Amlodipine Besylate versus Candesartan Cilexetil in Hypertensive Patients - Office and Self-Measured Blood Pressure : A Randomised, Double-Blind, Comparative, Multicentre Trial.

OBJECTIVE: The aim of this study was to compare the antihypertensive efficacy and tolerability of the calcium channel antagonist amlodipine besylate versus the angiotensin II type 1 receptor antagonist candesartan cilexetil in hypertensive patients. PATIENTS AND METHODS: After a 2-week placebo washout period, 326 patients with essential hypertension were randomised to receive amlodipine 5mg once daily or candesartan cilexetil 8mg once daily in a double-blind, parallel-group design with a 12-week active treatment period followed by a 4-day placebo drug-free period. The initial daily dose could be doubled at week 6 if office diastolic blood pressure (DBP) was still >/=90mm Hg. BP changes were assessed daily through patient self-measurements, and fortnightly by office BP measurements. RESULTS: A total of 294 patients (151 amlodipine and 143 candesartan cilexetil) were included in the per-protocol analysis of the primary endpoint of BP change from baseline at 12 weeks. Reductions in sitting office systolic BP (SBP) [amlodipine 24.4mm Hg, candesartan cilexetil 22.3mm Hg] and DBP (amlodipine 14.9mm Hg, candesartan cilexetil 14.8mm Hg) were statistically equivalent within the chosen range of equivalence (5mm Hg for SBP and 3mm Hg for DBP). The proportion of controlled patients (office BP <140/90mm Hg) at the end of therapy was similar in both treatment groups (amlodipine 46.9%, candesartan cilexetil 44.4%). The reduction in self-measured DBP was significantly greater (p < 0.05) for amlodipine (7.2mm Hg) compared with candesartan cilexetil (4.8mm Hg). There was no significant difference between the two treatments in the incidence of adverse events reported. CONCLUSIONS: Amlodipine besylate and candesartan cilexetil were both very effective in lowering office BP after 12 weeks of treatment. There was a trend towards a better self-measured BP reduction with amlodipine compared with candesartan cilexetil. The overall incidence of adverse events was comparable between the two treatments.

[Safety and antihypertensive efficacy of the dihydropyridine calcium antagonist Amlodipine besylate--results from an observational study in 9,672 patients]. / Verträglichkeit und antihypertensive Wirksamkeit des Dihydropyridin- Kalziumantagonisten Amlodipinbesilat. Ergebnisse einer Anwendungsbeobachtung mit 9672 Patienten.

OBJECTIVES: This observational study investigated prescription behavior and the efficacy and safety of Amlodipine besylate in hypertensive patients. METHODS: 9,672 hypertensive patients were treated with Amlodipine besylate 5-10 mg/day for 12 weeks. At the end of the observation period, the participating physicians were asked to give their subjective evaluation of the efficacy and safety of treatment with Amlodipine besylate as well as their therapeutic considerations regarding the use of Amlodipine besylate. RESULTS: 55.2% of the patients received Amlodipine besylate in combination with other antihypertensive agents. The mean baseline blood pressure was 168.0/96.7 mmHg and the mean blood pressure reduction achieved at the end of the observation period was -28.5/-14.5 mmHg. In 80.3% of the total population, a reduction to diastolic blood pressure values of < 90 mmHg was achieved. A reduction to systolic blood pressure values of < 140 mmHg was obtained in 41.6% of the patients. Adverse events were reported by only 1.2% of the patients. For the vast majority of the patients, efficacy (96.6%) and safety (98.9%) were rated "very good" or "good" by their physicians. 24-hour efficacy with once daily dosing was given as the most important argument for using Amlodipine besylate. CONCLUSION: The observation study confirmsthat Amlodipine besylate is an effective and safe antihypertensive drug both in mono and combination therapy.

[Amlodipine versus nifedipine retard. A randomized double-blind comparative study on long-term efficacy and safety of amlodipine and nifedipine retard in the monotherapy of chronic stable angina pectoris]. / Amlodipin versus Nifedipin retard. Eine randomisierte Doppelblindstudie zum Vergleich der Langzeitwirksamkeit und Verträglichkeit von Amlodipin und Nifedipin retard in der Monotherapie der chronisch stabilen Angina pectoris.

PATIENTS AND METHOD: This double-blind study compared the efficacy and safety of once daily amlodipine (5-10 mg/day) vs twice daily nifedipine (40-80 mg/day) in 244 patients with chronic stable angina pectoris. Efficacy was assessed after 4 and 24 weeks by bicycle exercise test. RESULTS: No statistically significant differences were found between the two treatment groups at the end of treatment with regard to the ergometry parameters determined (maximum ST segment deviation, maximum workload in watts, maximum exercise duration and time to 0.1 mV ST segment depression). Furthermore, the two treatment groups were comparable with regard to the effected reduction in anginal attacks and short acting nitrate consumption. The incidence of adverse events was lower in the amlodipine relative to the nifedipine group (11.5% vs 19.1%). CONCLUSION: The results of this study show that once daily amlodipine offers comparable antianginal and antiischemic efficacy as twice daily sustained release nifedipine in the monotreatment of chronic stable angina pectoris. Given the lower incidence of adverse events with amlodipine and its convenient once daily dosing regimen, however, amlodipine may help to enhance patient compliance.

[Anti-ischemic efficacy of sustained-release isosorbide-5-mononitrate: echocardiography during mental and physical stress]. / Antiischämische Wirkung von retardiertem Isosorbidmononitrat--Echokardiographieuntersuchung unter psychomentaler und körperlicher Belastung.

This double-blind, placebo-controlled study investigated the anti-ischemic efficacy of sustained-release isosorbide-5-mononitrate (IS-5-MN) 100 mg/day on the basis of stress echocardiography and stress ECG in patients subjected to physical (bicycle ergometry) and mental stress (mental stress test). Forty male patients with a stress-induced ST segment depression of > 0.1 mV during bicycle ergometry who received beta blocker background therapy were randomized into the 14-day treatment phase (IS-5-MN: 20 patients, placebo: 20 patients). After 2 weeks of treatment, a significant prolongation of the time to 0.1 mV ST segment depression and of the time to stress-induced anginal attacks could be demonstrated for IS-5-MN in the stress echocardiography. A significantly greater reduction in the wall motion score determined via stress echocardiography was found in IS-5-MN-treated vs. placebo-treated patients relative to baseline. There were only 4 patients who developed ST segment depression during mental stress; however, the echocardiography demonstrated a significantly greater reduction of the wall motion score after 2 weeks of treatment vs. baseline in the IS-5-MN vs. the placebo group. The efficacy of sustained-release IS-5-MN 100 mg/day was proved in this study both by stress echocardiography, and stress electrocardiography in situations of physical and mental stress. It was found that echocardiography is more sensitive for detecting ischemic reactions induced by mental stress than ECG.

[Amlodipine in long-term treatment of mild and moderate hypertension. A multicenter study]. / Amlodipin in der Langzeibehandlung der leichten bis mittelschweren Hypertonie. Eine multizentrische Studie.

METHOD: An open, multicenter study was conducted to investigate the antihypertensive efficacy and safety of amlodipine in the long-term treatment of patients with mild to moderate essential hypertension of a period of 178 weeks (3.4 years). RESULTS: 92 of the 110 patients participating in the study received amlodipine treatment throughout the total study period, with 77 patients on amlodipine monotherapy (mean daily dose 6.3 mg), and 15 patients on combination antihypertensive therapy including amlodipine (mean daily dose 7.1 mg). After 8 weeks of treatment the diastolic target blood pressure of < or = 90 mmHg was achieved in 86 out of 92 patients (93.5%). The mean diastolic blood pressure reduction was retained throughout the treatment, both in patients receiving monotherapy and those on combination therapy. The incidence of adverse events was highest during the first 12 weeks of treatment (30.0%); after another 54 weeks it dropped to 18.1%, and to 7.3% during the last 112 weeks. The side effects reported most frequently were headaches and edema. CONCLUSION: These results indicate that amlodipine effects sustained reduction in diastolic blood pressure over a period of more than 3 years in patients with mild to moderate hypertension.