Side Effects of aliskiren: A Synthesis of Findings from 30 Studies

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Original Abstract of the Article

Major Research Findings

Aliskiren is the first orally active renin inhibitor approved for clinical use as an antihypertensive agent. 17 It effectively lowers blood pressure in a dose-dependent manner, comparable to other major classes of antihypertensive drugs. 17 Aliskiren has been shown to be effective both as monotherapy and in combination with other antihypertensive drugs. 17 It has also demonstrated potential benefits in reducing the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. 5 However, its long-term effects on cardiovascular morbidity and mortality remain to be established. 17

Reasons for Side Effects

Aliskiren works by inhibiting the renin-angiotensin-aldosterone system (RAAS), which plays a key role in regulating blood pressure and fluid balance. By blocking this system, aliskiren can lower blood pressure but may also lead to various side effects.

Common Side Effects

Gastrointestinal

Common side effects of aliskiren include gastrointestinal symptoms such as stomach pain, nausea, vomiting, and diarrhea. 21

Fatigue

Fatigue is another common side effect associated with aliskiren. 21

Headache

Headaches are frequently reported as a side effect of aliskiren. 21

Hypotension

Aliskiren can cause hypotension due to its blood pressure-lowering action. 5 This can lead to dizziness, lightheadedness, and fainting. 5

Angioedema

Angioedema, characterized by swelling of the face, lips, and tongue, can occur as a side effect of aliskiren. 5 It can be severe enough to obstruct the airway, causing respiratory distress and requiring immediate medical attention. 5

Impaired Renal Function

Aliskiren may lead to impaired renal function, indicated by elevated blood urea nitrogen and creatinine levels. 5

Hyperkalemia

Hyperkalemia, or high potassium levels in the blood, is another possible side effect of aliskiren. 5 It can lead to abnormal heart rate and arrhythmias. 5

Measures to Address Side Effects

Hypotension

Staying hydrated is important if hypotension occurs. 5 Adjusting the dosage or discontinuing aliskiren may also be necessary as advised by your doctor. 5

Angioedema

Seek immediate medical attention if you experience angioedema. 5 Your doctor will administer appropriate treatment based on your specific symptoms. 5

Impaired Renal Function

If impaired renal function develops, your doctor may recommend discontinuing aliskiren. 5 Regular renal function tests may be necessary. 5

Hyperkalemia

Discontinuation of aliskiren may be necessary if hyperkalemia occurs. 5 It is essential to undergo serum potassium level tests as instructed by your doctor. 5

Comparison Between Studies

Commonalities

Multiple studies have consistently shown that aliskiren effectively reduces blood pressure. 21 , 23 , 20 These studies also indicate that aliskiren causes less fluctuation in serum potassium levels compared to ACE inhibitors or ARBs. 21 These findings suggest the potential of aliskiren as an effective treatment for hypertension.

Differences

Research findings regarding the long-term safety and efficacy of aliskiren vary. 21 , 23 Some studies suggest that aliskiren might lower the risk of cardiovascular disease and kidney disease. 21 , 23 However, other studies indicate that aliskiren could potentially worsen kidney disease or even increase the risk of mortality. 10 Further research is needed to draw definitive conclusions.

Things to Keep in Mind When Applying This Information to Real Life

Aliskiren holds potential for treating hypertension, but it is important to be aware of its potential side effects. 5 If you are considering taking aliskiren, consult your doctor to determine the appropriate dosage and administration method. 5 If you experience any changes in your health while taking aliskiren, it is crucial to promptly consult your doctor. 5

Current Research Limitations

Long-term safety and efficacy data on aliskiren are still limited. 21 , 23 The precise impact of aliskiren on the risk of cardiovascular disease and kidney disease remains unclear. 10

Future Research Directions

Further research is needed to thoroughly assess the long-term safety and efficacy of aliskiren. 21 , 23 Large-scale clinical trials are crucial to clarify the precise influence of aliskiren on the risk of cardiovascular disease and kidney disease. 10

Conclusion

Aliskiren shows potential as a promising treatment for hypertension. 21 , 23 However, it is crucial to be aware of its possible side effects. 5 If you are considering aliskiren, consult your doctor for guidance on the appropriate dosage and administration method. 5 If you experience any changes in your health while taking aliskiren, promptly contact your doctor. 5

Keywords
Benefit Keywords
Blood pressure reduction
1
Cost-effective
Increased survival
Well tolerated
3
Blood pressure reduction
4
Cardiovascular death reduction
Heart failure hospitalization reduction
5
Renoprotective treatment
7
Antiproteinuric effects
8
Albuminuria reduction
Hypertension treatment
10
Reduced blood pressure
Reduced cholesterol levels
Reduced glycated hemoglobin
Reduced triglyceride levels
11
Reduced proteinuria
12
Reduced blood pressure
13
Reduced blood pressure
14
BP reduction
Renoprotection
15
Hypertension treatment
16
Lowers blood pressure
17
Reduced morbidity
Reduced mortality
18
BP reduction
19
Blood pressure reduction
20
blood pressure control
hypertension treatment
21
Blood pressure lowering
22
Cardiac hypertrophy regression
Heart failure treatment
Reduced blood pressure
Renoprotection
23
Hypertension treatment
24
Ameliorate proteinuria
Control blood pressure
Minimise left ventricular remodelling
Prevent heart failure
Retard renal disease progression
25
Lower blood pressure
Potential for wide range of cardiovascular pathologies
Reduced Ang II levels
26
Drug-drug interaction prediction
27
Hypertension treatment
28
Renoprotection
29
AF treatment
30
Risk Keywords
Safety concerns
1
Adverse drug reactions
2
Mild side effects
3
Safety concerns
4
Angioedema
Hyperkalemia
Hypotension
Impaired renal function
5
Hyperkalemia
Hypotension
7
Renal fibrosis
Side effects
8
Bleeding
Bradycardia
Heart blocks
Liver enzymes
Pancreatitis
Rhabdomyolysis
9
Mortality increase
Side effects
10
Headache
11
Kidney function loss
12
Decreased serum potassium
Elevated serum potassium
13
Side effects
14
RAAS escape
15
Side effects
16
fatigue
gastrointestinal symptoms
headache
weakness
21
Adverse events
22
Bilateral renal artery stenosis contraindication
Pregnancy contraindication
23
Adverse events in certain populations
25
Side effects may be less frequent
26
Literature analysis of 30 papers
Positive Content
26
Neutral Content
2
Negative Content
2
Article Type
3
2
1
16
27
1.

Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

Author: ZhaoQiyuan, ShenJiantong, LuJingya, LiFan, JiangQi, WangYuanyuan

Blood pressure reduction
Safety concerns

This paper systematically summarizes the published studies on the clinical efficacy and side effects of aliskiren monotherapy. Aliskiren, a renin-angiotensin-aldosterone system inhibitor, has been recognized for its role in lowering blood pressure. However, its safety and tolerability remain controversial.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

The Prevalence of Adverse Drug Reactions and Adverse Drug Events from Heart Failure Medications in Frail Older Adults: A Systematic Review.

Author: DuongMai H, GnjidicDanijela, McLachlanAndrew J, SakirisMarissa A, GoyalParag, HilmerSarah N

Adverse drug reactions

This review focuses on the prevalence, causality, and severity of adverse drug reactions (ADRs) or adverse drug events (ADEs) related to heart failure medications in frail older adults, comparing them to non-frail older adults.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Treatment of glioblastoma with re-purposed renin-angiotensin system modulators: Results of a phase I clinical trial.

Author: O'RaweMichael, WickremesekeraAgadha C, PandeyRamesh, YoungDavid, SimDalice, FitzJohnTrevor, BurgessCarl, KayeAndrew H, TanSwee T

Cost-effective
Increased survival
Well tolerated
Mild side effects

A phase I clinical trial investigated the tolerability and efficacy of a treatment targeting the renin-angiotensin system (RAS) in patients with glioblastoma. The study showed a trend towards increased survival and a reduction in tumor volume in some patients. Further clinical trials are warranted to investigate this potential new therapeutic option.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

Author: ZhaoQiyuan, ShenJiantong, LuJingya, LiFan, JiangQi, WangYuanyuan

Blood pressure reduction
Safety concerns

This paper systematically summarizes the published studies on the clinical efficacy and side effects of aliskiren monotherapy. Aliskiren, a renin-angiotensin-aldosterone system inhibitor, has been recognized for its role in lowering blood pressure. However, its safety and tolerability remain controversial.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

[Angiotensin-receptor- and neprilysin-inhibition: a new option against heart failure].

Author: BruhnClaudia

Cardiovascular death reduction
Heart failure hospitalization reduction
Angioedema
Hyperkalemia
Hypotension
Impaired renal function

Sacubitril/valsartan is a new drug for treating heart failure that has shown benefits over enalapril in reducing death and hospitalization. Potential side effects include hypotension, angioedema, impaired renal function, and elevated potassium levels.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : German

6.

Maximum renal responses to renin inhibition in healthy study participants: VTP-27999 versus aliskiren.

Author: BarkoudahEbrahim, van ThielBibi S, FisherNaomi D L, GreggRichard A, DanserA H Jan, MoukarbelGeorge V, HollenbergNorman K

VTP-27999, a novel renin inhibitor, has potential to allow for greater renin inhibition than aliskiren without major side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

7.

Sequential RAAS blockade: is it worth the risk?

Author: PerssonFrederik, RossingPeter

Renoprotective treatment
Hyperkalemia
Hypotension

This review discusses the pros and cons of dual RAAS blockade, a strategy that combines more than one compound to block the renin-angiotensin-aldosterone system (RAAS), in the treatment of diabetic kidney disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Safety of enhanced renin-angiotensin-aldosterone system inhibition with aliskiren in nondiabetic patients with chronic kidney disease.

Author: LizakowskiSławomir, TylickiLeszek, RutkowskiPrzemysław, RenkeMarcin, SulikowskaBeata, HeleniakZbigniew, DonderskiRafał, BednarskiRafał, PrzybylskaMilena, ManitiusJacek, RutkowskiBolesław

Antiproteinuric effects
Renal fibrosis
Side effects

Combination therapies involving renin-angiotensin-aldosterone system blockade can be effective in treating kidney disease, but may have more side effects. This study highlights the potential for aliskiren, a direct renin inhibitor, to promote renal fibrosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

10.

Direct renin inhibition in chronic kidney disease.

Author: PerssonFrederik, RossingPeter, ParvingHans-Henrik

Albuminuria reduction
Hypertension treatment
Mortality increase
Side effects

Aliskiren, a direct renin inhibitor, has been shown to be effective in lowering albuminuria in diabetic nephropathy patients. However, a large morbidity and mortality trial was terminated early due to an increased frequency of side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Are we ready to use aliskiren in children?

Author: KellandErin Elizabeth, McAuleyLeanne Michelle, FillerGuido

Reduced proteinuria
Kidney function loss

This case series reviewed the safety and efficacy of aliskiren in combination with losartan in pediatric patients with chronic kidney disease (CKD). While proteinuria was reduced in all four patients, three experienced side effects requiring dose adjustments. One patient with CKD stage 3 experienced accelerated kidney function loss requiring dialysis. Further pediatric trials are needed to establish safe and effective dosing.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension.

Author: ChrysantSteven G, MurrayAlexander V, HoppeUta C, DattaniDan, PatelSamir, RitterShannon, ZhangJack

Reduced blood pressure
Decreased serum potassium
Elevated serum potassium

Aliskiren/valsartan combination therapy provides effective blood pressure control and is well-tolerated in patients with hypertension.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

The antihypertensive effectiveness and safety of dual RAAS blockade with aliskiren and valsartan.

Author: ChrysantSteven G

Reduced blood pressure
Side effects

This study reviewed the use of dual renin-angiotensin-aldosterone system (RAAS) blockade in the treatment of hypertension. The authors concluded that combining a direct renin inhibitor with an angiotensin receptor blocker may be more effective than using either drug alone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

[Direct renin inhibitor aliskiren in the treatment of cardiovascular and renal diseases].

Author: HorkýKarel

BP reduction
Renoprotection
RAAS escape

This study reviewed the role of renin-angiotensin-aldosterone system (RAAS) in regulating the volume and composition of extracellular fluid, blood pressure (BP) as well as onset and progression of cardiovascular and renal diseases. The development of aliskiren fumarate, the first non-peptide, orally long-term effective renin inhibitor, was highlighted.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Czech

17.

Aliskiren.

Author: BrownMorris J

Lowers blood pressure

Aliskiren, the first orally active renin inhibitor, is effective in reducing blood pressure and is well tolerated. It is likely to be most useful in patients who are uncontrolled or intolerant to other antihypertensive medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

Direct renin inhibition: an analysis of possible benefits.

Author: DockeryBrian K, BisognanoJohn D

Reduced morbidity
Reduced mortality

Aliskiren, the first direct renin inhibitor, has been approved for hypertension treatment. It has shown effectiveness in clinical trials and preclinical studies, with potential for reducing morbidity and mortality associated with cardiovascular and renal diseases. Further clinical studies are ongoing to confirm its effectiveness in various chronic diseases.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

[Is there a need for direct renin inhibitors?].

Author: GrossmanEhud

BP reduction

Aliskiren, a new oral direct renin inhibitor, is very effective in reducing blood pressure (BP). It is given once daily and has very few side effects. While this drug holds promise, further studies are needed to confirm its benefit on morbidity and mortality before it can be recommended as a first-line treatment.

EditorialAn article in which the editor or publisher expresses their opinion or perspective on a particular topic or issue. Its purpose is to convey a specific message or idea to the reader.
English AbstractA summary of a research paper/publication written in English for a wider audience.

Language : Hebrew

20.

Antihypertensive therapy with aliskiren.

Author: LuftF C, WeinbergerM H

Blood pressure reduction

Aliskiren is a new antihypertensive drug that inhibits the renin-angiotensin system at its rate-limiting step. It has high affinity for the human renin enzymatic site and a long half-life. Blood pressure reductions are comparable to other monotherapies, and further reductions are seen when combined with other antihypertensives. Studies are ongoing to assess the drug’s long-term cardiovascular and renal effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Aliskiren: an oral renin inhibitor for the treatment of hypertension.

Author: LamSum, ChoyMary

blood pressure control
hypertension treatment
fatigue
gastrointestinal symptoms
headache
weakness

Aliskiren, a direct renin inhibitor, lowers blood pressure by decreasing renin activity and angiotensin I and II levels. It is well tolerated and effective as monotherapy or in combination with other antihypertensive agents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension.

Author: VerdecchiaPaolo, CalvoCarlos, MöckelVolker, KeelingLucy, SatlinAndrew

Blood pressure lowering
Adverse events

Aliskiren, a novel direct renin inhibitor, was found to be effective in lowering blood pressure in elderly patients with essential hypertension. The study found no evidence of dose-related increases in the incidence of adverse events.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

[Does the rennin inhibitor aliskiren offer promising novel opportunities in the treatment of cardiovascular diseases?].

Author: HorkýK

Cardiac hypertrophy regression
Heart failure treatment
Reduced blood pressure
Renoprotection
Bilateral renal artery stenosis contraindication
Pregnancy contraindication

Aliskiren, a non-peptidic, oral renin inhibitor, has been developed to block the renin-angiotensin system (RAAS) at its initial stage. Aliskiren reduces blood pressure and shows potential for treating cardiovascular diseases, including hypertension, heart failure, and diabetic kidney disease.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : Czech

26.

Potential of renin inhibition in cardiovascular disease.

Author: StantonAlice

Lower blood pressure
Potential for wide range of cardiovascular pathologies
Reduced Ang II levels
Side effects may be less frequent

This study reviews the potential benefits of renin inhibitors, specifically aliskiren, in the management of cardiovascular pathologies.

EditorialAn article in which the editor or publisher expresses their opinion or perspective on a particular topic or issue. Its purpose is to convey a specific message or idea to the reader.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

27.

Molormer: a lightweight self-attention-based method focused on spatial structure of molecular graph for drug-drug interactions prediction.

Author: ZhangXudong, WangGan, MengXiangyu, WangShuang, ZhangYing, Rodriguez-PatonAlfonso, WangJianmin, WangXun

Drug-drug interaction prediction

Molormer is a method for predicting drug-drug interactions (DDIs) that uses a lightweight attention mechanism to encode the 2D structures of drugs. This method outperforms existing methods by accurately and rapidly identifying DDIs and enhancing the effectiveness of combination therapy while avoiding unintended side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

28.

Food protein-derived renin-inhibitory peptides: in vitro and in vivo properties.

Author: AlukoRotimi E

Hypertension treatment

Renin-inhibitory peptides derived from food proteins have potential for blood pressure-reducing effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

29.

Aliskiren reduces albuminuria after kidney transplantation.

Author: TylickiLeszek, Debska-SlizienAlicja M, LizakowskiSlawomir, PrzybylskaMilena, HeleniakZbigniew, RenkeMarcin, ChamieniaAndrzej L, BiedunkiewiczBogdan, RutkowskiPrzemyslaw, MałgorzewiczSylwia, RutkowskiBoleslaw

Renoprotection

This double-blind, cross-over study evaluated the influence of aliskiren, a direct renin inhibitor, on albuminuria and other markers of kidney injury in patients after renal transplantation. The results of this study are inconclusive, and further research is needed to confirm the renoprotective effects of aliskiren in renal transplant recipients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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