RESUME

Created by :
Group 7

Tasyaiva Syafilla G2B020007

Desi Novita Sari G2B020028
Cantika Novita G2B020062
Erika Kurniawati G2B020071
Amalia Ramadani G2B020112
Aliyya Rahmasari G2B020115
Shafa Salsa D.L G2B020119
Adinda Nur Hafizhah G2B020122
Filsa Afitri Cholidha G2B020129
Citra Deti Larasati G2B020135
Hasyifah Detya Katrinnada G2B020125
Mega Setiyaningsih G2B020142

PROGRAM STUDI S1 GIZI

FAKULTAS ILMU KEPERAWATAN DAN KESEHATAN
UNIVERSITAS MUHAMMADIYAH SEMARANG
2021 / 2022
 Robert D. Beckett, Andrea L. Wilhite, Nicholas Robinson, Audrey Rosene, 2016, ‘Drugs
That Affect Lipid Metabolism’, Natural and Health Sciences, vol 38, ch 42, ISSN : 0378-
6080

BILE ACID SEQUESTRANTS [SED-15, 1902; SEDA-36, 676; SEDA-37, 559]

Bile acid sequestrants, ion exchange polymers that decrease low-density lipoprotein
(LDL), cholesterol and total cholesterol, are not substantially absorbed through the
gastrointestinal tract. The most common adverse drug effects are constipation, dyspepsia,
nasopharyngitis, and nausea.
Serious events such as abdominal distention, dysphagia, fecal impaction,
gastrointestinal obstruction, heart disease (colesevelam), pancreatitis, and increased
triglycerides (colesevelam) have been reported.

CHOLESTERYL ESTER TRANSFER PROTEIN INHIBITORS [SEDA-35, 810;

SEDA-36, 677; SEDA-37, 560]
Sterol transporter inhibitors, such as ezetimibe, decrease gastrointestinal absorption of
cholesterol and other phytosterols, decreasing LDL and total cholesterol, with minor
increases in high-density lipoprotein cholesterol (HDL).

NICOTINIC ACID DERIVATIVE [SED-15, 2512; SEDA-35, 815; SEDA-36, 679;

SEDA- 37, 560]
Niacin is known to reduce total cholesterol and triglycerides, and to increase HDL,
through an unknown mechanism. Peripheral vasodilation associated with niacin can manifest
as flushing, orthostatic events, pruritus, tingling, and warmth. Laropiprant is a prostaglandin
antagonist used in combination with niacin to reduce vasodilation.

FIBRIC ACID DERIVATIVES [SED-15, 1358; SEDA-35, 812; SEDA-37,561]

Fibrates are generally preferred for patients with elevated triglycerides. Common
adverse effects of this class include gastrointestinal disturbances, elevated liver enzymes, and
myalgias and myopathy (particularly in combination with statins, in the case of gemfibrozil)
Fenofibrate
Co-Administration with Statins
In one randomized, open-label, crossover pharmacoki-netic study, Hispanic patients
(n=36) were administered a single dose of atorvastatin 20 mg, followed by the combination
of atorvastatin 20 mg and fenofibrate 160 mg to evaluate the effects of co-administration.
HMG-CoA REDUCTASE INHIBITORS [SED-15, 1632; SEDA-35, 812; SEDA-37; 562]
HMG-CoA reductase inhibitors (statins) are used to treat dyslipidemia and have
demonstrated potential to reduce cardiovascular risk.

Cataracts
A sub-study was performed from the Simvastatin and Ezetimibe Aortic Stenosis
Study. In this double-blind placebo controlled trial, patients were randomized to simvastatin
40 mg plus ezetimibe 10 mg versus placebo with a primary end point of incident cataract.
The simvastatin plus ezetimibe group was associated with a 44% lower risk of cataract
development [HR 0.56; 95% CI 0.33–0.96, p¼0.034].

Diabetes
A meta-analysis of 15 randomized controlled trials evaluated the effects of
pitavastatin (dose range, 1–8 mg daily) on glycemic levels and the incidence of NODM in
non-diabetic individuals. 4815 nondiabetic patients (3236 assigned to pitavastatin and 1579 to
control) were compared based on HbA1c, fasting blood glucose, and onset of NODM for an
average of 12 weeks. Based on BMI, FBG, and age, most patients included in the trials were
not considered high risk for the development of diabetes.

Pancreatitis
The risk of acute pancreatitis was reduced with simvastatin use, crude incidence rate
ratio 0.626, 95% CI, 0.588–0.668, p<0.0001. In a subsequent multivariate analysis,
simvastatin was independently associated with reduced risk of pancreatitis, adjusted RR 0.29
(95% CI 0.27–0.31). Atorvastatin demonstrated similar results, adjusted RR 0.33 (95% CI
0.29, 0.38). These findings suggest that there is a reduced incidence of pancreatitis, and it
may be a class effect.
Cancer
The average daily dose of simvastatin (the primary statin analyzed, representing 86.9%
of prescriptions) was lower in cases than in the control group (21–40 mg/day, 9.3% vs. 14.5%,
respectively, and >40 mg/day, 8.4% vs. 12.6%, respectively, p<0.01). Statin use was found to
be inversely associated with the development of esophageal adenocarcinoma (OR 0.65; 95%
CI, 0.47–0.91), specifically late-stage esophageal adenocarcinoma (OR 0.44, 95% CI, 0.25–
0.79).

PROPROTEIN CONVERTASE SUBTILISIN/ KEXIN TYPE 9 (PCSK9) INHIBITORS

However, long-term clinical trials have yet to reach completion. The most common
reported adverse effects were back pain, influenza symptoms, nasopharyngitis, and upper
respiratory tract infections; however, these generally occurred at the same rate as control.
Despite the subcutaneous route of administration, injection site reactions were not common.
Several types of hypersensitivity-related adverse events have been reported, including
cutaneous leucocytoclastic vasculitis, delayed-type rash, pruritis. For this reason, clinical trials
have focused on gathering hypersensitivity data.
Considering that PCSK9 inhibitors have been associated with substantial LDL
reduction in clinical trials (one study reached a mean LDL of 3416 mg/dL), in many cases even
following treatment with statins, concerns have been raised regarding risks that could be
associated with excessive LDL reduction.

Alirocumab
The adverse events that appeared to be most common among trials with alirocumab
were injection site reactions, nasopharyngitis, urinary tract infection, and upper respiratory
tract infection. Neurological adverse events were consistently, but less commonly, present.

Evolocumab
The adverse events that appeared to be most common based on the above evolocumab
studies were injection site reaction, nasopharyngitis, muscle related or myalgia, upper
respiratory tract infection and influenza. No inferential statistics were performed for the safety
data for these trials.