Antihypertensive efficacy and orthostatic tolerance of bunazosin vs nitrendipine : a multicentre double-blind randomized controlled study
Identifieur interne : 002D33 ( Main/Merge ); précédent : 002D32; suivant : 002D34Antihypertensive efficacy and orthostatic tolerance of bunazosin vs nitrendipine : a multicentre double-blind randomized controlled study
Auteurs : M. R. W. Langenfeld [Allemagne] ; M. Br Utigam [Allemagne] ; G. Weidinger [Allemagne] ; I. Assmann [Allemagne] ; B. Krönig [Allemagne] ; R. E. Schmieder [Allemagne]Source :
- Journal of human hypertension [ 0950-9240 ] ; 1996.
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Abstract
A multicentre double-blind randomized controlled study was conducted in 358 patients with mild to moderate essential hypertension. The goal was to compare the antihypertensive efficacy, tolerability, and in particular postural hypotension of the α1-adrenoreceptor blocker bunazosin with the calcium channel blocker nitrendipine. Both treatment groups had comparable baseline blood pressure (BP) values, namely diastolic BP (DBP) of 103.8±5.6 mm Hg in the bunazosin group, and 103.4±6.0 mm Hg in the nitrendipine group, respectively. Baseline systolic BPs (SBP) were 149.7± 14.4 mmHg (bunazosin) and 149.2±14.3 mmHg (nitrendipine). After 12 weeks of therapy, reduction of DBP (-6.1 ± 11.7 mm Hg on bunazosin vs -6.9 ± 9.9 mm Hg on nitrendipine; P=n.s.), and SBP (-4.4±14.3 mm Hg on bunazosin vs -7.0±14.4 mmHg on nitrendipine; P= n.s.) was similar in both groups. During a provocative orthostatic tolerance test after the first dose, the incidence of prae-collapses (ie termination of the test due to orthostatic complaints) was higher on bunazosin (17 vs 2; P< 0.05) but orthostatic dysregulation symptoms (symptom score 1.37 on bunazosin vs 0.95 on nitrendipine; n.s.) and collapses (four on bunazosin vs one on nitrendipine; n.s.) occurred to a similar extent in both treatment groups. Three and 9 weeks after treatment, no increased susceptibility to orthostatic stress compared to baseline could be found in either group. Under daily life conditions, the frequency of orthostatic dysregulation was identical in both groups (0.8%). Bunazosin, however, was far better tolerated with 43.8% of the patients complaining of adverse events as opposed to 63.6% on nitrendipine (P < 0.001). The rate of early discontinuations due to adverse events was only 1.3% on bunazosin compared to 13.6% on nitrendipine (P< 0.001). In conclusion, bunazosin has a similar antihypertensive efficacy as nitrendipine. Despite an initially higher susceptibility to orthostatic stress under a provocative manoeuver, bunazosin evoked the same low incidence of orthostatic dysregulation symptoms as nitrendipine under daily life conditions, but was significantly better tolerated than nitrendipine.
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R. W." last="Langenfeld">M. R. W. Langenfeld</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</s1><s3>DEU</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</wicri:noRegion><wicri:noRegion>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</wicri:noRegion></affiliation></author><author><name sortKey="Br Utigam, M" sort="Br Utigam, M" uniqKey="Br Utigam M" first="M." last="Br Utigam">M. Br Utigam</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Sandoz AG Nürnberg</s1><s3>DEU</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Sandoz AG Nürnberg</wicri:noRegion><wicri:noRegion>Sandoz AG Nürnberg</wicri:noRegion></affiliation></author><author><name sortKey="Weidinger, G" sort="Weidinger, G" uniqKey="Weidinger G" first="G." last="Weidinger">G. Weidinger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Sandoz AG Nürnberg</s1><s3>DEU</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Sandoz AG Nürnberg</wicri:noRegion><wicri:noRegion>Sandoz AG Nürnberg</wicri:noRegion></affiliation></author><author><name sortKey="Assmann, I" sort="Assmann, I" uniqKey="Assmann I" first="I." last="Assmann">I. Assmann</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Clinic of Internal Medicine, Cardiology</s1><s2>Erfurt</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Erfurt</wicri:noRegion><wicri:noRegion>Cardiology</wicri:noRegion><wicri:noRegion>Erfurt</wicri:noRegion></affiliation></author><author><name sortKey="Kronig, B" sort="Kronig, B" uniqKey="Kronig B" first="B." last="Krönig">B. Krönig</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Internal Medicine, Ev. Elisabeth Hospital</s1><s2>Trier</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Trier</wicri:noRegion><wicri:noRegion>Ev. Elisabeth Hospital</wicri:noRegion><wicri:noRegion>Trier</wicri:noRegion></affiliation></author><author><name sortKey="Schmieder, R E" sort="Schmieder, R E" uniqKey="Schmieder R" first="R. E." last="Schmieder">R. E. Schmieder</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</s1><s3>DEU</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</wicri:noRegion><wicri:noRegion>Department of Medicine IV/Nephrology University of Erlangen-Nürnberg</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Journal of human hypertension</title><title level="j" type="abbreviated">J. hum. hypertens.</title><idno type="ISSN">0950-9240</idno><imprint><date when="1996">1996</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of human hypertension</title><title level="j" type="abbreviated">J. hum. hypertens.</title><idno type="ISSN">0950-9240</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Alpha blocking agent</term><term>Antihypertensive agent</term><term>Bunazosin</term><term>Calcium antagonist</term><term>Chemotherapy</term><term>Comparative study</term><term>Dihydropyridine derivatives</term><term>Double blind study</term><term>Human</term><term>Hypertension</term><term>Nitrendipine</term><term>Orthostatic tolerance</term><term>Treatment</term><term>Treatment efficiency</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Hypertension artérielle</term><term>Bunazosine</term><term>Bloquant α-adrénergique</term><term>Nitrendipine</term><term>Antagoniste calcium</term><term>Tolérance orthostatique</term><term>Etude double insu</term><term>Chimiothérapie</term><term>Traitement</term><term>Efficacité traitement</term><term>Homme</term><term>Etude comparative</term><term>Antihypertenseur</term><term>Dihydropyridine dérivé</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">A multicentre double-blind randomized controlled study was conducted in 358 patients with mild to moderate essential hypertension. The goal was to compare the antihypertensive efficacy, tolerability, and in particular postural hypotension of the α<sub>1</sub>-adrenoreceptor blocker bunazosin with the calcium channel blocker nitrendipine. Both treatment groups had comparable baseline blood pressure (BP) values, namely diastolic BP (DBP) of 103.8±5.6 mm Hg in the bunazosin group, and 103.4±6.0 mm Hg in the nitrendipine group, respectively. Baseline systolic BPs (SBP) were 149.7± 14.4 mmHg (bunazosin) and 149.2±14.3 mmHg (nitrendipine). After 12 weeks of therapy, reduction of DBP (-6.1 ± 11.7 mm Hg on bunazosin vs -6.9 ± 9.9 mm Hg on nitrendipine; P=n.s.), and SBP (-4.4±14.3 mm Hg on bunazosin vs -7.0±14.4 mmHg on nitrendipine; P= n.s.) was similar in both groups. During a provocative orthostatic tolerance test after the first dose, the incidence of prae-collapses (ie termination of the test due to orthostatic complaints) was higher on bunazosin (17 vs 2; P< 0.05) but orthostatic dysregulation symptoms (symptom score 1.37 on bunazosin vs 0.95 on nitrendipine; n.s.) and collapses (four on bunazosin vs one on nitrendipine; n.s.) occurred to a similar extent in both treatment groups. Three and 9 weeks after treatment, no increased susceptibility to orthostatic stress compared to baseline could be found in either group. Under daily life conditions, the frequency of orthostatic dysregulation was identical in both groups (0.8%). Bunazosin, however, was far better tolerated with 43.8% of the patients complaining of adverse events as opposed to 63.6% on nitrendipine (P < 0.001). The rate of early discontinuations due to adverse events was only 1.3% on bunazosin compared to 13.6% on nitrendipine (P< 0.001). In conclusion, bunazosin has a similar antihypertensive efficacy as nitrendipine. Despite an initially higher susceptibility to orthostatic stress under a provocative manoeuver, bunazosin evoked the same low incidence of orthostatic dysregulation symptoms as nitrendipine under daily life conditions, but was significantly better tolerated than nitrendipine.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Langenfeld, M R W" sort="Langenfeld, M R W" uniqKey="Langenfeld M" first="M. R. W." last="Langenfeld">M. R. W. Langenfeld</name></noRegion><name sortKey="Assmann, I" sort="Assmann, I" uniqKey="Assmann I" first="I." last="Assmann">I. Assmann</name><name sortKey="Br Utigam, M" sort="Br Utigam, M" uniqKey="Br Utigam M" first="M." last="Br Utigam">M. Br Utigam</name><name sortKey="Kronig, B" sort="Kronig, B" uniqKey="Kronig B" first="B." last="Krönig">B. Krönig</name><name sortKey="Schmieder, R E" sort="Schmieder, R E" uniqKey="Schmieder R" first="R. E." last="Schmieder">R. E. Schmieder</name><name sortKey="Weidinger, G" sort="Weidinger, G" uniqKey="Weidinger G" first="G." last="Weidinger">G. Weidinger</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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