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.

Efficacy and safety of nifedipine GITS in Chinese patients with hypertension--a post-marketing surveillance study.

PURPOSE: This post-marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro-intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China. PATIENTS AND METHODS: A total of 3003 patients were included in 174 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine GITS. Data were collected at up to three follow-up visits. RESULTS: At the end of the observation period, mean treatment duration was 13.3 weeks. Mean blood pressure reduction was 27.6/13.6 mmHg, 62.1% of patients had a systolic blood pressure <140 mmHg, and 82.2% had a diastolic blood pressure <90 mmHg. Blood pressure control according to international guidelines was achieved in 45.0% of all patients. A total of 1515 patients received additional antihypertensive medications, of which angiotensin-converting enzyme (ACE) inhibitors were mostly used (42.2%) followed by beta-blockers (33.7%). Twenty-two patients (0.7%) experienced 27 adverse events. Physicians' assessments of efficacy, tolerability and patient acceptance had ratings of "very good" and "good" in 88.7% (efficacy), 92.8% (tolerability) and 89.1% (patient acceptance) of patients. CONCLUSIONS: Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 3003 Chinese patients. The results confirm the findings of previously performed clinical studies.

Post-marketing surveillance of acarbose treatment in patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance in China.

OBJECTIVE: This open, prospective, non-interventional, non-randomised, multi-centre postmarketing surveillance study was conducted over a mean period of 13.9 weeks to assess the efficacy, safety and acceptance of acarbose in Chinese patients with type 2 diabetes mellitus and subjects with impaired glucose tolerance (IGT) in routine clinical practice. Subjects with IGT were included in analyses because acarbose has been approved for treatment of this condition since 2002. PATIENTS AND METHODS: A total of 2550 study participants were enrolled by 133 physicians throughout China. Efficacy parameters were the changes from initial visit to the end of study in glycosylated haemoglobin (HbA(1c)), fasting blood glucose (FBG), postprandial BG and bodyweight. RESULTS: The majority of study participants (74.7%) were newly diagnosed. Most (77.0%) were administered acarbose 50mg three times daily (the recommended standard dose in China) throughout the study and more than half (51.7%) received concomitant antihyperglycaemic treatment. Acarbose treatment reduced HbA(1c) by 1.4% to 6.7%, FBG by 38.5 mg/dL to 116.4 mg/dL, 2-hour postprandial BG by 92.2 mg/dL to 149.0 mg/dL and bodyweight by 0.4 kg to 67.5 kg. Subgroup analyses for type 2 diabetes and IGT populations were also conducted. In diabetic patients, HbA(1c) was reduced by 1.4%, FBG by 42.1 mg/dL and 2-hour postprandial BG by 98.9 mg/dL. Marked reductions were also achieved in the IGT population (0.9% for HbA(1c), 11.8 mg/dL for FBG and 42.9 mg/dL for 2-hour postprandial BG) despite lower baseline glucose levels in this group than in patients with type 2 diabetes. Bodyweight slightly increased in the IGT population. Only 12 acarbose-related adverse events, none of which was serious, were reported. The attending physicians assessed treatment efficacy as 'good' or 'very good' for 92.4%, tolerability as 'good' or 'very good' for 91.1%, and patient acceptance as 'good' or 'very good' for 89.8% of all study participants. CONCLUSION: Acarbose was efficacious, safe and well accepted by Chinese patients with type 2 diabetes and subjects with IGT under day-to-day treatment conditions, both as monotherapy and in combination with other antihyperglycaemic medication.

Postmarketing surveillance of acarbose treatment in Taiwanese patients with type 2 diabetes mellitus.

OBJECTIVE: This postmarketing surveillance (PMS) study was conducted to assess the efficacy, safety and acceptance of acarbose treatment in patients with type 2 diabetes mellitus. METHODS: Patients were recruited in this open, prospective, uncontrolled, non-randomised multicentre study by 159 physicians throughout Taiwan, following the guidelines of the Bureau of National Health Insurance (BNHI) of Taiwan. Primary efficacy parameters were changes in fasting blood glucose, postprandial blood glucose and glycosylated haemoglobin (HbA(1c)) values during treatment with acarbose. RESULTS: The majority of the 1558 enrolled patients received acarbose 50 mg three times daily, had previously been treated with a sulphonylurea and/or biguanide, and were observed for a mean period of 13.9 weeks. Most patients (91.8%) received concomitant oral antihyperglycaemic agents. Acarbose reduced fasting blood glucose concentrations by 32.0 mg/dL and 2-hour postprandial blood glucose levels by 52.2 mg/dL. HbA(1c) was reduced by 1.0% from 9.9% to 8.9%, and bodyweight remained stable. The attending physicians assessed that acarbose was associated with 'very good' or 'good' general efficacy in 46.0% of patients, 'very good' or 'good' tolerability in 60.6% and 'very good' or 'good' patient acceptance in 63.4%. These ratings were higher for patients receiving acarbose monotherapy compared with those taking other antihyperglycaemic therapies in addition to acarbose. Only 2.0% of all patients experienced drug-related adverse events. CONCLUSION: Acarbose treatment provides an efficacious, safe and well accepted alternative for metabolic improvement in Taiwanese patients with type 2 diabetes under daily-life treatment conditions.