Patients who switch from branded statins to a generic alternative, could have an increased risk of heat attack or stroke, reported three newspapers (6th September 2007). The reports are based on a conference abstract and press release. The reliability of the findings cannot be assessed as full study details are not available.
-
On 6th September 2007 three newspapers (1-3) reported that patients who switched from taking the branded statin Lipitor (atorvastatin) to simvastatin, a generic alternative, were subject to an increased risk of cardiovascular events such as heart attack or stroke. The Times (1) also reports that the overall risk of death was not increased. Two of the newspaper articles (1-2) state that the study was funded by Pfizer, the manufacturer of Lipitor.
-
The newspaper articles are based on a conference abstract (4) and accompanying press release (5) which reported results of a retrospective matched cohort study involving 11,520 patients. The study compared mortality and cardiovascular outcomes for 2,511 patients who had switched to simvastatin after taking Lipitor for at least six months, with outcomes for 9,009 matched patients who had continued taking Lipitor. The study found a statistically significant 33% increased risk of death or major cardiovascular events (defined as myocardial infarction, stroke or coronary revascularisation) in patients who had switched to simvastatin compared to those who remained on Lipitor. However, there was no significant difference found for death, myocardial infarction or coronary revascularisation when assessed separately.
-
Generally the newspapers reported details from the abstract of the conference presentation accurately. Only the Times (1) included the authors' comments that because the study was observational it can show only an association between switching statins and the observed effects and not evidence of cause and effect. Full details of the research are currently in press and not yet publicly available, so it is not possible to comment on the reliability of the study or its findings.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).
References and resources
1. Using a generic drug ‘may raise risk of heart attack and strokes’. The Times, 6 September 2007, p15.
2. Switching statins 'can raise heart attack risk'. Daily Mail, 6 September 2007, p37.
3. Heart attack risks of cheap drugs. Daily Telegraph, 6 September 2007, p1.
4. Phillips B, Roberts C, Rudolph A E, Morant S, Aziz F, O'Regan C. Switching statins: the impact on patient outcomes. European Heart Journal 2007;28(Abstract Supplement):863.
5. Patients who switched from established lipitor therapy to simvastatin experienced a significant 30 percent increase in relative risk of cardiovascular events or death, new observational study shows. Pfizer Press Release, September 05, 2007.
Consumer information
British Heart Foundation
NHS Direct – Cholesterol
Stroke Association
Previous Hitting the Headlines summaries on this topic
'Statins are safe and they really work'. Hitting the Headlines archive, 8 June 2007.
Further information about Hitting the Headlines
Further information about Hitting the Headlines, together with selected relevant links, can be found at http://www.library.nhs.uk/hth/.
