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Peter T Sawicki

Publications and source records attributed to Peter T Sawicki.

11 recordsLinked to original sources
PubMed2006

[Assessment of the number of cardio- and cerebrovascular events due to rofecoxib (Vioxx) in Germany between 2001 and 2004].

BACKGROUND AND PURPOSE: After the recall of rofecoxib (Vioxx), there was repeated national and international discussion on the potential number of patients harmed by causally related cardio- and cerebrovascular events. In individual cases, it cannot be determined whether a myocardial infarction or stroke that occurred during rofecoxib therapy was actually directly caused by this drug. On the basis of the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial and German prescription data provided by the Scientific Institute of the Local Health Care Fund, the authors therefore conservatively estimated the number of patients harmed by rofecoxib in Germany between 2001 and 2004. METHODS: Under simplifying assumptions that, as in the VIGOR study, the risk of rofecoxib or naproxen therapy can be described by a Cox model with exponentially distributed event times, it is possible to calculate the daily risk of cardio- and cerebrovascular events in patients treated with these drugs. The estimated number of patients experiencing cardio- and cerebrovascular events under rofecoxib or naproxen therapy can be calculated by multiplying the daily risks by the defined daily doses prescribed in Germany. The difference between these numbers produces the estimated number of patients harmed by rofecoxib. RESULTS: On the basis of the data pool, a total of 7,092 additional diseased or deceased patients due to rofecoxib therapy were estimated (95% confidence interval: 2,004-15,416). The simplifying assumptions made together with the underreporting of events in the VIGOR trial are more likely to lead to an underestimation than an overestimation of affected patients. When assessing the benefit-harm ratio of rofecoxib, it needs to be considered that its protective gastrointestinal effects were not assessed compared with the optimum long-term therapy. It can be assumed that a comparison of rofecoxib with a combination of nonsteroidal anti-inflammatory drugs (NSAIDs) and gastric mucosal barrier protectors (e. g., misoprostol) would not have shown an advantage in favor of rofecoxib therapy. CONCLUSION: The example of rofecoxib and the relatively high number of patients harmed by it in Germany indicate that, before widely prescribing a new drug, a more thorough assessment of the benefit-harm ratio of the drug is required as well as a stronger consideration of therapeutic alternatives and a timely conduct of meaningful clinical studies. The results of these studies should be promptly communicated in full to physicians and patients.

Adult↗
PubMed2006

Influence of nebivolol and enalapril on metabolic parameters and arterial stiffness in hypertensive type 2 diabetic patients.

OBJECTIVE: To compare the effects of a cardioselective beta-blocker (nebivolol) with those of an angiotensin-converting enzyme inhibitor (enalapril) on parameters of insulin sensitivity, peripheral blood flow and arterial stiffness during one extended glucose clamp experiment. DESIGN: A randomized, double-blind crossover trial, consisting of two 12-week treatment phases separated by a 4-week wash-out phase. METHODS: Patients with type 2 diabetes and arterial hypertension were randomly assigned to one of two treatment sequences (nebivolol-enalapril, enalapril-nebivolol). Haemodynamic, metabolic and other laboratory measurements were carried out on the first and last day of each treatment period by means of a glucose clamp experiment that also involved the measurement of blood flow and arterial stiffness. RESULTS: Twelve patients were included in this study, of which two dropped out early. Efficacy parameters were therefore available for 10 patients. There was no significant difference in any of the primary efficacy parameters. Moreover, the effects on blood pressure did not significantly differ between both treatments. Six adverse events happened during treatment with nebivolol compared with two during treatment with enalapril, but only one was regarded as possibly related to the treatment. CONCLUSIONS: This pilot study shows that the combined measurement of insulin sensitivity, blood flow and arterial stiffness is feasible. Nebivolol and enalapril did not show different effects with regard to these parameters in hypertensive diabetic patients. If these results are confirmed in larger clinical trials, this would argue against the reservations against beta-blockers as drugs of first choice in patients with diabetes because of potential metabolic side-effects.

Adrenergic beta-Antagonists↗
PubMed2005

[Quality of health care in Germany. A six-country comparison].

Sicker adults in Germany suffer many of the same issues and concerns as do sicker adults in Australia, Canada, New Zealand, the United Kingdom, and the USA. However, quality of care in sicker adults in Germany stands out from the other countries in a few key areas: 1. DISSATISFACTION WITH THE HEALTH CARE SYSTEM: Almost one in three sicker adults in Germany feels that their health care system should be completely rebuilt. This is comparable to the USA and Australia and higher than in New Zealand, Canada, and the UK. 2. STRENGTHS AND WEAKNESSES IN COORDINATION OF CARE: On the plus side, Germany is doing better than most countries to insure that needed information is available at the time of a patient''s scheduled appointment. Also, sicker adults in Germany are more likely than in other countries to have a long-term relationship with their primary care physician and receive less often conflicting informations. However, Germany stands out in the proportion of sicker adults who feel that their doctors have ordered a medical test that they thought was unnecessary because it had already been done. 3. COMPARATIVELY EASY ACCESS TO OUTPATIENT, SPECIALTY AND EMERGENCY CARE: Though substantial minorities of sicker adults in Germany struggle with access to care as compared to other countries, they find it easier to get after hours care and have the shortest waits to see a doctor, to see a specialist, to have nonemergency surgery, and to be seen in the emergency room. Along with the USA, German respondents are most satisfied with the amount of choice they have in a surgeon 4. COMMUNICATION ABOUT RISKS DURING HOSPITALIZATIONS: Hospitalized sicker adults in Germany are more likely than those in other countries to have the risks of their treatment explained to some extent prior to the procedure. However, German patients are less likely to have the risks of their treatment fully explained than those in other countries. German patients who were given new medications were more likely than patients in other countries to report that they did not have a clear understanding of the purpose of these medications. Further, German patients are more likely than those in other countries to report that their regular doctor rarely or never explains the possible side effects of their medications. 5. FAILURES IN HOSPITAL DISCHARGE PLANNING: Overall, hospitalized sicker adults in Germany face more failures in discharge management than in other countries. Of particular note is that Germany is less likely than all other countries to ensure that hospitalized patients have appointments for follow-up care upon discharge from hospital. 6. HOSPITAL-BASED INFECTIONS ARE RARE.: Hospitalized patients in Germany are less likely than in other surveyed countries to report that they developed an infection while in the hospital. 7. LAB NOTIFICATION DELAYS ARE INFREQUENT: Sicker adults in Germany are less likely than in other surveyed countries to report that they have experienced delays in being notified about abnormal lab test results. 8. GERMAN DOCTORS ARE LESS LIKELY TO INFORM PATIENTS ABOUT AN ERROR: When German patients experience medical and medication errors, they are less likely than are patients in other countries to be told by a doctor or other health care professional that an error had been made. 9. BETTER QUALITY OF CARE IN CHRONICALLY ILL PATIENTS: Generally , Germany is doing a better job than other countries at providing patients with chronic conditions some basic standards of preventive care. These patients are more likely to have a nurse in their doctor's office who is regularly involved in the management of their care. Patients from the old Bundeslaender seem to receive a better quality of diabetes care compared to those from the new Bundeslaender. 10. HAVING PRIVATE INSURANCE IS ASSOCIATED WITH INCREASED USE OF HEALTH CARE: German respondents who have private health insurance are more likely to see a specialist, to be hospitalized, and to have nonemergency surgery than those without private insurance. They are also more likely than those without such supplemental insurance to report that doctors ordered an unnecessarily duplicative test. Wait times are shorter for those with private insurance, both to see a specialist and for nonemergency surgery. There is no difference in the overall quality of care for chronic diseases between patients having private or statutory insurance. 11. GERMAN FEMALE RESPONDENTS REPORT MORE COMMUNICATION AND COORDINATION FAILURES THAN DO MALES: German female patients are more likely than males to report failures by their doctors to communicate with them about treatment choices, the specific goals and treatment, symptoms to watch for and when to seek further care, and possible medication side effects. Women are also more likely to report coordination problems in unnecessarily duplicative tests or information not being available at the time of their appointment. Females are less likely than males to rate their overall care as excellent or very good.

Adolescent↗
PubMed2005

[Donepezil in patients with Alzheimer's disease--a critical appraisal of the AD2000 study].

The AD2000 study was a randomized placebo-controlled trial, the effects of donepezil, a cholinesterase inhibitor, in patients with Alzheimer's disease. It was the first long-term RCT not sponsored by the pharmaceutical industry. The study did not show any significant effect on patient-relevant outcomes. However, donepezil had a significant effect on cognitive scores. More patients taking donepezil stopped treatment due to adverse events, even when taking only 5 mg once daily. There are major concerns regarding the conduction of the AD2000 study as well as the presentation of the results. Much less patients than previously planned have been recruited, resulting in a low statistical power to detect a significant difference between both treatments. In addition, no true intention-to-treat analysis based on the first randomization is presented. The validity of the AD2000 trial has to be questioned. However, there is still insufficient evidence to support the claim that cholinesterase inhibitors have beneficial effects on patient-relevant outcomes in patients with Alzheimer's disease. The change of cognitive performance as measured by different scales does not necessarily correspond to substantial changes in patient-relevant outcomes. In conclusion, the widespread use of cholinesterase inhibitors in patients with Alzheimer's disease is not supported by current evidence. Long-term-randomized controlled trials focusing on patient-relevant outcomes instead of cognitive scores are urgently needed.

Activities of Daily Living↗
PubMed2004

Systematic review of studies of self-management of oral anticoagulation.

This work is aimed at assessing the evidence for the possible improvement of therapeutic control of anticoagulation, reduction of major bleedings, thromboembolism and improvement of treatment-related quality of life in patients with self-managed oral anticoagulation therapy versus oral anticoagulation patients on routine care. Randomised controlled trials (RCTs) were identified using the COCHRANE LIBRARY, MEDLINE and EMBASE from 1966 to 2003. RCTs were selected involving patients with oral anticoagulation, which were designed to compare a self-management group to a routine care group. Abstracts and keywords were screened and, in the case of potential inclusion, evaluated. We identified nine potentially relevant trials. Five were excluded for the following reasons: double publication, the patients involved performed only self-testing, or the results of the trial were only published as an abstract. Ultimately, four randomised controlled studies fulfilled the criteria for inclusion. Anticoagulation control: Statistical analysis was not possible because of the great variety of international normalised ratio measurements per patient between the different studies. Comparing the four studies, there was no difference in oral anticoagulation control between self-management care and management by a specialised anticoagulation clinic. In comparison with routine care by general practitioners, self-management care was found to be better. Major bleeding, arterial and venous thromboembolism: Data were available for all studies; however, the studies were either underpowered or obviously not valid and therefore not suitable for statistical analysis. Treatment-related quality of life: Data were available for two studies, which showed that self-management could clearly improve treatment-related quality of life. Patients' self-management can improve the quality of oral anticoagulation as an indirect parameter of a reduced risk for thromboembolic and bleeding complications. Self-management oral anticoagulation treatment is safe and improves treatment-related quality of life. Patients' self-management is safe and can improve the quality of anticoagulation control, however, no valid long term study has yet actually demonstrated reduction of bleeding and thromboembolic events.

Administration, Oral↗