Evidence map›Paper›PMID 39697471›Full record

ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2024

Real-World safety and effectiveness of evolocumab in primary hypercholesterolemia and mixed dyslipidemia in Saudi Arabia.

Abdulaali R Almutairi, Walaa A Alshahrani, Ghaida K Alhathlol, Fatimah Alsheikh, Abdulaziz Alakeel, Majed S Al Yami, Mohammad Fouda, Omar A Almohammed, Meshal S Alhamed, Awatif Hafiz and 6 more

Abstract read
In one paragraph

Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Abdulaali R AlmutairiDrug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Walaa A AlshahraniDepartment of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Pharmacy Practice, Riyadh, Saudi Arabia.
Ghaida K AlhathlolDepartment of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Pharmacy Practice, Riyadh, Saudi Arabia.
Fatimah AlsheikhDepartment of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Pharmacy Practice, Riyadh, Saudi Arabia.
Abdulaziz AlakeelDrug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Majed S Al YamiDepartment of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Pharmacy Practice, Riyadh, Saudi Arabia.
Mohammad FoudaDrug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Omar A AlmohammedDepartment of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Meshal S AlhamedCollege of Medicine, King Saud University, Riyadh, Saudi Arabia.
Awatif HafizDepartment of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
Hussam KutbiDepartment of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
Alaa BagalagelDepartment of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
Aisha AlharbiPharmaceutical Care Department, King Abdulaziz Medical City, Jeddah, Saudi Arabia.
Mashael AlaboudPharmaceutical Care Department, King Abdulaziz Medical City, Jeddah, Saudi Arabia.
Sarah AljohaniDepartment of Clinical Pharmacy, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia.
Waddah AshramDepartment of medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Evolocumab's short-term efficacy and safety were proven in phase-3 clinical trial, but its long-term safety and effectiveness in the Saudi population are yet to be studied. The aim of this study was to assess the long-term safety and effectiveness of evolocumab in Saudi patients with primary hypercholesterolemia or mixed dyslipidemia. Method: A retrospective cohort study evaluated adult patients who had newly been prescribed evolocumab for hypercholesterolemia or mixed dyslipidemia. Safety events included myocardial infarction, unstable angina, stroke, transient ischemic attack, heart failure, rhabdomyolysis, renal dysfunction, and myalgia. Effectiveness outcomes included changes in lipid profiles from baseline, assessed at 6-, 12-, 18-, and 24-month. Results: The study sample were 469 who newly prescribed evolocumab, from which 69.1 % being male, were included. The most prevalent comorbidities were coronary artery disease, diabetes, and hypertension. Statin was the most commonly used therapy. The most common adverse events at 6-month follow-up, based on the incidence rate per 1000 person-years, were coronary revascularization (63.20), myalgia (44.96), myocardial infarction (31.53), unstable angina (31.49), heart failure (26.94), rhabdomyolysis without renal dysfunction (8.93), transient ischemic attack (4.46), and rhabdomyolysis with renal dysfunction (4.46). Stroke incidence increased with follow-up length, from 8.87 per 1000 person-years at 6 months to 12.84 per 1000 person-years at 24 months. Evolocumab use significantly reduced LDL and total cholesterol levels at 6, 12, 18, and 24 months follow-up, while having no significant effect on HDL or triglycerides levels. Conclusion: Evolocumab appeared to be safe and effective therapeutic option for patients with primary hypercholesterolemia or mixed dyslipidemia to potentially reduce LDL levels to therapeutic levels when statins are insufficient.

Identifiers

PMID39697471
PMCPMC11653656

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.