Pharmaco-epidemiology of Sumatriptan : cardiovascular adverse reactions to a new antimigrainous drug

The rationale to study a potential adverse reaction of a specific drug mainly depends on three questions: 1) how serious is the adverse reaction? 2) what is the incidence of the adverse reaction among users of the dlUg?, and 3) what is the frequency of consumption of the specific dlUg in the population? Especially dlUgs which are frequently prescribed and used, also rare serious adverse reactions may be important, such as thromboembolism in users of oral contraceptives. The present thesis sunmlarizes our studies of a potential serious adverse reaction of sumatriptan, which turned out to be relatively frequent among users. This new drug, used in the treatment of acute attacks of migraine, appears to have more actions outside the head than was initially thought

Drug-induced chest pain and myocardial infarction. Reports to a national centre and review of the literature

Objectives: To analyse reports of drug-induced myocardial infarction and chest pain sent to a national reporting centre. To review which drugs were suspected of exhibiting these adverse events and what mechanisms were involved. Methods: During the 20-year period 1975 through 1994, a total of 19,141 reports on adverse reactions to drugs were received by the Netherlands Centre for Monitoring of Adverse Reactions to Drugs. Of these 19 141 reports, 220 (1.1%) were concerned with drug-induced chest pain or myocardial infarction. After excluding reports in which the causal relationship was unlikely, poorly documented reports and reports on cases of overdosage, 183 reports (84%) were analysed. Results: There were 130 reports (71%) of drug-induced chest pain and 53 reports (29%) of drug-induced myocardial infarction. A total of 104 reports concerned females (57%). The most frequently reported suspected drugs were the antimigraine drug sumatriptan (33 reports, 4 concerning myocardial inf

Intervensi Koroner Perkutan Primer untuk Infark Miokard Elevasi ST di Pusat Jantung Pemula di Indonesia: 100 pasien pertama

Background: The benefits of Primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI) have been demon-strated, but most studies were conducted in experienced centres in western world. Experience, logistics and patient characteristics may differ in other parts of the world, particularly in a starting center.Methods: Data on all consecutive STEMI patients treated with primary PCI in Cinere hospital, Jakarta, Indonesia were collected in a prospective database.Results:,Between July 2006 and December 2008, a total of 100 patients with STEMI were treated by primary PCI. Mean age was 56.9 ±10.4 years (range 37-82), 88% was male. Mean time between onset of chest pain and admission was 369 ± 388 minutes. The mean time between admission and balloon inflation was 258 minutes. Before PCI, 50% of patients had TIMI 0 flow. After primary PCI 94% of patients had TIMI 2/3 flow. There were no deaths in the catheterisation room, and no emergency coronary bypass surgery was needed as a result of PCI complications. Mean left ventricular ejection fraction as measured by echocardiography after 1 day was 48 ± 12 %.Conclusions: Outcome after primary PCI at a starting center is excellent in this series. Primary PCI was effective in restoration of TIMI flow, without complications. Time delay between symptom onset, admission and balloon inflation was long and all efforts should be encouraged to shorten this.Latar belakang: Manfaat Intervensi perkutan primer (IKP) untuk Infark Miokard Elevasi ST (IMEST) telah terbukti, namun-demikian kebanyakan penelitian mengenai ini di laksanakan dipusat layanan jantung yang berpengalaman di dunia barat, Pengalaman , logistik dan karakteristik pasien mungkin berbeda di belahan dunia ini, terutama di pusat yang baru mulai.Metode: Seluruh data pasien konsekutif dengan IMEST yang ditangani dengan IKP primer di pusat jantung Cinere , Jakarta, Indonesia dihimpun melalui seperangkat data yang dilaksanakan secara propekstif.Hasil: Antara Juli 2006 dan Desember 2008, dari seluruh jumlah 100 pasien dengan IMEST yang ditangani dengan IKP primer. Rerata usia adalah 56,9 tahun ± 10,4 tahun (berkisar 37-82 tahun), 88 % diantaranya adalah pria. Rerata waktu antara onset nyeri dada dan masuk rumah sakit adalah 369 ± 388 menit. Rerata waktu antara masuk rumah sakit dengan inflasi balon adalah 258 menit. Sebelum IKP, 50 % pasien dengan aliran TIMI 0. Setelah IKP primer 94 % pasien memperoleh aliran TIMI 2/3. Tidak ada kematian didalam ruang kateterisasi maupun diperlukan tindakan bedah graft pintas arteri koroner yang gawat akibat komplikasi dari IKP. Rerata fraksi ejeksi yang diukur dengan ekokardiografi setelah 1 hari adalah 48±12 %.Kesimpulan: Hasil akhir yang diperoleh setelah IKP primer pada pusat jantung yang baru dimulai adalah baik pada serial ini. IKP primer efektif dalam memeperbaiki aliran TIMI, tanpa komplikasi. Keterlambatan waktu antara permulaan gejala, saat masuk dan inflasi balon masih panjang dan segala usaha harus diupayakan untuk memendekan waktu ini

A nested case-control study on mortality in uses of ibopamine

Background: A recent interim analysis of the PRIME II placebo-controlled study showed a significantly higher mortality in the group treated with ibopamine than in the control group. The objective was to study mortality in patients on ibopamine, and to assess risk factors for death. Methods: All 2147 drug-dispensing outlets (DDO) in the Netherlands were asked to provide a printout of the complete medication history of users of ibopamine. A reaction was received from 92% of the DDO. From the 14,024 identified former or current users of ibopamine, a sample of 3148 patients (22%) was enrolled in the follow-up study. All general practitioners (GP) of these patients received an enquiry pertaining to the vital status of their patient, cause of death, primary cause and NYHA classification of heart failure, echo- and electrocardiographic data, serum creatinine, admissions and the effects of ibopamine. Cases were defined as patients who died during the follow-u

Long-term prognostic importance of a single pulmonary wedge pressure measurement after myocardial infarction: A ten-year follow-up study

To assess the influence on short- and long-term survival of haemodynamic variables measured after acute myocardial infarction, a 10-year prospective follow-up study was undertaken. A total of 304 patients (259 males, 45 females) discharged from hospital after myocardial infarction and under 66 years of age were studied. Haemodynamic variables measured shortly after admittance included pulmonary wedge pressure, mixed venous oxygen saturation, blood pressure and heart rate. In the analysis, adjustments were made for differences in age, gender, clinical parameters and cardiovascular risk factors. Pulmonary wedge pressure was found to be a strong and independent predictor of both short-term and long-term survival. A gradual increase of the 10-year mortality risk with elevated wedge pressure could be demonstrated (relative risk, 1.09/mmHg; 95% confidence interval, 1.04–1.15). Relative risks of patients in the three highest categories of wedge pressure, 12–15 mmHg, 15–19 mmHg and 19 mmHg and higher, compared with patients in the lowest category, lower than 12 mmHg, were 2.25 (95% CI, 1.11–4.55), 2.43 (95% CI, 1.20–4.92) and 2.57 (95% CI, 1.04–6.37), respectively. The other measured haemodynamic variables were found to be associated with short-term mortality only. In conclusion, haemodynamic measurements after myocardial infarction are of prognostic importance after discharge. A single measurement of an elevated wedge pressure in particular unfavourably influenced both short-term and long-term survival

Impact of new X-ray technology on patient dose in pacemaker and implantable cardioverter defibrillator (ICD) implantations

PURPOSE: New X-ray technology providing new image processing techniques may reduce radiation exposure. The aim of this study was to quantify this radiation exposure reduction for patients during pacemaker and implantable cardioverter defibrillator (ICD) implantation. METHODS: In this retrospective study, 1185 consecutive patients who had undergone de novo pacemaker or ICD implantation during a 2-year period were included. All implantations in the first year were performed using the reference technology (Allura Xper), whereas in the second year, the new X-ray technology (AlluraClarity) was used. Radiation exposure, expressed as the dose area product (DAP), was compared between the two time periods to determine the radiation exposure reduction for pacemaker and ICD implantations without cardiac resynchronization therapy (CRT) and with CRT. Procedure duration and contrast volume were used as measures to compare complexity and image quality. RESULTS: The study population consisted of 591 patients who had undergone an implantation using the reference technology, and 594 patients with the new X-ray technology. The two groups did not differ in age, gender, or body mass index. The DAP decreased with 69 % from 16.4 ± 18.5 to 5.2 ± 6.6 Gy cm(2) for the non-CRT implantations (p < 0.001). The DAP decreased with 75 % from 72.1 ± 60.0 to 17.8 ± 17.4 Gy cm(2) for the CRT implantations (p < 0.001). Nevertheless, procedure duration and contrast volume did not differ when using the new technology (p = 0.09 and p = 0.20, respectively). CONCLUSIONS: Introduction of new X-ray technology resulted in a radiation exposure reduction of more than 69 % for patients during pacemaker and ICD implantation while image quality was unaffected

NT-proBNP level before primary PCI and risk of poor myocardial reperfusion: Insight from the On-TIME II trial.

Background N-terminal fragment of the brain natriuretic peptide prohormone (NT-proBNP), a marker for neurohumoral activation, has been associated with adverse outcome in patients with myocardial infarction. NT-proBNP levels may reflect extensive ischemia and microvascular damage, therefore we investigated the potential association between baseline NTproBNP level and ST-resolution (STR), a marker of myocardial reperfusion, after primary percutaneous coronary intervention (pPCI).Methods we performed a post-hoc analysis of the On-TIME II trial (which randomized ST-elevation myocardial infarction (STEMI) patients to pre-hospital tirofiban administration vs placebo). Patients with measured NT-proBNP before angiography were included. Multivariate logistic-regression analyses was performed to investigate the association between baseline NTproBNP level and STR one hour after pPCI.Results Out of 984 STEMI patients, 918 (93.3%) had NT-proBNP values at baseline. Patients with STR 70% had higher NT-proBNP values compared to patients with complete STR (70%) [Mean +/- SD 375.2 +/- 1021.7 vs 1007.4 +/- 2842.3, Median (IQR) 111.7 (58.4-280.0) vs 168.0 (62.3-601.3), P < .001]. At multivariate logistic regression analysis, independent predictors associated with higher risk of poor myocardial reperfusion (STR < 70%) were: NT-proBNP (OR 1.17, 95%CI 1.041.31, P = .009), diabetes mellitus (OR 1.87, 95%CI 1.14-3.07, P = .013), anterior infarct location (OR 2.74, 95% CI 2.00-3.77, P < .001), time to intervention (OR 1.06, 95%CI 1.01-1.11, P = .021), randomisation to placebo (OR 1.45, 95%CI 1.05-1.99, P = .022).Conclusions In STEMI patients, higher baseline NT-proBNP level was independently associate with higher risk of poor myocardial reper fusion, suppor ting the potential use of NT-proBNP as an early marker for risk stratification of myocardial reperfusion after pPCI in STEMI patients