressure (BP) goals in patients with chronic kidney disease (CKD) and uncontrolled hypertension is a challenge. Various studies have shown the efficacy of nifedipine gastrointestinal therapeutic system (GITS) 60 mg in patients with hypertension. However, there is a paucity of clinical studies in patients with CKD. Hence, we conducted this study to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg in Chinese patients with CKD and uncontrolled hypertension in real-world clinical settings.MethodsIn a prospective, multicenter, observational study, Chinese patients with CKD and uncontrolled hypertension were given nifedipine GITS 60 mg with a primary endpoint of change in office systolic BP (SBP) at 12 weeks. The secondary endpoints included changes at 12 weeks in office diastolic BP (DBP), office SBP and DBP in SBP subgroups (140-160 mmHg and ≥ 160 mmHg) and CKD stages subgroups, SBP and DBP control rate, and the adverse events (AEs). Statistical analysis was performed using SAS® version 9.4.ResultsIn total, 871 and 622 patients were included in the safety analysis set and efficacy analysis set respectively. The mean office SBP and DBP at baseline were 162.9 and 97.3 mmHg, respectively. At week 12, the mean change in SBP was - 24.0 mmHg (95% confidence interval [CI] - 25.32, - 22.65 mmHg); after missing data were accounted for, it was - 23.9 mmHg (95% CI - 25.25, - 22.60 mmHg). Marked decreases in DBP, and office SBP and DBP in baseline SBP subgroups as well as CKD stages were observed at week 12. The BP control rate at week 12 was 50.0%. Twenty-three (2.6%) patients reported at least one drug-related AEs. No event of hypotension or death occurred during the study.ConclusionNifedipine GITS 60 mg showed effectiveness and tolerability in reducing office SBP and DBP in Chinese patients with CKD and uncontrolled hypertension.Trial registrationClinicalTrials.gov identifier NCT03194633.

Dataset Information

Combination therapy with nifedipine GITS 60?mg: subanalysis of a prospective, 12-week observational study (AdADOSE).

Publications

Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE).

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