Safety Profile of High-Dose Statin Therapy in Geriatric Patients with Stroke

Manocha, Divey; Bansal, Nidhi; Gumaste, Purva; Brangman, Sharon A.

doi:10.1097/smj.0000000000000024

Cited by 8 publications

(11 citation statements)

References 42 publications

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“…In this study, myalgia was the most common ADR manifestation associated with statin use, classified by preferred terms. Previous studies showed increased risk of myopathy and rhabdomyolysis, especially in older populations [13,14,30]. Hospitalization due to rhabdomyolysis was reported to be fourfold higher in >65-year-old patients compared to that in younger patients [30].…”

Section: Discussionmentioning

confidence: 91%

“…ADR rates depend on different factors such as patient age, ethnicity and drug dose [13,14]. Recently, a retrospective cohort study of 1535 patients using hospital medical records in Korea reported a higher rate of statin-related hepatotoxicity than was previously observed in Western populations, with liver injury according to the Council for International Organizations of Medical Sciences criteria of 17.0; this indicated that studies should be conducted in different populations [15].…”

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confidence: 99%

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Analysis of National Pharmacovigilance Data Associated with Statin Use in Korea

Kim

Lee

et al. 2017

Basic Clin Pharma Tox

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The aim of this study was to evaluate clinical manifestations, age distribution and risk factors of adverse drug reactions (ADRs) of statins. Korean Adverse Event Reporting System (KAERS) database records (July 2009-June 2014) on statin-treated adults were used. ADRs classified as 'certain', 'probable' and 'possible' based on the WHO-Uppsala Monitoring Centre criteria were analysed. The frequency of ADRs was compared between adults (18-64 years) and older people (age ≥65 years) groups. In total, 2161 ADRs from 1690 patients (579, 34.3% older people) were included for analysis. Mean patient age and ADRs per patient were 60.46 ± 12.72 years and 1.28, respectively. ADRs were reported with atorvastatin (48.4%), rosuvastatin (23.0%), pitavastatin (10.4%) and simvastatin (9.1%). The frequent ADRs were gastrointestinal (421 events, 19.5%), musculoskeletal (331, 15.3%), skin (312, 14.4%) and hepatobiliary disorders (286, 13.2%). Skin disorders were significantly more frequent in adults compared to those in older patients (16.3% versus 12.4%, p = 0.021). Common clinical symptoms were myalgia (263 events, 12.2%), dyspepsia (133, 6.2%) and pruritus (103, 4.8%). Myalgia was more frequently reported in adults (12.7% versus 9.5%, p = 0.039) and dizziness was more frequent in older people (3.4% versus 5.8%, p = 0.015). According to KAERS data, leading statin ADRs were gastrointestinal and musculoskeletal disorders. Myalgia and dyspepsia were the common clinical symptoms.

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Section: Discussionmentioning

confidence: 91%

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confidence: 99%

Analysis of National Pharmacovigilance Data Associated with Statin Use in Korea

Kim

Lee

et al. 2017

Basic Clin Pharma Tox

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“…For example, cited adverse events for rosuvastatin include constipation (3%–5%) and abdominal pain (2%), for simvastatin include abdominal pain (7%), constipation (2%–7%), and diarrhea (<1%), and for atorvastatin include diarrhea (7%–14%) and abdominal pain (2%) . Table includes a brief review of the literature that addresses statin therapy and lower gastrointestinal conditions . In one review of 27 clinical trials, 2361 patients with primary hypercholesterolemia were treated with simvastatin (maximal daily dose achieved in 56%), with a mean follow‐up of 1 year, and the most commonly reported drug‐related adverse events were constipation (2.2%) and abdominal pain (2.5%).…”

Section: Discussionmentioning

confidence: 99%

“…Observational studies on statin use and its association with diarrhea and colitis have also produced mixed findings. The majority of these studies are limited by study design, the presence of polypharmacy, and suboptimal definitions of statin use . To our knowledge, there have been no large studies that directly evaluated whether statins increase the risk of lower gastrointestinal conditions.…”

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Statins and Lower Gastrointestinal Conditions: A Retrospective Cohort Study

Pearlman

Covin

Schmidt

et al. 2017

The Journal of Clinical Pharma

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Several studies have reported constipation, abdominal pain, or diarrhea as common adverse events for statins. Statins are among the most commonly prescribed medications, and the impact on the prevalence of these conditions was rarely studied as main outcomes. The aim of this study is to determine if statin therapy is associated with constipation, abdominal pain, diarrhea, or colitis. This was a retrospective cohort study using a regional military health care data from October 1, 2003, to March 1, 2012. A propensity score-matched cohort of statin users and nonusers was created based on 82 variables. The primary analysis evaluated the odds ratios of the following diagnoses: constipation, ≥3 encounters for constipation; abdominal pain, ≥3 encounters for abdominal pain; diarrhea, ≥3 encounters for diarrhea; colitis, ≥3 encounters for colitis; and endoscopy of the lower gastrointestinal tract, ≥3 endoscopies of the lower gastrointestinal tract. After propensity score matching of 6342 statin users and 6342 nonusers, there was no statistically significant difference in constipation (OR, 0.96; 95%CI, 0.87-1.05; P = .33), abdominal pain (OR, 0.95; 95%CI, 0.88-1.02; P = .15), or colitis (OR, 1.02; 95%CI, 0.91-1.14; P = .73). However, there was an association between statin therapy and endoscopy of the lower gastrointestinal tract (OR, 1.14; 95%CI, 1.04-1.26; P = .002) and decreased odds of diarrhea (OR, 0.88; 95%CI, 0.80-0.97; P = .01). In this retrospective cohort study, an association between statin therapy and increased likelihood of being diagnosed with lower gastrointestinal conditions could not be demonstrated, contrary to some statins package inserts.

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Pharmacological management of stroke in older people

Thomson

New

2021

Pharmacy Practice and Res

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Stroke is one of the most common causes of death and disability. It is more common in people aged 65 years or older. Most patients survive the stroke and live with their disabilities, impacting their quality of life and day-today function to varying degrees. Stroke sequelae can be associated with a broad range of physical, functional, cognitive, behavioural, emotional and socioeconomic consequences. Optimising the management of stroke and its complications, as well as strategies to prevent stroke recurrence, using both non-pharmacological and pharmacological approaches, is crucial. This narrative review covers the pharmacological management of acute stroke, common post-stroke complications and secondary prevention, with a focus on older people.

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Safety Profile of High-Dose Statin Therapy in Geriatric Patients with Stroke

Abstract: The use of HDST in older adult patients with acute stroke is associated with a significantly increased burden of liver enzyme elevation and myalgias.

Cited by 8 publications

References 42 publications

Analysis of National Pharmacovigilance Data Associated with Statin Use in Korea

Analysis of National Pharmacovigilance Data Associated with Statin Use in Korea

Statins and Lower Gastrointestinal Conditions: A Retrospective Cohort Study

Pharmacological management of stroke in older people

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