Thomas Hedner, Krzysztof Narkiewicz, Sverre Kjeldsen
{"title":"Post-registration studies for the evaluation of antihypertensive drugs.","authors":"Thomas Hedner, Krzysztof Narkiewicz, Sverre Kjeldsen","doi":"10.3109/08037051.2011.631283","DOIUrl":"https://doi.org/10.3109/08037051.2011.631283","url":null,"abstract":"The full public health benefi t of new medicines is often only partially documented in the literature because of a lack of appropriate information. Much of this information is compiled after the drug is registered and has been available on the market for a large number of years. Such post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefi ts/risks as well as the impact on treatment strategies, healthcare procedures and on public health and importantly morbidity and mortality (1) assessed in many ways. In France, it is currently carried out by the National Health Authority, by assigning a level of improvement in actual benefi t (IAB) (2). IAB is based on two parameters – effi cacy and safety of the product – in a defi ned target population, compared with one or more other drugs with similar indications, or within a similar therapeutic strategy. What role do post-registration studies play in the long-term risk and benefi t assessment of drugs, and what conditions and methodologies could be used for such assessment? In order to improve our knowledge on appropriate benefi ts and relevant risks, a number of questions may be raised, such as e.g. what study procedures to follow in monitoring studies carried out after a drug has been authorized. How can health authorities establish relevant guidelines and a methodological basis for specifi cations; which purposes should be addressed; and which methodologies are relevant in terms of design and execution? Epidemiological observational monitoring of antihypertensive drugs are now well established, and applied to assessment of non-cardiovascular outcomes, extended therapeutic effects adverse events profi les, therapeutic benefi ts in special populations, relative added value with respect to available treatments as well as public health benefi t in a regional and global perspective (Table I). The current Blood Pressure Drug Therapeutic Issue includes three studies, which have evaluated the extended effi cacy and safety of antihypertensive treatment regimens in multi-center open settings (3,4,5). The paper by Liou and coworkers (3) evaluated a large cohort of Taiwanese hypertensive patients treated with valsartan alone or in combination with other antihypertensive drugs. In this setting, they report that valsartan monotherapy was well tolerated, and that higher doses as well as combination therapy provided added benefi ts to the lower dose range and monotherapy, respectively. The combination of metoprolol and amlodipine in two dose levels was evaluated by Delvi et al. (4) in an Indian cohort of patients with mild to moderate hypertension. Responder and control rates were high with both fi xed dose combinations and provided clinically meaningful reductions in blood pressure Blood Pressure, 2011; 20 (Suppl 2): 3–4","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"3-4"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2011.631283","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30474740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of early versus late titration of fixed-dose irbesartan/hydrochlorothiazide: ACTUAL study.","authors":"Xavier Girerd, David Rosenbaum, Joseph Aoun","doi":"10.3109/08037051.2011.633368","DOIUrl":"https://doi.org/10.3109/08037051.2011.633368","url":null,"abstract":"<p><p>Hypertension management guidelines recommend titrating antihypertensive drugs stepwise every 4-6 weeks.We compared efficacy and safety of early versus late titration after 10 weeks' treatment with irbesartan/hydrochlorothiazide. Hypertensive patients uncontrolled on monotherapy were randomized into two groups. In the early titration group (E), patients received irbesartan/hydrochlorothiazide 150/12.5 mg for 2 weeks; uncontrolled patients were up-titrated to 300/25 mg at weeks 2 and 6. In the late titration group (L), patients received 150/12.5 mg for 6 weeks; uncontrolled patients were up-titrated to 300/25 mg at week 6 (W6). The change of mean systolic (SBP) and diastolic blood pressure (DBP) from baseline to week 10 (W10) were studied using a covariance analysis model. The percentage of controlled patients at W10 was compared between groups using Fisher's exact test. Of 833 patients enrolled from 14 countries, the intent-to-treat (ITT) population included 795 (mean age 58 +/- 12 years, female 60%, obesity 38%, diabetes 22%). AtW6, mean SBP decrease was: E - 28.8 mmHg vs L - 26.3 mmHg (p = 0.02). At W10, there was similar mean SBP decrease: E - 29.5 mmHg vs L- 31.0 mmHg (p = 0.14). The control rate at W10 was 58% (E) and 64% (L), p = 0.06. Serious adverse events were more frequent in E (2.5% vs 0.7%, p= 0.044). Both early and late titration regimens provide similar BP decrease and control rate.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"22-9"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2011.633368","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30475169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of valsartan in hypertensive Taiwanese patients: post-marketing surveillance study.","authors":"Chia-Wei Liou, Tung-Chen Yeh, I-Chung Chen, Chi-Hung Huang, Yi-Jen Hung, Kwan-Lih Hsu, Jian-Der Lee, Meng-Huan Lei, Kuan-Cheng Chang, Pei-Yung Liao, Zhih-Cherng Chen, Jackson Wang, Charles Jia-yin Hou","doi":"10.3109/08037051.2011.588458","DOIUrl":"https://doi.org/10.3109/08037051.2011.588458","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of valsartan in Taiwanese patients with essential hypertension.</p><p><strong>Methods: </strong>This 12-week multi-center, open-label, observational, post-marketing surveillance study enrolled 2046 hypertensive patients who were prescribed valsartan 80 or 160 mg as monotherapy or in combination with other antihypertensives based on clinical judgment. The primary endpoint was the incidence rate of dizziness with valsartan 160 mg monotherapy or combination therapy at Week 4. Secondary endpoints included the blood-pressure-lowering efficacy and the overall safety and tolerability of valsartan at Weeks 4 and 12.</p><p><strong>Results: </strong>The monotherapy and combination groups had comparable baseline characteristics. At Week 4, monotherapy was found non-inferior to combination for incidence rate of dizziness (monotherapy, 9.25%; combination, 10%; difference in incidence of dizziness, 0.75%; 95% CI - 0.61% to 2.12%; non-inferiority margin, -1.33%;WaldTest approach). Greater blood pressure (BP) reduction was noted atWeek 12 than atWeek 4.The antihypertensive effect was greater with combination therapy and the 160-mg dose. BP control (systolic <140 mmHg or diastolic <90 mmHg) was achieved in 80-90% patients.Valsartan was well tolerated; most commonly reported adverse events included dizziness, headache, constipation and cough.</p><p><strong>Conclusion: </strong>Valsartan is an effective treatment option for essential hypertension in Taiwanese patients.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"13-21"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2011.588458","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30475165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS--a randomized controlled trial.","authors":"Padmini Devi, Denis Xavier, Alben Sigamani, Sudhanshu Pandey, Tinku Thomas, Sreenivas Murthy, Kamal Sharma, Balraj Bosco, Ketan Mehta, Sindhu Joshi, Rajeev Gupta, Girija Singh, Jagadish Hiremath, Chadha Ds, Ashokan Nambiar, Prem Pais","doi":"10.3109/08037051.2011.617040","DOIUrl":"https://doi.org/10.3109/08037051.2011.617040","url":null,"abstract":"<p><strong>Aim: </strong>To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in hypertension.</p><p><strong>Methods: </strong>We conducted this multicentre, randomized, open-label, trial in Indian patients with hypertension (140-180 mmHg/90-114 mmHg) in 11 centres from nine cities. Eligible patients (n = 402) were randomized into one of five treatment groups (metoprolol XL 50 mg + amlodipine 5 mg, metoprolol XL 25 mg + amlodipine 2.5 mg, metoprolol XL 50 mg, metoprolol XL 25 mg or amlodipine 5 mg) and treated for 8 weeks with five follow-up visits to record blood pressure (BP) and clinical status.</p><p><strong>Results: </strong>At baseline, treatment groups were well balanced; mean +/- SD BP was 154.87 +/- 11.91/96.63 +/- 6.97 mmHg. The greatest reduction in BP from baseline to 8 weeks was seen in the high-dose FDC group (23.61/14.91 mmHg; p<0.001). The remaining 4 groups too demonstrated a significant reduction (p< 0.001): low-dose FDC - 22.29/ - 14.66; metoprolol 50, - 23.17/ - 13.37; metoprolol 25,- 18.41/ 12.50 and amlodipine 5, - 23.01/- 13.08. BP reductions by FDCs, however, were not statistically superior to monotherapies. Responder rates (sitting diastolic BP< 90 mmHg or reduction > or =10 mmHg) were 93% in the high-dose FDC group and 97% in the low-dose FDC group, and control rates (sitting BP < 140/90 mmHg) were 66% and 58%, respectively. These rates were higher than that seen in individual components. There were no reports of serious adverse events related to study medications. One each from the low-dose FDC and metoprolol 25 mg group discontinued because of adverse events.</p><p><strong>Conclusions: </strong>FDCs of metoprolol and amlodipine are effective and safe in mild to moderate hypertension.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"5-12"},"PeriodicalIF":0.0,"publicationDate":"2011-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2011.617040","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30475164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
W Frank Peacock, Joseph Varon, Ramin Ebrahimi, Lala Dunbar, Charles V Pollack
{"title":"Clevidipine for severe hypertension in patients with renal dysfunction: a VELOCITY trial analysis.","authors":"W Frank Peacock, Joseph Varon, Ramin Ebrahimi, Lala Dunbar, Charles V Pollack","doi":"10.3109/08037051.2010.539317","DOIUrl":"https://doi.org/10.3109/08037051.2010.539317","url":null,"abstract":"<p><strong>Introduction: </strong>Acute and severe hypertension is common, especially in patients with renal dysfunction (RD). Clevidipine is a rapidly acting (t½∼1 min) intravenous (IV) dihydropyridine calcium-channel blocker metabolized by blood and tissue esterases and may be useful in patients with RD. The purpose of this analysis was to assess the safety and efficacy of clevidipine in patients with RD.</p><p><strong>Methods: </strong>VELOCITY, a multicenter open-label study of severe hypertension, enrolled 126 patients with persistent systolic blood pressure (SBP) >180 mmHg. Investigators pre-specified a SBP initial target range (ITR) for each patient to be achieved within 30 min. Blood pressure monitoring was by cuff. Clevidipine was infused via peripheral IV at 2 mg/h for at least 3 min, then doubled every 3 min as needed to a maximum of 32 mg/h (non-weight-based treat-to-target protocol). Per protocol, clevidipine was continued for at least 18 h (96 h maximum). RD was diagnosed and reported as an end-organ injury by the investigator and was defined as requiring dialysis or an initial creatinine >2.0 mg/dl. Primary endpoints were the percentage of patients within the ITR by 30 min and the percentage below the ITR after 3 min of clevidipine infusion.</p><p><strong>Results: </strong>Of the 24 patients with moderate to severe RD, most (13/24) were dialysis dependent. Forty-six percent were male, with mean age 51 ± 14 years; 63% were black and 96% had a hypertension history. Median time to achieve the ITR was 8.5 min. Almost 90% of patients reached the ITR in 30 min without evidence of overshoot and were maintained on clevidipine through 18 h. Most patients (88%) transitioned to oral antihypertensive therapy within 6 h of clevidipine termination.</p><p><strong>Conclusions: </strong>This report is the first demonstrating that clevidipine is safe and effective in RD complicated by severe hypertension. Prolonged infusion maintained blood pressure within a target range and allowed successful transition to oral therapy.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"20-5"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2010.539317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29481678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jean-Michel Mallion, Stefano Omboni, John Barton, Walter Van Mieghem, Krzysztof Narkiewicz, Peter-Klaus Panzer, Juan García Puig, Christodoulos Stefanadis, Robert Zweiker
{"title":"Antihypertensive efficacy and safety of olmesartan and ramipril in elderly patients with mild to moderate systolic and diastolic essential hypertension.","authors":"Jean-Michel Mallion, Stefano Omboni, John Barton, Walter Van Mieghem, Krzysztof Narkiewicz, Peter-Klaus Panzer, Juan García Puig, Christodoulos Stefanadis, Robert Zweiker","doi":"10.3109/08037051.2010.532332","DOIUrl":"https://doi.org/10.3109/08037051.2010.532332","url":null,"abstract":"<p><strong>Objective: </strong>To compare the efficacy and safety of olmesartan medoxomil (O) and ramipril (R) in elderly patients with essential arterial hypertension.</p><p><strong>Methods: </strong>After a 2-week placebo washout, 351 elderly hypertensive patients aged 65-89 years (office sitting diastolic blood pressure, DBP, 90-109 mmHg and office sitting systolic blood pressure, SBP, 140-179 mmHg) were randomized double-blind to 12-week treatment with O 10 mg or R 2.5 mg once daily. After the first 2 and 6 weeks, doses could be doubled in non-normalized (blood pressure <140/90 mmHg for non-diabetic and <130/80 mmHg for diabetic) subjects, up to 40 mg for O and 10 mg for R. Office blood pressures were assessed at randomization, after 2, 6 and 12 weeks of treatment; 24-h ambulatory blood pressure (ABP) was recorded at randomization and after 12 weeks.</p><p><strong>Results: </strong>At week 12, in the intention-to-treat population (170 patients O and 175 R) the rate of normalized subjects was significantly larger in the O group (38.8% vs 26.3% R; p = 0.013). Baseline-adjusted mean sitting office blood pressure reduction at final visit was not significantly greater under O [SBP: 16.6 (95% confidence interval 14.0/19.2) mmHg vs 13.0 (10.4/15.6) mmHg R, p = 0.206; DBP: 11.8 (10.3/13.3) mmHg vs 10.5 (9.0/12.0) mmHg, p = 0.351]. In the subgroup of patients with valid ABP recordings (38 O and 47 R), the reduction in 24-h average blood pressure was significantly (p < 0.01) larger with O [SBP: 8.9 (9.8/8.1) and DBP: 5.7 (6.3/5.1) mmHg] than with R [6.7 (7.9/5.6) and 4.4 (5.1/3.7) mmHg]. The superiority of O was particularly evident in the last 4 h from the dosing interval. The proportion of patients with drug-related adverse events was comparable in the two groups (4.0% O vs 4.5% R), as well as the number of patients discontinuing study drug because of a side-effect (8 O vs 7 R).</p><p><strong>Conclusions: </strong>In elderly patients with essential arterial hypertension, O provides an effective, prolonged and well tolerated blood pressure control, with significantly better blood pressure normalization than R and represents a useful option among first-line drug treatments of hypertension in this age group.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"3-11"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2010.532332","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29481679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Effects of candesartan versus amlodipine on home-measured blood pressure, QT dispersion and left ventricular hypertrophy in high-risk hypertensive patients.","authors":"Yasunari Matsuno, Shinya Minatoguchi, Hisayoshi Fujiwara","doi":"10.3109/08037051.2010.532339","DOIUrl":"https://doi.org/10.3109/08037051.2010.532339","url":null,"abstract":"<p><p>The GIFU substudy of the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial was conducted to compare the long-term effects of candesartan and amlodipine on office- and home-measured blood pressure (BP), QTc dispersion and left ventricular mass index (LVMI) in high-risk Japanese patients with hypertension. We used a prospective, randomized, open-label design with blinded assessment of endpoints. Patients were assigned to candesartan-based therapy up to 12 mg/day (n = 100) or amlodipine-based therapy up to 10 mg/day (n = 101) and followed for 3 years. LVMI was assessed by echocardiography and QTc dispersion was obtained from electrocardiograms. Both candesartan and amlodipine lowered and controlled office- and home-measured BP levels with no significant between-treatment differences. In patients diagnosed with left ventricular hypertrophy (LVH) at baseline, both candesartan and amlodipine significantly regressed LVMI after 3 years. However, candesartan (41.7 ± 15.1 ms at baseline vs 32.9 ± 16.6 ms after 3 years, p < 0.01), but not amlodipine (41.4 ± 13.5 ms at baseline vs 41.5 ± 16.1 ms after 3 years), produced a significant reduction in QTc dispersion. Larger studies in patients treated for longer periods are needed to determine whether this candesartan effect will translate into improved prognosis in terms of cardiovascular mortality and morbidity.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"12-9"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051.2010.532339","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29608908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giray Kabakci, Baris Ergun Kaya, Erol Tulumen, Ugur Kocabas, Gulcan Abali, Onur Deveci, Kudret Aytemir, Lale Tokgozoglu, Hilmi Ozkutlu
{"title":"The efficacy and safety of irbesartan in primary hypertension even if a dose is missed: Results from the NO PROBLEM Study.","authors":"Giray Kabakci, Baris Ergun Kaya, Erol Tulumen, Ugur Kocabas, Gulcan Abali, Onur Deveci, Kudret Aytemir, Lale Tokgozoglu, Hilmi Ozkutlu","doi":"10.3109/08037050903444099","DOIUrl":"https://doi.org/10.3109/08037050903444099","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to demonstrate that irbesartan is successful in reducing diastolic blood pressure (BP) even following a missed dose after 6-8-weeks' treatment as measured by 24-hour ambulatory BP monitoring (ABPM).</p><p><strong>Methods: </strong>Eighty-eight patients (64 females, mean age: 53.4 +/- 10.6 years) with primary hypertension were included in this national, single-center, single-arm, open-label, prospective clinical study. Irbesartan (150 or 300 mg/day) was administered for 8 weeks. All patients were asked to cease treatment for 1 day during weeks 6-8. Changes in diastolic and mean 24-hour BP on the day of cessation and diastolic BP values during visits were efficacy parameters. Adverse events were also recorded.</p><p><strong>Results: </strong>Systolic, diastolic, and mean BP values measured via ABPM before and on the day of a missed dose did not differ significantly. Irbesartan effectively controlled BP of the patients. BP normalization rates were 54% for 150 mg/day irbesartan only and 77% for both doses (150 or 300 mg/day) of irbesartan. None of the patients experienced serious adverse events throughout the study period.</p><p><strong>Conclusions: </strong>Irbesartan is successful and safe in the control of BP levels even following a missed dose at the end of a 6-8-week treatment period.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"5-9"},"PeriodicalIF":0.0,"publicationDate":"2010-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037050903444099","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28545656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of diuretics in combination with perindopril in hypertensive stroke patients: Results of the Japan Perindopril and Diuretics on Cerebrovascular Disease Study (J-PADOC).","authors":"Yasuhiro Hasegawa, Kazuyuki Shimada, Takenori Yamaguchi","doi":"10.3109/08037050903513497","DOIUrl":"https://doi.org/10.3109/08037050903513497","url":null,"abstract":"<p><strong>Aims: </strong>An international randomized controlled trial has shown that anti-hypertensive therapy using perindopril and indapamide significantly reduces the recurrence of stroke. To evaluate the efficacy and safety of diuretics given as add-on therapy to stroke patients, as needed, to perindopril, we conducted a prospective multicenter observational study.</p><p><strong>Methods: </strong>A total of 3825 hypertensive patients with a history of stroke were enrolled. The patients received a two-step therapy, starting with perindopril alone, and those who failed to achieve the blood pressure target were subsequently given a diuretic. Each group was followed for 6 months.</p><p><strong>Results: </strong>62.8% of the patients achieved the blood pressure goal. The incidence of adverse events was significantly higher in the perindopril plus diuretic combination therapy group than in the perindopril monotherapy group. Although these results may reflect that severely hypertensive patients were selectively assigned to combination therapy, the observed differences were essentially elevated serum creatinine, triglycerides, blood urea nitrogen and uric acid, whereas no significant inter-group difference was noted in total cholesterol and blood glucose.</p><p><strong>Conclusions: </strong>If adequate care of compromised renal function is taken, perindopril plus diuretic combination therapy exerts potent hypotensive effects without posing significant safety problems in patients with a history of stroke.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"10-6"},"PeriodicalIF":0.0,"publicationDate":"2010-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037050903513497","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28731655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas Hedner, Sverre Kjeldsen, Krzysztof Narkiewicz
{"title":"Implementation of 24-hour blood pressure control.","authors":"Thomas Hedner, Sverre Kjeldsen, Krzysztof Narkiewicz","doi":"10.3109/08037051003668884","DOIUrl":"https://doi.org/10.3109/08037051003668884","url":null,"abstract":"More than three decades ago, Millar-Craig et al. (1) described the patterns of the circadian variation of blood pressure (BP). They demonstrated by using continuous intra-arterial monitoring, that BP was highest in the early to mid-morning period and lowest at night, rapidly rising again before awakening. Their fi ndings marked the beginning of an era where 24 h assessment of BP was to become increasingly common. However, it took some 20 years before 24 hour ambulatory BP measurement (ABPM) became an integral part of clinical hypertension diagnosis and management. Today, 24 h ambulatory BP assessment is widely used in hypertension clinics, and a search on “24 hour blood pressure control” on Google results in about 4.500.000 hits in 0.32 sec.","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"3-4"},"PeriodicalIF":0.0,"publicationDate":"2010-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/08037051003668884","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28731654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}