Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension : two randomized, controlled trials
Two randomized studies were designed to assess the safety, tolerability and efficacy of losartan 100 mg (L100) plus hydrochlorothiazide 12.5 mg (H12.5) in a single fixed-dose combination. In one study, subjects received losartan 50 mg (L50) plus H12.5 during an 8-week filter period. They were then randomized to either L100/H12.5 or L50/H12.5 for another 8 weeks, followed by L100/H12.5 for 44 weeks. The primary end point was safety of L100/H12.5 for 52 weeks. In the second study, subjects received L100 during an 8-week filter period. Subjects were then randomized to receive either L100/H12.5 or L100 for a further 8 weeks. The primary end point was change from baseline in sitting diastolic blood pressure (SiDBP) at week 8. Safety was assessed throughout both studies. L100/H12.5 reduced SiDBP and sitting systolic blood pressure (SiSBP) at 8 weeks, and when compared with L100, the differences were statistically significant for both measures (P<0.001). L100/H12.5 reductions SiDBP for 8 weeks were comparable to L50/H12.5. The efficacy of L100/H12.5 was maintained to week 52. Drug-related adverse events with an incidence ⩾ 2% in the L100/H12.5 group during the 52-week extension period were an increase in aspartate aminotransferase and in blood uric acid. Additionally, mean uric acid levels were reduced by 0.57 mg dl(-1) from baseline with long-term treatment with L100/H12.5 in subjects whose baseline uric acid level was >7.0 mg dl(-1). In conclusion, L100/H12.5 was shown to be more effective than L100 at reducing SiDBP and SiSBP and showed good tolerability in Japanese patients with essential hypertension.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:37 |
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| Enthalten in: |
Hypertension research : official journal of the Japanese Society of Hypertension - 37(2014), 12 vom: 21. Dez., Seite 1042-9 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rakugi, Hiromi [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 03.08.2015 Date Revised 07.12.2022 published: Print-Electronic ErratumIn: Hypertens Res. 2014 Dec;37(12):1088 Citation Status MEDLINE |
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| doi: |
10.1038/hr.2014.114 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM239763750 |
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| 100 | 1 | |a Rakugi, Hiromi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension |b two randomized, controlled trials |
| 264 | 1 | |c 2014 | |
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| 500 | |a Date Completed 03.08.2015 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ErratumIn: Hypertens Res. 2014 Dec;37(12):1088 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Two randomized studies were designed to assess the safety, tolerability and efficacy of losartan 100 mg (L100) plus hydrochlorothiazide 12.5 mg (H12.5) in a single fixed-dose combination. In one study, subjects received losartan 50 mg (L50) plus H12.5 during an 8-week filter period. They were then randomized to either L100/H12.5 or L50/H12.5 for another 8 weeks, followed by L100/H12.5 for 44 weeks. The primary end point was safety of L100/H12.5 for 52 weeks. In the second study, subjects received L100 during an 8-week filter period. Subjects were then randomized to receive either L100/H12.5 or L100 for a further 8 weeks. The primary end point was change from baseline in sitting diastolic blood pressure (SiDBP) at week 8. Safety was assessed throughout both studies. L100/H12.5 reduced SiDBP and sitting systolic blood pressure (SiSBP) at 8 weeks, and when compared with L100, the differences were statistically significant for both measures (P<0.001). L100/H12.5 reductions SiDBP for 8 weeks were comparable to L50/H12.5. The efficacy of L100/H12.5 was maintained to week 52. Drug-related adverse events with an incidence ⩾ 2% in the L100/H12.5 group during the 52-week extension period were an increase in aspartate aminotransferase and in blood uric acid. Additionally, mean uric acid levels were reduced by 0.57 mg dl(-1) from baseline with long-term treatment with L100/H12.5 in subjects whose baseline uric acid level was >7.0 mg dl(-1). In conclusion, L100/H12.5 was shown to be more effective than L100 at reducing SiDBP and SiSBP and showed good tolerability in Japanese patients with essential hypertension | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Angiotensin II Type 1 Receptor Blockers |2 NLM | |
| 650 | 7 | |a Antihypertensive Agents |2 NLM | |
| 650 | 7 | |a Diuretics |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Hydrochlorothiazide |2 NLM | |
| 650 | 7 | |a 0J48LPH2TH |2 NLM | |
| 650 | 7 | |a Losartan |2 NLM | |
| 650 | 7 | |a JMS50MPO89 |2 NLM | |
| 700 | 1 | |a Tsuchihashi, Takuya |e verfasserin |4 aut | |
| 700 | 1 | |a Shimada, Kazuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Numaguchi, Hirotaka |e verfasserin |4 aut | |
| 700 | 1 | |a Nishida, Chisato |e verfasserin |4 aut | |
| 700 | 1 | |a Yamaguchi, Hiroya |e verfasserin |4 aut | |
| 700 | 1 | |a Fujimoto, Go |e verfasserin |4 aut | |
| 700 | 1 | |a Azuma, Kyoichi |e verfasserin |4 aut | |
| 700 | 1 | |a Shirakawa, Masayoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Hanson, Mary E |e verfasserin |4 aut | |
| 700 | 1 | |a Fujita, Kenji P |e verfasserin |4 aut | |
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