Efficacy and tolerability of long-acting nifedipine GITS/OROS monotherapy or combination therapy in hypertensive patients: results of a 12-week international, prospective, multicentre, observational study.

BACKGROUND: Achieving the maximum reduction in cardiovascular morbidity and mortality is the primary goal of blood pressure (BP) control. Current guidelines recommend several antihypertensive classes as first-line therapy for this purpose but the decision on which agent/s to use will likely be based upon the treating physician's clinical experience. Observational studies provide a useful way of ascertaining the efficacy and tolerability of an antihypertensive in a real-life clinical setting. OBJECTIVE: The aim of this observational study was to determine the efficacy, tolerability and physician/patient satisfaction with long-acting nifedipine (gastrointestinal therapeutic system [GITS]/osmotic-controlled release oral delivery system [OROS]) in a large multinational cohort of hypertensive patients. METHODS: This observational study was conducted in adults (aged ≥18 years) with previously untreated or treated hypertension. The decision to prescribe nifedipine 30 or 60 mg once daily was made by the treating physician. Patients then attended up to three clinic visits any time over a 12-week period when medication could be up- or down-titrated or switched. The mean reduction in systolic BP (SBP)/diastolic BP (DBP) from first visit and whether target BP (<140/<90 mmHg or <130/<80 mmHg [for patients with diabetes mellitus]) had been achieved were recorded at the final visit and stratified according to hypertension grade and presence of cardiovascular risk factors. Subjective assessment of efficacy was reported by physicians and patients. All adverse events and their possible relationship to study drug were recorded. All assessments were performed on patients who received at least one dose of nifedipine GITS/OROS. RESULTS: A total of 14 344 patients received nifedipine GITS/OROS treatment (58.7% male; 77.7% non-diabetic; mean age 57.5 years); 14 266 had at least one follow-up visit over a mean 10.2-week period, and 8000 patients had three visits over a mean 12-week period. Initially, 12 826 (89.4%) patients received nifedipine 30 mg, and 6912 patients (48.2%) overall received concomitant antihypertensive agents. The overall mean reduction in SBP/DBP was -27.7/-14.1 mmHg; BP reduction was linked to hypertension grade, age, the presence of five or more cardiovascular risk factors, and prior treatment. Target BP was achieved in 2485/7432 patients (33.4%) receiving nifedipine GITS/OROS monotherapy and in 1751/6912 (25.3%) receiving combination therapy (i.e. GITS/OROS plus any other antihypertensive agent). Non-diabetic patients with moderate (n = 3413) and high (n = 1138) risk reached their target BP goal in 62.5% and 54.2% of cases, respectively; the corresponding values in diabetic patients (moderate-added risk n = 8; high-added risk n = 684) were 75.0% and 54.8%, respectively. A total of 229 patients (1.6%) reported experiencing 286 adverse events. Physician/patient satisfaction with treatment was high. CONCLUSION: Long-acting nifedipine GITS/OROS, alone or in combination with other antihypertensive agents, provides effective and well tolerated treatment of hypertension in a broad spectrum of patients routinely seen in day-to-day clinical practice.

Efficacy and safety of nifedipine GITS in Asians with hypertension: results of a post-marketing surveillance study in China.

OBJECTIVE: This post-marketing surveillance study assessed the efficacy, safety and tolerability of treatment with nifedipine GITS (gastrointestinal therapeutic system) in hypertensive patients with different risk profiles under normal daily practice conditions in China. METHODS: A total of 7395 patients were included in 564 outpatient clinics. Patients received 30mg or 60mg of nifedipine GITS, which could be up- and down-titrated if necessary. Efficacy, safety and tolerability data were collected at up to three follow-up visits. Patient documentation was completed using standardised and barcoded case report forms. Descriptive and explorative analyses of the data were performed. RESULTS: At endpoint, 93% of patients were receiving 30mg of nifedipine GITS and 7% were taking 60mg of nifedipine GITS. The mean observation period was 9 +/- 7 weeks. At endpoint, the mean BP reduction was 27.7/14.8mm Hg; 43% of patients had a systolic BP <140mm Hg, and 58% had a diastolic BP <90mm Hg. BP control as recommended by international guidelines was achieved in 43.5% of all patients. A total of 3163 patients (42.8%) received additional antihypertensive medication, of which ACE inhibitors were most commonly used (40.7%), followed by beta-adrenoceptor antagonists (25.8%).Twenty-nine patients (0.4%) experienced a total of 39 adverse events. Subjective physicians' assessments of efficacy, tolerability and patient acceptance of nifedipine GITS treatment returned ratings of 'very good' and 'good' in 91-95% of each category. CONCLUSIONS: Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 7395 Chinese patients under normal daily practice conditions. The results confirm the findings and experience of previously performed clinical studies.