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Biomedical subjects

J Lubsen

Publications and source records attributed to J Lubsen.

At least 19 recordsLinked to original sources
PubMed1995

Diuretics, beta-blockers, and the risk for sudden cardiac death in hypertensive patients.

OBJECTIVE: To determine whether the use of non-potassium-sparing diuretics and beta-blockers is associated with an excess risk for sudden cardiac death in hypertensive patients. DESIGN: Case-control study. SETTING: Rotterdam, the Netherlands. PATIENTS: 257 case-patients who had died suddenly while receiving drug therapy for hypertension and 257 living controls also receiving drug therapy for hypertension. MEASUREMENTS: Detailed information on medication use and clinical characteristics of all case-patients and controls was collected from the files of general practitioners. Additional information on medication use was obtained from computerized pharmacy records. RESULTS: Patients receiving non-potassium-sparing diuretics had an increased risk for sudden cardiac death (relative risk, 1.8 [95% CI, 1.0 to 3.1]) compared with a reference group treated primarily with potassium-sparing diuretics. The corresponding relative risk for beta-blocker use was 1.7 (CI, 1.1 to 2.6). The use of non-potassium-sparing diuretics without beta-blockers was associated with a higher risk for sudden death (relative risk, 2.2 [CI, 1.1 to 4.6]) than was concomitant use of non-potassium-sparing diuretics and beta-blockers (relative risk, 1.4 [CI, 0.6 to 3.0]). The risk for sudden cardiac death among recipients of non-potassium-sparing diuretics was more pronounced in those who had been receiving the diuretic for less than 1 year and in those aged 75 years or younger. CONCLUSIONS: The use of non-potassium-sparing diuretics and beta-blockers is associated with an increased risk for sudden cardiac death. This association may offset part of the mortality benefit of these drugs in the treatment of hypertension.

Adrenergic beta-Antagonists↗
PubMed1995

Does drug treatment improve survival? Reconciling the trials in mild-to-moderate hypertension.

OBJECTIVE: To evaluate whether drug treatment for mild-to-moderate hypertension in middle-aged patients improves survival and to study how the conflicting results of individual trials may be explained. STUDY SELECTION: A meta-analysis was performed, including seven randomized trials in mild-to-moderate hypertensive (diastolic blood pressure 90-114 mmHg) middle-aged patients. DATA EXTRACTION: A comparison was made between all-cause mortality and fatal coronary heart disease and stroke in the intervention and control group of the individual trials, using a method of meta-analysis based on weighted linear regression. RESULTS: In trials with a high all-cause mortality rate (> 6 per 1000 patient-years) in the control group, antihypertensive drug treatment increased life expectancy. When all-cause mortality in the control group was low, treatment showed no effect or even an opposite effect. Findings on mortality from coronary heart disease were similar, whereas drug treatment decreased stroke mortality irrespective of the incidence of stroke in the control group. CONCLUSIONS: Drug treatment for mild-to-moderate hypertension in middle-aged patients may reduce all-cause mortality and the risk of fatal coronary events when treatment is initiated in those beyond a certain baseline mortality risk. Drug treatment in hypertensive patients at a lower mortality risk has no influence on or may even increase mortality.

Adult↗
PubMed1994

Exercise testing as outcome in congestive heart failure trials. Design considerations when interpreting results.

In addition to standard features of clinical trial design such as randomisation and double-blinding, sensitivity to drug effects is an important consideration when conducting exercise capacity trials in patients with heart failure. Two issues need to be addressed in this context. Firstly, it is important to enrol patients who are potential responders. Patients who have, for their age and sex, normal exercise capacity are unlikely to improve, even when given a drug that has a positive effect on exercise capacity. In addition, those patients who remain clinically stable following withdrawal of their previous drug therapy are unlikely to respond subsequently to an experimental drug with a similar mechanism of action. Secondly, failure to complete scheduled exercise tests during follow-up, prompting a 'per-protocol' analysis of results, may mask the drug's actual effect. To avoid this, an 'intention-to-treat' approach to data collection and analysis, with appropriate allowance made for missing test data, should be adopted.

Aged↗
PubMed1994

Do non-potassium-sparing diuretics increase the risk of sudden cardiac death in hypertensive patients? Recent evidence.

Whether non-potassium-sparing diuretics (NPSD) increase the risk of sudden cardiac death in hypertensive patients has been vigorously debated. Diuretic-induced potassium or magnesium depletion leading to cardiac arrhythmias has been suggested as the underlying mechanism. A clear dose-response relationship between NPSD and the reduction in serum K+ exists. Data regarding serum Mg++ and intracellular K+ and Mg++ are too limited to allow conclusions. NPSD seem to increase the risk of ventricular arrhythmias among hypertensive patients with clinical evidence of heart disease, but the number of studies is small. The findings among patients without evidence of heart disease are less conclusive. The interpretation of the studies on electrolyte changes and arrhythmias following diuretic therapy is obscured by the fact that only a minority of studies included a randomly allocated placebo-treated control group. The large hypertension trials provide the strongest evidence that NPSD for hypertension may induce sudden death. Although blood pressure lowering may be expected to reduce the incidence of sudden cardiac death, the incidence in the NPSD group is similar to or even higher than that in the control group in 9 of 10 trials. We conclude that the beneficial effect of NPSD therapy for hypertension is partly offset by an excess risk of sudden death. Thus, alternative drugs, notably potassium-sparing diuretics or beta-blockers, could be preferred as antihypertensive drugs of first choice, although the efficacy of beta-blockers in older patients has recently been challenged.

Adult↗
PubMed1992

[Risk factors for the occurrence of recurrent convulsions following an initial febrile convulsion].

The results of a follow up study of 155 Dutch children who visited the emergency room of an urban paediatric hospital after experiencing their first febrile seizure are presented. Median follow up time was 38 months (range 27-60). Of these 155 initially untreated children 58 (37%) suffered at least one, 47 (30%) at least two and 27 (17%) at least three recurrent seizures. The recurrence hazard after any seizure was highest in the first six months, and dropped markedly after 6 months without seizures. The effect of the various postulated risk factors on the occurrence of any recurrent seizure and three or more recurrences was assessed. A first degree family history of febrile or nonfebrile seizures appears to be a predictor of multiple recurrences; an age of at least 30 months and a temperature of 40.0 degrees C or higher at the initial seizure are associated with a decreased risk. Several factors act together on the risk of recurrent seizures, sometimes in opposite directions. By considering the action of all relevant factors (age at onset, family history and features of the initial febrile seizure) subgroups of children with one year seizure recurrence rates as low as 15% and as high as 48% were identified.

Age Factors↗
PubMed1992

Seizure recurrence after a first febrile seizure: a multivariate approach.

The results are presented of a follow-up study of 155 Dutch children after the first febrile seizure. Of these initially untreated children 37 per cent had had at least one, 30 per cent at least two and 17 per cent at least three subsequent seizures. The vulnerable period for recurrent seizures after the first febrile seizure was between 12 and 24 months, whereafter the risk was four to five times lower; after any seizure the risk was highest within the first six months, declining steadily after six months without seizures. A first-degree family history of any type of seizure predicted multiple recurrences; an age of at least 30 months and a temperature of greater than or equal to 40 degrees C at initial seizure were associated with reduced risk. Factors in combination influenced the risk of recurrent seizures, sometimes in opposite ways.

Body Temperature Regulation↗
PubMed1992

Recombinant tissue-type plasminogen activator and immediate angioplasty in acute myocardial infarction. One-year follow-up. The European Cooperative Study Group.

BACKGROUND: The European Cooperative Study Group conducted two randomized trials in patients with suspected myocardial infarction to assess the effect of 100 mg single-chain recombinant tissue-type plasminogen activator (rt-PA, alteplase) on enzymatic infarct size, left ventricular function, morbidity and mortality relative to placebo (alteplase/placebo trial) and to assess the effect of immediate percutaneous transluminal coronary angioplasty (PTCA) in addition to alteplase (alteplase/PTCA trial). One-year follow-up results are reported. METHODS AND RESULTS: In the alteplase/placebo trial, 721 patients with chest pain of less than 5 hours and extensive ST-segment elevation were allocated at random to 100 mg alteplase or placebo (double-blind) over 3 hours. In the alteplase/PTCA trial, 367 similar patients received alteplase and subsequently were allocated at random to immediate coronary angiography and angioplasty of the infarct-related vessel or control. All patients received aspirin and intravenous heparin. In the alteplase/placebo trial, mortality during the first year was reduced by 36% with alteplase (from 9.3% to 5.6%; difference, -3.7%; 95% confidence interval, -7.5% to 0.2%). Revascularization was performed more frequently after alteplase, and more patients in the alteplase group were in New York Heart Association functional class I or II. Reinfarction tended to occur more frequently after alteplase than after placebo. In the alteplase/PTCA trial, reinfarction was less common after immediate PTCA, and revascularization procedures were less frequent. However, this benefit was offset by a high rate of immediate reocclusion and early recurrent ischemia and by higher mortality at 1 year (9.3% versus 5.4%; difference, 3.9%; 95% confidence interval, -1.5% to 9.2%) in the invasive group. In a multivariate analysis of 1,043 hospital survivors, mortality after discharge was related to coronary anatomy, left ventricular function, age, and previous infarction but not to initial treatment allocation. Reinfarction after hospital discharge tended to be more common after alteplase and related to coronary anatomy. CONCLUSIONS: Benefit from treatment with alteplase, heparin, and aspirin is not diminished at 1 year. Routine immediate PTCA does not confer additional benefit. Prognosis after hospital discharge mainly is determined by coronary anatomy and residual left ventricular function and is unrelated to initial treatment assignment.

Angioplasty, Balloon, Coronary↗
PubMed1992

Seizures and fever: can we rule out meningitis on clinical grounds alone?

A study was done of 309 children seen in two ERs with a first seizure and fever to assess whether meningitis could be recognized using readily available clinical information. Among these children, 23 (7%) cases of meningitis were diagnosed. A group of 69 children with seizures and fever but no meningitis served as controls. Signs from ER examinations that discriminated between children with and those without meningitis were: petechiae, nuchal rigidity, coma, persistent drowsiness, ongoing convulsions, and paresis or paralysis; 21 cases were thus identified. Two children with a suspicious history but none of these signs proved to have meningitis. Children whose seizures showed no complex features and whose febrile illness revealed no suspicious features did not have meningitis. Our results indicate that based on available clinical data, meningitis can be ruled out in children presenting with seizures and fever; thus, there is no need for routine investigation of cerebrospinal fluid.

Blood Sedimentation↗
PubMed1991

Reasons for the lack of benefit of immediate angioplasty during recombinant tissue plasminogen activator therapy for acute myocardial infarction: a regional wall motion analysis. European Cooperative Study Group.

Regional ventricular wall motion analysis utilizing three different methods was performed on predischarge left ventriculograms from 291 of 367 patients enrolled in a randomized trial of single chain recombinant tissue-type plasminogen activator (rt-PA), aspirin and heparin with and without immediate angioplasty in patients with acute myocardial infarction. With univariate analysis, no difference in regional wall motion variables between the two treatment groups was observed. However, with individual baseline risk assessment by multivariate linear regression analysis using baseline characteristics known to be related to left ventricular function after thrombolytic therapy or outcome of coronary angioplasty, or both, an excess of high risk patients in the invasive treatment group was detected. To adjust for this unequal distribution of baseline risk, multivariate linear regression analysis was performed. No benefit of immediate coronary angioplasty was observed after adjustment. Reocclusion or reinfarction, or both, occurred more frequently in the invasive than in the noninvasive treatment group (18% versus 13%, respectively). Among patients with a patent infarct-related vessel on angiography between days 10 and 22 and without reinfarction before angiography, there was a trend toward benefit from the invasive strategy, indicating that reocclusion and reinfarction might be responsible for the lack of benefit of the invasive strategy. This implies that immediate coronary angioplasty may be beneficial in selected patients, provided that these complications can be prevented.

Angioplasty, Balloon, Coronary↗
PubMed1991

The effects of nisoldipine on the total ischaemic burden: the results of the ROCKET study.

This study was designed to examine the effects of nisoldipine (relative to placebo), a new dihydropyridine calcium entry blocking agent, in the treatment of silent ischaemia in conventional doses. A total of 409 patients with proven coronary artery disease were screened and of this 64 had at least six episodes or a total duration of 30 min of ST segment depression (1 mm lasting at least 1 min) over 48 h. Fifty-two patients ultimately completed a randomized double-blind cross-over study comparing nisoldipine 5 mg twice a day, nisoldipine 10 mg daily and placebo. There was a reduction in the ST segment integral and number of episodes of ST segment depression when compared to placebo on treatment with nisoldipine 5 mg twice a day and nisoldipine 10 mg daily. However, the confidence limits were wide and crossed the no-treatment effect line. In addition, the nisoldipine doses neither affected the circadian distribution of ischaemic episodes nor caused an alteration of the workload achieved either at peak exercise or at 1 mm ST segment depression measured 24 h after nisoldipine 10 mg or 12 h after nisoldipine 5 mg. We conclude that frequent silent ischaemia in patients with proven coronary artery disease is relatively uncommon; it accounts for approximately 16% of patients with positive exercise. In these patients nisoldipine, given as 5 mg twice a day and 10 mg daily, showed no significant therapeutic effects, either on the frequency or severity of silent ischaemia. New formulations of slow release nisoldipine are consequently being developed so that a fuller 24 h therapeutic profile may be obtained.

Coronary Disease↗
PubMed1991

QTc prolongation measured by standard 12-lead electrocardiography is an independent risk factor for sudden death due to cardiac arrest.

BACKGROUND: QTc prolongation has been implicated as a risk factor for sudden death; however, a controversy exists over its significance. METHODS AND RESULTS: In the Rotterdam QT Project, 6,693 consecutive patients who underwent 24-hour ambulatory electrocardiography were followed up for 2 years; of these, 245 patients died suddenly. A standard 12-lead electrocardiogram and clinical data at the time of 24-hour ambulatory electrocardiography were collected for all patients who died suddenly and for a random sample of 467 patients from the study cohort. In all patients without an intraventricular conduction defect (176 patients who died suddenly and 390 patients from the sample), QT interval duration was measured in leads I, II, and III and corrected for heart rate with Bazett's formula (QTc). In patients without evidence of cardiac dysfunction (history of symptoms of pump failure or an ejection fraction less than 40%), QTc of more than 440 msec was associated with a 2.3 times higher risk for sudden death compared with a QTc of 440 msec or less (95% confidence interval: 1.4, 3.9). In contrast, in patients with evidence of cardiac dysfunction, the relative risk of QTc prolongation was 1.0 (0.5, 1.9). Adjustment for age, gender, history of myocardial infarction, heart rate, and the use of drugs did not alter these relative risks. CONCLUSIONS: These data indicate that in patients without intraventricular conduction defects and cardiac dysfunction, QTc prolongation measured from the standard electrocardiogram is a risk factor for sudden death independent of age, history of myocardial infarction, heart rate, and drug use. In patients with cardiac dysfunction, QTc duration is not related to the risk for sudden death.

Death, Sudden↗
PubMed1991

Primary prevention in hypertension. Valid conclusions from observational studies.

Relatively few observational (i.e., nonexperimental) studies have been conducted to examine the role of antihypertensive drug therapy in the primary prevention of coronary heart disease. To draw valid conclusions from experimental or observational studies, internal validity should be ensured. In particular, similarity of "extraneous" effects, of information, and of prognosis between the treatment groups compared in a particular study is needed. Because allocation of participants to antihypertensive drug therapy in observational studies is nonrandomized by definition, special efforts should be made to achieve comparability of prognosis, that is, to avoid "confounding by indication." Follow-up and case-control studies, the two main types of observational studies, also offer certain advantages over randomized clinical trials, particularly when different classes of drugs are compared. Although few valid observational studies on the efficacy of drug therapy for hypertension in the primary prevention of first coronary events have been published, the available data suggest that beta-blockers might confer greater protection than other drug regimens. However, more evidence is needed to confirm these findings. It is concluded that observational studies could play an increasing role in the assessment of the role of antihypertensive therapy in the primary prevention of coronary heart disease when the inherent potentials and pitfalls of these studies are appreciated.

Adrenergic beta-Antagonists↗
PubMed1990

[Reliability of blood pressure measurements; comparison of an electronic meter and a mercury manometer in family practice].

The Riva-Rocci indirect method of measuring the blood pressure carries a number of sources of error. A report is presented of a study of the serviceability of an electronic blood pressure meter as compared with the conventional mercury manometer. Seventy-six paired measurements were carried out in patients selected at random using an electronic blood pressure meter and a mercury manometer meeting all Health Council requirements. The systematic error and the incidental error in both measuring procedures were compared. The differences found were so slight as to be negligible in practice. It is concluded that the electronic blood pressure meter in practice constitutes an acceptable substitute for the conventional mercury manometer.

Blood Pressure Determination↗
PubMed1990

Medical management of unstable angina. What have we learned from the randomized trials?

Because of the absence of a generally accepted definition of unstable angina, the clinical context of drug trials for this condition has varied from trial to trial. Early- versus late-entry trials must be distinguished, and the possibility of a modification of effect caused by the nature of drug therapy already given when the patient became unstable or by concomitant treatment in addition to experimental treatment must be taken into account. These factors cannot be overlooked when the results from a limited number of reported trials are pooled together. The largest early-entry trial with a beta-blocker and a calcium antagonist was the Holland Interuniversity Nifedipine/metoprolol Trial (HINT), which enrolled patients with suspected unstable angina diagnosed at coronary care unit admission. HINT results showed that unstable angina cannot be reliably differentiated from evolving myocardial infarction (MI) in this particular context and that there are few early MIs that could have been prevented. In patients who were not already taking a beta-blocker, metoprolol reduced the incidence of acute MI or recurrent ischemia, and there was no benefit of nifedipine. On the other hand, the addition of nifedipine was effective in patients whose conditions became unstable despite maintenance treatment with a beta-blocker. Thus, previous beta-blockade modified the effect of the calcium antagonist studied. Based on evidence from HINT and other trials, it is concluded that beta-blockers should be used as the first-line treatment in patients with unstable angina and that a calcium antagonist should be added when patients remain unstable despite beta-blockade.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗