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Analysis of risk factors in patients with severe chronic kidney disease. The role of atorvastatin.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine. Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background and aim: There had been no randomized end-point studies with statins for patients with severe renal failure. The purpose of this prospective, open, randomized, controlled study was to investigate whether atorvastatin (10 mg/day) would alter cardiovascular end-points and the overall mortality rate of patients with chronic kidney disease stage 4 or 5 (creatinine clearance</30 ml/min) and to influence risk factors.

Material & Methods: This was an open, prospective, randomized study. A total of 143 patients were included: 73 were controls and 70 were prescribed 10 mg/day of atorvastatin. As efficacy variables, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride levels were determined at the start of the study and at 1, 3, 6, 12, 18, 24, 30 and 36 months. The primary end-points were all cause of mortality, non-lethal acute myocardial infarction, and coronary artery intervention. Various risk factors were studied. In the 97 patients on haemodialysis inter dialysis weight gain (IDWG) was calculated as ultrafiltration in kg/body weight in kg given in percentage of the weight. The burden of IDWG was analyzed.

Results: In the atorvastatin group, total cholesterol and low-density lipoprotein cholesterol were significantly reduced, the latter by 35% at 1 month and then sustained. Atorvastatin was withdrawn in 23% of patients due to unacceptable side effects, most frequent complaints being gastrointestinal discomfort and headache. Primary end-points occurred in 74% of the subjects. There was no difference in cardiovascular endpoint and survival between the control and atorvastatin groups. The 5-year end-point-free survival rate from study entry was 20%. There was no evidence of more benefit of atorvastatin for patients with diabetes mellitus and chronic kidney disease versus the other patients; instead plasma fibrinogen increased. The IDWG was significantly larger in patients who suffered from end-points due to cardiovascular reasons, cardiac reasons, congestive heart failure, aortic aneurysm, and intracerebral bleeding.

Conclusion: These data showed that in contrast to other patient groups, patients with severe chronic kidney disease 4 and 5, including those with diabetes mellitus, seem to have no benefit from 10mg/day of atorvastatin. Instead we found a high IDWG to be an important risk factor that should be prevented. There was no evident connection between atorvastatin medication and IDWG.

Place, publisher, year, edition, pages
Umeå: Umeå universitet , 2013. , 86 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 1574
Keyword [en]
Atorvastatin, cholesterol, chronic kidney disease, haemodialysis, cholesterol, lipids, peritoneal dialysis, risk factors, statins, inter dialysis weight gain
National Category
Family Medicine
Identifiers
URN: urn:nbn:se:umu:diva-68682ISBN: 978-91-7459-554-3 (print)OAI: oai:DiVA.org:umu-68682DiVA: diva2:617392
Public defence
2013-05-30, Sal E04, by 6E, Norrlands universitetssjukhus, Umeå, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2013-05-02 Created: 2013-04-23 Last updated: 2013-05-02Bibliographically approved
List of papers
1. Safety and efficacy of atorvastatin in patients with severe renal dysfunction
Open this publication in new window or tab >>Safety and efficacy of atorvastatin in patients with severe renal dysfunction
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2005 (English)In: Scandinavian Journal of Urology and Nephrology, ISSN 0036-5599, E-ISSN 1651-2065, Vol. 39, no 6, 503-510 p.Article in journal (Refereed) Published
Keyword
Cholesterol, dialysis, high-density lipoprotein, lipids, low-density lipoprotein, risk factors, triglycerides
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:umu:diva-16044 (URN)16303728 (PubMedID)
Available from: 2007-08-16 Created: 2007-08-16 Last updated: 2017-12-14Bibliographically approved
2. Low-dose atorvastatin in severe chronic kidney disease patients: a randomized, controlled endpoint study
Open this publication in new window or tab >>Low-dose atorvastatin in severe chronic kidney disease patients: a randomized, controlled endpoint study
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2005 (English)In: Scandinavian Journal of Urology and Nephrology, ISSN 0036-5599, E-ISSN 1651-2065, Vol. 39, no 6, 489-497 p.Article in journal (Refereed) Published
Abstract [en]

Objective. There have been no endpoint studies with statins for patients with severe renal failure. The purpose of this prospective, open, randomized, controlled study was to investigate whether atorvastatin (10 mg/day) would alter cardiovascular endpoints and the overall mortality rate of patients with chronic kidney disease stage 4 or 5 (creatinine clearance < 30 ml/min).

Material and methods. The study subjects comprised 143 patients who were randomized either to placebo (controls; n=73; mean age 69.5 years) or to treatment with atorvastatin (n=70; mean age 67.9 years). The patients included were either non-dialysis (n=33), haemodialysis (n=97) or peritoneal dialysis (n=13) patients. Analysis focused on the primary endpoints of all-cause mortality, non-lethal acute myocardial infarction, coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty. Statistical analysis for endpoint data was mainly by intention-to-treat.

Results. Primary endpoints occurred in 74% of the subjects. There was no difference in outcome between the control and atorvastatin groups. The 5-year endpoint-free survival rate from study entry was 20%. Atorvastatin was withdrawn in 20% of patients due to unacceptable side-effects. In the atorvastatin group, low-density lipoprotein (LDL) cholesterol was reduced by 35% at 1 month and then sustained. The controls showed a progressive reduction in LDL cholesterol until 36 months.

Conclusions. Although atorvastatin reduced total and LDL cholesterol effectively it was not beneficial regarding the long-term outcomes of cardiovascular endpoints or survival. In contrast to other patient groups, patients with severe chronic kidney disease, especially those on dialysis, seem to derive limited benefit from this lower dose of atorvastatin.

Keyword
Atorvastatin; cholesterol; chronic kidney disease; hemodialysis; high-density lipoprotein cholesterol; lipids; low-density lipoprotein cholesterol; peritoneal dialysis; risk factors; statins; triglyceride
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:umu:diva-16062 (URN)
Available from: 2007-08-16 Created: 2007-08-16 Last updated: 2017-12-14Bibliographically approved
3. Minimized weight gain between hemodialysis contributes to a reduced risk of death
Open this publication in new window or tab >>Minimized weight gain between hemodialysis contributes to a reduced risk of death
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2006 (English)In: International Journal of Artificial Organs, ISSN 0391-3988, E-ISSN 1724-6040, Vol. 29, no 7, 675-680 p.Article in journal (Refereed) Published
Keyword
Adult, Aged, Aged; 80 and over, C-Reactive Protein/analysis, Hemodiafiltration, Humans, Kidney Failure/*mortality/therapy, Middle Aged, Proportional Hazards Models, Prospective Studies, Weight Gain
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:umu:diva-16353 (URN)16874672 (PubMedID)
Available from: 2007-09-12 Created: 2007-09-12 Last updated: 2017-12-14Bibliographically approved
4. Cardiovascular conditions in hemodialysis patients may be worsened by extensive interdialytic weight gain
Open this publication in new window or tab >>Cardiovascular conditions in hemodialysis patients may be worsened by extensive interdialytic weight gain
2009 (English)In: Hemodialysis International, ISSN 1492-7535, E-ISSN 1542-4758, Vol. 13, no 1, 27-31 p.Article in journal (Refereed) Published
Abstract [en]

The risk of death is increased for hemodialysis (HD) patients compared with age-matched healthy subjects, the main reason for this being cardiovascular conditions. This prospective study investigated whether the burden of interdialytic weight gain (IDWG) was of importance for cardiovascular end points and survival. A total of 97 HD patients were studied. The end points included death (reasons given), acute myocardial infarction, or coronary vascular intervention. The extent of ultrafiltration was measured at predefined follow-up points. The IDWG was calculated as ultrafiltration/body weight given in weight%. The burden of IDWG was analyzed. End points occurred in 77 (79%) of the patients during the 5-year study period. The extent of IDWG was higher in those with end points due to cardiovascular reasons (3.77 weight% vs. 3.19 P<0.001), cardiac reasons (P<0.001), congestive heart failure (P<0.01), aortic aneurysm, and intracerebral bleeding (P<0.024). To reduce the risk for cardiovascular events, it is important to avoid too extensive IDWG in HD patients.

Keyword
Interdialytic weight gain, cardiovascular, hemodialysis, survival, prognosis, risk factors
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:umu:diva-32373 (URN)10.1111/j.1542-4758.2009.00335.x (DOI)19210274 (PubMedID)
Available from: 2010-03-10 Created: 2010-03-10 Last updated: 2017-12-12Bibliographically approved
5. There is no benefit of atorvastatin for patients with severe renal impairment independent if they have DM or not
Open this publication in new window or tab >>There is no benefit of atorvastatin for patients with severe renal impairment independent if they have DM or not
(English)Article in journal (Other academic) Submitted
National Category
Urology and Nephrology
Identifiers
urn:nbn:se:umu:diva-68681 (URN)
Available from: 2013-04-23 Created: 2013-04-23 Last updated: 2013-05-03Bibliographically approved

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